{
  "name": "Label wording by medicine and country: a table",
  "schemaVersion": 1,
  "publisher": "SIDEfxHUB",
  "page": "https://sidefxhub.com/label-wording-by-country/",
  "documentation": "https://sidefxhub.com/label-wording-by-country/#files",
  "license": "https://creativecommons.org/licenses/by/4.0/",
  "licenseName": "Creative Commons Attribution 4.0 International (CC BY 4.0)",
  "attribution": "SIDEfxHUB, https://sidefxhub.com/label-wording-by-country/",
  "licenseScope": "The licence covers SIDEfxHUB's compilation: the selection, the dates, the checks and the explanations. The product information and other texts quoted in this file, in the original or in SIDEfxHUB's translation, are quoted, not licensed by SIDEfxHUB.",
  "changed": "2026-10-14",
  "lastChecked": "2026-10-14",
  "records": 301,
  "quote": "To quote this record, name SIDEfxHUB and give this page's address.",
  "notice": "SIDEfxHUB is a patient charity. We are not health professionals, and this does not replace medical advice. Don't start, stop or change any medicine because of what you read here. Talk to your doctor first.",
  "jurisdictions": [
    {
      "id": "uk",
      "iso": "GB",
      "regulator": "MHRA",
      "reportBody": "MHRA",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "United Kingdom",
        "de": "Vereinigtes Königreich",
        "es": "Reino Unido",
        "pt-br": "Reino Unido",
        "fr": "Royaume-Uni",
        "it": "Regno Unito",
        "hi": "ब्रिटेन"
      },
      "reportUrl": "https://yellowcard.mhra.gov.uk/"
    },
    {
      "id": "eu",
      "iso": "EU",
      "regulator": "EMA",
      "reportBody": "EMA",
      "core": true,
      "productTexts": false,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "European Union",
        "de": "Europäische Union",
        "es": "Unión Europea",
        "pt-br": "União Europeia",
        "fr": "Union européenne",
        "it": "Unione europea",
        "hi": "यूरोपीय संघ (EU)"
      },
      "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human"
    },
    {
      "id": "us",
      "iso": "US",
      "regulator": "FDA",
      "reportBody": "FDA",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "United States",
        "de": "USA",
        "es": "Estados Unidos",
        "pt-br": "Estados Unidos",
        "fr": "États-Unis",
        "it": "Stati Uniti",
        "hi": "अमेरिका"
      },
      "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home"
    },
    {
      "id": "ca",
      "iso": "CA",
      "regulator": "Health Canada",
      "reportBody": "Health Canada",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Canada",
        "de": "Kanada",
        "es": "Canadá",
        "pt-br": "Canadá",
        "fr": "Canada",
        "it": "Canada",
        "hi": "कनाडा"
      },
      "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html"
    },
    {
      "id": "au",
      "iso": "AU",
      "regulator": "TGA",
      "reportBody": "TGA",
      "core": true,
      "summaryOnly": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": false
      },
      "name": {
        "en": "Australia",
        "de": "Australien",
        "es": "Australia",
        "pt-br": "Austrália",
        "fr": "Australie",
        "it": "Australia",
        "hi": "ऑस्ट्रेलिया"
      },
      "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem"
    },
    {
      "id": "nz",
      "iso": "NZ",
      "regulator": "Medsafe",
      "reportBody": "Medsafe",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "New Zealand",
        "de": "Neuseeland",
        "es": "Nueva Zelanda",
        "pt-br": "Nova Zelândia",
        "fr": "Nouvelle-Zélande",
        "it": "Nuova Zelanda",
        "hi": "न्यूज़ीलैंड"
      },
      "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp"
    },
    {
      "id": "de",
      "iso": "DE",
      "regulator": "BfArM",
      "reportBody": "BfArM",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Germany",
        "de": "Deutschland",
        "es": "Alemania",
        "pt-br": "Alemanha",
        "fr": "Allemagne",
        "it": "Germania",
        "hi": "जर्मनी"
      },
      "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html"
    },
    {
      "id": "fr",
      "iso": "FR",
      "regulator": "ANSM",
      "reportBody": "ANSM",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "France",
        "de": "Frankreich",
        "es": "Francia",
        "pt-br": "França",
        "fr": "France",
        "it": "Francia",
        "hi": "फ़्रांस"
      },
      "reportUrl": "https://signalement.social-sante.gouv.fr/"
    },
    {
      "id": "it",
      "iso": "IT",
      "regulator": "AIFA",
      "reportBody": "AIFA",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Italy",
        "de": "Italien",
        "es": "Italia",
        "pt-br": "Itália",
        "fr": "Italie",
        "it": "Italia",
        "hi": "इटली"
      },
      "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/"
    },
    {
      "id": "es",
      "iso": "ES",
      "regulator": "AEMPS",
      "reportBody": "AEMPS",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Spain",
        "de": "Spanien",
        "es": "España",
        "pt-br": "Espanha",
        "fr": "Espagne",
        "it": "Spagna",
        "hi": "स्पेन"
      },
      "reportUrl": "https://www.notificaram.es/"
    },
    {
      "id": "br",
      "iso": "BR",
      "regulator": "ANVISA",
      "reportBody": "ANVISA",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Brazil",
        "de": "Brasilien",
        "es": "Brasil",
        "pt-br": "Brasil",
        "fr": "Brésil",
        "it": "Brasile",
        "hi": "ब्राज़ील"
      },
      "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed"
    },
    {
      "id": "in",
      "iso": "IN",
      "regulator": "CDSCO",
      "reportBody": "PvPI (Indian Pharmacopoeia Commission)",
      "core": true,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": false
      },
      "name": {
        "en": "India",
        "de": "Indien",
        "es": "India",
        "pt-br": "Índia",
        "fr": "Inde",
        "it": "India",
        "hi": "भारत"
      },
      "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html"
    },
    {
      "id": "ie",
      "iso": "IE",
      "regulator": "HPRA",
      "reportBody": "HPRA",
      "core": false,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Ireland",
        "de": "Irland",
        "es": "Irlanda",
        "pt-br": "Irlanda",
        "fr": "Irlande",
        "it": "Irlanda",
        "hi": "आयरलैंड"
      },
      "reportUrl": "https://forms.hpra.ie/Human-And-Covid-Report-Form/"
    },
    {
      "id": "sa",
      "iso": "SA",
      "regulator": "SFDA",
      "reportBody": "SFDA",
      "core": false,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": false
      },
      "name": {
        "en": "Saudi Arabia",
        "de": "Saudi-Arabien",
        "es": "Arabia Saudí",
        "pt-br": "Arábia Saudita",
        "fr": "Arabie saoudite",
        "it": "Arabia Saudita",
        "hi": "सऊदी अरब"
      },
      "reportUrl": "https://ade.sfda.gov.sa/"
    },
    {
      "id": "my",
      "iso": "MY",
      "regulator": "NPRA",
      "reportBody": "NPRA",
      "core": false,
      "reportChecked": {
        "date": "2026-10-13",
        "ok": true
      },
      "name": {
        "en": "Malaysia",
        "de": "Malaysia",
        "es": "Malasia",
        "pt-br": "Malásia",
        "fr": "Malaisie",
        "it": "Malesia",
        "hi": "मलेशिया"
      },
      "reportUrl": "https://www.npra.gov.my/index.php/en/consumers/reporting/reporting-side-effects-to-medicines-conserf-or-vaccines-aefi-2.html"
    }
  ],
  "medicines": [
    {
      "id": "sertraline",
      "inn": "sertraline",
      "names": {
        "en": "sertraline",
        "de": "Sertralin",
        "es": "sertralina",
        "pt-br": "sertralina",
        "fr": "sertraline",
        "it": "sertralina",
        "hi": "सर्ट्रालीन"
      },
      "class": "ssri",
      "classLabel": {
        "en": "SSRI antidepressant",
        "de": "SSRI-Antidepressivum",
        "es": "antidepresivo ISRS",
        "pt-br": "antidepressivo ISRS",
        "fr": "antidépresseur ISRS",
        "it": "antidepressivo SSRI",
        "hi": "SSRI एंटीडिप्रेसेंट"
      },
      "condition": "pssd",
      "lead": {
        "en": "For the SSRI antidepressant sertraline (Zoloft, Lustral), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, sertraline among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.",
        "de": "Zum SSRI-Antidepressivum Sertralin (Zoloft, Lustral) steht im Vereinigten Königreich in der Produktinformation, die wir gelesen haben, dass es Berichte über lang anhaltende sexuelle Funktionsstörungen gibt, bei denen die Symptome nach dem Absetzen von SSRI bestehen blieben. Das nennt man sexuelle Funktionsstörung nach SSRI-Einnahme (PSSD). Die Europäische Arzneimittel-Agentur (EMA) legte den Wortlaut dieses Warnhinweises 2019 für zehn Medikamente fest, darunter Sertralin. Laut einer Antwort der Regierung im britischen Parlament wurden die Produktinformationen für alle SSRI im Vereinigten Königreich 2019 um diesen Warnhinweis ergänzt.",
        "es": "En el caso de la sertralina (Zoloft, Lustral), un antidepresivo ISRS, la información del producto que hemos leído en el Reino Unido dice que se han notificado casos de disfunción sexual de larga duración en los que los síntomas continuaron después de dejar los ISRS. Esto se conoce como disfunción sexual post-ISRS (PSSD). La Agencia Europea de Medicamentos (EMA) fijó en 2019 el texto de esta advertencia para diez medicamentos, entre ellos la sertralina, y una respuesta del Gobierno en el Parlamento dice que la información del producto de todos los ISRS en el Reino Unido se actualizó en 2019 para incluirla.",
        "pt-br": "No caso do antidepressivo ISRS sertralina (Zoloft, Lustral), a bula que lemos no Reino Unido diz que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram depois da interrupção dos ISRS. Esse quadro é conhecido como disfunção sexual pós-ISRS (PSSD). A agência reguladora de medicamentos da UE definiu o texto desse alerta em 2019 para dez medicamentos, entre eles a sertralina. Uma resposta do governo no Parlamento diz que as bulas de todos os ISRS no Reino Unido foram atualizadas em 2019 para incluí-lo.",
        "fr": "Pour la sertraline (Zoloft, Lustral), un antidépresseur ISRS, les informations sur le produit que nous avons lues au Royaume-Uni indiquent que des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui ont persisté après l’arrêt des ISRS. C’est ce qu’on appelle la dysfonction sexuelle post-ISRS (PSSD). L’Agence européenne des médicaments (EMA) a fixé la formulation de cette mise en garde en 2019 pour dix médicaments, dont la sertraline. Selon une réponse du gouvernement britannique au Parlement, les informations sur le produit de tous les ISRS ont été mises à jour au Royaume-Uni en 2019 pour l’intégrer.",
        "it": "Per l’antidepressivo SSRI sertralina (Zoloft, Lustral), le informazioni sul prodotto che abbiamo letto nel Regno Unito dicono che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI. Questo quadro è noto come disfunzione sessuale post-SSRI (PSSD). L’agenzia del farmaco dell’UE ha fissato il testo di questa avvertenza nel 2019 per dieci medicinali, tra cui la sertralina. Una risposta del governo al Parlamento britannico dice che nel 2019 le informazioni sul prodotto britanniche di tutti gli SSRI sono state aggiornate per riportare questa avvertenza.",
        "hi": "SSRI एंटीडिप्रेसेंट सर्ट्रालीन (Zoloft, Lustral) के मामले में, ब्रिटेन में हमने दवा की जो आधिकारिक जानकारी (product information) पढ़ी, वह कहती है कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बाद भी लक्षण जारी रहे। इसे पोस्ट-SSRI सेक्शुअल डिस्फ़ंक्शन (PSSD) कहते हैं। यूरोपीय संघ (EU) के दवा नियामक ने 2019 में इस चेतावनी के शब्द दस दवाओं के लिए तय किए, जिनमें सर्ट्रालीन भी है। ब्रिटेन की संसद में सरकार का एक जवाब कहता है कि वहाँ सभी SSRI दवाओं की आधिकारिक जानकारी 2019 में अपडेट की गई, ताकि उसमें यह चेतावनी हो।"
      },
      "brands": [
        {
          "name": "Zoloft",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=13392",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=sertraline",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "BfArM's list of supply-shortage notices",
              "sourceUrl": "https://anwendungen.pharmnet-bund.de/lieferengpassmeldungen/faces/public/meldungen.xhtml",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60155788/extrait",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000021071?lang=it",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Lustral",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2310",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Altisben",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=65925",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Aremis",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=59734",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Besitran",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=59718",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Semonic",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=84190",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Tatig",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000021075?lang=it",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Eleva",
          "listings": [
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=sertraline",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Sertra",
          "listings": [
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=sertraline",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Setrona",
          "listings": [
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=sertraline",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Afetus",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Assert",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Dieloft",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Ralzin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Recapser",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Serenata",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Tolrest",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Trasolin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Zysertin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        }
      ],
      "leadBrands": [
        "Zoloft",
        "Lustral"
      ],
      "cardSince": "sertraline-uk#persistence",
      "unknowns": [
        {
          "id": "frequency-pssd",
          "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/37294623/",
          "text": {
            "en": "No reliable figure exists for how often PSSD happens.",
            "de": "Eine verlässliche Zahl dazu, wie oft PSSD vorkommt, gibt es nicht.",
            "es": "No existe ninguna cifra fiable sobre la frecuencia con la que se produce la PSSD.",
            "pt-br": "Não existe um número confiável sobre a frequência com que a PSSD acontece.",
            "fr": "Il n’existe aucun chiffre fiable sur la fréquence de la PSSD.",
            "it": "Non esiste una cifra affidabile su quanto spesso si verifichi la PSSD.",
            "hi": "PSSD कितनी बार होता है, इसका कोई भरोसेमंद आँकड़ा नहीं है।"
          }
        },
        {
          "id": "estimate-men-pssd",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10122283/",
          "text": {
            "en": "One study of health records gives an estimate for men, counted through prescriptions for erection medicines.",
            "de": "Eine Studie auf der Grundlage von Krankenakten nennt eine Schätzung für Männer, gezählt anhand der Verordnungen von Erektionsmitteln.",
            "es": "Un estudio de historias clínicas da una estimación para hombres, calculada a partir de las recetas de medicamentos para la erección.",
            "pt-br": "Um estudo com dados de prontuários médicos traz uma estimativa para homens, calculada a partir das receitas de medicamentos para ereção.",
            "fr": "Une étude menée sur des dossiers médicaux donne une estimation pour les hommes, établie à partir des prescriptions de médicaments contre les troubles de l’érection.",
            "it": "Uno studio su cartelle cliniche dà una stima per gli uomini, calcolata attraverso le prescrizioni di farmaci per l’erezione.",
            "hi": "मेडिकल रिकॉर्ड पर आधारित एक अध्ययन पुरुषों के लिए एक अनुमान देता है, जो इरेक्शन की दवाओं की पर्चियों से गिना गया।"
          }
        },
        {
          "id": "course",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11450419/",
          "text": {
            "en": "It is not known how many people fully recover.",
            "de": "Es ist nicht bekannt, wie viele Menschen vollständig genesen.",
            "es": "No se sabe cuántas personas se recuperan por completo.",
            "pt-br": "Não se sabe quantas pessoas se recuperam por completo.",
            "fr": "On ne sait pas combien de personnes se rétablissent complètement.",
            "it": "Non si sa quante persone guariscano del tutto.",
            "hi": "यह पता नहीं है कि कितने लोग पूरी तरह ठीक हो जाते हैं।"
          }
        },
        {
          "id": "duration-pssd",
          "sourceUrl": "https://sidefxhub.com/label-wording-by-country/#sertraline",
          "text": {
            "en": "None of the product texts we read says how long the sexual dysfunction can last.",
            "de": "In keinem der Produkttexte, die wir gelesen haben, steht, wie lange die sexuelle Funktionsstörung anhalten kann.",
            "es": "Ninguno de los textos de producto que hemos leído dice cuánto puede durar la disfunción sexual.",
            "pt-br": "Nenhuma das bulas que lemos diz quanto tempo a disfunção sexual pode durar.",
            "fr": "Aucun des textes de produits que nous avons lus ne dit combien de temps la dysfonction sexuelle peut durer.",
            "it": "Nessuno dei testi dei prodotti che abbiamo letto dice quanto può durare la disfunzione sessuale.",
            "hi": "हमने दवा के जो दस्तावेज़ पढ़े, उनमें से कोई नहीं बताता कि सेक्शुअल डिस्फ़ंक्शन कितने समय तक रह सकता है।"
          }
        }
      ],
      "changed": "2026-10-13",
      "records": [
        {
          "id": "sertraline-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Lustral 100mg film coated tablets",
            "lang": "en-GB",
            "product": {
              "name": "Lustral",
              "form": "100 mg film coated tablets",
              "holder": "Viatris Products Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/2835/smpc",
            "fetchedUrl": null,
            "textDate": "2025-12",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 12/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "sertraline-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahme-Hemmer (SSRIs) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual (ver sección 4.8). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual (ver seção 4.8). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8 देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-very-common",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1",
                "Reproductive system and breast disorders",
                "Very Common (≥1/10)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "ejaculation failure",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ejakulationsversagen",
                  "by": "ours"
                },
                "es": {
                  "text": "insuficiencia eyaculatoria",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "falha na ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "échec de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "mancata eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1",
                "Reproductive system and breast disorders",
                "Common (≥1/100 to <1/10)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "menstruation irregular∗, erectile dysfunction",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Menstruationsstörung∗, Erektionsstörung",
                  "by": "ours"
                },
                "es": {
                  "text": "irregularidades en la menstruación∗, disfunción eréctil",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "menstruação irregular∗, disfunção erétil",
                  "by": "ours"
                },
                "fr": {
                  "text": "irrégularités menstruelles∗, trouble de l’érection",
                  "by": "ours"
                },
                "it": {
                  "text": "irregolarità mestruali∗, disfunzione erettile",
                  "by": "ours"
                },
                "hi": {
                  "text": "अनियमित माहवारी∗, स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-uncommon",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1",
                "Reproductive system and breast disorders",
                "Uncommon (≥1/1,000 to <1/100)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "sexual dysfunction (see section 4.4), menorrhagia, vaginal haemorrhage, female sexual dysfunction (see section 4.4)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexualstörung (siehe Abschnitt 4.4), Menorrhagie, Vaginalblutung, Sexualstörungen bei der Frau (siehe Abschnitt 4.4)",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual (ver sección 4.4), menorragia, hemorragia vaginal, disfunción sexual femenina (ver sección 4.4)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual (ver seção 4.4), menorragia, hemorragia vaginal, disfunção sexual feminina (ver seção 4.4)",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonctionnement sexuel (voir rubrique 4.4), ménorragie, hémorragie vaginale, dysfonctionnement sexuel féminin (voir rubrique 4.4)",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale (vedere paragrafo 4.4), menorragia, emorragia vaginale, disfunzione sessuale femminile (vedere paragrafo 4.4)",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन (सेक्शन 4.4 देखें), माहवारी में बहुत ज़्यादा खून आना (menorrhagia), योनि से खून आना, महिलाओं में सेक्शुअल डिस्फ़ंक्शन (सेक्शन 4.4 देखें)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-rare",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1",
                "Reproductive system and breast disorders",
                "Rare (≥1/10,000 to <1/1,000)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "galactorrhoea*, atrophic vulvovaginitis, genital discharge, balanoposthitis∗§, gynaecomastia∗, priapism*",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Galaktorrhoe*, atrophische Vulvovaginitis, Genitalfluor, Balanoposthitis∗§, Gynäkomastie∗, Priapismus*",
                  "by": "ours"
                },
                "es": {
                  "text": "galactorrea*, vulvovaginitis atrófica, secreción genital, balanopostitis∗§, ginecomastia∗, priapismo*",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "galactorreia*, vulvovaginite atrófica, corrimento genital, balanopostite∗§, ginecomastia∗, priapismo*",
                  "by": "ours"
                },
                "fr": {
                  "text": "galactorrhée*, vulvo-vaginite atrophique, écoulement génital, balanoposthite∗§, gynécomastie∗, priapisme*",
                  "by": "ours"
                },
                "it": {
                  "text": "galattorrea*, vulvovaginite atrofica, secrezione genitale, balanopostite∗§, ginecomastia∗, priapismo*",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea)*, वल्वा और योनि के ऊतकों का पतला होना और सूजन (atrophic vulvovaginitis), जननांगों से स्राव, लिंग के अगले हिस्से और उसकी ऊपरी त्वचा में सूजन (balanoposthitis)∗§, पुरुषों में स्तन का बढ़ना (गाइनेकोमास्टिया)∗, लंबे समय तक बना रहने वाला इरेक्शन (priapism)*",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package leaflet: Information for the user. Lustral® 50 mg film coated tablets, Lustral® 100 mg film coated tablets. Sertraline",
            "lang": "en-GB",
            "product": {
              "name": "Lustral",
              "form": "50 mg and 100 mg film coated tablets",
              "holder": "Viatris Products Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.2835.pdf",
            "fetchedUrl": null,
            "textDate": "2025-12",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in 12/2025."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. What you need to know before you take Lustral",
                "Warnings and precautions",
                "Sexual problems:"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "sertraline-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Medicines like Lustral (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Lustral (sogenannte SSRIs) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Lustral (los llamados ISRS) pueden causar síntomas de disfunción sexual (ver sección 4). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Lustral (os chamados ISRS) podem causar sintomas de disfunção sexual (ver seção 4). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Lustral (appelés ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Lustral (i cosiddetti SSRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Lustral जैसी दवाओं (जिन्हें SSRI कहा जाता है) से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4 देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-uk-regulator-parliament",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-uk-regulator-parliament",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 50758, House of Commons: \"Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2025-05-07/50758",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/2025-05-07/50758",
            "textDate": "2025-05-13",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2025-05-13T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "sexual-persistence",
              "section": [
                "Answer"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die von der Medicines and Healthcare products Regulatory Agency (MHRA) genehmigten Produktinformationen, die medizinische Fachleute und Patientinnen und Patienten erhalten, wurden 2019 für alle selektiven Serotonin-Wiederaufnahmehemmer (SSRI) aktualisiert, um sie darüber zu informieren, dass Berichte über lang anhaltende sexuelle Funktionsstörungen eingegangen waren, bei denen die Symptome trotz Absetzen des SSRI anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto aprobada por la Medicines and Healthcare products Regulatory Agency (MHRA) que se facilita a profesionales sanitarios y pacientes para todos los inhibidores selectivos de la recaptación de serotonina (ISRS) se actualizó en 2019 para informarles de que se habían recibido notificaciones de disfunción sexual de larga duración en la que los síntomas continúan a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto aprovadas pela Medicines and Healthcare products Regulatory Agency (MHRA) e fornecidas a profissionais de saúde e pacientes para todos os inibidores seletivos da recaptação de serotonina (ISRS) foram atualizadas em 2019 para informá-los de que haviam sido recebidos relatos de disfunção sexual de longa duração em que os sintomas continuam apesar da descontinuação do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit approuvées par la Medicines and Healthcare products Regulatory Agency (MHRA) et fournies aux professionnels de santé et aux patients pour tous les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) ont été mises à jour en 2019 pour les informer que des signalements de dysfonction sexuelle durable, dans laquelle les symptômes persistent malgré l’arrêt de l’ISRS, avaient été reçus.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto approvate dalla Medicines and Healthcare products Regulatory Agency (MHRA) e fornite ai professionisti sanitari e ai pazienti per tutti gli inibitori selettivi della ricaptazione della serotonina (SSRI) sono state aggiornate nel 2019 per informarli che erano pervenute segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi continuano nonostante l’interruzione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Medicines and Healthcare products Regulatory Agency (MHRA) की मंज़ूर की हुई दवा की आधिकारिक जानकारी (product information), जो सभी सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं के लिए डॉक्टरों, दूसरे स्वास्थ्यकर्मियों और मरीज़ों को दी जाती है, 2019 में अपडेट की गई। मकसद उन्हें यह बताना था कि लंबे समय तक रहने वाले ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें मिली हैं, जिसमें SSRI बंद करने के बावजूद लक्षण जारी रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name sertraline.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Sertralin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo sertralina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita sertralina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif sertraline.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo sertralina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सर्ट्रालीन का नाम नहीं है।"
              }
            },
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-uk-regulator-chm202512",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-uk-regulator-chm202512",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Patient and family experiences inform antidepressant safety information review",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/government/news/patient-and-family-experiences-inform-antidepressant-safety-information-review",
            "fetchedUrl": null,
            "textDate": "2025-12-01",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 1 December 2025"
          },
          "passages": [
            {
              "key": "announcement",
              "kind": "sexual-persistence",
              "section": [
                "News story"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The CHM has also recommended updates to the PILs for certain antidepressants to better reflect patient feedback and emerging evidence on the potential for sexual dysfunction that may continue after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die CHM hat außerdem empfohlen, die Packungsbeilagen bestimmter Antidepressiva zu aktualisieren, damit sie die Rückmeldungen von Patientinnen und Patienten und neue Belege zur Möglichkeit sexueller Funktionsstörungen, die nach Beendigung der Behandlung anhalten können, besser wiedergeben.",
                  "by": "ours"
                },
                "es": {
                  "text": "La CHM también ha recomendado actualizar los prospectos de determinados antidepresivos para que reflejen mejor las aportaciones de los pacientes y la evidencia emergente sobre la posibilidad de una disfunción sexual que puede continuar después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A CHM também recomendou atualizações nas bulas para pacientes de certos antidepressivos, para refletir melhor os comentários dos pacientes e as evidências que vêm surgindo sobre a possibilidade de uma disfunção sexual que pode continuar após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La CHM a également recommandé de mettre à jour les notices de certains antidépresseurs afin de mieux refléter les retours des patients et les données nouvelles sur la possibilité d’une dysfonction sexuelle qui peut continuer après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La CHM ha inoltre raccomandato di aggiornare i fogli illustrativi di alcuni antidepressivi per rispecchiare meglio le osservazioni dei pazienti e i nuovi dati sulla possibilità di una disfunzione sessuale che può continuare dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "CHM ने कुछ एंटीडिप्रेसेंट दवाओं के मरीज़ों वाले लीफ़लेट (PIL) अपडेट करने की भी सिफ़ारिश की है। मकसद यह है कि उनमें मरीज़ों की राय और वे नए प्रमाण बेहतर ढंग से दिखें, जो ऐसे सेक्शुअल डिस्फ़ंक्शन की संभावना के बारे में हैं, जो इलाज बंद करने के बाद भी जारी रह सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "namesNoMedicine",
              "text": {
                "en": "This document does not say which medicines it means. It does not name sertraline.",
                "de": "Dieses Dokument sagt nicht, welche Medikamente es meint. Es nennt Sertralin nicht.",
                "es": "Este documento no dice a qué medicamentos se refiere. No nombra el principio activo sertralina.",
                "pt-br": "Este documento não diz a quais medicamentos se refere. Não cita sertralina pelo nome.",
                "fr": "Ce document ne dit pas de quels médicaments il parle. Il ne nomme pas le principe actif sertraline.",
                "it": "Questo documento non dice a quali medicinali si riferisce. Non nomina il principio attivo sertralina.",
                "hi": "यह दस्तावेज़ नहीं बताता कि इसका मतलब किन दवाओं से है। इसमें सर्ट्रालीन का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-uk-regulator-roundup202512",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-uk-regulator-roundup202512",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "MHRA Safety Roundup: December 2025",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-device-alerts/mhra-safety-roundup-december-2025",
            "fetchedUrl": null,
            "textDate": "2025-12-18",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 18 December 2025"
          },
          "passages": [
            {
              "key": "announcement",
              "kind": "sexual-persistence",
              "section": [
                "News Roundup",
                "Patient and family experiences inform antidepressant safety information review"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The CHM advised updates to the PILs for some antidepressants on the risk of sexual dysfunction where symptoms continue after stopping treatment to better reflect the views of patients and evolving data.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die CHM riet dazu, die Packungsbeilagen einiger Antidepressiva zum Risiko sexueller Funktionsstörungen, bei denen die Symptome nach Beendigung der Behandlung anhalten, zu aktualisieren, damit sie die Sicht der Patientinnen und Patienten und die sich entwickelnde Datenlage besser wiedergeben.",
                  "by": "ours"
                },
                "es": {
                  "text": "La CHM aconsejó actualizar los prospectos de algunos antidepresivos en lo relativo al riesgo de disfunción sexual en la que los síntomas continúan después de suspender el tratamiento, para que reflejen mejor las opiniones de los pacientes y la evolución de los datos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A CHM aconselhou atualizar as bulas para pacientes de alguns antidepressivos quanto ao risco de disfunção sexual em que os sintomas continuam após a interrupção do tratamento, para refletir melhor a visão dos pacientes e a evolução dos dados.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La CHM a conseillé de mettre à jour les notices de certains antidépresseurs au sujet du risque de dysfonction sexuelle dont les symptômes continuent après l’arrêt du traitement, afin de mieux refléter le point de vue des patients et l’évolution des données.",
                  "by": "ours"
                },
                "it": {
                  "text": "La CHM ha consigliato di aggiornare i fogli illustrativi di alcuni antidepressivi riguardo al rischio di disfunzione sessuale con sintomi che continuano dopo l’interruzione del trattamento, per rispecchiare meglio il punto di vista dei pazienti e l’evoluzione dei dati.",
                  "by": "ours"
                },
                "hi": {
                  "text": "CHM ने सलाह दी कि कुछ एंटीडिप्रेसेंट दवाओं के मरीज़ों वाले लीफ़लेट (PIL) में ऐसे सेक्शुअल डिस्फ़ंक्शन के जोखिम के बारे में अपडेट किए जाएँ, जिसमें इलाज बंद करने के बाद भी लक्षण जारी रहते हैं, ताकि उनमें मरीज़ों की राय और बदलते आँकड़े बेहतर ढंग से दिखें।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "namesNoMedicine",
              "text": {
                "en": "This document does not say which medicines it means. It does not name sertraline.",
                "de": "Dieses Dokument sagt nicht, welche Medikamente es meint. Es nennt Sertralin nicht.",
                "es": "Este documento no dice a qué medicamentos se refiere. No nombra el principio activo sertralina.",
                "pt-br": "Este documento não diz a quais medicamentos se refere. Não cita sertralina pelo nome.",
                "fr": "Ce document ne dit pas de quels médicaments il parle. Il ne nomme pas le principe actif sertraline.",
                "it": "Questo documento non dice a quali medicinali si riferisce. Non nomina il principio attivo sertralina.",
                "hi": "यह दस्तावेज़ नहीं बताता कि इसका मतलब किन दवाओं से है। इसमें सर्ट्रालीन का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "sertraline-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Zusammenfassung der Merkmale des Arzneimittels",
                    "4.4. Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                    "Sexuelle Funktionsstörung"
                  ],
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Résumé des caractéristiques du produit",
                    "4.4. Mises en garde spéciales et précautions d’emploi",
                    "Dysfonction sexuelle"
                  ],
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Riassunto delle caratteristiche del prodotto",
                    "4.4. Avvertenze speciali e precauzioni d’impiego",
                    "Disfunzione sessuale"
                  ],
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Ficha técnica o resumen de las características del producto",
                    "4.4. Advertencias y precauciones especiales de empleo",
                    "Disfunción sexual"
                  ],
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Resumo das Características do Medicamento",
                    "4.4. Advertências e precauções especiais de utilização",
                    "Disfunção sexual"
                  ],
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS."
                }
              ],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "official"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS.",
                  "by": "official"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "official"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "official"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "sertraline-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Packungsbeilage",
                    "2. Was sollten Sie vor der Einnahme von [Phantasiebezeichnung] beachten?",
                    "Warnhinweise und Vorsichtsmaßnahmen"
                  ],
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Notice",
                    "2. Quelles sont les informations à connaître avant de prendre [Nom de fantaisie]",
                    "Mises en garde et précautions"
                  ],
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Foglio illustrativo",
                    "2. Cosa deve sapere prima di prendere [denominazione del medicinale]",
                    "Avvertenze e precauzioni"
                  ],
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Prospecto",
                    "2. Qué necesita saber antes de empezar a tomar [nombre de fantasía]",
                    "Advertencias y precauciones"
                  ],
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Folheto Informativo",
                    "2. O que precisa de saber antes de tomar [Nome do medicamento]",
                    "Advertências e precauções"
                  ],
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento."
                }
              ],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "official"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento.",
                  "by": "official"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "official"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "official"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen. Verabschiedet im Rahmen der PRAC-Sitzung vom 13. bis 16. Mai 2019",
              "url": "https://www.ema.europa.eu/de/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_de.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Nouveau texte des informations sur le produit – Extraits des recommandations du PRAC sur les signaux. Adopté les 13-16 mai 2019 par le PRAC",
              "url": "https://www.ema.europa.eu/fr/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_fr.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Nuovo testo delle informazioni sul prodotto – Estratti dalle raccomandazioni del PRAC in merito ai segnali. Adottato nella riunione del PRAC del 13-16 maggio 2019",
              "url": "https://www.ema.europa.eu/it/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_it.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "es",
              "name": "Recomendaciones del PRAC sobre señales: nuevo texto de información sobre el producto. Adoptadas por el PRAC el 13-16 de mayo de 2019",
              "url": "https://www.ema.europa.eu/es/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_es.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Novo texto da informação do medicamento – Extratos das recomendações do PRAC relativamente aos sinais. Adotado na reunião do PRAC de 13-16 de maio de 2019",
              "url": "https://www.ema.europa.eu/pt/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_pt.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "corrected"
              }
            }
          ],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            },
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-eu-regulator-prac201905",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-eu-regulator-prac201905",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "sertraline-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ZOLOFT (sertraline hydrochloride) tablets, for oral use; ZOLOFT (sertraline hydrochloride) oral solution: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Zoloft",
              "form": "tablets 25 mg, 50 mg and 100 mg, and oral solution 20 mg/mL",
              "holder": "Viatris Specialty LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7",
            "fetchedUrl": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/fda754f6-d0f3-4dce-a17a-927d64f912f7.xml",
            "textDate": "2023-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 8/2023"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.11 Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Use of SSRIs, including ZOLOFT, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Anwendung von SSRI, einschließlich ZOLOFT, kann Symptome einer sexuellen Funktionsstörung verursachen [siehe Nebenwirkungen (6.1)]. Bei männlichen Patienten kann die Anwendung von SSRI zu verzögerter oder ausbleibender Ejakulation, verminderter Libido und erektiler Dysfunktion führen. Bei Patientinnen kann die Anwendung von SSRI zu verminderter Libido und verzögertem oder ausbleibendem Orgasmus führen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El uso de ISRS, incluido ZOLOFT, puede causar síntomas de disfunción sexual [ver Reacciones adversas (6.1)]. En los pacientes varones, el uso de ISRS puede dar lugar a retraso o insuficiencia de la eyaculación, disminución de la libido y disfunción eréctil. En las pacientes mujeres, el uso de ISRS puede dar lugar a disminución de la libido y a retraso o ausencia del orgasmo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O uso de ISRS, incluindo o ZOLOFT, pode causar sintomas de disfunção sexual [ver Reações adversas (6.1)]. Em pacientes do sexo masculino, o uso de ISRS pode resultar em retardo ou falha na ejaculação, diminuição da libido e disfunção erétil. Em pacientes do sexo feminino, o uso de ISRS pode resultar em diminuição da libido e em orgasmo retardado ou ausente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’utilisation des ISRS, dont ZOLOFT, peut causer des symptômes de dysfonction sexuelle [voir Effets indésirables (6.1)]. Chez les hommes, l’utilisation d’un ISRS peut entraîner un retard ou un échec de l’éjaculation, une diminution de la libido et une dysfonction érectile. Chez les femmes, l’utilisation d’un ISRS peut entraîner une diminution de la libido et un orgasme retardé ou absent.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’uso di SSRI, compreso ZOLOFT, può causare sintomi di disfunzione sessuale [vedere Reazioni avverse (6.1)]. Nei pazienti di sesso maschile, l’uso di SSRI può comportare eiaculazione ritardata o mancata, calo della libido e disfunzione erettile. Nelle pazienti di sesso femminile, l’uso di SSRI può comportare calo della libido e orgasmo ritardato o assente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ZOLOFT समेत SSRI दवाओं के इस्तेमाल से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं [Adverse Reactions (6.1) देखें]। पुरुष मरीज़ों में SSRI के इस्तेमाल से स्खलन में देरी या स्खलन न हो पाना, कामेच्छा में कमी और स्तंभन दोष हो सकते हैं। महिला मरीज़ों में SSRI के इस्तेमाल से कामेच्छा में कमी हो सकती है, और ऑर्गेज़्म देर से हो सकता है या नहीं भी हो सकता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, continu, after discontinu, after stopping, following discontinu, upon discontinu, long-lasting, long lasting, enduring, irreversib, permanent, despite, sexual",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "usLabelSearch",
              "text": {
                "en": "On 13 October 2026 we searched the labels in the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 423 labels that name sertraline.",
                "de": "Am 13. Oktober 2026 haben wir die Fachinformationen in der offenen Datenbank der FDA durchsucht. In keiner der 423 Fachinformationen, die Sertralin nennen, stand ein Satz dazu, dass sexuelle Funktionsstörungen nach dem Absetzen anhalten.",
                "es": "El 13 de octubre de 2026 buscamos en las fichas técnicas de la base de datos abierta de la FDA. Ninguna de las 423 fichas técnicas que nombran la sertralina tenía una frase sobre una disfunción sexual que continúe después de dejar el medicamento.",
                "pt-br": "Em 13 de outubro de 2026, pesquisamos as bulas no banco de dados aberto da FDA. Nenhuma das 423 bulas que citam sertralina trazia uma frase sobre disfunção sexual que continua depois de parar o medicamento.",
                "fr": "Le 13 octobre 2026, nous avons cherché dans les notices de la base de données ouverte de la FDA. Aucune des 423 notices qui nomment la sertraline ne contenait de phrase sur une dysfonction sexuelle qui se poursuit après l’arrêt.",
                "it": "Il 13 ottobre 2026 abbiamo cercato tra le schede tecniche nella banca dati aperta della FDA. Una frase sulla disfunzione sessuale che continua dopo l’interruzione non compariva in nessuna delle 423 schede tecniche che nominano la sertralina.",
                "hi": "13 अक्टूबर 2026 को हमने FDA के खुले डेटाबेस में लेबल खोजे। जिन 423 लेबलों में सर्ट्रालीन का नाम है, उनमें से किसी में दवा बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के बने रहने के बारे में कोई वाक्य नहीं था।"
              }
            }
          ]
        },
        {
          "id": "sertraline-us-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-us-leaflet",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "MEDICATION GUIDE: ZOLOFT (ZOH-loft) (sertraline hydrochloride) Tablets and Oral Solution",
            "lang": "en-US",
            "product": {
              "name": "Zoloft",
              "form": "tablets 25 mg, 50 mg and 100 mg, and oral solution 20 mg/mL",
              "holder": "Viatris Specialty LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7",
            "fetchedUrl": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/fda754f6-d0f3-4dce-a17a-927d64f912f7.xml",
            "textDate": "2023-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 8/2023"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about ZOLOFT?"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including ZOLOFT, may cause sexual problems.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Probleme (Funktionsstörung). Die Einnahme von selektiven Serotonin-Wiederaufnahmehemmern (SSRI), einschließlich ZOLOFT, kann sexuelle Probleme verursachen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas sexuales (disfunción). Tomar inhibidores selectivos de la recaptación de serotonina (ISRS), incluido ZOLOFT, puede causar problemas sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas sexuais (disfunção). Tomar inibidores seletivos da recaptação de serotonina (ISRS), incluindo o ZOLOFT, pode causar problemas sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (dysfonction). La prise d’inhibiteurs sélectifs de la recapture de la sérotonine (ISRS), dont ZOLOFT, peut causer des troubles sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi sessuali (disfunzione). L’assunzione di inibitori selettivi della ricaptazione della serotonina (SSRI), compreso ZOLOFT, può causare problemi sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ (डिस्फ़ंक्शन)। ZOLOFT समेत सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाएँ लेने से यौन समस्याएँ हो सकती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "sexual, sex drive, erection, orgasm, persist, continu, after stopping, after you stop, long-lasting, permanent",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-us-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-us-regulator",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Drug Safety-related Labeling Changes (SrLC): ZOLOFT (NDA-019839) (SERTRALINE HYDROCHLORIDE)",
            "lang": "en-US",
            "product": {
              "name": "Zoloft",
              "form": "tablets",
              "holder": "Viatris"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Safety-related Labeling Changes (SrLC)"
            },
            "url": "https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=640",
            "fetchedUrl": null,
            "textDate": "2021-09-20",
            "textDateKind": "publication",
            "textDateAsPrinted": "09/20/2021 (SUPPL-100)"
          },
          "passages": [
            {
              "key": "entry",
              "kind": "regulator-statement",
              "section": [
                "09/20/2021 (SUPPL-100)",
                "5 Warnings and Precautions",
                "5.11 Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-US",
              "text": "(Newly added subsection)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "(Neu hinzugefügter Unterabschnitt)",
                  "by": "ours"
                },
                "es": {
                  "text": "(Subapartado recién añadido)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "(Subseção recém-acrescentada)",
                  "by": "ours"
                },
                "fr": {
                  "text": "(Sous-rubrique nouvellement ajoutée)",
                  "by": "ours"
                },
                "it": {
                  "text": "(Nuova sottosezione aggiunta)",
                  "by": "ours"
                },
                "hi": {
                  "text": "(नया जोड़ा गया उप-सेक्शन)",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the entry was read in full; the text it adds has no sentence about sexual dysfunction continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ZOLOFT, Sertraline Hydrochloride Capsules",
            "lang": "en-CA",
            "product": {
              "name": "Zoloft",
              "form": "capsules 25 mg, 50 mg and 100 mg",
              "holder": "BGP Pharma ULC"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00072140.PDF",
            "fetchedUrl": null,
            "textDate": "2023-08-22",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised AUG 22, 2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Sexual Dysfunction: Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Funktionsstörung: Selektive Serotonin-Wiederaufnahme-Hemmer (SSRIs) können Symptome einer sexuellen Funktionsstörung verursachen. Patientinnen und Patienten sollten darüber informiert werden, dass lang anhaltende sexuelle Funktionsstörungen berichtet wurden, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual: los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual. Se debe informar a los pacientes de que se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual: os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual. Os pacientes devem ser informados de que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction sexuelle : les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle. Les patients doivent être informés que des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale: gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale. I pazienti devono essere informati che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन: सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। मरीज़ों को बताया जाना चाहिए कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions",
                "Depression"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "The most commonly observed adverse events associated with the use of ZOLOFT were: gastrointestinal complaints; including nausea, diarrhea/loose stools and dyspepsia; male sexual dysfunction (primarily ejaculatory delay) (see 7 WARNINGS AND PRECAUTIONS); insomnia and somnolence; tremor; increased sweating and dry mouth; and dizziness.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die am häufigsten beobachteten unerwünschten Ereignisse im Zusammenhang mit der Anwendung von ZOLOFT waren: Magen-Darm-Beschwerden; darunter Übelkeit, Durchfall/weicher Stuhl und Dyspepsie; sexuelle Funktionsstörung beim Mann (vor allem verzögerte Ejakulation) (siehe 7 WARNHINWEISE UND VORSICHTSMASSNAHMEN); Schlaflosigkeit und Schläfrigkeit; Tremor; vermehrtes Schwitzen und Mundtrockenheit; sowie Schwindel.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los acontecimientos adversos observados con más frecuencia asociados al uso de ZOLOFT fueron: molestias gastrointestinales, incluidas náuseas, diarrea o heces blandas y dispepsia; disfunción sexual masculina (principalmente retraso de la eyaculación) (ver 7 ADVERTENCIAS Y PRECAUCIONES); insomnio y somnolencia; temblor; aumento de la sudoración y sequedad de boca; y mareo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os eventos adversos mais comumente observados associados ao uso de ZOLOFT foram: queixas gastrointestinais, incluindo náusea, diarreia/fezes amolecidas e dispepsia; disfunção sexual masculina (principalmente retardo na ejaculação) (ver 7 ADVERTÊNCIAS E PRECAUÇÕES); insônia e sonolência; tremor; aumento da sudorese e boca seca; e tontura.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les événements indésirables le plus souvent observés en association avec l’utilisation de ZOLOFT ont été : des troubles gastro-intestinaux, notamment nausées, diarrhée ou selles molles et dyspepsie ; une dysfonction sexuelle masculine (principalement un retard de l’éjaculation) (voir 7 MISES EN GARDE ET PRÉCAUTIONS) ; une insomnie et une somnolence ; des tremblements ; une augmentation de la transpiration et une sécheresse de la bouche ; et des étourdissements.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli eventi avversi osservati più comunemente in associazione all’uso di ZOLOFT sono stati: disturbi gastrointestinali, compresi nausea, diarrea/feci molli e dispepsia; disfunzione sessuale maschile (principalmente eiaculazione ritardata) (vedere 7 AVVERTENZE E PRECAUZIONI); insonnia e sonnolenza; tremore; aumento della sudorazione e secchezza della bocca; e capogiri.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ZOLOFT के इस्तेमाल से जुड़ी सबसे ज़्यादा देखी गई प्रतिकूल घटनाएँ (adverse events) ये थीं: पेट और आँतों की शिकायतें, जिनमें जी मिचलाना, दस्त या पतला मल और अपच शामिल हैं; पुरुषों में सेक्शुअल डिस्फ़ंक्शन (मुख्य रूप से स्खलन में देरी) (7 WARNINGS AND PRECAUTIONS देखें); नींद न आना और उनींदापन; कंपन; ज़्यादा पसीना आना और मुँह सूखना; और चक्कर आना।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-ca-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-ca-leaflet",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: ZOLOFT, Sertraline Hydrochloride Capsules",
            "lang": "en-CA",
            "product": {
              "name": "Zoloft",
              "form": "capsules 25 mg, 50 mg and 100 mg",
              "holder": "BGP Pharma ULC"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00072140.PDF",
            "fetchedUrl": null,
            "textDate": "2023-08-22",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised AUG 22, 2023"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Serious side effects and what to do about them",
                "COMMON"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Sexual dysfunction: low sex drive, not being able to ejaculate, delayed ejaculation, erectile dysfunction",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Funktionsstörung: geringes sexuelles Verlangen, ausbleibender Samenerguss, verzögerter Samenerguss, Erektionsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual: deseo sexual bajo, no poder eyacular, eyaculación retardada, disfunción eréctil",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual: desejo sexual baixo, não conseguir ejacular, ejaculação retardada, disfunção erétil",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction sexuelle : baisse du désir sexuel, impossibilité d’éjaculer, éjaculation retardée, dysfonction érectile",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale: riduzione del desiderio sessuale, impossibilità di eiaculare, eiaculazione ritardata, disfunzione erettile",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन: कामेच्छा में कमी, स्खलन न हो पाना, स्खलन में देरी, स्तंभन दोष",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "sexual, sex, continu, stop, long, lasting, persist",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-ca-regulator-review2021",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-ca-regulator-review2021",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254",
            "fetchedUrl": null,
            "textDate": "2021-01-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Issued: 2021-01-06"
          },
          "passages": [
            {
              "key": "action",
              "kind": "sexual-persistence",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die Sicherheitsinformationen zu allen SSRI und SNRI zu aktualisieren, um zu empfehlen, dass medizinische Fachleute ihre Patientinnen und Patienten über das mögliche Risiko lang anhaltender (möglicherweise Wochen bis Jahre) sexueller Symptome informieren, die nach dem Absetzen einer SSRI- oder SNRI-Behandlung fortbestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para actualizar la información de seguridad del producto de todos los ISRS e IRSN, con el fin de recomendar que los profesionales sanitarios informen a los pacientes del posible riesgo de síntomas sexuales de larga duración (posiblemente de semanas a años) que persisten después de suspender el tratamiento con ISRS o IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para atualizar as informações de segurança do produto de todos os ISRS e IRSN, a fim de recomendar que os profissionais de saúde informem os pacientes sobre o risco potencial de sintomas sexuais de longa duração (possivelmente de semanas a anos) que persistem após a interrupção do tratamento com ISRS ou IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour mettre à jour les informations de sécurité des produits pour tous les ISRS et IRSN, afin de recommander aux professionnels de santé d’informer les patients du risque potentiel de symptômes sexuels durables (peut-être de plusieurs semaines à plusieurs années) qui persistent après l’arrêt d’un traitement par ISRS ou IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per aggiornare le informazioni di sicurezza sul prodotto di tutti gli SSRI e gli SNRI, in modo da raccomandare ai professionisti sanitari di informare i pazienti del potenziale rischio di sintomi sessuali a lungo termine (forse da settimane ad anni) che persistono dopo l’interruzione del trattamento con SSRI o SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada दवा बनाने वाली कंपनियों के साथ मिलकर सभी SSRI और SNRI दवाओं की सुरक्षा जानकारी अपडेट करेगा। उसमें यह सिफ़ारिश होगी कि डॉक्टर और दूसरे स्वास्थ्यकर्मी मरीज़ों को इस संभावित जोखिम के बारे में बताएँ कि SSRI या SNRI से इलाज बंद करने के बाद यौन लक्षण लंबे समय तक (शायद हफ़्तों से लेकर सालों तक) बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "Health Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a interrupção do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names sertraline among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Sertralin.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo sertralina.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita sertralina entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif sertraline.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo sertralina.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें सर्ट्रालीन का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-ca-regulator-infowatch202112",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-ca-regulator-infowatch202112",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, December 2021",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2021/sc-hc/H167-1-2021-12-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2021-12",
            "textDateKind": "publication",
            "textDateAsPrinted": "December 2021"
          },
          "passages": [
            {
              "key": "update",
              "kind": "sexual-persistence",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Abschnitt Warnhinweise und Vorsichtsmaßnahmen der kanadischen Fachinformationen zu SSRI (Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Vilazodon und Vortioxetin) und SNRI (Desvenlafaxin, Duloxetin, Levomilnacipran und Venlafaxin) wurde oder wird um neue Sicherheitsinformationen zu Berichten über lang anhaltende sexuelle Funktionsstörungen ergänzt, bei denen die Symptome trotz Absetzen der Behandlung fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "El apartado de advertencias y precauciones de las monografías de producto canadienses de los ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona y vortioxetina) y de los IRSN (desvenlafaxina, duloxetina, levomilnaciprán y venlafaxina) se ha actualizado, o se actualizará, con nueva información de seguridad relativa a notificaciones de disfunción sexual de larga duración en la que los síntomas han continuado a pesar de la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A seção Advertências e Precauções das monografias de produto canadenses dos ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona e vortioxetina) e dos IRSN (desvenlafaxina, duloxetina, levomilnaciprana e venlafaxina) foi, ou será, atualizada com novas informações de segurança sobre relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La section Mises en garde et précautions des monographies de produit canadiennes des ISRS (citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, vilazodone et vortioxétine) et des IRSN (desvenlafaxine, duloxétine, lévomilnacipran et venlafaxine) a été, ou sera, mise à jour avec de nouvelles informations de sécurité concernant des signalements de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La sezione Avvertenze e precauzioni delle monografie di prodotto canadesi degli SSRI (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodone e vortioxetina) e degli SNRI (desvenlafaxina, duloxetina, levomilnacipran e venlafaxina) è stata, o sarà, aggiornata con nuove informazioni di sicurezza relative a segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कनाडा में SSRI दवाओं (सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, विलाज़ोडोन और वोर्टिऑक्सेटीन) और SNRI दवाओं (डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, लेवोमिल्नासिप्रान और वेनलाफ़ैक्सीन) की आधिकारिक जानकारी (product monograph) के Warnings and Precautions सेक्शन को नई सुरक्षा जानकारी के साथ अपडेट कर दिया गया है, या किया जाएगा। यह जानकारी लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की उन रिपोर्टों के बारे में है, जिनमें इलाज बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names sertraline among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Sertralin.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo sertralina.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita sertralina entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif sertraline.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo sertralina.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें सर्ट्रालीन का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION ZOLOFT (sertraline hydrochloride) tablet",
            "lang": "en-AU",
            "product": {
              "name": "ZOLOFT",
              "form": null,
              "holder": "Viatris"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-02438-1",
            "textDate": "2026-06-30",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual Dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Section 4.4 of Australia's product information for Zoloft has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs were stopped.",
                "de": "Abschnitt 4.4 der australischen Fachinformation zu Zoloft enthält einen Warnhinweis mit der Überschrift sexuelle Funktionsstörung. Dort heißt es, es gebe Berichte über sexuelle Funktionsstörungen, die lange andauerten und bei denen die Symptome nach dem Absetzen von SSRI weitergingen.",
                "es": "La sección 4.4 de la información del producto australiana de Zoloft tiene una advertencia titulada disfunción sexual. Dice que hay notificaciones de disfunción sexual que duró mucho tiempo, con síntomas que siguieron después de dejar los ISRS.",
                "pt-br": "A seção 4.4 da bula australiana do Zoloft para o profissional de saúde tem um alerta com o título disfunção sexual. Ela diz que há relatos de disfunção sexual que durou muito tempo, com sintomas que continuaram depois que os ISRS foram interrompidos.",
                "fr": "En Australie, la rubrique 4.4 des informations sur le produit de Zoloft contient une mise en garde qui a pour titre la dysfonction sexuelle. Elle indique que des cas de dysfonction sexuelle ayant duré longtemps ont été signalés, avec des symptômes qui ont continué après l’arrêt des ISRS.",
                "it": "La sezione 4.4 delle informazioni sul prodotto australiane di Zoloft ha un’avvertenza intitolata disfunzione sessuale. Dice che ci sono segnalazioni di disfunzione sessuale durata a lungo, con sintomi proseguiti dopo l’interruzione degli SSRI.",
                "hi": "ऑस्ट्रेलिया में Zoloft की आधिकारिक जानकारी (product information) के सेक्शन 4.4 में सेक्शुअल डिस्फ़ंक्शन के शीर्षक से एक चेतावनी है। वह कहती है कि ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें हैं, जो लंबे समय तक रहा और जिसमें SSRI दवाएँ बंद करने के बाद भी लक्षण चलते रहे।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Section 4.8",
                "Reproductive system and breast disorders",
                "Common"
              ],
              "since": null,
              "summary": {
                "en": "Section 4.8 lists ejaculation disorder and sexual dysfunction as common side effects and points back to section 4.4.",
                "de": "Abschnitt 4.8 führt Ejakulationsstörung und sexuelle Funktionsstörung als häufige Nebenwirkungen auf und verweist zurück auf Abschnitt 4.4.",
                "es": "La sección 4.8 recoge el trastorno de la eyaculación y la disfunción sexual como efectos secundarios frecuentes y remite a la sección 4.4.",
                "pt-br": "A seção 4.8 lista distúrbio da ejaculação e disfunção sexual como efeitos colaterais comuns e remete à seção 4.4.",
                "fr": "La rubrique 4.8 cite les troubles de l’éjaculation et la dysfonction sexuelle parmi les effets secondaires fréquents et renvoie à la rubrique 4.4.",
                "it": "La sezione 4.8 elenca il disturbo dell’eiaculazione e la disfunzione sessuale tra gli effetti collaterali comuni e rimanda alla sezione 4.4.",
                "hi": "सेक्शन 4.8 स्खलन की गड़बड़ी और सेक्शुअल डिस्फ़ंक्शन को आम साइड इफ़ेक्ट में गिनाता है, और वापस सेक्शन 4.4 का हवाला देता है।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "ZOLOFT",
              "form": null,
              "holder": "Viatris"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-01248-1",
            "textDate": "2026-06",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Less serious side effects"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "Australia's consumer medicine information for Zoloft lists sexual dysfunction among the less serious side effects. It says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.",
                "de": "Die australische Packungsbeilage zu Zoloft führt sexuelle Funktionsstörungen unter den weniger schwerwiegenden Nebenwirkungen auf. Dort heißt es, Medikamente wie dieses könnten sexuelle Probleme verursachen, und in manchen Fällen seien diese nach dem Ende der Behandlung weitergegangen.",
                "es": "El prospecto australiano de Zoloft (Consumer Medicine Information) recoge la disfunción sexual entre los efectos secundarios menos graves. Dice que los medicamentos como este pueden causar problemas sexuales y que, en algunos casos, estos han seguido después de terminar el tratamiento.",
                "pt-br": "A bula australiana do Zoloft para pacientes lista a disfunção sexual entre os efeitos colaterais menos graves. Ela diz que medicamentos como este podem causar problemas sexuais e que, em alguns casos, eles continuaram depois do fim do tratamento.",
                "fr": "En Australie, la notice de Zoloft destinée aux patients cite la dysfonction sexuelle parmi les effets secondaires moins graves. Elle indique que les médicaments de ce type peuvent causer des troubles sexuels et que, dans certains cas, ceux-ci ont continué après l’arrêt du traitement.",
                "it": "Il foglio illustrativo australiano di Zoloft (Consumer Medicine Information) elenca la disfunzione sessuale tra gli effetti collaterali meno gravi. Dice che medicinali come questo possono causare problemi sessuali, e che in alcuni casi questi sono proseguiti dopo la fine del trattamento.",
                "hi": "ऑस्ट्रेलिया में Zoloft का मरीज़ों वाला लीफ़लेट (consumer medicine information) सेक्शुअल डिस्फ़ंक्शन को कम गंभीर साइड इफ़ेक्ट में गिनाता है। वह कहता है कि इस तरह की दवाओं से यौन समस्याएँ हो सकती हैं, और कुछ मामलों में ये इलाज बंद होने के बाद भी चलती रहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-au-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-au-regulator",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "could-not-open",
          "accessReason": [
            "no-answer"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": null,
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.tga.gov.au/news/safety-updates/updated-warnings-about-persistent-sexual-dysfunction-antidepressants"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, SETRONA",
            "lang": "en-NZ",
            "product": {
              "name": "Setrona",
              "form": "50 mg and 100 mg film coated tablets",
              "holder": "Douglas Pharmaceuticals Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/s/setronatab.pdf",
            "fetchedUrl": null,
            "textDate": "2025-02-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. DATE OF REVISION OF THE TEXT 11 February 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahme-Hemmer (SSRIs) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual (ver sección 4.8). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual (ver seção 4.8). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8 देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information, SETRONA",
            "lang": "en-NZ",
            "product": {
              "name": "Setrona",
              "form": "50 mg and 100 mg tablets",
              "holder": "Douglas Pharmaceuticals Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/consumers/cmi/s/setrona.pdf",
            "fetchedUrl": null,
            "textDate": "2025-02-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of preparation 11 February 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Before you take SETRONA",
                "Before you start to take it"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Medicines like SETRONA may cause symptoms of sexual dysfunction (see “Side effects” section). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie SETRONA können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt „Nebenwirkungen“). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como SETRONA pueden causar síntomas de disfunción sexual (ver el apartado «Efectos secundarios»). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o SETRONA podem causar sintomas de disfunção sexual (ver a seção “Efeitos colaterais”). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme SETRONA peuvent causer des symptômes de dysfonction sexuelle (voir la rubrique « Effets indésirables »). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali SETRONA possono causare sintomi di disfunzione sessuale (vedere il paragrafo «Effetti indesiderati»). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "SETRONA जैसी दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (“Side effects” सेक्शन देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-nz-regulator-marc201909",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-nz-regulator-marc201909",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes179.htm",
            "fetchedUrl": null,
            "textDate": "2019-09-12",
            "textDateKind": "adoption",
            "textDateAsPrinted": "MINUTES OF THE 179th MEDICINES ADVERSE REACTIONS COMMITTEE MEETING 12 September 2019"
          },
          "passages": [
            {
              "key": "determination",
              "kind": "sexual-persistence",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "The Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss befasste sich mit den europäischen Produktinformationen zu diesem Thema und stellte nach Prüfung der verfügbaren Informationen fest, dass die Fachinformationen in Bezug auf das Risiko anhaltender sexueller Funktionsstörungen aktualisiert werden müssen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité examinó la información del producto europea sobre esta cuestión y determinó, a partir de su revisión de la información disponible, que es necesario actualizar las fichas técnicas en lo relativo al riesgo de disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê analisou as informações do produto europeias sobre essa questão e determinou, com base em sua revisão das informações disponíveis, que são necessárias atualizações nas bulas para profissionais de saúde quanto ao risco de disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a examiné les informations européennes sur le produit à ce sujet et a conclu, sur la base de son examen des informations disponibles, que des mises à jour des fiches techniques concernant le risque de dysfonction sexuelle persistante sont nécessaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha esaminato le informazioni sul prodotto europee su questo tema e ha stabilito, sulla base della propria revisione delle informazioni disponibili, che sono necessari aggiornamenti delle schede tecniche riguardo al rischio di disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने इस मुद्दे पर यूरोप में दवा की आधिकारिक जानकारी (product information) पर विचार किया। उपलब्ध जानकारी की अपनी समीक्षा के आधार पर उसने तय किया कि बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के जोखिम के बारे में data sheet में अपडेट ज़रूरी हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "evidence",
              "kind": "qualification",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "qualifies": "determination",
              "lang": "en-NZ",
              "text": "The Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss hielt die Aussagekraft der Belege für gering, und aus den verfügbaren Daten lassen sich schwer Schlüsse ziehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité consideró que la solidez de la evidencia es baja, y es difícil extraer conclusiones de los datos disponibles.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê considerou baixa a força das evidências, e é difícil tirar conclusões dos dados disponíveis.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a jugé faible le niveau de preuve, et il est difficile de tirer des conclusions des données disponibles.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha ritenuto bassa la forza delle prove, ed è difficile trarre conclusioni dai dati disponibili.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने माना कि प्रमाण कमज़ोर हैं, और उपलब्ध आँकड़ों से निष्कर्ष निकालना मुश्किल है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "recommendation",
              "kind": "regulator-statement",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction",
                "Recommendation 5"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss empfahl, dass Medsafe die für Serotonin-Wiederaufnahmehemmer verantwortlichen Unternehmen anschreibt und um Aktualisierungen der neuseeländischen Fachinformationen bittet.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité recomendó que Medsafe escriba a los laboratorios titulares de los inhibidores de la recaptación de serotonina para solicitar la actualización de las fichas técnicas de Nueva Zelanda.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê recomendou que a Medsafe escreva às empresas responsáveis pelos inibidores da recaptação de serotonina pedindo atualizações nas bulas para profissionais de saúde da Nova Zelândia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a recommandé que Medsafe écrive aux laboratoires responsables des inhibiteurs de la recapture de la sérotonine pour demander des mises à jour des fiches techniques néo-zélandaises.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha raccomandato che Medsafe scriva alle aziende titolari (sponsor) degli inibitori della ricaptazione della serotonina per chiedere l’aggiornamento delle schede tecniche neozelandesi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने सिफ़ारिश की कि Medsafe सेरोटोनिन रीअपटेक इनहिबिटर दवाओं की कंपनियों (sponsors) को पत्र लिखे और न्यूज़ीलैंड की data sheet अपडेट करने को कहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name sertraline.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Sertralin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo sertralina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita sertralina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif sertraline.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo sertralina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सर्ट्रालीन का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-nz-regulator-marc202606",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-nz-regulator-marc202606",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes206.htm",
            "fetchedUrl": null,
            "textDate": "2026-06-11",
            "textDateKind": "adoption",
            "textDateAsPrinted": "The two hundred and sixth meeting of the Medicines Adverse Reactions Committee (MARC) was held on 11 June 2026"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "sexual-persistence",
              "section": [
                "3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors",
                "Background"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "A warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ein Warnhinweis, dass lang anhaltende Symptome einer sexuellen Funktionsstörung nach dem Absetzen einer Behandlung mit selektiven Serotonin-Wiederaufnahmehemmern (SSRI) und Serotonin-Noradrenalin-Wiederaufnahmehemmern (SNRI) berichtet wurden, steht derzeit in Abschnitt 4.4 der Fachinformationen dieser Medikamente.",
                  "by": "ours"
                },
                "es": {
                  "text": "En la sección 4.4 de las fichas técnicas de estos medicamentos figura actualmente una advertencia de que se han notificado síntomas de disfunción sexual de larga duración tras la suspensión del tratamiento con inhibidores selectivos de la recaptación de serotonina (ISRS) e inhibidores de la recaptación de serotonina y noradrenalina (IRSN).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Um alerta de que foram relatados sintomas de disfunção sexual de longa duração após a descontinuação do tratamento com inibidores seletivos da recaptação de serotonina (ISRS) e inibidores da recaptação de serotonina e noradrenalina (IRSN) consta atualmente na seção 4.4 das bulas para profissionais de saúde desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une mise en garde indiquant que des symptômes durables de dysfonction sexuelle ont été signalés après l’arrêt d’un traitement par inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) et par inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) figure actuellement à la rubrique 4.4 des fiches techniques de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Un’avvertenza secondo cui sono stati segnalati sintomi di disfunzione sessuale a lungo termine dopo l’interruzione del trattamento con inibitori selettivi della ricaptazione della serotonina (SSRI) e inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) è attualmente riportata nel paragrafo 4.4 delle schede tecniche di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन दवाओं की data sheet के सेक्शन 4.4 में फ़िलहाल यह चेतावनी दर्ज है कि सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) और सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) से इलाज बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के लंबे समय तक रहने वाले लक्षण रिपोर्ट हुए हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name sertraline.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Sertralin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo sertralina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita sertralina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif sertraline.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo sertralina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सर्ट्रालीन का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-nz-regulator-pu202103",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-nz-regulator-pu202103",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gathering knowledge from adverse reaction reports: March 2021",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/PUArticles/March2021/Gathering-knowledge-from-adverse-reaction-reports-March-2021.html",
            "fetchedUrl": null,
            "textDate": "2021-03-04",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 4 March 2021"
          },
          "passages": [
            {
              "key": "data-sheet",
              "kind": "sexual-persistence",
              "section": [
                "CARM ID: 138298",
                "Reaction description and data sheet information"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "The Arrow Sertraline data sheet states that selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In der Fachinformation zu Arrow Sertraline steht, dass selektive Serotonin-Wiederaufnahmehemmer (SSRI)/Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI) Symptome einer sexuellen Funktionsstörung verursachen können. Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "La ficha técnica de Arrow Sertraline afirma que los inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores de la recaptación de serotonina y noradrenalina (IRSN) pueden causar síntomas de disfunción sexual. Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A bula para o profissional de saúde do Arrow Sertraline afirma que os inibidores seletivos da recaptação de serotonina (ISRS)/inibidores da recaptação de serotonina e noradrenalina (IRSN) podem causar sintomas de disfunção sexual. Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fiche technique d’Arrow Sertraline indique que les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS)/inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) peuvent causer des symptômes de dysfonction sexuelle. Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La scheda tecnica di Arrow Sertraline afferma che gli inibitori selettivi della ricaptazione della serotonina (SSRI)/inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) possono causare sintomi di disfunzione sessuale. Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Arrow Sertraline की data sheet कहती है कि सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI)/सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation",
            "lang": "de",
            "product": {
              "name": "Zoloft",
              "form": "Filmtabletten",
              "holder": "Viatris Pharma GmbH"
            },
            "source": {
              "type": "compendium",
              "name": "fachinfo.de"
            },
            "url": "https://www.fachinfo.de/fi/pdf/000405",
            "fetchedUrl": "https://www.fachinfo.de/pdf/000405",
            "textDate": "2025-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. STAND DER INFORMATION Juli 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                "Sexuelle Funktionsstörung"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRIs being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione degli SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "compendiumCopyRegulatorTerms",
              "text": {
                "en": "This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie er in einer Sammlung von Produktinformationen steht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia de un compendio de información del producto. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia que está em um compêndio de bulas. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel qu’il figure dans un recueil d’informations sur les produits. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata in un compendio di informazioni sui prodotti. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह वह प्रति है, जो दवाओं की आधिकारिक जानकारी के एक संग्रह में है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            }
          ]
        },
        {
          "id": "sertraline-de-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-de-leaflet",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Anwender",
            "lang": "de",
            "product": {
              "name": "Zoloft",
              "form": "50 mg und 100 mg, Filmtabletten",
              "holder": "Viatris Pharma GmbH"
            },
            "source": {
              "type": "compendium",
              "name": "PatientenInfo-Service"
            },
            "url": "https://www.patienteninfo-service.de/a-z-liste/xyz/zoloftR-50-mg-und-100-mg-filmtabletten",
            "fetchedUrl": null,
            "textDate": "2025-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im Juli 2025."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Was sollten Sie vor der Einnahme von Zoloft beachten?",
                "Warnhinweise und Vorsichtsmaßnahmen",
                "Sexuelle Probleme"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In certain cases these symptoms continued after treatment was ended.",
                  "by": "ours"
                },
                "es": {
                  "text": "En determinados casos, estos síntomas persistieron después de finalizar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em certos casos, esses sintomas permaneceram após o término do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In determinati casi questi sintomi sono persistiti dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में ये लक्षण इलाज खत्म होने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "compendiumCopyRegulatorTerms",
              "text": {
                "en": "This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie er in einer Sammlung von Produktinformationen steht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia de un compendio de información del producto. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia que está em um compêndio de bulas. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel qu’il figure dans un recueil d’informations sur les produits. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata in un compendio di informazioni sui prodotti. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह वह प्रति है, जो दवाओं की आधिकारिक जानकारी के एक संग्रह में है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            }
          ]
        },
        {
          "id": "sertraline-de-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-de-regulator",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Bulletin/2019/2-2019.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2019-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Ausgabe 2 | Juni 2019"
          },
          "passages": [
            {
              "key": "wording",
              "kind": "sexual-persistence",
              "section": [
                "PRAC-Meldungen",
                "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen",
                "Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "sertraline-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "ZOLOFT",
              "form": "50 mg, gélule",
              "holder": "VIATRIS UP"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60683198/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60683198/extrait",
            "textDate": "2025-12-18",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 18/12/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Mises en garde spéciales et précautions d'emploi",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von sexueller Funktionsstörung berichtet, bei denen die Symptome trotz Absetzen der Behandlung mit SSRI anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual cuyos síntomas se han prolongado a pesar de la suspensión del tratamiento con ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual cujos sintomas se prolongaram apesar da interrupção do tratamento com ISRS.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale i cui sintomi si sono protratti nonostante l’interruzione del trattamento con SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाओं से इलाज बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-fr-leaflet",
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          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
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          "document": {
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            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60683198/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/60683198/extrait",
            "textDate": "2025-12-18",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 18/12/2025"
          },
          "passages": [
            {
              "key": "persistence",
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              "section": [
                "2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE ZOLOFT 50 mg, gélule ?",
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                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms continued after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas se han prolongado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas se prolongaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi si sono protratti dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी जारी रहे।",
                  "by": "ours"
                }
              }
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          ],
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          "officialVersions": [],
          "checked": "2026-10-13",
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            "result": "exact"
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          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
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            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-fr-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-fr-regulator",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
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          "document": {
            "name": "Xeljanz® (tofacitinib), Fenspiride (Pneumorel), ibuprofène et kétoprofène : retour d’information sur le PRAC de mai 2019",
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            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
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            "url": "https://ansm.sante.fr/actualites/xeljanz-r-tofacitinib-fenspiride-pneumorel-ibuprofene-et-ketoprofene-retour-dinformation-sur-le-prac-de-mai-2019",
            "fetchedUrl": null,
            "textDate": "2019-06-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 06/06/2019"
          },
          "passages": [],
          "searched": "\"sérotonine\", \"dysfonction\", \"sexuel\", \"signal\", \"ISRS\", \"IRSN\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
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            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
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            "name": "Riassunto delle Caratteristiche del Prodotto",
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              "name": "Zoloft",
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            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/4995/farmaci/27753/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2026-04-11",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 11/04/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Avvertenze speciali e precauzioni di impiego",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome nach dem Absetzen von SSRI fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual a largo plazo con persistencia de los síntomas tras la interrupción del uso de ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual de longo prazo, com persistência dos sintomas após a interrupção do uso de ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle à long terme ont été signalés, avec persistance des symptômes après l’arrêt de l’utilisation des ISRS.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाओं का इस्तेमाल बंद करने के बाद भी लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
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              "name": "Zoloft",
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              "holder": "Viatris Pharma S.r.l."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/4995/farmaci/27753/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2026-04-11",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 11/04/2026"
          },
          "passages": [
            {
              "key": "persistence",
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              "section": [
                "2. Cosa deve sapere prima di prendere Zoloft",
                "Avvertenze e precauzioni",
                "Problemi sessuali:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms have been seen to persist after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, se ha observado la persistencia de estos síntomas tras la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, observou-se a persistência desses sintomas após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la persistance de ces symptômes a été observée après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में देखा गया है कि ये लक्षण इलाज बंद करने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
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            "result": "corrected"
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              "date": "2026-10-13",
              "fields": [
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            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "sertraline-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-es",
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          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
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              "holder": "Viatris Healthcare Limited"
            },
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              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/59717/FT_59717.html",
            "fetchedUrl": null,
            "textDate": "2025-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO Julio 2025"
          },
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            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
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              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen des SSRI fortbestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da suspensão do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’arrêt de l’ISRS, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante la sospensione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI बंद करने के बावजूद लक्षण बने रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
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              "date": "2026-10-13",
              "fields": [
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              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
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          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
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            },
            "source": {
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              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/59717/P_59717.html",
            "fetchedUrl": null,
            "textDate": "2025-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: Julio 2025"
          },
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              "section": [
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                "Problemas sexuales:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas persistem depois de suspender o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes persistent après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi persistono dopo la sospensione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
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          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "sertraline-es-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-es-regulator",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/boletines-aemps/boletinMensual/2019-boletinMensual/boletin-mensual-de-la-aemps-sobre-medicamentos-de-uso-humano-del-mes-de-mayo-de-2019/",
            "fetchedUrl": null,
            "textDate": "2019-06-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 26 de junio de 2019"
          },
          "passages": [
            {
              "key": "bulletin",
              "kind": "sexual-persistence",
              "section": [
                "Información sobre seguridad",
                "Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia",
                "Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexual"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "En pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Serotonin-Noradrenalin-Wiederaufnahmehemmern oder mit selektiven Serotonin-Wiederaufnahmehemmern behandelt werden, wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen der Behandlung fortbestehen. Diese Erkenntnis wird in die Warnhinweise dieser Medikamente aufgenommen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em pacientes em tratamento com inibidores da recaptação de serotonina e noradrenalina, ou com inibidores seletivos da recaptação de serotonina, foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da interrupção do tratamento. Esse achado será incorporado às advertências desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez des patients traités par inhibiteurs de la recapture de la sérotonine et de la noradrénaline, ou par inhibiteurs sélectifs de la recapture de la sérotonine, des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’interruption du traitement, ont été signalés. Cette observation sera ajoutée aux mises en garde de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti in trattamento con inibitori della ricaptazione della serotonina e della noradrenalina, o con inibitori selettivi della ricaptazione della serotonina, sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante l’interruzione del trattamento. Questo dato sarà inserito nelle avvertenze di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर या सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर से जिन मरीज़ों का इलाज चल रहा है, उनमें लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें इलाज बंद करने के बावजूद लक्षण बने रहते हैं। यह बात इन दवाओं की चेतावनियों में जोड़ी जाएगी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name sertraline.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Sertralin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo sertralina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita sertralina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif sertraline.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo sertralina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सर्ट्रालीन का नाम नहीं है।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "sertraline-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ZOLOFT® cloridrato de sertralina: bula do profissional de saúde (VPS)",
            "lang": "pt-BR",
            "product": {
              "name": "Zoloft",
              "form": "comprimidos revestidos 50 mg e 100 mg",
              "holder": "Viatris Farmacêutica do Brasil Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Viatris Farmacêutica do Brasil Ltda."
            },
            "url": "https://www.viatris.com.br/-/media/project/common/viatriscombr/pdf/leaflets_legacy_myl_brazil/zoloft_bula_profissional.pdf",
            "fetchedUrl": null,
            "textDate": "2025-12-15",
            "textDateKind": "change-history",
            "textDateAsPrinted": "15/12/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "5. ADVERTÊNCIAS E PRECAUÇÕES",
                "Disfunção sexual"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "pt-BR",
              "text": "Inibidores seletivos da recaptação da serotonina (ISRSs) podem causar sintomas de disfunção sexual (vide item 9. Reações Adversas). Houve relatos de disfunção sexual de longa duração onde os sintomas continuaram apesar da descontinuação dos ISRSs.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see item 9. Adverse reactions). There have been reports of long-lasting sexual dysfunction where the symptoms continued despite the SSRIs being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahme-Hemmer (SSRIs) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Punkt 9. Nebenwirkungen). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual (ver apartado 9. Reacciones adversas). Ha habido notificaciones de disfunción sexual de larga duración en la que los síntomas continuaron a pesar de la suspensión de los ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir point 9. Effets indésirables). Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes ont continué malgré l’arrêt des ISRS, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale (vedere il punto 9. Reazioni avverse). Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione degli SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (आइटम 9, Reações Adversas देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "sertraline-br-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-br-leaflet",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ZOLOFT® cloridrato de sertralina: bula do paciente (VP)",
            "lang": "pt-BR",
            "product": {
              "name": "Zoloft",
              "form": "comprimidos revestidos 50 mg e 100 mg",
              "holder": "Viatris Farmacêutica do Brasil Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Viatris Farmacêutica do Brasil Ltda."
            },
            "url": "https://www.viatris.com.br/-/media/project/common/viatriscombr/pdf/leaflets_legacy_myl_brazil/zoloft_bula_paciente_.pdf",
            "fetchedUrl": null,
            "textDate": "2025-12-15",
            "textDateKind": "change-history",
            "textDateAsPrinted": "15/12/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4. O QUE DEVO SABER ANTES DE USAR ESTE MEDICAMENTO?"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "pt-BR",
              "text": "Medicamentos inibidores seletivos da recaptação da serotonina, como o Zoloft®, podem causar sintomas de disfunção sexual. Houve relatos de disfunção sexual de longa duração onde os sintomas continuaram apesar da descontinuação destes medicamentos.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Selective serotonin reuptake inhibitor medicines, such as Zoloft®, may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms continued despite these medicines being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Arzneimittel aus der Gruppe der selektiven Serotonin-Wiederaufnahmehemmer, wie Zoloft®, können Symptome einer sexuellen Funktionsstörung verursachen. Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung dieser Arzneimittel bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos inhibidores selectivos de la recaptación de serotonina, como Zoloft®, pueden causar síntomas de disfunción sexual. Ha habido notificaciones de disfunción sexual de larga duración en la que los síntomas continuaron a pesar de la suspensión de estos medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments inhibiteurs sélectifs de la recapture de la sérotonine, comme Zoloft®, peuvent causer des symptômes de dysfonction sexuelle. Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes ont continué malgré l’arrêt de ces médicaments, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "I medicinali inibitori selettivi della ricaptazione della serotonina, come Zoloft®, possono causare sintomi di disfunzione sessuale. Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Zoloft® जैसी सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें ये दवाएँ बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "sertraline-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#sertraline-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "no-public-database",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Daxid",
              "form": "25 mg, 50 mg, 100 mg tablets",
              "holder": "Viatris India"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/",
            "https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/",
            "https://www.viatris.in/en-in/products/brands",
            "https://www.viatris.in/en-in/products/product-details",
            "https://www.pfizerltd.co.in/files/products.json",
            "https://www.torrentpharma.com/",
            "https://sunpharma.com/india-prescribing-information/",
            "https://www.intaspharma.com/products/"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        }
      ]
    },
    {
      "id": "citalopram",
      "inn": "citalopram",
      "names": {
        "en": "citalopram",
        "de": "Citalopram",
        "es": "citalopram",
        "pt-br": "citalopram",
        "fr": "citalopram",
        "it": "citalopram",
        "hi": "सिटालोप्राम"
      },
      "class": "ssri",
      "classLabel": {
        "en": "SSRI antidepressant",
        "de": "SSRI-Antidepressivum",
        "es": "antidepresivo ISRS",
        "pt-br": "antidepressivo ISRS",
        "fr": "antidépresseur ISRS",
        "it": "antidepressivo SSRI",
        "hi": "SSRI एंटीडिप्रेसेंट"
      },
      "condition": "pssd",
      "lead": {
        "en": "For the SSRI antidepressant citalopram (Celexa, Cipramil), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs or SNRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, citalopram among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.",
        "de": "Zum SSRI-Antidepressivum Citalopram (Celexa, Cipramil) steht im Vereinigten Königreich in der Produktinformation, die wir gelesen haben, dass es Berichte über lang anhaltende sexuelle Funktionsstörungen gibt, bei denen die Symptome nach dem Absetzen von SSRI oder SNRI bestehen blieben. Das nennt man sexuelle Funktionsstörung nach SSRI-Einnahme (PSSD). Die Europäische Arzneimittel-Agentur (EMA) legte den Wortlaut dieses Warnhinweises 2019 für zehn Medikamente fest, darunter Citalopram. Laut einer Antwort der Regierung im britischen Parlament wurden die Produktinformationen für alle SSRI im Vereinigten Königreich 2019 um diesen Warnhinweis ergänzt.",
        "es": "En el caso del citalopram (Celexa, Cipramil), un antidepresivo ISRS, la información del producto que hemos leído en el Reino Unido dice que se han notificado casos de disfunción sexual de larga duración en los que los síntomas continuaron después de dejar los ISRS o los IRSN. Esto se conoce como disfunción sexual post-ISRS (PSSD). La Agencia Europea de Medicamentos (EMA) fijó en 2019 el texto de esta advertencia para diez medicamentos, entre ellos el citalopram, y una respuesta del Gobierno en el Parlamento dice que la información del producto de todos los ISRS en el Reino Unido se actualizó en 2019 para incluirla.",
        "pt-br": "No caso do antidepressivo ISRS citalopram (Celexa, Cipramil), a bula que lemos no Reino Unido diz que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram depois da interrupção dos ISRS ou IRSN. Esse quadro é conhecido como disfunção sexual pós-ISRS (PSSD). A agência reguladora de medicamentos da UE definiu o texto desse alerta em 2019 para dez medicamentos, entre eles o citalopram. Uma resposta do governo no Parlamento diz que as bulas de todos os ISRS no Reino Unido foram atualizadas em 2019 para incluí-lo.",
        "fr": "Pour le citalopram (Celexa, Cipramil), un antidépresseur ISRS, les informations sur le produit que nous avons lues au Royaume-Uni indiquent que des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui ont persisté après l’arrêt des ISRS ou des IRSN. C’est ce qu’on appelle la dysfonction sexuelle post-ISRS (PSSD). L’Agence européenne des médicaments (EMA) a fixé la formulation de cette mise en garde en 2019 pour dix médicaments, dont le citalopram. Selon une réponse du gouvernement britannique au Parlement, les informations sur le produit de tous les ISRS ont été mises à jour au Royaume-Uni en 2019 pour l’intégrer.",
        "it": "Per l’antidepressivo SSRI citalopram (Celexa, Cipramil), le informazioni sul prodotto che abbiamo letto nel Regno Unito dicono che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI o SNRI. Questo quadro è noto come disfunzione sessuale post-SSRI (PSSD). L’agenzia del farmaco dell’UE ha fissato il testo di questa avvertenza nel 2019 per dieci medicinali, tra cui il citalopram. Una risposta del governo al Parlamento britannico dice che nel 2019 le informazioni sul prodotto britanniche di tutti gli SSRI sono state aggiornate per riportare questa avvertenza.",
        "hi": "SSRI एंटीडिप्रेसेंट सिटालोप्राम (Celexa, Cipramil) के मामले में, ब्रिटेन में हमने दवा की जो आधिकारिक जानकारी (product information) पढ़ी, वह कहती है कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI या SNRI दवाएँ बंद करने के बाद भी लक्षण जारी रहे। इसे पोस्ट-SSRI सेक्शुअल डिस्फ़ंक्शन (PSSD) कहते हैं। यूरोपीय संघ (EU) के दवा नियामक ने 2019 में इस चेतावनी के शब्द दस दवाओं के लिए तय किए, जिनमें सिटालोप्राम भी है। ब्रिटेन की संसद में सरकार का एक जवाब कहता है कि वहाँ सभी SSRI दवाओं की आधिकारिक जानकारी 2019 में अपडेट की गई, ताकि उसमें यह चेतावनी हो।"
      },
      "brands": [
        {
          "name": "Celexa",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=63077",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "CTP 30",
          "listings": [
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78149",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Cipramil",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2234",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "PatientenInfo-Service",
              "sourceUrl": "https://www.patienteninfo-service.de/a-z-liste/c/cipramil-20-mg-filmtabletten",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Seropram",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69388669/extrait",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000023207?lang=it",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=63564",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Celapram",
          "listings": [
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Elopram",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000022999?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Frimaind",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000036742?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Ricap",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000036574?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Sintopram",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000037089?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Kaidor",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000036940?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Return",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000038029?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prisdal",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=60884",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Citalvir",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=66402",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Alcytam",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Città",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Denyl",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Maxapran",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Nypram",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Procimax",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        }
      ],
      "leadBrands": [
        "Celexa",
        "Cipramil"
      ],
      "cardSince": "citalopram-uk#persistence",
      "unknowns": [
        {
          "id": "frequency-pssd",
          "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/37294623/",
          "text": {
            "en": "No reliable figure exists for how often PSSD happens.",
            "de": "Eine verlässliche Zahl dazu, wie oft PSSD vorkommt, gibt es nicht.",
            "es": "No existe ninguna cifra fiable sobre la frecuencia con la que se produce la PSSD.",
            "pt-br": "Não existe um número confiável sobre a frequência com que a PSSD acontece.",
            "fr": "Il n’existe aucun chiffre fiable sur la fréquence de la PSSD.",
            "it": "Non esiste una cifra affidabile su quanto spesso si verifichi la PSSD.",
            "hi": "PSSD कितनी बार होता है, इसका कोई भरोसेमंद आँकड़ा नहीं है।"
          }
        },
        {
          "id": "estimate-men-pssd",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10122283/",
          "text": {
            "en": "One study of health records gives an estimate for men, counted through prescriptions for erection medicines.",
            "de": "Eine Studie auf der Grundlage von Krankenakten nennt eine Schätzung für Männer, gezählt anhand der Verordnungen von Erektionsmitteln.",
            "es": "Un estudio de historias clínicas da una estimación para hombres, calculada a partir de las recetas de medicamentos para la erección.",
            "pt-br": "Um estudo com dados de prontuários médicos traz uma estimativa para homens, calculada a partir das receitas de medicamentos para ereção.",
            "fr": "Une étude menée sur des dossiers médicaux donne une estimation pour les hommes, établie à partir des prescriptions de médicaments contre les troubles de l’érection.",
            "it": "Uno studio su cartelle cliniche dà una stima per gli uomini, calcolata attraverso le prescrizioni di farmaci per l’erezione.",
            "hi": "मेडिकल रिकॉर्ड पर आधारित एक अध्ययन पुरुषों के लिए एक अनुमान देता है, जो इरेक्शन की दवाओं की पर्चियों से गिना गया।"
          }
        },
        {
          "id": "course",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11450419/",
          "text": {
            "en": "It is not known how many people fully recover.",
            "de": "Es ist nicht bekannt, wie viele Menschen vollständig genesen.",
            "es": "No se sabe cuántas personas se recuperan por completo.",
            "pt-br": "Não se sabe quantas pessoas se recuperam por completo.",
            "fr": "On ne sait pas combien de personnes se rétablissent complètement.",
            "it": "Non si sa quante persone guariscano del tutto.",
            "hi": "यह पता नहीं है कि कितने लोग पूरी तरह ठीक हो जाते हैं।"
          }
        },
        {
          "id": "duration-pssd",
          "sourceUrl": "https://sidefxhub.com/label-wording-by-country/#citalopram",
          "text": {
            "en": "None of the product texts we read says how long the sexual dysfunction can last.",
            "de": "In keinem der Produkttexte, die wir gelesen haben, steht, wie lange die sexuelle Funktionsstörung anhalten kann.",
            "es": "Ninguno de los textos de producto que hemos leído dice cuánto puede durar la disfunción sexual.",
            "pt-br": "Nenhuma das bulas que lemos diz quanto tempo a disfunção sexual pode durar.",
            "fr": "Aucun des textes de produits que nous avons lus ne dit combien de temps la dysfonction sexuelle peut durer.",
            "it": "Nessuno dei testi dei prodotti che abbiamo letto dice quanto può durare la disfunzione sessuale.",
            "hi": "हमने दवा के जो दस्तावेज़ पढ़े, उनमें से कोई नहीं बताता कि सेक्शुअल डिस्फ़ंक्शन कितने समय तक रह सकता है।"
          }
        }
      ],
      "changed": "2026-10-14",
      "records": [
        {
          "id": "citalopram-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Cipramil 20 mg film-coated tablets",
            "lang": "en-GB",
            "product": {
              "name": "Cipramil",
              "form": "20 mg film-coated tablets",
              "holder": "Lundbeck Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/992/smpc",
            "fetchedUrl": null,
            "textDate": "2023-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 11/2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "citalopram-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Selective serotonin reuptake inhibitors (SSRIs/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI)/Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores de la recaptación de serotonina y noradrenalina (IRSN) pueden causar síntomas de disfunción sexual (ver sección 4.8). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS)/inibidores da recaptação de serotonina e noradrenalina (IRSN) podem causar sintomas de disfunção sexual (ver seção 4.8). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS)/inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI)/inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI)/सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8 देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Agitation, libido decreased, anxiety, nervousness, confusional state, abnormal orgasm (female), abnormal dreams, apathy",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Orgasmusstörungen (Frauen), anormale Träume, Apathie",
                  "by": "ours"
                },
                "es": {
                  "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, estado de confusión, orgasmo anormal (mujeres), sueños anormales, apatía",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agitação, diminuição da libido, ansiedade, nervosismo, estado confusional, orgasmo anormal (mulheres), sonhos anormais, apatia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agitation, baisse de la libido, anxiété, nervosité, état confusionnel, orgasme anormal (chez la femme), rêves anormaux, apathie",
                  "by": "ours"
                },
                "it": {
                  "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, orgasmo anormale (donne), disturbi dell’attività onirica, apatia",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम की अवस्था (confusional state), ऑर्गेज़्म में गड़बड़ी (महिलाओं में), असामान्य सपने, उदासीनता (apathy)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders",
                "Uncommon"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Aggression, depersonalisation, hallucination, mania, libido increased",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Aggression, Depersonalisation, Halluzination, Manie, gesteigerte Libido",
                  "by": "ours"
                },
                "es": {
                  "text": "Agresión, despersonalización, alucinación, manía, aumento de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agressividade, despersonalização, alucinação, mania, aumento da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agression, dépersonnalisation, hallucination, manie, augmentation de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Aggressione, depersonalizzazione, allucinazione, mania, aumento della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "आक्रामकता, डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना), मतिभ्रम (hallucination), मेनिया (mania), कामेच्छा में बढ़ोतरी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Impotence, ejaculation disorder, ejaculation failure",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation",
                  "by": "ours"
                },
                "es": {
                  "text": "Impotencia, trastorno de la eyaculación, insuficiencia eyaculatoria",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência, distúrbio da ejaculação, falha na ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Impuissance, trouble de l’éjaculation, échec de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza, disturbi di eiaculazione, mancata eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (impotence), स्खलन की गड़बड़ी, स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Not known"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Female: Metrorrhagia, postpartum haemorrhage2 Male: Priapism Galactorrhoea",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Frauen: Metrorrhagie, postpartale Hämorrhagie2 Männer: Priapismus Galaktorrhö",
                  "by": "ours"
                },
                "es": {
                  "text": "Mujeres: metrorragia, hemorragia posparto2 Hombres: priapismo Galactorrea",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Mulheres: Metrorragia, hemorragia pós-parto2 Homens: Priapismo Galactorreia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez la femme : métrorragie, hémorragie du post-partum2 Chez l’homme : priapisme Galactorrhée",
                  "by": "ours"
                },
                "it": {
                  "text": "Donne: Metrorragia, emorragia postpartum2 Uomini: Priapismo Galattorrea",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाएँ: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)2 पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism) स्तनों से दूध जैसा स्राव (galactorrhoea)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "en-GB",
              "text": "Adverse effects observed with citalopram are in general mild and transient. They are most frequent during the first one or two weeks of treatment and usually attenuate subsequently.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht und vorübergehend. Sie treten am häufigsten in den ersten ein oder zwei Behandlungswochen auf und klingen anschließend im Allgemeinen wieder ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos observados con citalopram son, en general, leves y transitorios. Son más frecuentes durante la primera o las dos primeras semanas de tratamiento y normalmente se atenúan después.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos observados com o citalopram são, em geral, leves e transitórios. São mais frequentes durante a primeira ou as duas primeiras semanas de tratamento e geralmente se atenuam em seguida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables observés avec le citalopram sont en général légers et transitoires. Ils sont plus fréquents pendant la première ou les deux premières semaines de traitement et s’atténuent habituellement par la suite.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati osservati con citalopram sono in generale di lieve entità e transitori. Sono più frequenti durante la prima o le prime due settimane di trattamento e di solito si attenuano successivamente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम के साथ देखे गए साइड इफ़ेक्ट आम तौर पर हल्के और अस्थायी होते हैं। ये इलाज के पहले एक या दो हफ़्तों में सबसे ज़्यादा होते हैं और उसके बाद आम तौर पर कम हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package leaflet: Information for the user. Cipramil® 20 mg film-coated tablets. citalopram (as hydrobromide)",
            "lang": "en-GB",
            "product": {
              "name": "Cipramil",
              "form": "20 mg film-coated tablets",
              "holder": "Lundbeck Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.992.pdf",
            "fetchedUrl": null,
            "textDate": "2025-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in 01/2025."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. What you need to know before you take Cipramil",
                "Warnings and precautions",
                "Please note:"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "citalopram-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Medicines like Cipramil (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Cipramil (so genannte SSRI/SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Cipramil (los llamados ISRS/IRSN) pueden causar síntomas de disfunción sexual (ver sección 4). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Cipramil (os chamados ISRS/IRSN) podem causar sintomas de disfunção sexual (ver seção 4). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Cipramil (appelés ISRS/IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Cipramil (i cosiddetti SSRI/SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Cipramil जैसी दवाओं (जिन्हें SSRI/SNRI कहा जाता है) से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4 देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Common side effects (may affect up to 1 in 10 people)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Common side effects (may affect up to 1 in 10 people)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "For men, problems with ejaculation and erection",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Männern Probleme mit Ejakulation und Erektion",
                  "by": "ours"
                },
                "es": {
                  "text": "En los hombres, problemas con la eyaculación y la erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Nos homens, problemas de ejaculação e de ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme, troubles de l’éjaculation et de l’érection",
                  "by": "ours"
                },
                "it": {
                  "text": "Per gli uomini, problemi di eiaculazione e di erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में, स्खलन और इरेक्शन की समस्याएँ",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Common side effects (may affect up to 1 in 10 people)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "For women, failing to reach an orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Frauen ausbleibender Orgasmus",
                  "by": "ours"
                },
                "es": {
                  "text": "En las mujeres, no alcanzar el orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Nas mulheres, não conseguir chegar ao orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez la femme, incapacité à atteindre l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "Per le donne, mancato raggiungimento dell’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं में, ऑर्गेज़्म तक न पहुँच पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Rare (may affect up to 1 in 1000 people)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Increased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Gesteigertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Aumento del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Aumento do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Augmentation du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Aumento del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में बढ़ोतरी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-5",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Some patient have reported (frequency not known)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "In men, painful erections",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Männern schmerzhafte Erektionen",
                  "by": "ours"
                },
                "es": {
                  "text": "En los hombres, erecciones dolorosas",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em homens, ereções dolorosas",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme, érections douloureuses",
                  "by": "ours"
                },
                "it": {
                  "text": "Negli uomini, erezioni dolorose",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में, दर्दनाक इरेक्शन",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "qualifies": "listed-5",
              "lang": "en-GB",
              "text": "The following side effects are often mild and usually disappear after a few days’ treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die folgenden Nebenwirkungen sind oft leicht und verschwinden gewöhnlich nach wenigen Behandlungstagen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los siguientes efectos secundarios son a menudo leves y normalmente desaparecen después de algunos días de tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais a seguir muitas vezes são leves e geralmente desaparecem após alguns dias de tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants sont souvent légers et disparaissent habituellement après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "I seguenti effetti indesiderati sono spesso lievi e di solito scompaiono dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे दिए गए साइड इफ़ेक्ट अक्सर हल्के होते हैं और आम तौर पर कुछ दिनों के इलाज के बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-uk-regulator-parliament",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-uk-regulator-parliament",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 50758, House of Commons: \"Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2025-05-07/50758",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/2025-05-07/50758",
            "textDate": "2025-05-13",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2025-05-13T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "sexual-persistence",
              "section": [
                "Answer"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die von der Medicines and Healthcare products Regulatory Agency (MHRA) genehmigten Produktinformationen, die medizinische Fachleute und Patientinnen und Patienten erhalten, wurden 2019 für alle selektiven Serotonin-Wiederaufnahmehemmer (SSRI) aktualisiert, um sie darüber zu informieren, dass Berichte über lang anhaltende sexuelle Funktionsstörungen eingegangen waren, bei denen die Symptome trotz Absetzen des SSRI anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto aprobada por la Medicines and Healthcare products Regulatory Agency (MHRA) que se facilita a profesionales sanitarios y pacientes para todos los inhibidores selectivos de la recaptación de serotonina (ISRS) se actualizó en 2019 para informarles de que se habían recibido notificaciones de disfunción sexual de larga duración en la que los síntomas continúan a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto aprovadas pela Medicines and Healthcare products Regulatory Agency (MHRA) e fornecidas a profissionais de saúde e pacientes para todos os inibidores seletivos da recaptação de serotonina (ISRS) foram atualizadas em 2019 para informá-los de que haviam sido recebidos relatos de disfunção sexual de longa duração em que os sintomas continuam apesar da descontinuação do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit approuvées par la Medicines and Healthcare products Regulatory Agency (MHRA) et fournies aux professionnels de santé et aux patients pour tous les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) ont été mises à jour en 2019 pour les informer que des signalements de dysfonction sexuelle durable, dans laquelle les symptômes persistent malgré l’arrêt de l’ISRS, avaient été reçus.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto approvate dalla Medicines and Healthcare products Regulatory Agency (MHRA) e fornite ai professionisti sanitari e ai pazienti per tutti gli inibitori selettivi della ricaptazione della serotonina (SSRI) sono state aggiornate nel 2019 per informarli che erano pervenute segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi continuano nonostante l’interruzione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Medicines and Healthcare products Regulatory Agency (MHRA) की मंज़ूर की हुई दवा की आधिकारिक जानकारी (product information), जो सभी सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं के लिए डॉक्टरों, दूसरे स्वास्थ्यकर्मियों और मरीज़ों को दी जाती है, 2019 में अपडेट की गई। मकसद उन्हें यह बताना था कि लंबे समय तक रहने वाले ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें मिली हैं, जिसमें SSRI बंद करने के बावजूद लक्षण जारी रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name citalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Citalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo citalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita citalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif citalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo citalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सिटालोप्राम का नाम नहीं है।"
              }
            },
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "citalopram-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Zusammenfassung der Merkmale des Arzneimittels",
                    "4.4. Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                    "Sexuelle Funktionsstörung"
                  ],
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Résumé des caractéristiques du produit",
                    "4.4. Mises en garde spéciales et précautions d’emploi",
                    "Dysfonction sexuelle"
                  ],
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Riassunto delle caratteristiche del prodotto",
                    "4.4. Avvertenze speciali e precauzioni d’impiego",
                    "Disfunzione sessuale"
                  ],
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Ficha técnica o resumen de las características del producto",
                    "4.4. Advertencias y precauciones especiales de empleo",
                    "Disfunción sexual"
                  ],
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Resumo das Características do Medicamento",
                    "4.4. Advertências e precauções especiais de utilização",
                    "Disfunção sexual"
                  ],
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS."
                }
              ],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "official"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS.",
                  "by": "official"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "official"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "official"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "citalopram-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Packungsbeilage",
                    "2. Was sollten Sie vor der Einnahme von [Phantasiebezeichnung] beachten?",
                    "Warnhinweise und Vorsichtsmaßnahmen"
                  ],
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Notice",
                    "2. Quelles sont les informations à connaître avant de prendre [Nom de fantaisie]",
                    "Mises en garde et précautions"
                  ],
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Foglio illustrativo",
                    "2. Cosa deve sapere prima di prendere [denominazione del medicinale]",
                    "Avvertenze e precauzioni"
                  ],
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Prospecto",
                    "2. Qué necesita saber antes de empezar a tomar [nombre de fantasía]",
                    "Advertencias y precauciones"
                  ],
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Folheto Informativo",
                    "2. O que precisa de saber antes de tomar [Nome do medicamento]",
                    "Advertências e precauções"
                  ],
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento."
                }
              ],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "official"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento.",
                  "by": "official"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "official"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "official"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen. Verabschiedet im Rahmen der PRAC-Sitzung vom 13. bis 16. Mai 2019",
              "url": "https://www.ema.europa.eu/de/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_de.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Nouveau texte des informations sur le produit – Extraits des recommandations du PRAC sur les signaux. Adopté les 13-16 mai 2019 par le PRAC",
              "url": "https://www.ema.europa.eu/fr/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_fr.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Nuovo testo delle informazioni sul prodotto – Estratti dalle raccomandazioni del PRAC in merito ai segnali. Adottato nella riunione del PRAC del 13-16 maggio 2019",
              "url": "https://www.ema.europa.eu/it/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_it.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "es",
              "name": "Recomendaciones del PRAC sobre señales: nuevo texto de información sobre el producto. Adoptadas por el PRAC el 13-16 de mayo de 2019",
              "url": "https://www.ema.europa.eu/es/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_es.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Novo texto da informação do medicamento – Extratos das recomendações do PRAC relativamente aos sinais. Adotado na reunião do PRAC de 13-16 de maio de 2019",
              "url": "https://www.ema.europa.eu/pt/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_pt.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            }
          ],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            },
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-eu-regulator-prac201905",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-eu-regulator-prac201905",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "citalopram-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "CELEXA (citalopram) tablets, for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Celexa",
              "form": "film-coated tablets 10 mg, 20 mg and 40 mg",
              "holder": "Allergan, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177",
            "fetchedUrl": null,
            "textDate": "2023-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 10/2023"
          },
          "passages": [
            {
              "key": "listed-warnings",
              "kind": "sexual-side-effects",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.10 Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Use of SSRIs, including CELEXA, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Anwendung von SSRI, einschließlich CELEXA, kann Symptome einer sexuellen Funktionsstörung verursachen [siehe Nebenwirkungen (6.1)]. Bei männlichen Patienten kann die Anwendung von SSRI zu verzögerter oder ausbleibender Ejakulation, verminderter Libido und erektiler Dysfunktion führen. Bei Patientinnen kann die Anwendung von SSRI zu verminderter Libido und verzögertem oder ausbleibendem Orgasmus führen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El uso de ISRS, incluido CELEXA, puede causar síntomas de disfunción sexual [ver Reacciones adversas (6.1)]. En los pacientes varones, el uso de ISRS puede dar lugar a retraso o insuficiencia de la eyaculación, disminución de la libido y disfunción eréctil. En las pacientes mujeres, el uso de ISRS puede dar lugar a disminución de la libido y a retraso o ausencia del orgasmo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O uso de ISRS, incluindo o CELEXA, pode causar sintomas de disfunção sexual [ver Reações adversas (6.1)]. Em pacientes do sexo masculino, o uso de ISRS pode resultar em retardo ou falha na ejaculação, diminuição da libido e disfunção erétil. Em pacientes do sexo feminino, o uso de ISRS pode resultar em diminuição da libido e em orgasmo retardado ou ausente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’utilisation des ISRS, dont CELEXA, peut causer des symptômes de dysfonction sexuelle [voir Effets indésirables (6.1)]. Chez les hommes, l’utilisation d’un ISRS peut entraîner un retard ou un échec de l’éjaculation, une diminution de la libido et une dysfonction érectile. Chez les femmes, l’utilisation d’un ISRS peut entraîner une diminution de la libido et un orgasme retardé ou absent.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’uso di SSRI, compreso CELEXA, può causare sintomi di disfunzione sessuale [vedere Reazioni avverse (6.1)]. Nei pazienti di sesso maschile, l’uso di SSRI può comportare eiaculazione ritardata o mancata, calo della libido e disfunzione erettile. Nelle pazienti di sesso femminile, l’uso di SSRI può comportare calo della libido e orgasmo ritardato o assente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "CELEXA समेत SSRI दवाओं के इस्तेमाल से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं [Adverse Reactions (6.1) देखें]। पुरुष मरीज़ों में SSRI के इस्तेमाल से स्खलन में देरी या स्खलन न हो पाना, कामेच्छा में कमी और स्तंभन दोष हो सकते हैं। महिला मरीज़ों में SSRI के इस्तेमाल से कामेच्छा में कमी हो सकती है, और ऑर्गेज़्म देर से हो सकता है या नहीं भी हो सकता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "other-causes",
              "kind": "qualification",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.10 Sexual Dysfunction"
              ],
              "since": null,
              "qualifies": "listed-warnings",
              "lang": "en-US",
              "text": "When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei der Beurteilung von Veränderungen der Sexualfunktion ist eine ausführliche Anamnese (einschließlich des zeitlichen Beginns der Symptome) wichtig, da sexuelle Symptome andere Ursachen haben können, einschließlich der zugrunde liegenden psychiatrischen Erkrankung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Al evaluar los cambios en la función sexual, es importante obtener una historia clínica detallada (incluido el momento en que aparecieron los síntomas), ya que los síntomas sexuales pueden tener otras causas, entre ellas el trastorno psiquiátrico subyacente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ao avaliar alterações na função sexual, é importante obter uma anamnese detalhada (incluindo o momento de início dos sintomas), porque os sintomas sexuais podem ter outras causas, entre elas o transtorno psiquiátrico subjacente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Lors de l’évaluation de changements de la fonction sexuelle, il est important de recueillir une anamnèse détaillée (y compris le moment d’apparition des symptômes), car les symptômes sexuels peuvent avoir d’autres causes, notamment le trouble psychiatrique sous-jacent.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nel valutare le alterazioni della funzione sessuale, è importante raccogliere un’anamnesi dettagliata (compreso il momento di insorgenza dei sintomi), perché i sintomi sessuali possono avere altre cause, tra cui il disturbo psichiatrico di base.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया में बदलावों का आकलन करते समय मरीज़ की विस्तृत मेडिकल हिस्ट्री लेना (जिसमें लक्षण शुरू होने का समय भी शामिल है) ज़रूरी है, क्योंकि यौन लक्षणों के दूसरे कारण भी हो सकते हैं, जिनमें पहले से मौजूद मानसिक बीमारी भी शामिल है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, long-lasting, long lasting, enduring, irreversib, permanent, after discontinu, after stopping, after you stop, following discontinu, upon discontinu, despite, does not go away, continu (every hit within 200 characters of a sexual word read), sexual, sex drive, libido, ejaculat, orgasm, erecti, impoten, priapism, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            },
            {
              "date": "2026-10-14",
              "fields": [
                "passages"
              ],
              "previous": {
                "passages": []
              }
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "usLabelSearchCitalopram",
              "text": {
                "en": "On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 320 labels in that database that name citalopram.",
                "de": "Am 14. Oktober 2026 haben wir die Fachinformationen in openFDA durchsucht, der offenen Datenbank der FDA. In keiner der 320 Fachinformationen in dieser Datenbank, die Citalopram nennen, stand ein Satz dazu, dass sexuelle Funktionsstörungen nach dem Absetzen anhalten.",
                "es": "El 14 de octubre de 2026 buscamos en las fichas técnicas de openFDA, la base de datos abierta de la FDA. Ninguna de las 320 fichas técnicas de esa base de datos que nombran el citalopram tenía una frase sobre una disfunción sexual que continúe después de dejar el medicamento.",
                "pt-br": "Em 14 de outubro de 2026, pesquisamos as bulas no openFDA, o banco de dados aberto da FDA. Nenhuma das 320 bulas desse banco de dados que mencionam citalopram trazia uma frase sobre disfunção sexual que continua depois de parar o medicamento.",
                "fr": "Le 14 octobre 2026, nous avons cherché dans les notices d’openFDA, la base de données ouverte de la FDA. Aucune des 320 notices de cette base qui nomment le citalopram ne contenait de phrase sur une dysfonction sexuelle qui se poursuit après l’arrêt.",
                "it": "Il 14 ottobre 2026 abbiamo cercato tra le schede tecniche in openFDA, la banca dati aperta della FDA. Una frase sulla disfunzione sessuale che continua dopo l’interruzione non compariva in nessuna delle 320 schede tecniche di quella banca dati che nominano il citalopram.",
                "hi": "14 अक्टूबर 2026 को हमने FDA के खुले डेटाबेस openFDA में लेबल खोजे। उस डेटाबेस के जिन 320 लेबलों में सिटालोप्राम का नाम है, उनमें से किसी में दवा बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के बने रहने के बारे में कोई वाक्य नहीं था।"
              }
            }
          ]
        },
        {
          "id": "citalopram-us-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-us-leaflet",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "MEDICATION GUIDE: CELEXA® (Suh-leks-uh) (citalopram) Tablets, for oral use",
            "lang": "en-US",
            "product": {
              "name": "Celexa",
              "form": "film-coated tablets 10 mg, 20 mg and 40 mg",
              "holder": "Allergan, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177",
            "fetchedUrl": null,
            "textDate": "2023-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 10/2023"
          },
          "passages": [
            {
              "key": "listed-problems",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including CELEXA, may cause sexual problems.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Probleme (Funktionsstörung). Die Einnahme von selektiven Serotonin-Wiederaufnahmehemmern (SSRI), einschließlich CELEXA, kann sexuelle Probleme verursachen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas sexuales (disfunción). Tomar inhibidores selectivos de la recaptación de serotonina (ISRS), incluido CELEXA, puede causar problemas sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas sexuais (disfunção). Tomar inibidores seletivos da recaptação de serotonina (ISRS), incluindo o CELEXA, pode causar problemas sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (dysfonction). La prise d’inhibiteurs sélectifs de la recapture de la sérotonine (ISRS), dont CELEXA, peut causer des troubles sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi sessuali (disfunzione). L’assunzione di inibitori selettivi della ricaptazione della serotonina (SSRI), compreso CELEXA, può causare problemi sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ (डिस्फ़ंक्शन)। CELEXA समेत सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाएँ लेने से यौन समस्याएँ हो सकती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Delayed ejaculation or inability to have an ejaculation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Verzögerte Ejakulation oder Unfähigkeit zu ejakulieren",
                  "by": "ours"
                },
                "es": {
                  "text": "Eyaculación retardada o incapacidad para eyacular",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ejaculação retardada ou incapacidade de ter uma ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Éjaculation retardée ou incapacité à avoir une éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Eiaculazione ritardata o incapacità di eiaculare",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में देरी या स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Problems getting or keeping an erection",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme, eine Erektion zu bekommen oder aufrechtzuerhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas para conseguir o mantener una erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas para ter ou manter uma ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’obtention ou de maintien d’une érection",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi a raggiungere o mantenere l’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-4",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-5",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Delayed orgasm or inability to have an orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Verzögerter Orgasmus oder Unfähigkeit, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "Orgasmo retardado o incapacidad para tener un orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Orgasmo retardado ou incapacidade de ter um orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Orgasme retardé ou incapacité à avoir un orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "Orgasmo ritardato o incapacità di raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में देरी या ऑर्गेज़्म न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-most-common",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of CELEXA?"
              ],
              "since": null,
              "lang": "en-US",
              "text": "The most common side effect of CELEXA is delayed ejaculation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die häufigste Nebenwirkung von CELEXA ist eine verzögerte Ejakulation.",
                  "by": "ours"
                },
                "es": {
                  "text": "El efecto secundario más frecuente de CELEXA es la eyaculación retardada.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O efeito colateral mais comum do CELEXA é a ejaculação retardada.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’effet indésirable le plus fréquent de CELEXA est l’éjaculation retardée.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’effetto indesiderato più comune di CELEXA è l’eiaculazione ritardata.",
                  "by": "ours"
                },
                "hi": {
                  "text": "CELEXA का सबसे आम साइड इफ़ेक्ट स्खलन में देरी है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, long-lasting, long lasting, enduring, irreversib, permanent, after discontinu, after stopping, after you stop, following discontinu, upon discontinu, despite, does not go away, continu, sexual, sex drive, libido, ejaculat, orgasm, erecti, impoten",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Product Monograph Including Patient Medication Information: CELEXA®, citalopram hydrobromide, Tablets",
            "lang": "en-CA",
            "product": {
              "name": "Celexa",
              "form": "tablets 10 mg, 20 mg and 40 mg",
              "holder": "Lundbeck Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00082636.PDF",
            "fetchedUrl": null,
            "textDate": "2025-12-01",
            "textDateKind": "approval",
            "textDateAsPrinted": "Date of Authorization: 2025-12-01"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7. Warnings and Precautions",
                "Reproductive Health",
                "Function"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI) können Symptome einer sexuellen Funktionsstörung verursachen. Patientinnen und Patienten sollten darüber informiert werden, dass lang anhaltende sexuelle Funktionsstörungen berichtet wurden, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual. Se debe informar a los pacientes de que se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual. Os pacientes devem ser informados de que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle. Les patients doivent être informés que des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale. I pazienti devono essere informati che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। मरीज़ों को बताया जाना चाहिए कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-8-2",
              "kind": "sexual-persistence",
              "section": [
                "8. Adverse Reactions",
                "8.2. Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Furthermore, there have been reports of long-lasting sexual dysfunction where these symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Darüber hinaus wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen diese Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, se han notificado casos de disfunción sexual de larga duración en los que estos síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, houve relatos de disfunção sexual de longa duração em que esses sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "En outre, des cas de dysfonction sexuelle durable, dans lesquels ces symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS, ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza di questi sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद ये लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "underestimated",
              "kind": "qualification",
              "section": [
                "8. Adverse Reactions",
                "8.2. Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "qualifies": "persistence-8-2",
              "lang": "en-CA",
              "text": "This is a difficult area to study because patients may not spontaneously report symptoms of this nature, and therefore, it is thought that sexual side effects with SSRIs may be underestimated.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dieser Bereich ist schwer zu untersuchen, weil Patientinnen und Patienten Symptome dieser Art womöglich nicht von sich aus berichten; daher wird angenommen, dass sexuelle Nebenwirkungen unter SSRI möglicherweise unterschätzt werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Es un ámbito difícil de estudiar porque es posible que los pacientes no comuniquen espontáneamente síntomas de esta naturaleza y, por tanto, se cree que los efectos secundarios sexuales con los ISRS pueden estar subestimados.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esta é uma área difícil de estudar porque os pacientes podem não relatar espontaneamente sintomas dessa natureza e, por isso, acredita-se que os efeitos colaterais sexuais com ISRS possam estar subestimados.",
                  "by": "ours"
                },
                "fr": {
                  "text": "C’est un domaine difficile à étudier, car les patients peuvent ne pas signaler spontanément des symptômes de cette nature ; on pense donc que les effets indésirables sexuels des ISRS peuvent être sous-estimés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Si tratta di un ambito difficile da studiare perché i pazienti possono non riferire spontaneamente sintomi di questa natura e, pertanto, si ritiene che gli effetti indesiderati sessuali con gli SSRI possano essere sottostimati.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस विषय का अध्ययन करना मुश्किल है, क्योंकि हो सकता है कि मरीज़ इस तरह के लक्षण अपनी ओर से न बताएँ, और इसलिए माना जाता है कि SSRI दवाओं के यौन साइड इफ़ेक्ट शायद कम करके आँके जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-ca-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-ca-leaflet",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Patient Medication Information: CELEXA®, Citalopram Hydrobromide Tablets",
            "lang": "en-CA",
            "product": {
              "name": "Celexa",
              "form": "tablets 10 mg, 20 mg and 40 mg",
              "holder": "Lundbeck Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00082636.PDF",
            "fetchedUrl": null,
            "textDate": "2025-12-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: 2025-12-01"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Effects on Sexual Function: Taking medicines like CELEXA may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping CELEXA treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Auswirkungen auf die Sexualfunktion: Die Einnahme von Arzneimitteln wie CELEXA kann Symptome einer sexuellen Funktionsstörung verursachen. In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung mit CELEXA bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Efectos sobre la función sexual: tomar medicamentos como CELEXA puede causar síntomas de disfunción sexual. En algunos casos, estos síntomas han continuado después de suspender el tratamiento con CELEXA.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Efeitos sobre a função sexual: tomar medicamentos como o CELEXA pode causar sintomas de disfunção sexual. Em alguns casos, esses sintomas continuaram após a interrupção do tratamento com CELEXA.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Effets sur la fonction sexuelle : la prise de médicaments comme CELEXA peut causer des symptômes de dysfonction sexuelle. Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement par CELEXA.",
                  "by": "ours"
                },
                "it": {
                  "text": "Effetti sulla funzione sessuale: l’assunzione di medicinali quali CELEXA può causare sintomi di disfunzione sessuale. In alcuni casi si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento con CELEXA.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया पर असर: CELEXA जैसी दवाएँ लेने से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। कुछ मामलों में ये लक्षण CELEXA से इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "Possible side effects from using CELEXA",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Ejaculation disorder",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ejakulationsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastorno de la eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbio da ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Trouble de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbo dell’eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की गड़बड़ी",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-ca-regulator-review2021",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-ca-regulator-review2021",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254",
            "fetchedUrl": null,
            "textDate": "2021-01-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Issued: 2021-01-06"
          },
          "passages": [
            {
              "key": "action",
              "kind": "sexual-persistence",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die Sicherheitsinformationen zu allen SSRI und SNRI zu aktualisieren, um zu empfehlen, dass medizinische Fachleute ihre Patientinnen und Patienten über das mögliche Risiko lang anhaltender (möglicherweise Wochen bis Jahre) sexueller Symptome informieren, die nach dem Absetzen einer SSRI- oder SNRI-Behandlung fortbestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para actualizar la información de seguridad del producto de todos los ISRS e IRSN, con el fin de recomendar que los profesionales sanitarios informen a los pacientes del posible riesgo de síntomas sexuales de larga duración (posiblemente de semanas a años) que persisten después de suspender el tratamiento con ISRS o IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para atualizar as informações de segurança do produto de todos os ISRS e IRSN, a fim de recomendar que os profissionais de saúde informem os pacientes sobre o risco potencial de sintomas sexuais de longa duração (possivelmente de semanas a anos) que persistem após a interrupção do tratamento com ISRS ou IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour mettre à jour les informations de sécurité des produits pour tous les ISRS et IRSN, afin de recommander aux professionnels de santé d’informer les patients du risque potentiel de symptômes sexuels durables (peut-être de plusieurs semaines à plusieurs années) qui persistent après l’arrêt d’un traitement par ISRS ou IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per aggiornare le informazioni di sicurezza sul prodotto di tutti gli SSRI e gli SNRI, in modo da raccomandare ai professionisti sanitari di informare i pazienti del potenziale rischio di sintomi sessuali a lungo termine (forse da settimane ad anni) che persistono dopo l’interruzione del trattamento con SSRI o SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada दवा बनाने वाली कंपनियों के साथ मिलकर सभी SSRI और SNRI दवाओं की सुरक्षा जानकारी अपडेट करेगा। उसमें यह सिफ़ारिश होगी कि डॉक्टर और दूसरे स्वास्थ्यकर्मी मरीज़ों को इस संभावित जोखिम के बारे में बताएँ कि SSRI या SNRI से इलाज बंद करने के बाद यौन लक्षण लंबे समय तक (शायद हफ़्तों से लेकर सालों तक) बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "Health Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a interrupção do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names citalopram among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Citalopram.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo citalopram.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita citalopram entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif citalopram.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo citalopram.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें सिटालोप्राम का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-ca-regulator-infowatch202112",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-ca-regulator-infowatch202112",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, December 2021",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2021/sc-hc/H167-1-2021-12-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2021-12",
            "textDateKind": "publication",
            "textDateAsPrinted": "December 2021"
          },
          "passages": [
            {
              "key": "update",
              "kind": "sexual-persistence",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Abschnitt Warnhinweise und Vorsichtsmaßnahmen der kanadischen Fachinformationen zu SSRI (Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Vilazodon und Vortioxetin) und SNRI (Desvenlafaxin, Duloxetin, Levomilnacipran und Venlafaxin) wurde oder wird um neue Sicherheitsinformationen zu Berichten über lang anhaltende sexuelle Funktionsstörungen ergänzt, bei denen die Symptome trotz Absetzen der Behandlung fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "El apartado de advertencias y precauciones de las monografías de producto canadienses de los ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona y vortioxetina) y de los IRSN (desvenlafaxina, duloxetina, levomilnaciprán y venlafaxina) se ha actualizado, o se actualizará, con nueva información de seguridad relativa a notificaciones de disfunción sexual de larga duración en la que los síntomas han continuado a pesar de la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A seção Advertências e Precauções das monografias de produto canadenses dos ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona e vortioxetina) e dos IRSN (desvenlafaxina, duloxetina, levomilnaciprana e venlafaxina) foi, ou será, atualizada com novas informações de segurança sobre relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La section Mises en garde et précautions des monographies de produit canadiennes des ISRS (citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, vilazodone et vortioxétine) et des IRSN (desvenlafaxine, duloxétine, lévomilnacipran et venlafaxine) a été, ou sera, mise à jour avec de nouvelles informations de sécurité concernant des signalements de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La sezione Avvertenze e precauzioni delle monografie di prodotto canadesi degli SSRI (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodone e vortioxetina) e degli SNRI (desvenlafaxina, duloxetina, levomilnacipran e venlafaxina) è stata, o sarà, aggiornata con nuove informazioni di sicurezza relative a segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कनाडा में SSRI दवाओं (सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, विलाज़ोडोन और वोर्टिऑक्सेटीन) और SNRI दवाओं (डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, लेवोमिल्नासिप्रान और वेनलाफ़ैक्सीन) की आधिकारिक जानकारी (product monograph) के Warnings and Precautions सेक्शन को नई सुरक्षा जानकारी के साथ अपडेट कर दिया गया है, या किया जाएगा। यह जानकारी लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की उन रिपोर्टों के बारे में है, जिनमें इलाज बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)",
                "Key messages for healthcare professionals:"
              ],
              "since": null,
              "qualifies": "update",
              "lang": "en-CA",
              "text": "Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a descontinuação do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names citalopram among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Citalopram.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo citalopram.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita citalopram entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif citalopram.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo citalopram.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें सिटालोप्राम का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION – CIPRAMIL (CITALOPRAM HYDROBROMIDE) FILM-COATED TABLETS",
            "lang": "en-AU",
            "product": {
              "name": "CIPRAMIL",
              "form": null,
              "holder": "Lundbeck Australia Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05612-3",
            "textDate": "2025-08-04",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Section 4.4 of Australia's product information for Cipramil has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.",
                "de": "Abschnitt 4.4 der australischen Fachinformation zu Cipramil enthält einen Warnhinweis mit der Überschrift sexuelle Funktionsstörung. Dort heißt es, es gebe Berichte über sexuelle Funktionsstörungen, die lange andauerten und bei denen die Symptome nach dem Absetzen von SSRI oder SNRI weitergingen.",
                "es": "La sección 4.4 de la información del producto australiana de Cipramil tiene una advertencia titulada disfunción sexual. Dice que hay notificaciones de disfunción sexual que duró mucho tiempo, con síntomas que siguieron después de dejar los ISRS o los IRSN.",
                "pt-br": "A seção 4.4 da bula australiana do Cipramil para o profissional de saúde tem um alerta com o título disfunção sexual. Ela diz que há relatos de disfunção sexual que durou muito tempo, com sintomas que continuaram depois que os ISRS ou IRSN foram interrompidos.",
                "fr": "En Australie, la rubrique 4.4 des informations sur le produit de Cipramil contient une mise en garde qui a pour titre la dysfonction sexuelle. Elle indique que des cas de dysfonction sexuelle ayant duré longtemps ont été signalés, avec des symptômes qui ont continué après l’arrêt des ISRS ou des IRSN.",
                "it": "La sezione 4.4 delle informazioni sul prodotto australiane di Cipramil ha un’avvertenza intitolata disfunzione sessuale. Dice che ci sono segnalazioni di disfunzione sessuale durata a lungo, con sintomi proseguiti dopo l’interruzione degli SSRI o degli SNRI.",
                "hi": "ऑस्ट्रेलिया में Cipramil की आधिकारिक जानकारी (product information) के सेक्शन 4.4 में सेक्शुअल डिस्फ़ंक्शन के शीर्षक से एक चेतावनी है। वह कहती है कि ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें हैं, जो लंबे समय तक रहा और जिसमें SSRI या SNRI दवाएँ बंद करने के बाद भी लक्षण चलते रहे।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "CIPRAMIL Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "CIPRAMIL",
              "form": null,
              "holder": "Lundbeck Australia Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-05611-3",
            "textDate": "2025-08",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 2",
                "Warnings"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Australia's consumer medicine information for Cipramil says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.",
                "de": "In der australischen Packungsbeilage zu Cipramil heißt es, Medikamente wie dieses könnten sexuelle Probleme verursachen, und in manchen Fällen seien diese nach dem Ende der Behandlung weitergegangen.",
                "es": "El prospecto australiano de Cipramil (Consumer Medicine Information) dice que los medicamentos como este pueden causar problemas sexuales y que, en algunos casos, estos han seguido después de terminar el tratamiento.",
                "pt-br": "A bula australiana do Cipramil para pacientes diz que medicamentos como este podem causar problemas sexuais e que, em alguns casos, eles continuaram depois do fim do tratamento.",
                "fr": "En Australie, la notice de Cipramil destinée aux patients indique que les médicaments de ce type peuvent causer des troubles sexuels et que, dans certains cas, ceux-ci ont continué après l’arrêt du traitement.",
                "it": "Il foglio illustrativo australiano di Cipramil (Consumer Medicine Information) dice che medicinali come questo possono causare problemi sessuali, e che in alcuni casi questi sono proseguiti dopo la fine del trattamento.",
                "hi": "ऑस्ट्रेलिया में Cipramil का मरीज़ों वाला लीफ़लेट (consumer medicine information) कहता है कि इस तरह की दवाओं से यौन समस्याएँ हो सकती हैं, और कुछ मामलों में ये इलाज बंद होने के बाद भी चलती रहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, Cipramil",
            "lang": "en-NZ",
            "product": {
              "name": "Cipramil",
              "form": "20 mg film-coated tablets",
              "holder": "Pharmacy Retailing t/a Healthcare Logistics"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/c/cipramiltab.pdf",
            "fetchedUrl": null,
            "textDate": "2025-11-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT 07 November 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Warnings",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see Section 4.8 Undesirable effects). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI)/Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8 Nebenwirkungen). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores de la recaptación de serotonina y noradrenalina (IRSN) pueden causar síntomas de disfunción sexual (ver sección 4.8 Reacciones adversas). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS)/inibidores da recaptação de serotonina e noradrenalina (IRSN) podem causar sintomas de disfunção sexual (ver seção 4.8 Efeitos indesejáveis). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS)/inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8 Effets indésirables). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI)/inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8 Effetti indesiderati). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI)/सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8, Undesirable effects देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information (CMI), Cipramil",
            "lang": "en-NZ",
            "product": {
              "name": "Cipramil",
              "form": "20 mg film-coated tablets",
              "holder": "Pharmacy Retailing t/a Healthcare Logistics"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/Consumers/CMI/c/cipramil.pdf",
            "fetchedUrl": null,
            "textDate": "2025-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was prepared in November 2025."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "While you are taking it",
                "Things you must do"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Medicines like Cipramil may cause symptoms of sexual dysfunction (see section \"Side effects\"). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Cipramil können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt „Nebenwirkungen“). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Cipramil pueden causar síntomas de disfunción sexual (ver el apartado «Efectos secundarios»). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Cipramil podem causar sintomas de disfunção sexual (ver a seção “Efeitos colaterais”). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Cipramil peuvent causer des symptômes de dysfonction sexuelle (voir la rubrique « Effets indésirables »). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Cipramil possono causare sintomi di disfunzione sessuale (vedere il paragrafo «Effetti indesiderati»). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Cipramil जैसी दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (“Side effects” सेक्शन देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "Side effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "sexual disturbances (decreased sexual drive, problems with orgasm; problems with ejaculation or erection)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Störungen der Sexualfunktion (vermindertes sexuelles Verlangen, Probleme mit dem Orgasmus; Probleme mit der Ejakulation oder der Erektion)",
                  "by": "ours"
                },
                "es": {
                  "text": "alteraciones sexuales (disminución del deseo sexual, problemas con el orgasmo; problemas con la eyaculación o la erección)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais (diminuição do desejo sexual, problemas de orgasmo; problemas de ejaculação ou de ereção)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels (baisse du désir sexuel, troubles de l’orgasme ; troubles de l’éjaculation ou de l’érection)",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi sessuali (riduzione del desiderio sessuale, problemi di orgasmo; problemi di eiaculazione o di erezione)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (कामेच्छा में कमी, ऑर्गेज़्म की समस्याएँ; स्खलन या इरेक्शन की समस्याएँ)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "Side effects"
              ],
              "since": null,
              "qualifies": "listed-1",
              "lang": "en-NZ",
              "text": "The side effects of Cipramil are, in general, mild and disappear after a short period of time.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen von Cipramil sind im Allgemeinen leicht und verschwinden nach kurzer Zeit.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios de Cipramil son, en general, leves y desaparecen al cabo de poco tiempo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais do Cipramil são, em geral, leves e desaparecem depois de pouco tempo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables de Cipramil sont, en général, légers et disparaissent après une courte période.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati di Cipramil sono, in generale, lievi e scompaiono dopo un breve periodo di tempo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Cipramil के साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और थोड़े समय बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-nz-regulator-marc201909",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-nz-regulator-marc201909",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes179.htm",
            "fetchedUrl": null,
            "textDate": "2019-09-12",
            "textDateKind": "adoption",
            "textDateAsPrinted": "MINUTES OF THE 179th MEDICINES ADVERSE REACTIONS COMMITTEE MEETING 12 September 2019"
          },
          "passages": [
            {
              "key": "determination",
              "kind": "sexual-persistence",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "The Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss befasste sich mit den europäischen Produktinformationen zu diesem Thema und stellte nach Prüfung der verfügbaren Informationen fest, dass die Fachinformationen in Bezug auf das Risiko anhaltender sexueller Funktionsstörungen aktualisiert werden müssen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité examinó la información del producto europea sobre esta cuestión y determinó, a partir de su revisión de la información disponible, que es necesario actualizar las fichas técnicas en lo relativo al riesgo de disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê analisou as informações do produto europeias sobre essa questão e determinou, com base em sua revisão das informações disponíveis, que são necessárias atualizações nas bulas para profissionais de saúde quanto ao risco de disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a examiné les informations européennes sur le produit à ce sujet et a conclu, sur la base de son examen des informations disponibles, que des mises à jour des fiches techniques concernant le risque de dysfonction sexuelle persistante sont nécessaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha esaminato le informazioni sul prodotto europee su questo tema e ha stabilito, sulla base della propria revisione delle informazioni disponibili, che sono necessari aggiornamenti delle schede tecniche riguardo al rischio di disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने इस मुद्दे पर यूरोप में दवा की आधिकारिक जानकारी (product information) पर विचार किया। उपलब्ध जानकारी की अपनी समीक्षा के आधार पर उसने तय किया कि बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के जोखिम के बारे में data sheet में अपडेट ज़रूरी हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "evidence",
              "kind": "qualification",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "qualifies": "determination",
              "lang": "en-NZ",
              "text": "The Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss hielt die Aussagekraft der Belege für gering, und aus den verfügbaren Daten lassen sich schwer Schlüsse ziehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité consideró que la solidez de la evidencia es baja, y es difícil extraer conclusiones de los datos disponibles.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê considerou baixa a força das evidências, e é difícil tirar conclusões dos dados disponíveis.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a jugé faible le niveau de preuve, et il est difficile de tirer des conclusions des données disponibles.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha ritenuto bassa la forza delle prove, ed è difficile trarre conclusioni dai dati disponibili.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने माना कि प्रमाण कमज़ोर हैं, और उपलब्ध आँकड़ों से निष्कर्ष निकालना मुश्किल है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "recommendation",
              "kind": "regulator-statement",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction",
                "Recommendation 5"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss empfahl, dass Medsafe die für Serotonin-Wiederaufnahmehemmer verantwortlichen Unternehmen anschreibt und um Aktualisierungen der neuseeländischen Fachinformationen bittet.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité recomendó que Medsafe escriba a los laboratorios titulares de los inhibidores de la recaptación de serotonina para solicitar la actualización de las fichas técnicas de Nueva Zelanda.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê recomendou que a Medsafe escreva às empresas responsáveis pelos inibidores da recaptação de serotonina pedindo atualizações nas bulas para profissionais de saúde da Nova Zelândia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a recommandé que Medsafe écrive aux laboratoires responsables des inhibiteurs de la recapture de la sérotonine pour demander des mises à jour des fiches techniques néo-zélandaises.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha raccomandato che Medsafe scriva alle aziende titolari (sponsor) degli inibitori della ricaptazione della serotonina per chiedere l’aggiornamento delle schede tecniche neozelandesi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने सिफ़ारिश की कि Medsafe सेरोटोनिन रीअपटेक इनहिबिटर दवाओं की कंपनियों (sponsors) को पत्र लिखे और न्यूज़ीलैंड की data sheet अपडेट करने को कहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name citalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Citalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo citalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita citalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif citalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo citalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सिटालोप्राम का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-nz-regulator-marc202606",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-nz-regulator-marc202606",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes206.htm",
            "fetchedUrl": null,
            "textDate": "2026-06-11",
            "textDateKind": "adoption",
            "textDateAsPrinted": "The two hundred and sixth meeting of the Medicines Adverse Reactions Committee (MARC) was held on 11 June 2026"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "sexual-persistence",
              "section": [
                "3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors",
                "Background"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "A warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ein Warnhinweis, dass lang anhaltende Symptome einer sexuellen Funktionsstörung nach dem Absetzen einer Behandlung mit selektiven Serotonin-Wiederaufnahmehemmern (SSRI) und Serotonin-Noradrenalin-Wiederaufnahmehemmern (SNRI) berichtet wurden, steht derzeit in Abschnitt 4.4 der Fachinformationen dieser Medikamente.",
                  "by": "ours"
                },
                "es": {
                  "text": "En la sección 4.4 de las fichas técnicas de estos medicamentos figura actualmente una advertencia de que se han notificado síntomas de disfunción sexual de larga duración tras la suspensión del tratamiento con inhibidores selectivos de la recaptación de serotonina (ISRS) e inhibidores de la recaptación de serotonina y noradrenalina (IRSN).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Um alerta de que foram relatados sintomas de disfunção sexual de longa duração após a descontinuação do tratamento com inibidores seletivos da recaptação de serotonina (ISRS) e inibidores da recaptação de serotonina e noradrenalina (IRSN) consta atualmente na seção 4.4 das bulas para profissionais de saúde desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une mise en garde indiquant que des symptômes durables de dysfonction sexuelle ont été signalés après l’arrêt d’un traitement par inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) et par inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) figure actuellement à la rubrique 4.4 des fiches techniques de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Un’avvertenza secondo cui sono stati segnalati sintomi di disfunzione sessuale a lungo termine dopo l’interruzione del trattamento con inibitori selettivi della ricaptazione della serotonina (SSRI) e inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) è attualmente riportata nel paragrafo 4.4 delle schede tecniche di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन दवाओं की data sheet के सेक्शन 4.4 में फ़िलहाल यह चेतावनी दर्ज है कि सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) और सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) से इलाज बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के लंबे समय तक रहने वाले लक्षण रिपोर्ट हुए हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors",
                "Discussion"
              ],
              "since": null,
              "qualifies": "statement",
              "lang": "en-NZ",
              "text": "It was highlighted that this makes it difficult to confirm a causal relationship with SSRIs/SNRIs",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurde hervorgehoben, dass es dadurch schwierig ist, einen ursächlichen Zusammenhang mit SSRI/SNRI zu bestätigen",
                  "by": "ours"
                },
                "es": {
                  "text": "Se destacó que esto hace difícil confirmar una relación causal con los ISRS/IRSN",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foi destacado que isso torna difícil confirmar uma relação causal com os ISRS/IRSN",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il a été souligné que cela rend difficile la confirmation d’un lien de causalité avec les ISRS/IRSN",
                  "by": "ours"
                },
                "it": {
                  "text": "È stato sottolineato che questo rende difficile confermare una relazione causale con gli SSRI/SNRI",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस बात पर ध्यान दिलाया गया कि इससे SSRI/SNRI के साथ कारण और असर के संबंध की पुष्टि करना मुश्किल हो जाता है",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name citalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Citalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo citalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita citalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif citalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo citalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सिटालोप्राम का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Patienten",
            "lang": "de",
            "product": {
              "name": "Cipramil",
              "form": "20 mg, Filmtabletten",
              "holder": "Lundbeck GmbH"
            },
            "source": {
              "type": "compendium",
              "name": "PatientenInfo-Service"
            },
            "url": "https://www.patienteninfo-service.de/a-z-liste/c/cipramil-20-mg-filmtabletten",
            "fetchedUrl": null,
            "textDate": "2026-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im Januar 2026."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Was sollten Sie vor der Einnahme von Cipramil beachten?",
                "Warnhinweise und Vorsichtsmaßnahmen"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In certain cases these symptoms continued after treatment was ended.",
                  "by": "ours"
                },
                "es": {
                  "text": "En determinados casos, estos síntomas persistieron después de finalizar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em certos casos, esses sintomas permaneceram após o término do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In determinati casi questi sintomi sono persistiti dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में ये लक्षण इलाज खत्म होने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Häufig (kann bis zu 1 von 10 Behandelten betreffen)"
              ],
              "since": null,
              "lang": "de",
              "text": "Störungen der Sexualfunktion, wie Ejakulationsstörungen, ausbleibende Ejakulation, Impotenz, Minderung des sexuellen Interesses, bei Frauen Orgasmusstörungen",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Disorders of sexual function, such as ejaculation disorders, absent ejaculation, impotence, reduced sexual interest, and in women orgasm disorders",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos de la función sexual, como trastornos de la eyaculación, ausencia de eyaculación, impotencia, disminución del interés sexual y, en las mujeres, trastornos del orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios da função sexual, como distúrbios da ejaculação, falha na ejaculação, impotência, diminuição do interesse sexual e, em mulheres, distúrbios do orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de la fonction sexuelle, tels que troubles de l’éjaculation, absence d’éjaculation, impuissance, baisse de l’intérêt sexuel, troubles de l’orgasme chez la femme",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi della funzione sessuale, come disturbi di eiaculazione, mancata eiaculazione, impotenza, riduzione dell’interesse sessuale, nelle donne disturbi dell’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की गड़बड़ियाँ, जैसे स्खलन की गड़बड़ियाँ, स्खलन न हो पाना, स्तंभन दोष (impotence), यौन रुचि में कमी, महिलाओं में ऑर्गेज़्म की गड़बड़ियाँ",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)"
              ],
              "since": null,
              "lang": "de",
              "text": "Männer: Schmerzhafte Erektionen",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men: painful erections",
                  "by": "ours"
                },
                "es": {
                  "text": "Hombres: erecciones dolorosas",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Homens: ereções dolorosas",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : érections douloureuses",
                  "by": "ours"
                },
                "it": {
                  "text": "Uomini: erezioni dolorose",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: दर्दनाक इरेक्शन",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "de",
              "text": "Die Nebenwirkungen sind im Allgemeinen leicht und klingen gewöhnlich nach wenigen Behandlungswochen ab. Sie sollten auch wissen, dass viele dieser Symptome auch auf Ihre Krankheit zurückzuführen sein können und daher abklingen, wenn Sie beginnen, sich besser zu fühlen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects are generally mild and usually subside after a few weeks of treatment. You should also know that many of these symptoms may also be due to your illness and will therefore subside when you begin to feel better.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios son, en general, leves y suelen remitir al cabo de pocas semanas de tratamiento. También debe saber que muchos de estos síntomas pueden deberse igualmente a su enfermedad y, por tanto, remiten cuando usted empieza a sentirse mejor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são em geral leves e costumam regredir depois de poucas semanas de tratamento. Você também deve saber que muitos desses sintomas podem ser causados também pela sua doença e, por isso, regridem quando você começa a se sentir melhor.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont en général légers et s’atténuent habituellement après quelques semaines de traitement. Vous devez également savoir que beaucoup de ces symptômes peuvent aussi être dus à votre maladie et s’atténueront donc lorsque vous commencerez à vous sentir mieux.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere lievi e di solito regrediscono dopo poche settimane di trattamento. Deve anche sapere che molti di questi sintomi possono essere dovuti anche alla sua malattia e quindi regrediscono quando comincia a sentirsi meglio.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और सामान्य तौर पर इलाज के कुछ हफ़्तों बाद धीरे-धीरे खत्म हो जाते हैं। आपको यह भी पता होना चाहिए कि इनमें से कई लक्षण आपकी बीमारी की वजह से भी हो सकते हैं, और इसलिए जब आप बेहतर महसूस करने लगते हैं, तब ये धीरे-धीरे खत्म हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "compendiumCopyRegulatorTerms",
              "text": {
                "en": "This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie er in einer Sammlung von Produktinformationen steht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia de un compendio de información del producto. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia que está em um compêndio de bulas. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel qu’il figure dans un recueil d’informations sur les produits. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata in un compendio di informazioni sui prodotti. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह वह प्रति है, जो दवाओं की आधिकारिक जानकारी के एक संग्रह में है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            }
          ]
        },
        {
          "id": "citalopram-de-pro-cipramil",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-de-pro-cipramil",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "login",
            "terms-not-accepted"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Cipramil",
              "form": null,
              "holder": "Lundbeck GmbH"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.fachinfo.de/",
            "https://portal.bfarm.de/amguifree/",
            "https://www.lundbeck.com/de/unsere-forschung/produkte"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-de-pro-ratiopharm",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-de-pro-ratiopharm",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation",
            "lang": "de",
            "product": {
              "name": "Citalopram-ratiopharm®",
              "form": "10 mg / 20 mg / 40 mg Filmtabletten",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/label/Citalopram-ratiopharm%20Filmtabletten%20-%208.pdf?pzn=1409464",
            "fetchedUrl": null,
            "textDate": "2024-12",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. STAND DER INFORMATION Dezember 2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                "Sexuelle Funktionsstörung"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Frauen: Orgasmusstörungen, anormale Träume, Apathie",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Agitation, decreased libido, anxiety, nervousness, confusion, women: orgasm disorders, abnormal dreams, apathy",
                  "by": "ours"
                },
                "es": {
                  "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, confusión, mujeres: trastornos del orgasmo, sueños anormales, apatía",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agitação, diminuição da libido, ansiedade, nervosismo, confusão, mulheres: distúrbios do orgasmo, sonhos anormais, apatia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agitation, baisse de la libido, anxiété, nervosité, confusion, chez la femme : troubles de l’orgasme, rêves anormaux, apathie",
                  "by": "ours"
                },
                "it": {
                  "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, donne: disturbi dell’orgasmo, disturbi dell’attività onirica, apatia",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम (confusion), महिलाएँ: ऑर्गेज़्म की गड़बड़ियाँ, असामान्य सपने, उदासीनता (apathy)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Selten"
              ],
              "since": null,
              "lang": "de",
              "text": "Gesteigerte Libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Increased libido",
                  "by": "ours"
                },
                "es": {
                  "text": "Aumento de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Aumento da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "Augmentation de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Aumento della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में बढ़ोतरी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation, Dysmenorrhö",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence, ejaculation disorders, absent ejaculation, dysmenorrhoea",
                  "by": "ours"
                },
                "es": {
                  "text": "Impotencia, trastornos de la eyaculación, insuficiencia eyaculatoria, dismenorrea",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência, distúrbios da ejaculação, falha na ejaculação, dismenorreia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Impuissance, troubles de l’éjaculation, absence d’éjaculation, dysménorrhée",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza, disturbi di eiaculazione, mancata eiaculazione, dismenorrea",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ, स्खलन न हो पाना, माहवारी में दर्द (dysmenorrhoea)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Nicht bekannt"
              ],
              "since": null,
              "lang": "de",
              "text": "Frauen: Metrorrhagie, postpartale Hämorrhagie2; Männer: Priapismus; Galaktorrhö",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Women: metrorrhagia, postpartum haemorrhage2; men: priapism; galactorrhoea",
                  "by": "ours"
                },
                "es": {
                  "text": "Mujeres: metrorragia, hemorragia posparto2; hombres: priapismo; galactorrea",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Mulheres: metrorragia, hemorragia pós-parto2; homens: priapismo; galactorreia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez la femme : métrorragie, hémorragie du post-partum2 ; chez l’homme : priapisme ; galactorrhée",
                  "by": "ours"
                },
                "it": {
                  "text": "Donne: metrorragia, emorragia postpartum2; uomini: priapismo; galattorrea",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाएँ: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)2; पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism); स्तनों से दूध जैसा स्राव (galactorrhoea)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "de",
              "text": "Die unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht und vorübergehend. Sie treten am häufigsten in den ersten ein oder zwei Behandlungswochen auf und klingen anschließend im Allgemeinen wieder ab.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects observed with citalopram are generally mild and transient. They occur most often in the first one or two weeks of treatment and generally subside afterwards.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios observados con citalopram son, en general, leves y transitorios. Aparecen con más frecuencia en la primera o las dos primeras semanas de tratamiento y, en general, remiten después.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais observados com o citalopram são em geral leves e transitórios. Ocorrem com mais frequência na primeira ou nas duas primeiras semanas de tratamento e, em geral, regridem em seguida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables observés sous citalopram sont en général légers et transitoires. Ils surviennent le plus souvent au cours de la première ou des deux premières semaines de traitement et s’atténuent en général par la suite.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati osservati con citalopram sono in genere lievi e transitori. Compaiono più spesso nella prima o nelle prime due settimane di trattamento e in seguito, in genere, regrediscono.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम के साथ देखे गए साइड इफ़ेक्ट आम तौर पर हल्के और अस्थायी होते हैं। ये इलाज के पहले एक या दो हफ़्तों में सबसे ज़्यादा होते हैं और उसके बाद आम तौर पर धीरे-धीरे खत्म हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-de-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-de-regulator",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Bulletin/2019/2-2019.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2019-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Ausgabe 2 | Juni 2019"
          },
          "passages": [
            {
              "key": "wording",
              "kind": "sexual-persistence",
              "section": [
                "PRAC-Meldungen",
                "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen",
                "Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "citalopram-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "SEROPRAM",
              "form": "20 mg, comprimé pelliculé sécable",
              "holder": "LUNDBECK SAS"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69388669/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69388669/extrait",
            "textDate": "2025-05-22",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 22/05/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Mises en garde spéciales et précautions d'emploi",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs/SNRIs have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von sexueller Funktionsstörung berichtet, bei denen die Symptome trotz Absetzen der Behandlung mit SSRI/SNRI anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual cuyos síntomas se han prolongado a pesar de la suspensión del tratamiento con ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual cujos sintomas se prolongaram apesar da interrupção do tratamento com ISRS/IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale i cui sintomi si sono protratti nonostante l’interruzione del trattamento con SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI दवाओं से इलाज बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Agitation, baisse de la libido, anxiété, nervosité, confusion, anorgasmie chez la femme, rêves anormaux",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Agitation, decreased libido, anxiety, nervousness, confusion, anorgasmia in women, abnormal dreams",
                  "by": "ours"
                },
                "de": {
                  "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Anorgasmie bei Frauen, anormale Träume",
                  "by": "ours"
                },
                "es": {
                  "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, confusión, anorgasmia en la mujer, sueños anormales",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agitação, diminuição da libido, ansiedade, nervosismo, confusão, anorgasmia na mulher, sonhos anormais",
                  "by": "ours"
                },
                "it": {
                  "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, anorgasmia nella donna, disturbi dell’attività onirica",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम (confusion), महिलाओं में ऑर्गेज़्म न हो पाना (anorgasmia), असामान्य सपने",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Chez l’homme : impuissance, troubles de l’éjaculation",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In men: impotence, ejaculation disorders",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Männern: Impotenz, Ejakulationsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "En el hombre: impotencia, trastornos de la eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "No homem: impotência, distúrbios da ejaculação",
                  "by": "ours"
                },
                "it": {
                  "text": "Nell’uomo: impotenza, disturbi di eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में: स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquence indéterminée"
              ],
              "since": null,
              "lang": "fr",
              "text": "Galactorrhée Chez la femme : métrorragie, hémorragie du post-partum3 Chez l’homme : priapisme",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea In women: metrorrhagia, postpartum haemorrhage3 In men: priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Bei Frauen: Metrorrhagie, postpartale Hämorrhagie3 Bei Männern: Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea En la mujer: metrorragia, hemorragia posparto3 En el hombre: priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Na mulher: metrorragia, hemorragia pós-parto3 No homem: priapismo",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Nella donna: metrorragia, emorragia postpartum3 Nell’uomo: priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) महिलाओं में: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)3 पुरुषों में: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "fr",
              "text": "Les effets indésirables observés durant le traitement par citalopram sont en général d’intensité peu sévère et transitoires et sont plus fréquemment observés durant la première voire les deux premières semaines du traitement et s'estompent par la suite en intensité et en fréquence.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects observed during treatment with citalopram are in general mild in intensity and transient, are seen more often during the first week, or even the first two weeks, of treatment, and then fade in intensity and in frequency.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die während der Behandlung mit Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht ausgeprägt und vorübergehend; sie werden häufiger in der ersten oder auch in den ersten beiden Behandlungswochen beobachtet und lassen danach an Stärke und Häufigkeit nach.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos observados durante el tratamiento con citalopram son, en general, de intensidad leve y transitorios, se observan con más frecuencia durante la primera semana o incluso las dos primeras semanas del tratamiento y después se atenúan en intensidad y en frecuencia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos observados durante o tratamento com citalopram são em geral de intensidade leve e transitórios, são observados com mais frequência durante a primeira ou mesmo as duas primeiras semanas do tratamento e depois se atenuam em intensidade e em frequência.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati osservati durante il trattamento con citalopram sono in generale di lieve intensità e transitori, si osservano più frequentemente durante la prima o anche le prime due settimane di trattamento e in seguito si attenuano per intensità e frequenza.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम से इलाज के दौरान देखे गए साइड इफ़ेक्ट आम तौर पर हल्की तीव्रता के और अस्थायी होते हैं। ये इलाज के पहले हफ़्ते में, या पहले दो हफ़्तों में भी, ज़्यादा बार देखे जाते हैं, और उसके बाद इनकी तीव्रता घटती जाती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-fr-leaflet",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "SEROPRAM",
              "form": "20 mg, comprimé pelliculé sécable",
              "holder": "LUNDBECK SAS"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69388669/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69388669/extrait",
            "textDate": "2025-05-22",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 22/05/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SEROPRAM 20 mg, comprimé pelliculé sécable ?",
                "Avertissements et précautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms continued after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas se han prolongado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas se prolongaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi si sono protratti dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquemment (de 1 à 10 personnes sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Diminution de la libido,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decreased libido,",
                  "by": "ours"
                },
                "de": {
                  "text": "Verringerte Libido,",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución de la libido,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição da libido,",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione della libido,",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquemment (de 1 à 10 personnes sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Troubles de l’orgasme chez la femme,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Orgasm disorders in women,",
                  "by": "ours"
                },
                "de": {
                  "text": "Orgasmusstörungen bei Frauen,",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos del orgasmo en la mujer,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios do orgasmo na mulher,",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi dell’orgasmo nella donna,",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं में ऑर्गेज़्म की गड़बड़ियाँ,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquemment (de 1 à 10 personnes sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Troubles de l’éjaculation et de l’érection chez l’homme,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Ejaculation and erection disorders in men,",
                  "by": "ours"
                },
                "de": {
                  "text": "Ejakulations- und Erektionsstörungen bei Männern,",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos de la eyaculación y de la erección en el hombre,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios da ejaculação e da ereção no homem,",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi dell’eiaculazione e dell’erezione nell’uomo,",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में स्खलन और इरेक्शन की गड़बड़ियाँ,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Effets indésirables dont on ne connaît pas la fréquence :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Erections douloureuses,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erections,",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektionen,",
                  "by": "ours"
                },
                "es": {
                  "text": "Erecciones dolorosas,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas,",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose,",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-5",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Effets indésirables dont on ne connaît pas la fréquence :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Erection douloureuse et qui dure dans le temps,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erection that goes on for a long time,",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte und lang anhaltende Erektion,",
                  "by": "ours"
                },
                "es": {
                  "text": "Erección dolorosa y que se prolonga en el tiempo,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereção dolorosa e que se prolonga no tempo,",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezione dolorosa e prolungata,",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन, जो लंबे समय तक बना रहता है,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?"
              ],
              "since": null,
              "qualifies": "listed-5",
              "lang": "fr",
              "text": "Les effets indésirables disparaissent habituellement après quelques semaines de traitement. Certains effets indésirables peuvent être des symptômes de la maladie pour laquelle vous êtes traité, qui par conséquent s’amélioreront quand vous commencerez à aller mieux.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects usually disappear after a few weeks of treatment. Some side effects may be symptoms of the illness you are being treated for, and will therefore improve when you start to feel better.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen verschwinden gewöhnlich nach einigen Behandlungswochen. Manche Nebenwirkungen können Symptome der Krankheit sein, wegen der Sie behandelt werden, und werden sich daher bessern, wenn Sie beginnen, sich besser zu fühlen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos suelen desaparecer después de algunas semanas de tratamiento. Algunos efectos adversos pueden ser síntomas de la enfermedad para la que recibe tratamiento y, por tanto, mejorarán cuando usted empiece a encontrarse mejor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos geralmente desaparecem após algumas semanas de tratamento. Alguns efeitos adversos podem ser sintomas da doença para a qual você está em tratamento e, por isso, vão melhorar quando você começar a se sentir melhor.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati di solito scompaiono dopo alcune settimane di trattamento. Alcuni effetti indesiderati possono essere sintomi della malattia per la quale lei è in trattamento e, di conseguenza, miglioreranno quando comincerà a stare meglio.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर इलाज के कुछ हफ़्तों बाद चले जाते हैं। कुछ साइड इफ़ेक्ट उस बीमारी के लक्षण हो सकते हैं, जिसके लिए आपका इलाज हो रहा है, और इसलिए जब आप बेहतर महसूस करने लगेंगे, तब उनमें सुधार होगा।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "citalopram-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Seropram",
              "form": "compresse rivestite con film",
              "holder": "Lundbeck Italia S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7184/farmaci/28759/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2025-10-25",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 25/10/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Avvertenze speciali e precauzioni di impiego",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome nach dem Absetzen von SSRI/SNRI fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual a largo plazo con persistencia de los síntomas tras la interrupción del uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual de longo prazo, com persistência dos sintomas após a interrupção do uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle à long terme ont été signalés, avec persistance des symptômes après l’arrêt de l’utilisation des ISRS/IRSN.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI का इस्तेमाल बंद करने के बाद भी लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Disturbi psichiatrici",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, orgasmo anormale (donne), disturbi dell’attività onirica",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Agitation, decreased libido, anxiety, nervousness, confusional state, abnormal orgasm (women), disturbed dreaming",
                  "by": "ours"
                },
                "de": {
                  "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Orgasmusstörungen (Frauen), Störungen der Traumaktivität",
                  "by": "ours"
                },
                "es": {
                  "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, estado de confusión, orgasmo anormal (mujeres), trastornos de la actividad onírica",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agitação, diminuição da libido, ansiedade, nervosismo, estado confusional, orgasmo anormal (mulheres), distúrbios da atividade onírica",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agitation, baisse de la libido, anxiété, nervosité, état confusionnel, orgasme anormal (chez la femme), troubles de l’activité onirique",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम की अवस्था (confusional state), ऑर्गेज़्म में गड़बड़ी (महिलाओं में), सपनों में गड़बड़ी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Impotenza, disturbi di eiaculazione, mancata eiaculazione",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence, ejaculation disorders, failure to ejaculate",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation",
                  "by": "ours"
                },
                "es": {
                  "text": "Impotencia, trastornos de la eyaculación, insuficiencia eyaculatoria",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência, distúrbios da ejaculação, falha na ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Impuissance, troubles de l’éjaculation, absence d’éjaculation",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ, स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Non nota"
              ],
              "since": null,
              "lang": "it",
              "text": "Galattorrea Donne: metrorragia, emorragia postpartum2 Uomini: priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Women: metrorrhagia, postpartum haemorrhage2 Men: priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Frauen: Metrorrhagie, postpartale Hämorrhagie2 Männer: Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Mujeres: metrorragia, hemorragia posparto2 Hombres: priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Mulheres: metrorragia, hemorragia pós-parto2 Homens: priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez la femme : métrorragie, hémorragie du post-partum2 Chez l’homme : priapisme",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) महिलाएँ: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)2 पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "it",
              "text": "Gli effetti indesiderati osservati con citalopram sono in generale, di lieve entità e di tipo transitorio. Essi si manifestano soprattutto nella prima o seconda settimana di terapia, per poi attenuarsi successivamente.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects observed with citalopram are in general mild and transient. They appear mostly in the first or second week of treatment and then lessen.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht und vorübergehend. Sie treten vor allem in der ersten oder zweiten Behandlungswoche auf und schwächen sich anschließend ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos observados con citalopram son, en general, de intensidad leve y de carácter transitorio. Se manifiestan sobre todo en la primera o la segunda semana de tratamiento y después se atenúan.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos observados com citalopram são, em geral, de intensidade leve e de tipo transitório. Eles se manifestam sobretudo na primeira ou na segunda semana de terapia e depois se atenuam.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables observés avec le citalopram sont en général légers et de nature transitoire. Ils se manifestent surtout pendant la première ou la deuxième semaine de traitement, puis s’atténuent par la suite.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम के साथ देखे गए साइड इफ़ेक्ट आम तौर पर हल्के और अस्थायी होते हैं। ये ज़्यादातर इलाज के पहले या दूसरे हफ़्ते में सामने आते हैं, और उसके बाद कम हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per il paziente",
            "lang": "it",
            "product": {
              "name": "Seropram",
              "form": "compresse rivestite con film",
              "holder": "Lundbeck Italia S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7184/farmaci/28759/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2025-10-25",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 25/10/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Cosa deve sapere prima di prendere SEROPRAM",
                "Avvertenze e precauzioni"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms have been seen to persist after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, se ha observado la persistencia de estos síntomas tras la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, observou-se a persistência desses sintomas após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la persistance de ces symptômes a été observée après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में देखा गया है कि ये लक्षण इलाज बंद करने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Comuni (possono interessare fino a 1 su 10 persone):"
              ],
              "since": null,
              "lang": "it",
              "text": "agitazione, riduzione del desiderio sessuale (libido), ansia, nervosismo, confusione (stato confusionale), orgasmo anormale nelle donne, sogni anomali (disturbi dell’attività onirica);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "agitation, reduced sexual desire (libido), anxiety, nervousness, confusion (confusional state), abnormal orgasm in women, abnormal dreams (disturbed dreaming);",
                  "by": "ours"
                },
                "de": {
                  "text": "Agitiertheit, vermindertes sexuelles Verlangen (Libido), Ängstlichkeit, Nervosität, Verwirrtheit (Verwirrtheitszustand), Orgasmusstörungen bei Frauen, anormale Träume (Störungen der Traumaktivität);",
                  "by": "ours"
                },
                "es": {
                  "text": "agitación, disminución del deseo sexual (libido), ansiedad, nerviosismo, confusión (estado de confusión), orgasmo anormal en las mujeres, sueños anormales (trastornos de la actividad onírica);",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "agitação, diminuição do desejo sexual (libido), ansiedade, nervosismo, confusão (estado confusional), orgasmo anormal nas mulheres, sonhos anormais (distúrbios da atividade onírica);",
                  "by": "ours"
                },
                "fr": {
                  "text": "agitation, baisse du désir sexuel (libido), anxiété, nervosité, confusion (état confusionnel), orgasme anormal chez la femme, rêves anormaux (troubles de l’activité onirique) ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), यौन इच्छा में कमी (कामेच्छा), एंग्ज़ायटी, घबराहट, भ्रम (confusional state), महिलाओं में ऑर्गेज़्म में गड़बड़ी, असामान्य सपने (सपनों में गड़बड़ी);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Comuni (possono interessare fino a 1 su 10 persone):"
              ],
              "since": null,
              "lang": "it",
              "text": "disturbi sessuali nell’uomo (impotenza, disturbi di eiaculazione, mancata eiaculazione)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual disorders in men (impotence, ejaculation disorders, failure to ejaculate)",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion bei Männern (Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation)",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos sexuales en el hombre (impotencia, trastornos de la eyaculación, ausencia de eyaculación)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais no homem (impotência, distúrbios da ejaculação, falha na ejaculação)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels chez l’homme (impuissance, troubles de l’éjaculation, absence d’éjaculation)",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में यौन गड़बड़ियाँ (स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ, स्खलन न हो पाना)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Frequenza non nota (la cui frequenza non può essere definita sulla base dei dati disponibili):"
              ],
              "since": null,
              "lang": "it",
              "text": "erezione prolungata e dolorosa (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "prolonged and painful erection (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "lang anhaltende und schmerzhafte Erektion (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "erección prolongada y dolorosa (priapismo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereção prolongada e dolorosa (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection prolongée et douloureuse (priapisme)",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "it",
              "text": "Gli effetti indesiderati si manifestano soprattutto nella prima o seconda settimana di terapia, per poi successivamente scomparire.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects appear mostly in the first or second week of treatment and then disappear.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen treten vor allem in der ersten oder zweiten Behandlungswoche auf und verschwinden anschließend wieder.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos se manifiestan sobre todo en la primera o la segunda semana de tratamiento y después desaparecen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos se manifestam sobretudo na primeira ou na segunda semana de terapia e depois desaparecem.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables se manifestent surtout pendant la première ou la deuxième semaine de traitement, puis disparaissent par la suite.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट ज़्यादातर इलाज के पहले या दूसरे हफ़्ते में सामने आते हैं, और उसके बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-es",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "Seropram",
              "form": "30 mg comprimidos recubiertos con película",
              "holder": "Lundbeck España, SA"
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/63564/FT_63564.html",
            "fetchedUrl": null,
            "textDate": "2023-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO Octubre 2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Advertencias y precauciones especiales de empleo",
                "Disfunción sexual"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen des SSRI/SNRI fortbestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da suspensão do ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’arrêt de l’ISRS/IRSN, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante la sospensione dell’SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos psiquiátricos",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, estado de confusión, mujeres: orgasmos anormales, sueños anormales",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Agitation, decreased libido, anxiety, nervousness, confusional state, women: abnormal orgasms, abnormal dreams",
                  "by": "ours"
                },
                "de": {
                  "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Frauen: Orgasmusstörungen, anormale Träume",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Agitação, diminuição da libido, ansiedade, nervosismo, estado de confusão, mulheres: orgasmos anormais, sonhos anormais",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agitation, baisse de la libido, anxiété, nervosité, état confusionnel, chez la femme : orgasmes anormaux, rêves anormaux",
                  "by": "ours"
                },
                "it": {
                  "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, donne: orgasmi anormali, disturbi dell’attività onirica",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम की अवस्था (confusional state), महिलाएँ: ऑर्गेज़्म में गड़बड़ी, असामान्य सपने",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "Impotencia, trastornos de la eyaculación, insuficiencia eyaculatoria",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence, ejaculation disorders, ejaculation failure",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência, distúrbios da ejaculação, falha na ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Impuissance, troubles de l’éjaculation, échec de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza, disturbi di eiaculazione, mancata eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ, स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "No conocida"
              ],
              "since": null,
              "lang": "es",
              "text": "Galactorrea Mujeres: metrorragia, hemorragia posparto2 Hombres: priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Women: metrorrhagia, postpartum haemorrhage2 Men: priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Frauen: Metrorrhagie, postpartale Hämorrhagie2 Männer: Priapismus",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Mulheres: metrorragia, hemorragia pós-parto2 Homens: priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez la femme : métrorragie, hémorragie du post-partum2 Chez l’homme : priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Donne: metrorragia, emorragia postpartum2 Uomini: priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) महिलाएँ: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)2 पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "es",
              "text": "Las reacciones adversas observadas con citalopram son generalmente de intensidad leve y transitoria. Son más frecuentes durante la primera o las dos primeras semanas del tratamiento, y posteriormente, normalmente, van desapareciendo.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse reactions observed with citalopram are generally mild in intensity and transient. They are most frequent during the first one or two weeks of treatment, and afterwards they normally fade away.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht und vorübergehend. Sie sind in der ersten oder den ersten beiden Behandlungswochen am häufigsten und verschwinden danach in der Regel nach und nach.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas observadas com citalopram são geralmente de intensidade leve e transitória. São mais frequentes durante a primeira ou as duas primeiras semanas do tratamento e, depois, normalmente vão desaparecendo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables observés avec le citalopram sont généralement d’intensité légère et transitoires. Ils sont plus fréquents pendant la première ou les deux premières semaines du traitement et, par la suite, disparaissent normalement peu à peu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse osservate con citalopram sono generalmente di intensità lieve e transitoria. Sono più frequenti durante la prima o le prime due settimane di trattamento e in seguito, di norma, vanno scomparendo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम के साथ देखे गए साइड इफ़ेक्ट आम तौर पर हल्की तीव्रता के और अस्थायी होते हैं। ये इलाज के पहले हफ़्ते या पहले दो हफ़्तों के दौरान ज़्यादा होते हैं, और उसके बाद सामान्य तौर पर धीरे-धीरे चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-es-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-es-leaflet",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: información para el usuario",
            "lang": "es",
            "product": {
              "name": "Seropram",
              "form": "30 mg Comprimidos recubiertos con película",
              "holder": "Lundbeck España, SA"
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/63564/P_63564.html",
            "fetchedUrl": null,
            "textDate": "2025-06",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: Junio 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Qué necesita saber antes de empezar a tomar Seropram",
                "Advertencias y precauciones"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas persistem depois de suspender o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes persistent après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi persistono dopo la sospensione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):"
              ],
              "since": null,
              "lang": "es",
              "text": "Disminución de la conducta sexual.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decrease in sexual behaviour.",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des Sexualverhaltens.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do comportamento sexual.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Diminution du comportement sexuel.",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del comportamento sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन व्यवहार में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):"
              ],
              "since": null,
              "lang": "es",
              "text": "Los hombres pueden experimentar problemas con la eyaculación y erección.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men may experience problems with ejaculation and erection.",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer können Probleme mit der Ejakulation und der Erektion haben.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os homens podem apresentar problemas de ejaculação e ereção.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les hommes peuvent présenter des troubles de l’éjaculation et de l’érection.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli uomini possono avere problemi di eiaculazione e di erezione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों को स्खलन और इरेक्शन की समस्याएँ हो सकती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):"
              ],
              "since": null,
              "lang": "es",
              "text": "Las mujeres pueden experimentar dificultad para alcanzar el orgasmo.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Women may experience difficulty reaching orgasm.",
                  "by": "ours"
                },
                "de": {
                  "text": "Frauen können Schwierigkeiten haben, zum Orgasmus zu kommen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As mulheres podem apresentar dificuldade para chegar ao orgasmo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les femmes peuvent présenter des difficultés à atteindre l’orgasme.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le donne possono avere difficoltà a raggiungere l’orgasmo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida (no puede estimarse a partir de los datos disponibles):"
              ],
              "since": null,
              "lang": "es",
              "text": "Erecciones dolorosas.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erections.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektionen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érections douloureuses.",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Posibles efectos adversos"
              ],
              "since": null,
              "qualifies": "listed-4",
              "lang": "es",
              "text": "Los siguientes efectos adversos son generalmente leves y normalmente desaparecen después de algunos días de tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The following side effects are generally mild and normally disappear after a few days of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die folgenden Nebenwirkungen sind im Allgemeinen leicht und verschwinden normalerweise nach einigen Behandlungstagen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos a seguir são geralmente leves e normalmente desaparecem depois de alguns dias de tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants sont généralement légers et disparaissent normalement après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "I seguenti effetti avversi sono generalmente lievi e di norma scompaiono dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे दिए गए साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और सामान्य तौर पर कुछ दिनों के इलाज के बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-es-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-es-regulator",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/boletines-aemps/boletinMensual/2019-boletinMensual/boletin-mensual-de-la-aemps-sobre-medicamentos-de-uso-humano-del-mes-de-mayo-de-2019/",
            "fetchedUrl": null,
            "textDate": "2019-06-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 26 de junio de 2019"
          },
          "passages": [
            {
              "key": "bulletin",
              "kind": "sexual-persistence",
              "section": [
                "Información sobre seguridad",
                "Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia",
                "Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexual"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "En pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Serotonin-Noradrenalin-Wiederaufnahmehemmern oder mit selektiven Serotonin-Wiederaufnahmehemmern behandelt werden, wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen der Behandlung fortbestehen. Diese Erkenntnis wird in die Warnhinweise dieser Medikamente aufgenommen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em pacientes em tratamento com inibidores da recaptação de serotonina e noradrenalina, ou com inibidores seletivos da recaptação de serotonina, foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da interrupção do tratamento. Esse achado será incorporado às advertências desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez des patients traités par inhibiteurs de la recapture de la sérotonine et de la noradrénaline, ou par inhibiteurs sélectifs de la recapture de la sérotonine, des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’interruption du traitement, ont été signalés. Cette observation sera ajoutée aux mises en garde de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti in trattamento con inibitori della ricaptazione della serotonina e della noradrenalina, o con inibitori selettivi della ricaptazione della serotonina, sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante l’interruzione del trattamento. Questo dato sarà inserito nelle avvertenze di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर या सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर से जिन मरीज़ों का इलाज चल रहा है, उनमें लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें इलाज बंद करने के बावजूद लक्षण बने रहते हैं। यह बात इन दवाओं की चेतावनियों में जोड़ी जाएगी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name citalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Citalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo citalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita citalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif citalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo citalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें सिटालोप्राम का नाम नहीं है।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "DENYL® bromidrato de citalopram: bula para o profissional de saúde",
            "lang": "pt-BR",
            "product": {
              "name": "Denyl",
              "form": "comprimidos revestidos 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/77/bula-profissional",
            "fetchedUrl": null,
            "textDate": "2026-07-10",
            "textDateKind": "change-history",
            "textDateAsPrinted": "10/07/2026"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios psiquiátricos",
                "Comum"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Agitação, diminuição da libido, ansiedade, nervosismo, confusão, sonhos anormais, orgasmo anormal em mulheres",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Agitation, decreased libido, anxiety, nervousness, confusion, abnormal dreams, abnormal orgasm in women",
                  "by": "ours"
                },
                "de": {
                  "text": "Agitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, anormale Träume, Orgasmusstörungen bei Frauen",
                  "by": "ours"
                },
                "es": {
                  "text": "Agitación, disminución de la libido, ansiedad, nerviosismo, confusión, sueños anormales, orgasmo anormal en mujeres",
                  "by": "ours"
                },
                "fr": {
                  "text": "Agitation, baisse de la libido, anxiété, nervosité, confusion, rêves anormaux, orgasme anormal chez la femme",
                  "by": "ours"
                },
                "it": {
                  "text": "Agitazione, riduzione della libido, ansia, nervosismo, stato confusionale, disturbi dell’attività onirica, orgasmo anormale nelle donne",
                  "by": "ours"
                },
                "hi": {
                  "text": "बेचैनी (agitation), कामेच्छा में कमी, एंग्ज़ायटी, घबराहट, भ्रम (confusion), असामान्य सपने, महिलाओं में ऑर्गेज़्म में गड़बड़ी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios do sistema reprodutor e mamas",
                "Comum"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Impotência, alterações da ejaculação, falha da ejaculação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence, ejaculation disorders, ejaculation failure",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz, Ejakulationsstörungen, ausbleibende Ejakulation",
                  "by": "ours"
                },
                "es": {
                  "text": "Impotencia, alteraciones de la eyaculación, insuficiencia eyaculatoria",
                  "by": "ours"
                },
                "fr": {
                  "text": "Impuissance, troubles de l’éjaculation, échec de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza, disturbi di eiaculazione, mancata eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (impotence), स्खलन की गड़बड़ियाँ, स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios do sistema reprodutor e mamas",
                "Desconhecido"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Galactorréia Mulheres: metrorragia, Hemorragia pós-parto² Homens: priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Women: metrorrhagia, postpartum haemorrhage² Men: priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Frauen: Metrorrhagie, postpartale Hämorrhagie² Männer: Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Mujeres: metrorragia, hemorragia posparto² Hombres: priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez la femme : métrorragie, hémorragie du post-partum² Chez l’homme : priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Donne: metrorragia, emorragia postpartum² Uomini: priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) महिलाएँ: दो माहवारियों के बीच खून आना (metrorrhagia), प्रसव के बाद खून बहना (postpartum haemorrhage)² पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "9. REAÇÕES ADVERSAS"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "pt-BR",
              "text": "As reações adversas observadas com citalopram são em geral moderadas e transitórias. As reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse reactions observed with citalopram are in general moderate and transient. Adverse reactions are most frequent during the first or second week of treatment and generally decrease in intensity and frequency as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen mäßig ausgeprägt und vorübergehend. Die Nebenwirkungen sind in der ersten oder zweiten Behandlungswoche am häufigsten und nehmen im weiteren Verlauf der Behandlung in der Regel an Stärke und Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas observadas con citalopram son, en general, moderadas y transitorias. Las reacciones adversas son más frecuentes durante la primera o la segunda semana de tratamiento y, generalmente, disminuyen en intensidad y frecuencia al continuar el tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables observés avec le citalopram sont en général modérés et transitoires. Les effets indésirables sont plus fréquents pendant la première ou la deuxième semaine de traitement et, généralement, diminuent en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse osservate con citalopram sono in generale moderate e transitorie. Le reazioni avverse sono più frequenti durante la prima o la seconda settimana di trattamento e, generalmente, diminuiscono di intensità e frequenza con il proseguimento del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सिटालोप्राम के साथ देखे गए साइड इफ़ेक्ट आम तौर पर मध्यम दर्जे के और अस्थायी होते हैं। साइड इफ़ेक्ट इलाज के पहले या दूसरे हफ़्ते में ज़्यादा होते हैं, और इलाज जारी रहने के साथ आम तौर पर इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "originatorNotOpened",
              "text": {
                "en": "The originator product's text could not be opened. This is the text of another product, the one named in this row.",
                "de": "Der Text des Originalpräparats ließ sich nicht öffnen. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "El texto del producto original no se pudo abrir. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Não foi possível abrir o texto do produto original. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Le texte du produit d’origine n’a pas pu être ouvert. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Non è stato possibile aprire il testo del medicinale originatore. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "दवा के मूल (originator) उत्पाद का दस्तावेज़ खोला नहीं जा सका। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "citalopram-br-leaflet-denyl",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-br-leaflet-denyl",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "DENYL® bromidrato de citalopram: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Denyl",
              "form": "comprimidos revestidos 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/77/bula-paciente",
            "fetchedUrl": null,
            "textDate": "2026-07-10",
            "textDateKind": "change-history",
            "textDateAsPrinted": "10/07/2026"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR?",
                "Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "diminuição do desejo sexual",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR?",
                "Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "homens podem apresentar problemas de ereção e ejaculação,e mulheres podem apresentar dificuldade para chegar ao orgasmo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "men may have problems with erection and ejaculation, and women may have difficulty reaching orgasm",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer können Probleme mit Erektion und Ejakulation haben, und Frauen können Schwierigkeiten haben, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "los hombres pueden presentar problemas de erección y eyaculación, y las mujeres pueden presentar dificultad para llegar al orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "les hommes peuvent présenter des troubles de l’érection et de l’éjaculation, et les femmes peuvent présenter des difficultés à atteindre l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "gli uomini possono presentare problemi di erezione e di eiaculazione, e le donne possono presentare difficoltà a raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों को इरेक्शन और स्खलन की समस्याएँ हो सकती हैं, और महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR?",
                "Alguns pacientes já apresentaram (frequência desconhecida):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "ereção dolorosa (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "painful erection (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "schmerzhafte Erektion (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "erección dolorosa (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection douloureuse (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "erezione dolorosa (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "pt-BR",
              "text": "Os seguintes efeitos adversos descritos a seguir são geralmente ligeiros e desaparecem habitualmente após alguns dias de tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects described below are generally mild and usually disappear after a few days of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die im Folgenden beschriebenen Nebenwirkungen sind im Allgemeinen leicht und verschwinden gewöhnlich nach einigen Behandlungstagen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos descritos a continuación son generalmente leves y habitualmente desaparecen después de algunos días de tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables décrits ci-dessous sont généralement légers et disparaissent habituellement après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi descritti di seguito sono generalmente lievi e di solito scompaiono dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे बताए गए साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और सामान्य तौर पर कुछ दिनों के इलाज के बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "citalopram-br-leaflet-alcytam",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-br-leaflet-alcytam",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ALCYTAM® bromidrato de citalopram: bula para paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Alcytam",
              "form": "comprimido revestido 20 mg",
              "holder": "Torrent do Brasil Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Torrent do Brasil Ltda."
            },
            "url": "https://www.torrent.com.br/uploads/01-%20Alcytam_Bula%20Paciente_BU-14.pdf",
            "fetchedUrl": null,
            "textDate": "2026-06-29",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi aprovada pela Anvisa em 29/06/2026."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% (> 1/100 e < 1/10) dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "diminuição do desejo sexual",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% (> 1/100 e < 1/10) dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "homens podem apresentar problemas de ereção e ejaculação, e mulheres podem apresentar dificuldade para chegar ao orgasmo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "men may have problems with erection and ejaculation, and women may have difficulty reaching orgasm",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer können Probleme mit Erektion und Ejakulation haben, und Frauen können Schwierigkeiten haben, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "los hombres pueden presentar problemas de erección y eyaculación, y las mujeres pueden presentar dificultad para llegar al orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "les hommes peuvent présenter des troubles de l’érection et de l’éjaculation, et les femmes peuvent présenter des difficultés à atteindre l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "gli uomini possono presentare problemi di erezione e di eiaculazione, e le donne possono presentare difficoltà a raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों को इरेक्शन और स्खलन की समस्याएँ हो सकती हैं, और महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Alguns pacientes já apresentaram (frequência desconhecida):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "ereção dolorosa (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "painful erection (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "schmerzhafte Erektion (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "erección dolorosa (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection douloureuse (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "erezione dolorosa (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "pt-BR",
              "text": "Os seguintes efeitos adversos descritos a seguir são geralmente ligeiros e desaparecem habitualmente após alguns dias de tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects described below are generally mild and usually disappear after a few days of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die im Folgenden beschriebenen Nebenwirkungen sind im Allgemeinen leicht und verschwinden gewöhnlich nach einigen Behandlungstagen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos descritos a continuación son generalmente leves y habitualmente desaparecen después de algunos días de tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables décrits ci-dessous sont généralement légers et disparaissent habituellement après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi descritti di seguito sono generalmente lievi e di solito scompaiono dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे बताए गए साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और सामान्य तौर पर कुछ दिनों के इलाज के बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "citalopram-br-pro-cipramil",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-br-pro-cipramil",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Cipramil",
              "form": null,
              "holder": "Lundbeck Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=cipramil&page=1",
            "https://www.lundbeck.com/br/our-science/Products"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-br-leaflet-cipramil",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-br-leaflet-cipramil",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Cipramil",
              "form": null,
              "holder": "Lundbeck Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=cipramil&page=1",
            "https://www.lundbeck.com/br/our-science/Products"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "citalopram-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#citalopram-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "no-public-database"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": null,
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/",
            "https://sunpharma.com/india-products/",
            "https://sunpharma.com/india-prescribing-information/",
            "https://www.intaspharma.com/products/",
            "https://www.zyduslife.com/products.html",
            "https://www.zydushealthcare.com/brands/",
            "https://www.torrentpharma.com/pi/",
            "https://www.ciplamed.com/sitemap-pages.xml"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        }
      ]
    },
    {
      "id": "escitalopram",
      "inn": "escitalopram",
      "names": {
        "en": "escitalopram",
        "de": "Escitalopram",
        "es": "escitalopram",
        "pt-br": "escitalopram",
        "fr": "escitalopram",
        "it": "escitalopram",
        "hi": "एस्सिटालोप्राम"
      },
      "class": "ssri",
      "classLabel": {
        "en": "SSRI antidepressant",
        "de": "SSRI-Antidepressivum",
        "es": "antidepresivo ISRS",
        "pt-br": "antidepressivo ISRS",
        "fr": "antidépresseur ISRS",
        "it": "antidepressivo SSRI",
        "hi": "SSRI एंटीडिप्रेसेंट"
      },
      "condition": "pssd",
      "lead": {
        "en": "For the SSRI antidepressant escitalopram (Lexapro, Cipralex), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs or SNRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, escitalopram among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.",
        "de": "Zum SSRI-Antidepressivum Escitalopram (Lexapro, Cipralex) steht im Vereinigten Königreich in der Produktinformation, die wir gelesen haben, dass es Berichte über lang anhaltende sexuelle Funktionsstörungen gibt, bei denen die Symptome nach dem Absetzen von SSRI oder SNRI bestehen blieben. Das nennt man sexuelle Funktionsstörung nach SSRI-Einnahme (PSSD). Die Europäische Arzneimittel-Agentur (EMA) legte den Wortlaut dieses Warnhinweises 2019 für zehn Medikamente fest, darunter Escitalopram. Laut einer Antwort der Regierung im britischen Parlament wurden die Produktinformationen für alle SSRI im Vereinigten Königreich 2019 um diesen Warnhinweis ergänzt.",
        "es": "En el caso del escitalopram (Lexapro, Cipralex), un antidepresivo ISRS, la información del producto que hemos leído en el Reino Unido dice que se han notificado casos de disfunción sexual de larga duración en los que los síntomas continuaron después de dejar los ISRS o los IRSN. Esto se conoce como disfunción sexual post-ISRS (PSSD). La Agencia Europea de Medicamentos (EMA) fijó en 2019 el texto de esta advertencia para diez medicamentos, entre ellos el escitalopram, y una respuesta del Gobierno en el Parlamento dice que la información del producto de todos los ISRS en el Reino Unido se actualizó en 2019 para incluirla.",
        "pt-br": "No caso do antidepressivo ISRS escitalopram (Lexapro, Cipralex), a bula que lemos no Reino Unido diz que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram depois da interrupção dos ISRS ou IRSN. Esse quadro é conhecido como disfunção sexual pós-ISRS (PSSD). A agência reguladora de medicamentos da UE definiu o texto desse alerta em 2019 para dez medicamentos, entre eles o escitalopram. Uma resposta do governo no Parlamento diz que as bulas de todos os ISRS no Reino Unido foram atualizadas em 2019 para incluí-lo.",
        "fr": "Pour l’escitalopram (Lexapro, Cipralex), un antidépresseur ISRS, les informations sur le produit que nous avons lues au Royaume-Uni indiquent que des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui ont persisté après l’arrêt des ISRS ou des IRSN. C’est ce qu’on appelle la dysfonction sexuelle post-ISRS (PSSD). L’Agence européenne des médicaments (EMA) a fixé la formulation de cette mise en garde en 2019 pour dix médicaments, dont l’escitalopram. Selon une réponse du gouvernement britannique au Parlement, les informations sur le produit de tous les ISRS ont été mises à jour au Royaume-Uni en 2019 pour l’intégrer.",
        "it": "Per l’antidepressivo SSRI escitalopram (Lexapro, Cipralex), le informazioni sul prodotto che abbiamo letto nel Regno Unito dicono che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI o SNRI. Questo quadro è noto come disfunzione sessuale post-SSRI (PSSD). L’agenzia del farmaco dell’UE ha fissato il testo di questa avvertenza nel 2019 per dieci medicinali, tra cui l’escitalopram. Una risposta del governo al Parlamento britannico dice che nel 2019 le informazioni sul prodotto britanniche di tutti gli SSRI sono state aggiornate per riportare questa avvertenza.",
        "hi": "SSRI एंटीडिप्रेसेंट एस्सिटालोप्राम (Lexapro, Cipralex) के मामले में, ब्रिटेन में हमने दवा की जो आधिकारिक जानकारी (product information) पढ़ी, वह कहती है कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI या SNRI दवाएँ बंद करने के बाद भी लक्षण जारी रहे। इसे पोस्ट-SSRI सेक्शुअल डिस्फ़ंक्शन (PSSD) कहते हैं। यूरोपीय संघ (EU) के दवा नियामक ने 2019 में इस चेतावनी के शब्द दस दवाओं के लिए तय किए, जिनमें एस्सिटालोप्राम भी है। ब्रिटेन की संसद में सरकार का एक जवाब कहता है कि वहाँ सभी SSRI दवाओं की आधिकारिक जानकारी 2019 में अपडेट की गई, ताकि उसमें यह चेतावनी हो।"
      },
      "brands": [
        {
          "name": "Lexapro",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Cipralex",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2228",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=74862",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "PatientenInfo-Service",
              "sourceUrl": "https://www.patienteninfo-service.de/a-z-liste/c/cipralex-10-mg-filmtabletten",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000035875?lang=it",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=65230",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Seroplex",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67219535/extrait",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Enalto",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2228",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Balansya",
          "listings": [
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106886",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Loxalate",
          "listings": [
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Giachela",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000047447?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prameffex",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000052294?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Gomeisa",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000052527?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Entact",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000035881?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Sosecit",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000047993?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Amasci",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000048191?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Escertal",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000048421?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Xipram",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000067553?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Esertia",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=68875",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Diprex",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=78235",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Essential",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=78237",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Heipram",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=78080",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Deciprax",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Esc",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Esc ODT",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Escena",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Escilex",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Escip",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Espran",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Eudok",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Exodus",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Felissa",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fusor",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Lexaprass",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Mind",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Reconter",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Reconter ODT",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Sytoc",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Unitram",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        }
      ],
      "leadBrands": [
        "Lexapro",
        "Cipralex"
      ],
      "cardSince": "escitalopram-uk#persistence",
      "unknowns": [
        {
          "id": "frequency-pssd",
          "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/37294623/",
          "text": {
            "en": "No reliable figure exists for how often PSSD happens.",
            "de": "Eine verlässliche Zahl dazu, wie oft PSSD vorkommt, gibt es nicht.",
            "es": "No existe ninguna cifra fiable sobre la frecuencia con la que se produce la PSSD.",
            "pt-br": "Não existe um número confiável sobre a frequência com que a PSSD acontece.",
            "fr": "Il n’existe aucun chiffre fiable sur la fréquence de la PSSD.",
            "it": "Non esiste una cifra affidabile su quanto spesso si verifichi la PSSD.",
            "hi": "PSSD कितनी बार होता है, इसका कोई भरोसेमंद आँकड़ा नहीं है।"
          }
        },
        {
          "id": "estimate-men-pssd",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10122283/",
          "text": {
            "en": "One study of health records gives an estimate for men, counted through prescriptions for erection medicines.",
            "de": "Eine Studie auf der Grundlage von Krankenakten nennt eine Schätzung für Männer, gezählt anhand der Verordnungen von Erektionsmitteln.",
            "es": "Un estudio de historias clínicas da una estimación para hombres, calculada a partir de las recetas de medicamentos para la erección.",
            "pt-br": "Um estudo com dados de prontuários médicos traz uma estimativa para homens, calculada a partir das receitas de medicamentos para ereção.",
            "fr": "Une étude menée sur des dossiers médicaux donne une estimation pour les hommes, établie à partir des prescriptions de médicaments contre les troubles de l’érection.",
            "it": "Uno studio su cartelle cliniche dà una stima per gli uomini, calcolata attraverso le prescrizioni di farmaci per l’erezione.",
            "hi": "मेडिकल रिकॉर्ड पर आधारित एक अध्ययन पुरुषों के लिए एक अनुमान देता है, जो इरेक्शन की दवाओं की पर्चियों से गिना गया।"
          }
        },
        {
          "id": "course",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11450419/",
          "text": {
            "en": "It is not known how many people fully recover.",
            "de": "Es ist nicht bekannt, wie viele Menschen vollständig genesen.",
            "es": "No se sabe cuántas personas se recuperan por completo.",
            "pt-br": "Não se sabe quantas pessoas se recuperam por completo.",
            "fr": "On ne sait pas combien de personnes se rétablissent complètement.",
            "it": "Non si sa quante persone guariscano del tutto.",
            "hi": "यह पता नहीं है कि कितने लोग पूरी तरह ठीक हो जाते हैं।"
          }
        },
        {
          "id": "duration-pssd",
          "sourceUrl": "https://sidefxhub.com/label-wording-by-country/#escitalopram",
          "text": {
            "en": "None of the product texts we read says how long the sexual dysfunction can last.",
            "de": "In keinem der Produkttexte, die wir gelesen haben, steht, wie lange die sexuelle Funktionsstörung anhalten kann.",
            "es": "Ninguno de los textos de producto que hemos leído dice cuánto puede durar la disfunción sexual.",
            "pt-br": "Nenhuma das bulas que lemos diz quanto tempo a disfunção sexual pode durar.",
            "fr": "Aucun des textes de produits que nous avons lus ne dit combien de temps la dysfonction sexuelle peut durer.",
            "it": "Nessuno dei testi dei prodotti che abbiamo letto dice quanto può durare la disfunzione sessuale.",
            "hi": "हमने दवा के जो दस्तावेज़ पढ़े, उनमें से कोई नहीं बताता कि सेक्शुअल डिस्फ़ंक्शन कितने समय तक रह सकता है।"
          }
        }
      ],
      "changed": "2026-10-14",
      "records": [
        {
          "id": "escitalopram-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Cipralex 10 mg film-coated tablets",
            "lang": "en-GB",
            "product": {
              "name": "Cipralex",
              "form": "5 mg, 10 mg and 20 mg film-coated tablets",
              "holder": "Lundbeck Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/7718/smpc",
            "fetchedUrl": null,
            "textDate": "2025-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 05/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "escitalopram-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI)/Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores de la recaptación de serotonina y noradrenalina (IRSN) pueden causar síntomas de disfunción sexual (ver sección 4.8). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS)/inibidores da recaptação de serotonina e noradrenalina (IRSN) podem causar sintomas de disfunção sexual (ver seção 4.8). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS)/inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI)/inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI)/सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8 देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Anxiety, restlessness, abnormal dreams libido decreased Female: anorgasmia",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Frauen: Anorgasmie",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, inquietud, sueños anormales libido disminuida Mujeres: anorgasmia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, inquietude, sonhos anormais diminuição da libido Mulheres: anorgasmia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmie",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido Donne: anorgasmia",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने कामेच्छा में कमी महिलाएँ: ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Male: ejaculation disorder, impotence",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Männer: Ejakulationsstörungen, Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "Hombres: trastorno de la eyaculación, impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Homens: distúrbio da ejaculação, impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : trouble de l’éjaculation, impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "Uomini: disturbi di eiaculazione, impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: स्खलन की गड़बड़ी, स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Not known"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Galactorrhoea Male: priapism Postpartum haemorrhage3",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Galaktorrhö Männer: Priapismus Postpartale Hämorrhagie3",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Hombres: priapismo Hemorragia posparto3",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Homens: priapismo Hemorragia pós-parto3",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez l’homme : priapisme Hémorragie du post-partum3",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Uomini: priapismo Emorragia postpartum3",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism) प्रसव के बाद खून बहना (postpartum haemorrhage)3",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "en-GB",
              "text": "Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Am häufigsten treten Nebenwirkungen in der ersten oder zweiten Behandlungswoche auf und nehmen normalerweise bei fortgesetzter Behandlung an Intensität und Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas son más frecuentes durante la primera o segunda semana del tratamiento y habitualmente disminuyen en intensidad y frecuencia con el tratamiento continuado.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont plus fréquents pendant la première ou la deuxième semaine de traitement et diminuent habituellement en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse si manifestano più frequentemente durante la prima o seconda settimana di trattamento, per poi di solito diminuire d’intensità e frequenza con la continuazione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट इलाज के पहले या दूसरे हफ़्ते में सबसे ज़्यादा होते हैं, और इलाज जारी रहने के साथ आम तौर पर इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PACKAGE LEAFLET: INFORMATION FOR THE USER. Cipralex 5 mg film-coated tablets, Cipralex 10 mg film-coated tablets, Cipralex 20 mg film-coated tablets. escitalopram",
            "lang": "en-GB",
            "product": {
              "name": "Cipralex",
              "form": "5 mg, 10 mg and 20 mg film-coated tablets",
              "holder": "Lundbeck Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.7718.pdf",
            "fetchedUrl": null,
            "textDate": "2025-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in 05/2025."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. What you need to know before you take Cipralex",
                "Warning and Precautions",
                "Please note"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "escitalopram-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Medicines like Cipralex (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Cipralex (so genannte SSRI/SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Cipralex (los llamados ISRS/IRSN) pueden causar síntomas de disfunción sexual (ver sección 4). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Cipralex (os chamados ISRS/IRSN) podem causar sintomas de disfunção sexual (ver seção 4). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Cipralex (appelés ISRS/IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Cipralex (i cosiddetti SSRI/SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Cipralex जैसी दवाओं (जिन्हें SSRI/SNRI कहा जाता है) से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4 देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. POSSIBLE SIDE EFFECTS",
                "Common (may affect up to 1 in 10 people):"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Probleme mit der Erektion, vermindertes sexuelles Verlangen, außerdem können Frauen Schwierigkeiten haben, zum Orgasmus zu kommen)",
                  "by": "ours"
                },
                "es": {
                  "text": "Alteraciones sexuales (retraso de la eyaculación, problemas con la erección, disminución del deseo sexual y las mujeres pueden experimentar dificultades para alcanzar el orgasmo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios sexuais (ejaculação retardada, problemas de ereção, diminuição do desejo sexual e as mulheres podem ter dificuldades para chegar ao orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (éjaculation retardée, troubles de l’érection, baisse du désir sexuel, et les femmes peuvent présenter des difficultés à atteindre l’orgasme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali (ritardata eiaculazione, problemi di erezione, diminuzione degli impulsi sessuali e le donne possono avere difficoltà nel raggiungere l’orgasmo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन की समस्याएँ, कामेच्छा में कमी, और महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. POSSIBLE SIDE EFFECTS",
                "Not known (frequency cannot be estimated from the available data):"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Painful erections (priapism)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schmerzhafte Erektionen (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "Erecciones dolorosas (priapismo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érections douloureuses (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. POSSIBLE SIDE EFFECTS"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "en-GB",
              "text": "The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen gewöhnlich nach wenigen Behandlungswochen ab. Sie sollten auch wissen, dass viele dieser Symptome auch auf Ihre Krankheit zurückzuführen sein können und daher abklingen, wenn Sie beginnen, sich besser zu fühlen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios normalmente desaparecen después de unas pocas semanas de tratamiento. Tenga en cuenta que muchos de estos efectos también pueden ser síntomas de su enfermedad y, por tanto, mejorarán cuando empiece a encontrarse mejor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais geralmente desaparecem após algumas semanas de tratamento. Saiba que muitos dos efeitos também podem ser sintomas da sua doença e, por isso, vão melhorar quando você começar a se sentir melhor.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables disparaissent habituellement après quelques semaines de traitement. Sachez que beaucoup de ces effets peuvent aussi être des symptômes de votre maladie et s’amélioreront donc quand vous commencerez à aller mieux.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati solitamente scompaiono dopo alcune settimane di trattamento. Tenga presente che molti di questi effetti possono essere anche sintomi della sua malattia e quindi miglioreranno quando comincerà a stare meglio.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर इलाज के कुछ हफ़्तों बाद चले जाते हैं। ध्यान रखें कि इनमें से कई असर आपकी बीमारी के लक्षण भी हो सकते हैं, और इसलिए जब आप ठीक होने लगेंगे, तब उनमें सुधार होगा।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-uk-regulator-parliament",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-uk-regulator-parliament",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 50758, House of Commons: \"Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2025-05-07/50758",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/2025-05-07/50758",
            "textDate": "2025-05-13",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2025-05-13T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "sexual-persistence",
              "section": [
                "Answer"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die von der Medicines and Healthcare products Regulatory Agency (MHRA) genehmigten Produktinformationen, die medizinische Fachleute und Patientinnen und Patienten erhalten, wurden 2019 für alle selektiven Serotonin-Wiederaufnahmehemmer (SSRI) aktualisiert, um sie darüber zu informieren, dass Berichte über lang anhaltende sexuelle Funktionsstörungen eingegangen waren, bei denen die Symptome trotz Absetzen des SSRI anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto aprobada por la Medicines and Healthcare products Regulatory Agency (MHRA) que se facilita a profesionales sanitarios y pacientes para todos los inhibidores selectivos de la recaptación de serotonina (ISRS) se actualizó en 2019 para informarles de que se habían recibido notificaciones de disfunción sexual de larga duración en la que los síntomas continúan a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto aprovadas pela Medicines and Healthcare products Regulatory Agency (MHRA) e fornecidas a profissionais de saúde e pacientes para todos os inibidores seletivos da recaptação de serotonina (ISRS) foram atualizadas em 2019 para informá-los de que haviam sido recebidos relatos de disfunção sexual de longa duração em que os sintomas continuam apesar da descontinuação do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit approuvées par la Medicines and Healthcare products Regulatory Agency (MHRA) et fournies aux professionnels de santé et aux patients pour tous les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) ont été mises à jour en 2019 pour les informer que des signalements de dysfonction sexuelle durable, dans laquelle les symptômes persistent malgré l’arrêt de l’ISRS, avaient été reçus.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto approvate dalla Medicines and Healthcare products Regulatory Agency (MHRA) e fornite ai professionisti sanitari e ai pazienti per tutti gli inibitori selettivi della ricaptazione della serotonina (SSRI) sono state aggiornate nel 2019 per informarli che erano pervenute segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi continuano nonostante l’interruzione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Medicines and Healthcare products Regulatory Agency (MHRA) की मंज़ूर की हुई दवा की आधिकारिक जानकारी (product information), जो सभी सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं के लिए डॉक्टरों, दूसरे स्वास्थ्यकर्मियों और मरीज़ों को दी जाती है, 2019 में अपडेट की गई। मकसद उन्हें यह बताना था कि लंबे समय तक रहने वाले ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें मिली हैं, जिसमें SSRI बंद करने के बावजूद लक्षण जारी रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name escitalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Escitalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo escitalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita escitalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif escitalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo escitalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें एस्सिटालोप्राम का नाम नहीं है।"
              }
            },
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "escitalopram-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Zusammenfassung der Merkmale des Arzneimittels",
                    "4.4. Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                    "Sexuelle Funktionsstörung"
                  ],
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Résumé des caractéristiques du produit",
                    "4.4. Mises en garde spéciales et précautions d’emploi",
                    "Dysfonction sexuelle"
                  ],
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Riassunto delle caratteristiche del prodotto",
                    "4.4. Avvertenze speciali e precauzioni d’impiego",
                    "Disfunzione sessuale"
                  ],
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Ficha técnica o resumen de las características del producto",
                    "4.4. Advertencias y precauciones especiales de empleo",
                    "Disfunción sexual"
                  ],
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Resumo das Características do Medicamento",
                    "4.4. Advertências e precauções especiais de utilização",
                    "Disfunção sexual"
                  ],
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS."
                }
              ],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "official"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS.",
                  "by": "official"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "official"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "official"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "escitalopram-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Packungsbeilage",
                    "2. Was sollten Sie vor der Einnahme von [Phantasiebezeichnung] beachten?",
                    "Warnhinweise und Vorsichtsmaßnahmen"
                  ],
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Notice",
                    "2. Quelles sont les informations à connaître avant de prendre [Nom de fantaisie]",
                    "Mises en garde et précautions"
                  ],
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Foglio illustrativo",
                    "2. Cosa deve sapere prima di prendere [denominazione del medicinale]",
                    "Avvertenze e precauzioni"
                  ],
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Prospecto",
                    "2. Qué necesita saber antes de empezar a tomar [nombre de fantasía]",
                    "Advertencias y precauciones"
                  ],
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Folheto Informativo",
                    "2. O que precisa de saber antes de tomar [Nome do medicamento]",
                    "Advertências e precauções"
                  ],
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento."
                }
              ],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "official"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento.",
                  "by": "official"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "official"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "official"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen. Verabschiedet im Rahmen der PRAC-Sitzung vom 13. bis 16. Mai 2019",
              "url": "https://www.ema.europa.eu/de/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_de.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Nouveau texte des informations sur le produit – Extraits des recommandations du PRAC sur les signaux. Adopté les 13-16 mai 2019 par le PRAC",
              "url": "https://www.ema.europa.eu/fr/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_fr.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Nuovo testo delle informazioni sul prodotto – Estratti dalle raccomandazioni del PRAC in merito ai segnali. Adottato nella riunione del PRAC del 13-16 maggio 2019",
              "url": "https://www.ema.europa.eu/it/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_it.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "es",
              "name": "Recomendaciones del PRAC sobre señales: nuevo texto de información sobre el producto. Adoptadas por el PRAC el 13-16 de mayo de 2019",
              "url": "https://www.ema.europa.eu/es/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_es.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Novo texto da informação do medicamento – Extratos das recomendações do PRAC relativamente aos sinais. Adotado na reunião do PRAC de 13-16 de maio de 2019",
              "url": "https://www.ema.europa.eu/pt/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_pt.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            }
          ],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            },
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-eu-regulator-prac201905",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-eu-regulator-prac201905",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Lexapro® (escitalopram) tablets, for oral use; Lexapro® (escitalopram) oral solution: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Lexapro",
              "form": "film-coated tablets 5 mg, 10 mg and 20 mg, and oral solution 1 mg per mL",
              "holder": "Allergan, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a",
            "fetchedUrl": null,
            "textDate": "2023-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 10/2023"
          },
          "passages": [
            {
              "key": "listed-warnings",
              "kind": "sexual-side-effects",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.11 Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Use of SSRIs, including Lexapro, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Anwendung von SSRI, einschließlich Lexapro, kann Symptome einer sexuellen Funktionsstörung verursachen [siehe Nebenwirkungen (6.1)]. Bei männlichen Patienten kann die Anwendung von SSRI zu verzögerter oder ausbleibender Ejakulation, verminderter Libido und erektiler Dysfunktion führen. Bei Patientinnen kann die Anwendung von SSRI zu verminderter Libido und verzögertem oder ausbleibendem Orgasmus führen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El uso de ISRS, incluido Lexapro, puede causar síntomas de disfunción sexual [ver Reacciones adversas (6.1)]. En los pacientes varones, el uso de ISRS puede dar lugar a retraso o insuficiencia de la eyaculación, disminución de la libido y disfunción eréctil. En las pacientes mujeres, el uso de ISRS puede dar lugar a disminución de la libido y a retraso o ausencia del orgasmo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O uso de ISRS, incluindo o Lexapro, pode causar sintomas de disfunção sexual [ver Reações adversas (6.1)]. Em pacientes do sexo masculino, o uso de ISRS pode resultar em retardo ou falha na ejaculação, diminuição da libido e disfunção erétil. Em pacientes do sexo feminino, o uso de ISRS pode resultar em diminuição da libido e em orgasmo retardado ou ausente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’utilisation des ISRS, dont Lexapro, peut causer des symptômes de dysfonction sexuelle [voir Effets indésirables (6.1)]. Chez les hommes, l’utilisation d’un ISRS peut entraîner un retard ou un échec de l’éjaculation, une diminution de la libido et une dysfonction érectile. Chez les femmes, l’utilisation d’un ISRS peut entraîner une diminution de la libido et un orgasme retardé ou absent.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’uso di SSRI, compreso Lexapro, può causare sintomi di disfunzione sessuale [vedere Reazioni avverse (6.1)]. Nei pazienti di sesso maschile, l’uso di SSRI può comportare eiaculazione ritardata o mancata, calo della libido e disfunzione erettile. Nelle pazienti di sesso femminile, l’uso di SSRI può comportare calo della libido e orgasmo ritardato o assente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Lexapro समेत SSRI दवाओं के इस्तेमाल से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं [Adverse Reactions (6.1) देखें]। पुरुष मरीज़ों में SSRI के इस्तेमाल से स्खलन में देरी या स्खलन न हो पाना, कामेच्छा में कमी और स्तंभन दोष हो सकते हैं। महिला मरीज़ों में SSRI के इस्तेमाल से कामेच्छा में कमी हो सकती है, और ऑर्गेज़्म देर से हो सकता है या नहीं भी हो सकता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "other-causes",
              "kind": "qualification",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.11 Sexual Dysfunction"
              ],
              "since": null,
              "qualifies": "listed-warnings",
              "lang": "en-US",
              "text": "When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei der Beurteilung von Veränderungen der Sexualfunktion ist eine ausführliche Anamnese (einschließlich des zeitlichen Beginns der Symptome) wichtig, da sexuelle Symptome andere Ursachen haben können, einschließlich der zugrunde liegenden psychiatrischen Erkrankung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Al evaluar los cambios en la función sexual, es importante obtener una historia clínica detallada (incluido el momento en que aparecieron los síntomas), ya que los síntomas sexuales pueden tener otras causas, entre ellas el trastorno psiquiátrico subyacente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ao avaliar alterações na função sexual, é importante obter uma anamnese detalhada (incluindo o momento de início dos sintomas), porque os sintomas sexuais podem ter outras causas, entre elas o transtorno psiquiátrico subjacente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Lors de l’évaluation de changements de la fonction sexuelle, il est important de recueillir une anamnèse détaillée (y compris le moment d’apparition des symptômes), car les symptômes sexuels peuvent avoir d’autres causes, notamment le trouble psychiatrique sous-jacent.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nel valutare le alterazioni della funzione sessuale, è importante raccogliere un’anamnesi dettagliata (compreso il momento di insorgenza dei sintomi), perché i sintomi sessuali possono avere altre cause, tra cui il disturbo psichiatrico di base.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया में बदलावों का आकलन करते समय मरीज़ की विस्तृत मेडिकल हिस्ट्री लेना (जिसमें लक्षण शुरू होने का समय भी शामिल है) ज़रूरी है, क्योंकि यौन लक्षणों के दूसरे कारण भी हो सकते हैं, जिनमें पहले से मौजूद मानसिक बीमारी भी शामिल है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, long-lasting, long lasting, enduring, irreversib, permanent, after discontinu, after stopping, after you stop, following discontinu, upon discontinu, despite, does not go away, continu (every hit within 200 characters of a sexual word read), sexual, sex drive, libido, ejaculat, orgasm, erecti, impoten, priapism, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "usLabelSearchEscitalopram",
              "text": {
                "en": "On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 332 labels in that database that name escitalopram.",
                "de": "Am 14. Oktober 2026 haben wir die Fachinformationen in openFDA durchsucht, der offenen Datenbank der FDA. In keiner der 332 Fachinformationen in dieser Datenbank, die Escitalopram nennen, stand ein Satz dazu, dass sexuelle Funktionsstörungen nach dem Absetzen anhalten.",
                "es": "El 14 de octubre de 2026 buscamos en las fichas técnicas de openFDA, la base de datos abierta de la FDA. Ninguna de las 332 fichas técnicas de esa base de datos que nombran el escitalopram tenía una frase sobre una disfunción sexual que continúe después de dejar el medicamento.",
                "pt-br": "Em 14 de outubro de 2026, pesquisamos as bulas no openFDA, o banco de dados aberto da FDA. Nenhuma das 332 bulas desse banco de dados que mencionam escitalopram trazia uma frase sobre disfunção sexual que continua depois de parar o medicamento.",
                "fr": "Le 14 octobre 2026, nous avons cherché dans les notices d’openFDA, la base de données ouverte de la FDA. Aucune des 332 notices de cette base qui nomment l’escitalopram ne contenait de phrase sur une dysfonction sexuelle qui se poursuit après l’arrêt.",
                "it": "Il 14 ottobre 2026 abbiamo cercato tra le schede tecniche in openFDA, la banca dati aperta della FDA. Una frase sulla disfunzione sessuale che continua dopo l’interruzione non compariva in nessuna delle 332 schede tecniche di quella banca dati che nominano l’escitalopram.",
                "hi": "14 अक्टूबर 2026 को हमने FDA के खुले डेटाबेस openFDA में लेबल खोजे। उस डेटाबेस के जिन 332 लेबलों में एस्सिटालोप्राम का नाम है, उनमें से किसी में दवा बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के बने रहने के बारे में कोई वाक्य नहीं था।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-us-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-us-leaflet",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "MEDICATION GUIDE: Lexapro® (leks-a-pro) (escitalopram) tablets oral solution",
            "lang": "en-US",
            "product": {
              "name": "Lexapro",
              "form": "film-coated tablets 5 mg, 10 mg and 20 mg, and oral solution 1 mg per mL",
              "holder": "Allergan, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a",
            "fetchedUrl": null,
            "textDate": "2024-04",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised:4/2024"
          },
          "passages": [
            {
              "key": "listed-problems",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Sexual problems (dysfunction). Taking Lexapro may cause sexual problems.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Probleme (Funktionsstörung). Die Einnahme von Lexapro kann sexuelle Probleme verursachen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas sexuales (disfunción). Tomar Lexapro puede causar problemas sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas sexuais (disfunção). Tomar Lexapro pode causar problemas sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (dysfonction). La prise de Lexapro peut causer des troubles sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi sessuali (disfunzione). L’assunzione di Lexapro può causare problemi sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ (डिस्फ़ंक्शन)। Lexapro लेने से यौन समस्याएँ हो सकती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "delayed ejaculation or inability to have an ejaculation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verzögerte Ejakulation oder Unfähigkeit zu ejakulieren",
                  "by": "ours"
                },
                "es": {
                  "text": "eyaculación retardada o incapacidad para eyacular",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ejaculação retardada ou incapacidade de ter uma ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "éjaculation retardée ou incapacité à avoir une éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "eiaculazione ritardata o incapacità di eiaculare",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में देरी या स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "problems getting or keeping an erection",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme, eine Erektion zu bekommen oder aufrechtzuerhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas para conseguir o mantener una erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas para ter ou manter uma ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’obtention ou de maintien d’une érection",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi a raggiungere o mantenere l’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-4",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-5",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "delayed orgasm or inability to have an orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verzögerter Orgasmus oder Unfähigkeit, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "orgasmo retardado o incapacidad para tener un orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "orgasmo retardado ou incapacidade de ter um orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "orgasme retardé ou incapacité à avoir un orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "orgasmo ritardato o incapacità di raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में देरी या ऑर्गेज़्म न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "The most common side effects of Lexapro include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "The most common side effects of Lexapro include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "delayed ejaculation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verzögerte Ejakulation",
                  "by": "ours"
                },
                "es": {
                  "text": "eyaculación retardada",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ejaculação retardada",
                  "by": "ours"
                },
                "fr": {
                  "text": "éjaculation retardée",
                  "by": "ours"
                },
                "it": {
                  "text": "eiaculazione ritardata",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में देरी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of Lexapro?",
                "The most common side effects of Lexapro include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "delayed orgasm or inability to have an orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verzögerter Orgasmus oder Unfähigkeit, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "orgasmo retardado o incapacidad para tener un orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "orgasmo retardado ou incapacidade de ter um orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "orgasme retardé ou incapacité à avoir un orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "orgasmo ritardato o incapacità di raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में देरी या ऑर्गेज़्म न हो पाना",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, long-lasting, long lasting, enduring, irreversib, permanent, after discontinu, after stopping, after you stop, following discontinu, upon discontinu, despite, does not go away, continu, sexual, sex drive, libido, ejaculat, orgasm, erecti, impoten",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: CIPRALEX, escitalopram oxalate (as escitalopram), Tablets",
            "lang": "en-CA",
            "product": {
              "name": "Cipralex",
              "form": "tablets 5, 10, 15 and 20 mg escitalopram (base)",
              "holder": "Lundbeck Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00072474.PDF",
            "fetchedUrl": null,
            "textDate": "2023-09-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: SEP 01, 2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI) können Symptome einer sexuellen Funktionsstörung verursachen. Patientinnen und Patienten sollten darüber informiert werden, dass lang anhaltende sexuelle Funktionsstörungen berichtet wurden, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual. Se debe informar a los pacientes de que se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual. Os pacientes devem ser informados de que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle. Les patients doivent être informés que des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale. I pazienti devono essere informati che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। मरीज़ों को बताया जाना चाहिए कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-8-2",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Furthermore, there have been reports of long-lasting sexual dysfunction where these symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Darüber hinaus wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen diese Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, se han notificado casos de disfunción sexual de larga duración en los que estos síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, houve relatos de disfunção sexual de longa duração em que esses sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "En outre, des cas de dysfonction sexuelle durable, dans lesquels ces symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS, ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza di questi sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद ये लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "underestimated",
              "kind": "qualification",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "qualifies": "persistence-8-2",
              "lang": "en-CA",
              "text": "This is a difficult area to study because patients may not spontaneously report symptoms of this nature, and therefore, it is thought that sexual side effects with SSRIs may be underestimated.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dieser Bereich ist schwer zu untersuchen, weil Patientinnen und Patienten Symptome dieser Art womöglich nicht von sich aus berichten; daher wird angenommen, dass sexuelle Nebenwirkungen unter SSRI möglicherweise unterschätzt werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Es un ámbito difícil de estudiar porque es posible que los pacientes no comuniquen espontáneamente síntomas de esta naturaleza y, por tanto, se cree que los efectos secundarios sexuales con los ISRS pueden estar subestimados.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esta é uma área difícil de estudar porque os pacientes podem não relatar espontaneamente sintomas dessa natureza e, por isso, acredita-se que os efeitos colaterais sexuais com ISRS possam estar subestimados.",
                  "by": "ours"
                },
                "fr": {
                  "text": "C’est un domaine difficile à étudier, car les patients peuvent ne pas signaler spontanément des symptômes de cette nature ; on pense donc que les effets indésirables sexuels des ISRS peuvent être sous-estimés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Si tratta di un ambito difficile da studiare perché i pazienti possono non riferire spontaneamente sintomi di questa natura e, pertanto, si ritiene che gli effetti indesiderati sessuali con gli SSRI possano essere sottostimati.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस विषय का अध्ययन करना मुश्किल है, क्योंकि हो सकता है कि मरीज़ इस तरह के लक्षण अपनी ओर से न बताएँ, और इसलिए माना जाता है कि SSRI दवाओं के यौन साइड इफ़ेक्ट शायद कम करके आँके जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-ca-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-ca-leaflet",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: CIPRALEX, escitalopram oxalate tablets",
            "lang": "en-CA",
            "product": {
              "name": "Cipralex",
              "form": "tablets 5, 10, 15 and 20 mg escitalopram (base)",
              "holder": "Lundbeck Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00072474.PDF",
            "fetchedUrl": null,
            "textDate": "2023-09-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised SEP 01, 2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Effects on Sexual Function: Taking medicines like CIPRALEX may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping CIPRALEX treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Auswirkungen auf die Sexualfunktion: Die Einnahme von Arzneimitteln wie CIPRALEX kann Symptome einer sexuellen Funktionsstörung verursachen. In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung mit CIPRALEX bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Efectos sobre la función sexual: tomar medicamentos como CIPRALEX puede causar síntomas de disfunción sexual. En algunos casos, estos síntomas han continuado después de suspender el tratamiento con CIPRALEX.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Efeitos sobre a função sexual: tomar medicamentos como o CIPRALEX pode causar sintomas de disfunção sexual. Em alguns casos, esses sintomas continuaram após a interrupção do tratamento com CIPRALEX.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Effets sur la fonction sexuelle : la prise de médicaments comme CIPRALEX peut causer des symptômes de dysfonction sexuelle. Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement par CIPRALEX.",
                  "by": "ours"
                },
                "it": {
                  "text": "Effetti sulla funzione sessuale: l’assunzione di medicinali quali CIPRALEX può causare sintomi di disfunzione sessuale. In alcuni casi si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento con CIPRALEX.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया पर असर: CIPRALEX जैसी दवाएँ लेने से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। कुछ मामलों में ये लक्षण CIPRALEX से इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using CIPRALEX?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "decreased interest in sex",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes Interesse an Sex",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del interés por el sexo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do interesse por sexo",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse de l’intérêt sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione dell’interesse per il sesso",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स में रुचि कम होना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using CIPRALEX?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "decreased ability to reach orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verminderte Fähigkeit, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la capacidad para alcanzar el orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da capacidade de chegar ao orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la capacité à atteindre l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "ridotta capacità di raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म तक पहुँचने की क्षमता में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using CIPRALEX?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "erectile dysfunction",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Erektionsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción eréctil",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção erétil",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction érectile",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione erettile",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-ca-regulator-review2021",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-ca-regulator-review2021",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254",
            "fetchedUrl": null,
            "textDate": "2021-01-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Issued: 2021-01-06"
          },
          "passages": [
            {
              "key": "action",
              "kind": "sexual-persistence",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die Sicherheitsinformationen zu allen SSRI und SNRI zu aktualisieren, um zu empfehlen, dass medizinische Fachleute ihre Patientinnen und Patienten über das mögliche Risiko lang anhaltender (möglicherweise Wochen bis Jahre) sexueller Symptome informieren, die nach dem Absetzen einer SSRI- oder SNRI-Behandlung fortbestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para actualizar la información de seguridad del producto de todos los ISRS e IRSN, con el fin de recomendar que los profesionales sanitarios informen a los pacientes del posible riesgo de síntomas sexuales de larga duración (posiblemente de semanas a años) que persisten después de suspender el tratamiento con ISRS o IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para atualizar as informações de segurança do produto de todos os ISRS e IRSN, a fim de recomendar que os profissionais de saúde informem os pacientes sobre o risco potencial de sintomas sexuais de longa duração (possivelmente de semanas a anos) que persistem após a interrupção do tratamento com ISRS ou IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour mettre à jour les informations de sécurité des produits pour tous les ISRS et IRSN, afin de recommander aux professionnels de santé d’informer les patients du risque potentiel de symptômes sexuels durables (peut-être de plusieurs semaines à plusieurs années) qui persistent après l’arrêt d’un traitement par ISRS ou IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per aggiornare le informazioni di sicurezza sul prodotto di tutti gli SSRI e gli SNRI, in modo da raccomandare ai professionisti sanitari di informare i pazienti del potenziale rischio di sintomi sessuali a lungo termine (forse da settimane ad anni) che persistono dopo l’interruzione del trattamento con SSRI o SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada दवा बनाने वाली कंपनियों के साथ मिलकर सभी SSRI और SNRI दवाओं की सुरक्षा जानकारी अपडेट करेगा। उसमें यह सिफ़ारिश होगी कि डॉक्टर और दूसरे स्वास्थ्यकर्मी मरीज़ों को इस संभावित जोखिम के बारे में बताएँ कि SSRI या SNRI से इलाज बंद करने के बाद यौन लक्षण लंबे समय तक (शायद हफ़्तों से लेकर सालों तक) बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "Health Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a interrupção do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names escitalopram among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Escitalopram.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo escitalopram.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita escitalopram entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif escitalopram.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo escitalopram.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें एस्सिटालोप्राम का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-ca-regulator-infowatch202112",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-ca-regulator-infowatch202112",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, December 2021",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2021/sc-hc/H167-1-2021-12-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2021-12",
            "textDateKind": "publication",
            "textDateAsPrinted": "December 2021"
          },
          "passages": [
            {
              "key": "update",
              "kind": "sexual-persistence",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Abschnitt Warnhinweise und Vorsichtsmaßnahmen der kanadischen Fachinformationen zu SSRI (Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Vilazodon und Vortioxetin) und SNRI (Desvenlafaxin, Duloxetin, Levomilnacipran und Venlafaxin) wurde oder wird um neue Sicherheitsinformationen zu Berichten über lang anhaltende sexuelle Funktionsstörungen ergänzt, bei denen die Symptome trotz Absetzen der Behandlung fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "El apartado de advertencias y precauciones de las monografías de producto canadienses de los ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona y vortioxetina) y de los IRSN (desvenlafaxina, duloxetina, levomilnaciprán y venlafaxina) se ha actualizado, o se actualizará, con nueva información de seguridad relativa a notificaciones de disfunción sexual de larga duración en la que los síntomas han continuado a pesar de la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A seção Advertências e Precauções das monografias de produto canadenses dos ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona e vortioxetina) e dos IRSN (desvenlafaxina, duloxetina, levomilnaciprana e venlafaxina) foi, ou será, atualizada com novas informações de segurança sobre relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La section Mises en garde et précautions des monographies de produit canadiennes des ISRS (citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, vilazodone et vortioxétine) et des IRSN (desvenlafaxine, duloxétine, lévomilnacipran et venlafaxine) a été, ou sera, mise à jour avec de nouvelles informations de sécurité concernant des signalements de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La sezione Avvertenze e precauzioni delle monografie di prodotto canadesi degli SSRI (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodone e vortioxetina) e degli SNRI (desvenlafaxina, duloxetina, levomilnacipran e venlafaxina) è stata, o sarà, aggiornata con nuove informazioni di sicurezza relative a segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कनाडा में SSRI दवाओं (सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, विलाज़ोडोन और वोर्टिऑक्सेटीन) और SNRI दवाओं (डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, लेवोमिल्नासिप्रान और वेनलाफ़ैक्सीन) की आधिकारिक जानकारी (product monograph) के Warnings and Precautions सेक्शन को नई सुरक्षा जानकारी के साथ अपडेट कर दिया गया है, या किया जाएगा। यह जानकारी लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की उन रिपोर्टों के बारे में है, जिनमें इलाज बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)",
                "Key messages for healthcare professionals:"
              ],
              "since": null,
              "qualifies": "update",
              "lang": "en-CA",
              "text": "Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a descontinuação do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names escitalopram among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Escitalopram.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo escitalopram.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita escitalopram entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif escitalopram.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo escitalopram.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें एस्सिटालोप्राम का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION – LEXAPRO (ESCITALOPRAM OXALATE) FILM-COATED TABLETS AND ORAL SOLUTION",
            "lang": "en-AU",
            "product": {
              "name": "LEXAPRO",
              "form": null,
              "holder": "Lundbeck Australia Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-06883-3",
            "textDate": "2023-08-23",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.4",
                "Sexual Dysfunction"
              ],
              "since": {
                "date": "2023-08-23",
                "scope": "product",
                "basis": [
                  "escitalopram-au"
                ]
              },
              "inWarnings": true,
              "summary": {
                "en": "Section 4.4 of Australia's product information for Lexapro has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.",
                "de": "Abschnitt 4.4 der australischen Fachinformation zu Lexapro enthält einen Warnhinweis mit der Überschrift sexuelle Funktionsstörung. Dort heißt es, es gebe Berichte über sexuelle Funktionsstörungen, die lange andauerten und bei denen die Symptome nach dem Absetzen von SSRI oder SNRI weitergingen.",
                "es": "La sección 4.4 de la información del producto australiana de Lexapro tiene una advertencia titulada disfunción sexual. Dice que hay notificaciones de disfunción sexual que duró mucho tiempo, con síntomas que siguieron después de dejar los ISRS o los IRSN.",
                "pt-br": "A seção 4.4 da bula australiana do Lexapro para o profissional de saúde tem um alerta com o título disfunção sexual. Ela diz que há relatos de disfunção sexual que durou muito tempo, com sintomas que continuaram depois que os ISRS ou IRSN foram interrompidos.",
                "fr": "En Australie, la rubrique 4.4 des informations sur le produit de Lexapro contient une mise en garde qui a pour titre la dysfonction sexuelle. Elle indique que des cas de dysfonction sexuelle ayant duré longtemps ont été signalés, avec des symptômes qui ont continué après l’arrêt des ISRS ou des IRSN.",
                "it": "La sezione 4.4 delle informazioni sul prodotto australiane di Lexapro ha un’avvertenza intitolata disfunzione sessuale. Dice che ci sono segnalazioni di disfunzione sessuale durata a lungo, con sintomi proseguiti dopo l’interruzione degli SSRI o degli SNRI.",
                "hi": "ऑस्ट्रेलिया में Lexapro की आधिकारिक जानकारी (product information) के सेक्शन 4.4 में सेक्शुअल डिस्फ़ंक्शन के शीर्षक से एक चेतावनी है। वह कहती है कि ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें हैं, जो लंबे समय तक रहा और जिसमें SSRI या SNRI दवाएँ बंद करने के बाद भी लक्षण चलते रहे।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Lexapro Tablets, Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "LEXAPRO",
              "form": null,
              "holder": "Lundbeck Australia Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-05608-3",
            "textDate": "2023-08",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 2",
                "Warnings"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Australia's consumer medicine information for Lexapro tablets says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.",
                "de": "In der australischen Packungsbeilage zu Lexapro-Tabletten heißt es, Medikamente wie dieses könnten sexuelle Probleme verursachen, und in manchen Fällen seien diese nach dem Ende der Behandlung weitergegangen.",
                "es": "El prospecto australiano de los comprimidos de Lexapro (Consumer Medicine Information) dice que los medicamentos como este pueden causar problemas sexuales y que, en algunos casos, estos han seguido después de terminar el tratamiento.",
                "pt-br": "A bula australiana para pacientes do Lexapro em comprimidos diz que medicamentos como este podem causar problemas sexuais e que, em alguns casos, eles continuaram depois do fim do tratamento.",
                "fr": "En Australie, la notice de Lexapro comprimés destinée aux patients indique que les médicaments de ce type peuvent causer des troubles sexuels et que, dans certains cas, ceux-ci ont continué après l’arrêt du traitement.",
                "it": "Il foglio illustrativo australiano di Lexapro compresse (Consumer Medicine Information) dice che medicinali come questo possono causare problemi sessuali, e che in alcuni casi questi sono proseguiti dopo la fine del trattamento.",
                "hi": "ऑस्ट्रेलिया में Lexapro गोलियों का मरीज़ों वाला लीफ़लेट (consumer medicine information) कहता है कि इस तरह की दवाओं से यौन समस्याएँ हो सकती हैं, और कुछ मामलों में ये इलाज बंद होने के बाद भी चलती रहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, Lexapro",
            "lang": "en-NZ",
            "product": {
              "name": "Lexapro",
              "form": "10 mg and 20 mg film-coated tablets",
              "holder": "Pharmacy Retailing t/a Healthcare Logistics"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/l/Lexaprotab.pdf",
            "fetchedUrl": null,
            "textDate": "2024-08-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT 08 August 2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Warnings",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see Section 4.8 Undesirable effects). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI)/Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8 Nebenwirkungen). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS)/inhibidores de la recaptación de serotonina y noradrenalina (IRSN) pueden causar síntomas de disfunción sexual (ver sección 4.8 Reacciones adversas). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS)/inibidores da recaptação de serotonina e noradrenalina (IRSN) podem causar sintomas de disfunção sexual (ver seção 4.8 Efeitos indesejáveis). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS)/inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8 Effets indésirables). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI)/inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8 Effetti indesiderati). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI)/सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8, Undesirable effects देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information, Lexapro",
            "lang": "en-NZ",
            "product": {
              "name": "Lexapro",
              "form": "10 mg and 20 mg film-coated tablets",
              "holder": "Pharmacy Retailing t/a Healthcare Logistics"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/Consumers/CMI/l/Lexapro.pdf",
            "fetchedUrl": null,
            "textDate": "2023-09-18",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was prepared on 18 September 2023"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "While you are taking it",
                "Things you must do"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Medicines like Lexapro may cause symptoms of sexual dysfunction (see section \"Side effects\"). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Lexapro können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt „Nebenwirkungen“). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Lexapro pueden causar síntomas de disfunción sexual (ver el apartado «Efectos secundarios»). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Lexapro podem causar sintomas de disfunção sexual (ver a seção “Efeitos colaterais”). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Lexapro peuvent causer des symptômes de dysfonction sexuelle (voir la rubrique « Effets indésirables »). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Lexapro possono causare sintomi di disfunzione sessuale (vedere il paragrafo «Effetti indesiderati»). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Lexapro जैसी दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (“Side effects” सेक्शन देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "Side effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "sexual disturbances (decreased sexual drive; problems with ejaculation or erection; women may experience difficulties achieving orgasm)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Störungen der Sexualfunktion (vermindertes sexuelles Verlangen; Probleme mit der Ejakulation oder der Erektion; Frauen können Schwierigkeiten haben, zum Orgasmus zu kommen)",
                  "by": "ours"
                },
                "es": {
                  "text": "alteraciones sexuales (disminución del deseo sexual; problemas con la eyaculación o la erección; las mujeres pueden experimentar dificultades para alcanzar el orgasmo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais (diminuição do desejo sexual; problemas de ejaculação ou de ereção; as mulheres podem ter dificuldades para chegar ao orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels (baisse du désir sexuel ; troubles de l’éjaculation ou de l’érection ; les femmes peuvent présenter des difficultés à atteindre l’orgasme)",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi sessuali (riduzione del desiderio sessuale; problemi di eiaculazione o di erezione; le donne possono avere difficoltà a raggiungere l’orgasmo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (कामेच्छा में कमी; स्खलन या इरेक्शन की समस्याएँ; महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "Side effects"
              ],
              "since": null,
              "qualifies": "listed-1",
              "lang": "en-NZ",
              "text": "The side effects of Lexapro are, in general, mild and disappear after a short period of time.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen von Lexapro sind im Allgemeinen leicht und verschwinden nach kurzer Zeit.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios de Lexapro son, en general, leves y desaparecen al cabo de poco tiempo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais do Lexapro são, em geral, leves e desaparecem depois de pouco tempo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables de Lexapro sont, en général, légers et disparaissent après une courte période.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati di Lexapro sono, in generale, lievi e scompaiono dopo un breve periodo di tempo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Lexapro के साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और थोड़े समय बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-nz-regulator-marc201909",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-nz-regulator-marc201909",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes179.htm",
            "fetchedUrl": null,
            "textDate": "2019-09-12",
            "textDateKind": "adoption",
            "textDateAsPrinted": "MINUTES OF THE 179th MEDICINES ADVERSE REACTIONS COMMITTEE MEETING 12 September 2019"
          },
          "passages": [
            {
              "key": "determination",
              "kind": "sexual-persistence",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "The Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss befasste sich mit den europäischen Produktinformationen zu diesem Thema und stellte nach Prüfung der verfügbaren Informationen fest, dass die Fachinformationen in Bezug auf das Risiko anhaltender sexueller Funktionsstörungen aktualisiert werden müssen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité examinó la información del producto europea sobre esta cuestión y determinó, a partir de su revisión de la información disponible, que es necesario actualizar las fichas técnicas en lo relativo al riesgo de disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê analisou as informações do produto europeias sobre essa questão e determinou, com base em sua revisão das informações disponíveis, que são necessárias atualizações nas bulas para profissionais de saúde quanto ao risco de disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a examiné les informations européennes sur le produit à ce sujet et a conclu, sur la base de son examen des informations disponibles, que des mises à jour des fiches techniques concernant le risque de dysfonction sexuelle persistante sont nécessaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha esaminato le informazioni sul prodotto europee su questo tema e ha stabilito, sulla base della propria revisione delle informazioni disponibili, che sono necessari aggiornamenti delle schede tecniche riguardo al rischio di disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने इस मुद्दे पर यूरोप में दवा की आधिकारिक जानकारी (product information) पर विचार किया। उपलब्ध जानकारी की अपनी समीक्षा के आधार पर उसने तय किया कि बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के जोखिम के बारे में data sheet में अपडेट ज़रूरी हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "evidence",
              "kind": "qualification",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction"
              ],
              "since": null,
              "qualifies": "determination",
              "lang": "en-NZ",
              "text": "The Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss hielt die Aussagekraft der Belege für gering, und aus den verfügbaren Daten lassen sich schwer Schlüsse ziehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité consideró que la solidez de la evidencia es baja, y es difícil extraer conclusiones de los datos disponibles.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê considerou baixa a força das evidências, e é difícil tirar conclusões dos dados disponíveis.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a jugé faible le niveau de preuve, et il est difficile de tirer des conclusions des données disponibles.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha ritenuto bassa la forza delle prove, ed è difficile trarre conclusioni dai dati disponibili.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने माना कि प्रमाण कमज़ोर हैं, और उपलब्ध आँकड़ों से निष्कर्ष निकालना मुश्किल है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "recommendation",
              "kind": "regulator-statement",
              "section": [
                "3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction",
                "Recommendation 5"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Ausschuss empfahl, dass Medsafe die für Serotonin-Wiederaufnahmehemmer verantwortlichen Unternehmen anschreibt und um Aktualisierungen der neuseeländischen Fachinformationen bittet.",
                  "by": "ours"
                },
                "es": {
                  "text": "El Comité recomendó que Medsafe escriba a los laboratorios titulares de los inhibidores de la recaptación de serotonina para solicitar la actualización de las fichas técnicas de Nueva Zelanda.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O Comitê recomendou que a Medsafe escreva às empresas responsáveis pelos inibidores da recaptação de serotonina pedindo atualizações nas bulas para profissionais de saúde da Nova Zelândia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le Comité a recommandé que Medsafe écrive aux laboratoires responsables des inhibiteurs de la recapture de la sérotonine pour demander des mises à jour des fiches techniques néo-zélandaises.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il Comitato ha raccomandato che Medsafe scriva alle aziende titolari (sponsor) degli inibitori della ricaptazione della serotonina per chiedere l’aggiornamento delle schede tecniche neozelandesi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समिति ने सिफ़ारिश की कि Medsafe सेरोटोनिन रीअपटेक इनहिबिटर दवाओं की कंपनियों (sponsors) को पत्र लिखे और न्यूज़ीलैंड की data sheet अपडेट करने को कहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name escitalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Escitalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo escitalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita escitalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif escitalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo escitalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें एस्सिटालोप्राम का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-nz-regulator-marc202606",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-nz-regulator-marc202606",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes206.htm",
            "fetchedUrl": null,
            "textDate": "2026-06-11",
            "textDateKind": "adoption",
            "textDateAsPrinted": "The two hundred and sixth meeting of the Medicines Adverse Reactions Committee (MARC) was held on 11 June 2026"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "sexual-persistence",
              "section": [
                "3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors",
                "Background"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "A warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ein Warnhinweis, dass lang anhaltende Symptome einer sexuellen Funktionsstörung nach dem Absetzen einer Behandlung mit selektiven Serotonin-Wiederaufnahmehemmern (SSRI) und Serotonin-Noradrenalin-Wiederaufnahmehemmern (SNRI) berichtet wurden, steht derzeit in Abschnitt 4.4 der Fachinformationen dieser Medikamente.",
                  "by": "ours"
                },
                "es": {
                  "text": "En la sección 4.4 de las fichas técnicas de estos medicamentos figura actualmente una advertencia de que se han notificado síntomas de disfunción sexual de larga duración tras la suspensión del tratamiento con inhibidores selectivos de la recaptación de serotonina (ISRS) e inhibidores de la recaptación de serotonina y noradrenalina (IRSN).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Um alerta de que foram relatados sintomas de disfunção sexual de longa duração após a descontinuação do tratamento com inibidores seletivos da recaptação de serotonina (ISRS) e inibidores da recaptação de serotonina e noradrenalina (IRSN) consta atualmente na seção 4.4 das bulas para profissionais de saúde desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une mise en garde indiquant que des symptômes durables de dysfonction sexuelle ont été signalés après l’arrêt d’un traitement par inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) et par inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN) figure actuellement à la rubrique 4.4 des fiches techniques de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Un’avvertenza secondo cui sono stati segnalati sintomi di disfunzione sessuale a lungo termine dopo l’interruzione del trattamento con inibitori selettivi della ricaptazione della serotonina (SSRI) e inibitori della ricaptazione della serotonina e della noradrenalina (SNRI) è attualmente riportata nel paragrafo 4.4 delle schede tecniche di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन दवाओं की data sheet के सेक्शन 4.4 में फ़िलहाल यह चेतावनी दर्ज है कि सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) और सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर (SNRI) से इलाज बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के लंबे समय तक रहने वाले लक्षण रिपोर्ट हुए हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors",
                "Discussion"
              ],
              "since": null,
              "qualifies": "statement",
              "lang": "en-NZ",
              "text": "It was highlighted that this makes it difficult to confirm a causal relationship with SSRIs/SNRIs",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurde hervorgehoben, dass es dadurch schwierig ist, einen ursächlichen Zusammenhang mit SSRI/SNRI zu bestätigen",
                  "by": "ours"
                },
                "es": {
                  "text": "Se destacó que esto hace difícil confirmar una relación causal con los ISRS/IRSN",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foi destacado que isso torna difícil confirmar uma relação causal com os ISRS/IRSN",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il a été souligné que cela rend difficile la confirmation d’un lien de causalité avec les ISRS/IRSN",
                  "by": "ours"
                },
                "it": {
                  "text": "È stato sottolineato che questo rende difficile confermare una relazione causale con gli SSRI/SNRI",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस बात पर ध्यान दिलाया गया कि इससे SSRI/SNRI के साथ कारण और असर के संबंध की पुष्टि करना मुश्किल हो जाता है",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name escitalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Escitalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo escitalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita escitalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif escitalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo escitalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें एस्सिटालोप्राम का नाम नहीं है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Anwender",
            "lang": "de",
            "product": {
              "name": "Cipralex",
              "form": "10 mg Filmtabletten",
              "holder": "H. Lundbeck A/S"
            },
            "source": {
              "type": "compendium",
              "name": "PatientenInfo-Service"
            },
            "url": "https://www.patienteninfo-service.de/a-z-liste/c/cipralex-10-mg-filmtabletten",
            "fetchedUrl": null,
            "textDate": "2026-01",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im Januar 2026."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Was sollten Sie vor der Einnahme von Cipralex beachten?",
                "Warnhinweise und Vorsichtsmaßnahmen"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In certain cases these symptoms continued after treatment was ended.",
                  "by": "ours"
                },
                "es": {
                  "text": "En determinados casos, estos síntomas persistieron después de finalizar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em certos casos, esses sintomas permaneceram após o término do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In determinati casi questi sintomi sono persistiti dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में ये लक्षण इलाज खत्म होने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Häufig (kann bis zu 1 von 10 Behandelten betreffen):"
              ],
              "since": null,
              "lang": "de",
              "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsstörungen, Minderung des sexuellen Interesses und bei Frauen Orgasmusstörungen)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Disorders of sexual function (delayed ejaculation, erection problems, reduced sexual interest and, in women, orgasm problems)",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos de la función sexual (retraso de la eyaculación, trastornos de la erección, disminución del interés sexual y, en las mujeres, trastornos del orgasmo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios da função sexual (ejaculação retardada, distúrbios da ereção, diminuição do interesse sexual e, em mulheres, distúrbios do orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de la fonction sexuelle (éjaculation retardée, troubles de l’érection, baisse de l’intérêt sexuel et, chez la femme, troubles de l’orgasme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi della funzione sessuale (eiaculazione ritardata, disturbi dell’erezione, riduzione dell’interesse sessuale e nelle donne disturbi dell’orgasmo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की गड़बड़ियाँ (स्खलन में देरी, इरेक्शन की गड़बड़ियाँ, यौन रुचि में कमी और महिलाओं में ऑर्गेज़्म की गड़बड़ियाँ)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar):"
              ],
              "since": null,
              "lang": "de",
              "text": "Schmerzhafte Erektionen (Priapismus)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erections (priapism)",
                  "by": "ours"
                },
                "es": {
                  "text": "Erecciones dolorosas (priapismo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érections douloureuses (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "de",
              "text": "Die Nebenwirkungen klingen gewöhnlich nach wenigen Behandlungswochen ab. Sie sollten auch wissen, dass viele dieser Symptome auch auf Ihre Krankheit zurückzuführen sein können und daher abklingen, wenn Sie beginnen, sich besser zu fühlen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects usually wear off after a few weeks of treatment. You should also know that many of these symptoms can also be due to your illness and so wear off when you begin to feel better.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios suelen remitir al cabo de pocas semanas de tratamiento. También debe saber que muchos de estos síntomas pueden deberse igualmente a su enfermedad y, por tanto, remiten cuando usted empieza a sentirse mejor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais costumam regredir depois de poucas semanas de tratamento. Você também deve saber que muitos desses sintomas podem ser causados também pela sua doença e, por isso, regridem quando você começa a se sentir melhor.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables s’atténuent habituellement après quelques semaines de traitement. Vous devez également savoir que beaucoup de ces symptômes peuvent aussi être dus à votre maladie et s’atténueront donc lorsque vous commencerez à vous sentir mieux.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati di solito regrediscono dopo poche settimane di trattamento. Deve anche sapere che molti di questi sintomi possono essere dovuti anche alla sua malattia e quindi regrediscono quando comincia a sentirsi meglio.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट सामान्य तौर पर इलाज के कुछ हफ़्तों बाद धीरे-धीरे खत्म हो जाते हैं। आपको यह भी पता होना चाहिए कि इनमें से कई लक्षण आपकी बीमारी की वजह से भी हो सकते हैं, और इसलिए जब आप बेहतर महसूस करने लगते हैं, तब ये धीरे-धीरे खत्म हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "compendiumCopyRegulatorTerms",
              "text": {
                "en": "This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie er in einer Sammlung von Produktinformationen steht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia de un compendio de información del producto. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia que está em um compêndio de bulas. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel qu’il figure dans un recueil d’informations sur les produits. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata in un compendio di informazioni sui prodotti. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह वह प्रति है, जो दवाओं की आधिकारिक जानकारी के एक संग्रह में है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-de-pro-cipralex",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-de-pro-cipralex",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "login",
            "terms-not-accepted"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Cipralex",
              "form": null,
              "holder": "H. Lundbeck A/S"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.fachinfo.de/",
            "https://portal.bfarm.de/amguifree/",
            "https://www.lundbeck.com/de/unsere-forschung/produkte"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-de-pro-ratiopharm",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-de-pro-ratiopharm",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation",
            "lang": "de",
            "product": {
              "name": "Escitalopram-ratiopharm®",
              "form": "5 mg / 10 mg / 15 mg / 20 mg Filmtabletten",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/label/Escitalopram-ratiopharm%20Filmtabletten%20-%2012.pdf?pzn=270484",
            "fetchedUrl": null,
            "textDate": "2026-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. STAND DER INFORMATION September 2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                "Sexuelle Funktionsstörung"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Frauen: Anorgasmie",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, restlessness, abnormal dreams, decreased libido Women: anorgasmia",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, inquietud, sueños anormales, disminución de la libido Mujeres: anorgasmia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, inquietude, sonhos anormais, diminuição da libido Mulheres: anorgasmia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmie",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido Donne: anorgasmia",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने, कामेच्छा में कमी महिलाएँ: ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Männer: Ejakulationsstörungen, Impotenz",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men: ejaculation disorders, impotence",
                  "by": "ours"
                },
                "es": {
                  "text": "Hombres: trastornos de la eyaculación, impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Homens: distúrbios da ejaculação, impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : troubles de l’éjaculation, impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "Uomini: disturbi di eiaculazione, impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: स्खलन की गड़बड़ियाँ, स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Nicht bekannt"
              ],
              "since": null,
              "lang": "de",
              "text": "Galaktorrhö, postpartale Hämorrhagie3 Männer: Priapismus",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea, postpartum haemorrhage3 Men: priapism",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea, hemorragia posparto3 Hombres: priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia, hemorragia pós-parto3 Homens: priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée, hémorragie du post-partum3 Chez l’homme : priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea, emorragia postpartum3 Uomini: priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea), प्रसव के बाद खून बहना (postpartum haemorrhage)3 पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "de",
              "text": "Am häufigsten treten Nebenwirkungen in der ersten oder zweiten Behandlungswoche auf und nehmen normalerweise bei fortgesetzter Behandlung an Intensität und Häufigkeit ab.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Side effects occur most often in the first or second week of treatment and normally decrease in intensity and frequency with continued treatment.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios aparecen con más frecuencia en la primera o la segunda semana de tratamiento y normalmente disminuyen en intensidad y frecuencia al continuar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais ocorrem com mais frequência na primeira ou na segunda semana de tratamento e normalmente diminuem de intensidade e frequência com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables surviennent le plus souvent au cours de la première ou de la deuxième semaine de traitement et diminuent normalement en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati compaiono più spesso nella prima o nella seconda settimana di trattamento e di norma diminuiscono di intensità e frequenza con il proseguimento del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट सबसे ज़्यादा इलाज के पहले या दूसरे हफ़्ते में होते हैं, और इलाज जारी रहने पर सामान्य तौर पर इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-de-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-de-regulator",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Bulletin/2019/2-2019.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2019-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Ausgabe 2 | Juni 2019"
          },
          "passages": [
            {
              "key": "wording",
              "kind": "sexual-persistence",
              "section": [
                "PRAC-Meldungen",
                "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen",
                "Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "SEROPLEX",
              "form": "10 mg, comprimé pelliculé sécable",
              "holder": "H. LUNDBECK A/S"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67219535/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67219535/extrait",
            "textDate": "2026-01-15",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 15/01/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Mises en garde spéciales et précautions d'emploi",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs/SNRIs have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von sexueller Funktionsstörung berichtet, bei denen die Symptome trotz Absetzen der Behandlung mit SSRI/SNRI anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual cuyos síntomas se han prolongado a pesar de la suspensión del tratamiento con ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual cujos sintomas se prolongaram apesar da interrupção do tratamento com ISRS/IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale i cui sintomi si sono protratti nonostante l’interruzione del trattamento con SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI दवाओं से इलाज बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmie",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, restlessness, abnormal dreams, decreased libido In women: anorgasmia",
                  "by": "ours"
                },
                "de": {
                  "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Bei Frauen: Anorgasmie",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, inquietud, sueños anormales, disminución de la libido En la mujer: anorgasmia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, inquietude, sonhos anormais, diminuição da libido Na mulher: anorgasmia",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido Nella donna: anorgasmia",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने, कामेच्छा में कमी महिलाओं में: ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Chez l’homme : troubles de l’éjaculation, impuissance",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In men: ejaculation disorders, impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Männern: Ejakulationsstörungen, Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "En el hombre: trastornos de la eyaculación, impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "No homem: distúrbios da ejaculação, impotência",
                  "by": "ours"
                },
                "it": {
                  "text": "Nell’uomo: disturbi di eiaculazione, impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुषों में: स्खलन की गड़बड़ियाँ, स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquence indéterminée"
              ],
              "since": null,
              "lang": "fr",
              "text": "Galactorrhée Chez l’homme : priapisme Hémorragie du post-partum3",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea In men: priapism Postpartum haemorrhage3",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Bei Männern: Priapismus Postpartale Hämorrhagie3",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea En el hombre: priapismo Hemorragia posparto3",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia No homem: priapismo Hemorragia pós-parto3",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Nell’uomo: priapismo Emorragia postpartum3",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) पुरुषों में: लंबे समय तक बना रहने वाला इरेक्शन (priapism) प्रसव के बाद खून बहना (postpartum haemorrhage)3",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "fr",
              "text": "Les effets indésirables sont surtout notés durant la première ou la seconde semaine du traitement et s'estompent habituellement par la suite en intensité et en fréquence.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects are noted above all during the first or second week of treatment and usually fade afterwards in intensity and frequency.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen werden vor allem in der ersten oder zweiten Behandlungswoche beobachtet und lassen danach gewöhnlich an Stärke und Häufigkeit nach.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos se observan sobre todo durante la primera o la segunda semana del tratamiento y después suelen atenuarse en intensidad y en frecuencia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos são observados sobretudo durante a primeira ou a segunda semana do tratamento e depois geralmente se atenuam em intensidade e em frequência.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati si osservano soprattutto durante la prima o la seconda settimana di trattamento e in seguito di solito si attenuano per intensità e frequenza.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट खास तौर पर इलाज के पहले या दूसरे हफ़्ते में देखे जाते हैं, और उसके बाद आम तौर पर इनकी तीव्रता घटती जाती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "productsDifferSearched",
              "text": {
                "en": "Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Wir haben sie nach Sätzen dazu durchsucht, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten, und sie nicht vollständig gelesen. Diese Zeile zeigt das genannte Produkt und kein anderes.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Hemos buscado en ellos frases sobre efectos secundarios sexuales que continúen después de dejar el medicamento, y no los hemos leído enteros. Esta fila muestra el producto que se nombra, y ningún otro.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. Procuramos nelas frases sobre efeitos colaterais sexuais que continuam depois de parar o medicamento, mas não as lemos por inteiro. Esta linha mostra o produto indicado, e nenhum outro.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Nous y avons cherché des phrases sur des effets secondaires sexuels qui persistent après l’arrêt, sans les lire en entier. Cette ligne montre le produit nommé, et aucun autre.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Vi abbiamo cercato frasi sugli effetti collaterali sessuali che continuano dopo l’interruzione e non li abbiamo letti per intero. Questa riga mostra il prodotto indicato, e nessun altro.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। हमने उनमें दवा बंद करने के बाद यौन साइड इफ़ेक्ट के बने रहने के बारे में वाक्य खोजे, और उन्हें पूरा नहीं पढ़ा। यह पंक्ति उसी उत्पाद की है, जिसका नाम दिया गया है, किसी और की नहीं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-fr-leaflet",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "SEROPLEX",
              "form": "10 mg, comprimé pelliculé sécable",
              "holder": "H. LUNDBECK A/S"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67219535/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67219535/extrait",
            "textDate": "2026-01-15",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 15/01/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SEROPLEX 10 mg, comprimé pelliculé sécable ?",
                "Avertissements et précautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms continued after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas se han prolongado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas se prolongaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi si sono protratti dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquemment (peut concerner jusqu’à 1 patient sur 10) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Troubles sexuels (éjaculation retardée, troubles de l’érection, baisse de la libido, troubles de l’orgasme chez la femme).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disorders (delayed ejaculation, erection problems, decreased libido, orgasm problems in women).",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsstörungen, verringerte Libido, Orgasmusstörungen bei Frauen).",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos sexuales (retraso de la eyaculación, trastornos de la erección, disminución de la libido, trastornos del orgasmo en la mujer).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios sexuais (ejaculação retardada, distúrbios da ereção, diminuição da libido, distúrbios do orgasmo na mulher).",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali (eiaculazione ritardata, disturbi dell’erezione, riduzione della libido, disturbi dell’orgasmo nella donna).",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन की गड़बड़ियाँ, कामेच्छा में कमी, महिलाओं में ऑर्गेज़्म की गड़बड़ियाँ)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquence indéterminée (fréquence ne pouvant pas être estimée à partir des données disponibles) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Erections douloureuses (priapisme).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erections (priapism).",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektionen (Priapismus).",
                  "by": "ours"
                },
                "es": {
                  "text": "Erecciones dolorosas (priapismo).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas (priapismo).",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose (priapismo).",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "fr",
              "text": "Ces effets indésirables s’estompent habituellement après quelques semaines de traitement. Sachez que certains de ces effets peuvent aussi être des symptômes liés à votre maladie qui s’amélioreront ainsi quand vous commencerez à vous sentir mieux.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "These side effects usually fade after a few weeks of treatment. Be aware that some of these effects may also be symptoms of your illness, which will improve when you begin to feel better.",
                  "by": "ours"
                },
                "de": {
                  "text": "Diese Nebenwirkungen klingen gewöhnlich nach einigen Behandlungswochen ab. Bedenken Sie, dass manche dieser Wirkungen auch Symptome Ihrer Krankheit sein können, die sich daher bessern, wenn Sie beginnen, sich besser zu fühlen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos adversos suelen atenuarse después de algunas semanas de tratamiento. Tenga en cuenta que algunos de estos efectos también pueden ser síntomas relacionados con su enfermedad, que, por tanto, mejorarán cuando empiece a sentirse mejor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses efeitos adversos geralmente se atenuam após algumas semanas de tratamento. Saiba que alguns desses efeitos também podem ser sintomas ligados à sua doença, que assim vão melhorar quando você começar a se sentir melhor.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi effetti indesiderati di solito si attenuano dopo alcune settimane di trattamento. Tenga presente che alcuni di questi effetti possono anche essere sintomi legati alla sua malattia, che quindi miglioreranno quando comincerà a sentirsi meglio.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये साइड इफ़ेक्ट आम तौर पर इलाज के कुछ हफ़्तों बाद धीरे-धीरे खत्म हो जाते हैं। ध्यान रखें कि इनमें से कुछ असर आपकी बीमारी से जुड़े लक्षण भी हो सकते हैं, और ऐसे में जब आप बेहतर महसूस करने लगेंगे, तब उनमें सुधार होगा।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Cipralex",
              "form": "5 mg, 10 mg, 15 mg e 20 mg compresse rivestite con film",
              "holder": "H. Lundbeck A/S"
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/911/farmaci/35767/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2026-02-24",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 24/02/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Avvertenze speciali e precauzioni di impiego",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome nach dem Absetzen von SSRI/SNRI fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual a largo plazo con persistencia de los síntomas tras la interrupción del uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual de longo prazo, com persistência dos sintomas após a interrupção do uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle à long terme ont été signalés, avec persistance des symptômes après l’arrêt de l’utilisation des ISRS/IRSN.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI का इस्तेमाल बंद करने के बाद भी लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Disturbi psichiatrici",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido Donne: anorgasmia",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, restlessness, abnormal dreams, decreased libido Women: anorgasmia",
                  "by": "ours"
                },
                "de": {
                  "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Frauen: Anorgasmie",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, inquietud, sueños anormales, disminución de la libido Mujeres: anorgasmia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, inquietude, sonhos anormais, diminuição da libido Mulheres: anorgasmia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmie",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने, कामेच्छा में कमी महिलाएँ: ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie del sistema riproduttivo e della mammella",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Uomini: disturbi di eiaculazione, impotenza",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men: ejaculation disorders, impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer: Ejakulationsstörungen, Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "Hombres: trastornos de la eyaculación, impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Homens: distúrbios da ejaculação, impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : troubles de l’éjaculation, impuissance",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: स्खलन की गड़बड़ियाँ, स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie del sistema riproduttivo e della mammella",
                "Non nota"
              ],
              "since": null,
              "lang": "it",
              "text": "Galattorea Uomini: priapismo emorragia postpartum3",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Men: priapism postpartum haemorrhage3",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Männer: Priapismus postpartale Hämorrhagie3",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Hombres: priapismo hemorragia posparto3",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Homens: priapismo hemorragia pós-parto3",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez l’homme : priapisme hémorragie du post-partum3",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism) प्रसव के बाद खून बहना (postpartum haemorrhage)3",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "it",
              "text": "Le reazioni avverse si manifestano più frequentemente durante la prima o seconda settimana di trattamento, per poi diminuire d’intensità e frequenza con la continuazione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Adverse reactions occur most frequently during the first or second week of treatment and then decrease in intensity and frequency as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Am häufigsten treten Nebenwirkungen in der ersten oder zweiten Behandlungswoche auf und nehmen dann bei fortgesetzter Behandlung an Intensität und Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas se manifiestan con más frecuencia durante la primera o la segunda semana de tratamiento y después disminuyen en intensidad y frecuencia al continuar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas se manifestam com mais frequência durante a primeira ou a segunda semana de tratamento e depois diminuem de intensidade e frequência com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables se manifestent le plus fréquemment pendant la première ou la deuxième semaine de traitement, puis diminuent en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट सबसे ज़्यादा इलाज के पहले या दूसरे हफ़्ते में सामने आते हैं, और फिर इलाज जारी रहने के साथ इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
            "lang": "it",
            "product": {
              "name": "Cipralex",
              "form": "5 mg, 10 mg, 15 mg e 20 mg compresse rivestite con film",
              "holder": "H. Lundbeck A/S"
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/911/farmaci/35767/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2026-02-24",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 24/02/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Cosa deve sapere prima di prendere Cipralex",
                "Avvertenze e precauzioni"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms have been seen to persist after treatment was stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, se ha observado la persistencia de estos síntomas tras la interrupción del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, observou-se a persistência desses sintomas após a interrupção do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la persistance de ces symptômes a été observée après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में देखा गया है कि ये लक्षण इलाज बंद करने के बाद भी बने रहे",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Comune (può interessare fino a 1 persona su 10):"
              ],
              "since": null,
              "lang": "it",
              "text": "disturbi sessuali (ritardata eiaculazione, problemi di erezione, diminuzione degli impulsi sessuali e le donne possono avere difficoltà nel raggiungere l’orgasmo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual disorders (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty reaching orgasm)",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsprobleme, vermindertes sexuelles Verlangen, außerdem können Frauen Schwierigkeiten haben, zum Orgasmus zu kommen)",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos sexuales (retraso de la eyaculación, problemas de erección, disminución de los impulsos sexuales y las mujeres pueden tener dificultades para alcanzar el orgasmo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais (ejaculação retardada, problemas de ereção, diminuição do impulso sexual e as mulheres podem ter dificuldade para chegar ao orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels (éjaculation retardée, troubles de l’érection, baisse du désir sexuel, et les femmes peuvent avoir des difficultés à atteindre l’orgasme)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन की समस्याएँ, कामेच्छा में कमी, और महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non nota (la frequenza non può essere stimata sulla base dei dati disponibili):"
              ],
              "since": null,
              "lang": "it",
              "text": "erezioni dolorose (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "painful erections (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "schmerzhafte Erektionen (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "erecciones dolorosas (priapismo)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereções dolorosas (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "érections douloureuses (priapisme)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "it",
              "text": "Gli effetti indesiderati solitamente scompaiono dopo alcune settimane di trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects usually disappear after a few weeks of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen verschwinden gewöhnlich nach einigen Behandlungswochen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos suelen desaparecer después de algunas semanas de tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos geralmente desaparecem após algumas semanas de tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables disparaissent habituellement après quelques semaines de traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर इलाज के कुछ हफ़्तों बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-es",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "Cipralex",
              "form": "10 mg comprimidos recubiertos con película",
              "holder": "Lundbeck España, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/65230/FT_65230.html",
            "fetchedUrl": null,
            "textDate": "2024-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO Noviembre 2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Advertencias y precauciones especiales de empleo",
                "Disfunción sexual"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen des SSRI/SNRI fortbestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da suspensão do ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’arrêt de l’ISRS/IRSN, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante la sospensione dell’SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos psiquiátricos",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "Ansiedad, inquietud, sueños anormales libido disminuida Mujeres: anorgasmia",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, restlessness, abnormal dreams decreased libido Women: anorgasmia",
                  "by": "ours"
                },
                "de": {
                  "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Frauen: Anorgasmie",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, inquietude, sonhos anormais diminuição da libido Mulheres: anorgasmia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmie",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido Donne: anorgasmia",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने कामेच्छा में कमी महिलाएँ: ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "Hombres: trastorno de la eyaculación, impotencia",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men: ejaculation disorder, impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer: Ejakulationsstörungen, Impotenz",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Homens: distúrbio da ejaculação, impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : trouble de l’éjaculation, impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "Uomini: disturbo dell’eiaculazione, impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: स्खलन की गड़बड़ी, स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Desconocida"
              ],
              "since": null,
              "lang": "es",
              "text": "Galactorrea Hombres: priapismo Hemorragia posparto3",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Men: priapism Postpartum haemorrhage3",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Männer: Priapismus Postpartale Hämorrhagie3",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Homens: priapismo Hemorragia pós-parto3",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez l’homme : priapisme Hémorragie du post-partum3",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Uomini: priapismo Emorragia postpartum3",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism) प्रसव के बाद खून बहना (postpartum haemorrhage)3",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "es",
              "text": "Las reacciones adversas son más frecuentes durante la primera o segunda semana del tratamiento y habitualmente disminuyen en intensidad y frecuencia con el tratamiento continuado.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Am häufigsten treten Nebenwirkungen in der ersten oder zweiten Behandlungswoche auf und nehmen normalerweise bei fortgesetzter Behandlung an Intensität und Häufigkeit ab.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont plus fréquents pendant la première ou la deuxième semaine de traitement et diminuent habituellement en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse sono più frequenti durante la prima o la seconda settimana di trattamento e di solito diminuiscono di intensità e frequenza con la continuazione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट इलाज के पहले या दूसरे हफ़्ते के दौरान सबसे ज़्यादा होते हैं, और इलाज जारी रहने पर आम तौर पर इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-es-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-es-leaflet",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: información para el usuario",
            "lang": "es",
            "product": {
              "name": "Cipralex",
              "form": "10 mg comprimidos recubiertos con película",
              "holder": "Lundbeck España, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/65230/P_65230.html",
            "fetchedUrl": null,
            "textDate": "2024-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: Noviembre 2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Qué necesita saber antes de empezar a tomar Cipralex",
                "Advertencias y precauciones"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas persistem depois de suspender o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes persistent après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi persistono dopo la sospensione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuente (puede afectar hasta 1 de cada 10 personas):"
              ],
              "since": null,
              "lang": "es",
              "text": "Alteraciones sexuales (retraso de la eyaculación, problemas con la erección, disminución de la conducta sexual y las mujeres pueden experimentar dificultades para alcanzar el orgasmo).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disturbances (delayed ejaculation, problems with erection, reduced sexual behaviour, and women may have difficulty reaching orgasm).",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Probleme mit der Erektion, Abnahme des Sexualverhaltens, außerdem können Frauen Schwierigkeiten haben, zum Orgasmus zu kommen).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Alterações sexuais (retardo na ejaculação, problemas de ereção, diminuição do comportamento sexual e as mulheres podem ter dificuldades para chegar ao orgasmo).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (éjaculation retardée, troubles de l’érection, diminution du comportement sexuel, et les femmes peuvent présenter des difficultés à atteindre l’orgasme).",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali (ritardo dell’eiaculazione, problemi di erezione, riduzione del comportamento sessuale e le donne possono avere difficoltà a raggiungere l’orgasmo).",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन की समस्याएँ, यौन व्यवहार में कमी, और महिलाओं को ऑर्गेज़्म तक पहुँचने में दिक्कत हो सकती है)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Desconocido (no se puede determinar la frecuencia a partir de los datos disponibles):"
              ],
              "since": null,
              "lang": "es",
              "text": "Erecciones dolorosas (priapismo).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erections (priapism).",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektionen (Priapismus).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereções dolorosas (priapismo).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érections douloureuses (priapisme).",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezioni dolorose (priapismo).",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Posibles efectos adversos"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "es",
              "text": "Los efectos adversos normalmente desaparecen después de pocas semanas de tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects usually disappear after a few weeks of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen verschwinden normalerweise nach wenigen Behandlungswochen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos normalmente desaparecem depois de poucas semanas de tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables disparaissent normalement après quelques semaines de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi di norma scompaiono dopo poche settimane di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट सामान्य तौर पर इलाज के कुछ हफ़्तों बाद चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-es-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-es-regulator",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/boletines-aemps/boletinMensual/2019-boletinMensual/boletin-mensual-de-la-aemps-sobre-medicamentos-de-uso-humano-del-mes-de-mayo-de-2019/",
            "fetchedUrl": null,
            "textDate": "2019-06-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 26 de junio de 2019"
          },
          "passages": [
            {
              "key": "bulletin",
              "kind": "sexual-persistence",
              "section": [
                "Información sobre seguridad",
                "Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia",
                "Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexual"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "En pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Serotonin-Noradrenalin-Wiederaufnahmehemmern oder mit selektiven Serotonin-Wiederaufnahmehemmern behandelt werden, wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen der Behandlung fortbestehen. Diese Erkenntnis wird in die Warnhinweise dieser Medikamente aufgenommen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em pacientes em tratamento com inibidores da recaptação de serotonina e noradrenalina, ou com inibidores seletivos da recaptação de serotonina, foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da interrupção do tratamento. Esse achado será incorporado às advertências desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez des patients traités par inhibiteurs de la recapture de la sérotonine et de la noradrénaline, ou par inhibiteurs sélectifs de la recapture de la sérotonine, des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’interruption du traitement, ont été signalés. Cette observation sera ajoutée aux mises en garde de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti in trattamento con inibitori della ricaptazione della serotonina e della noradrenalina, o con inibitori selettivi della ricaptazione della serotonina, sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante l’interruzione del trattamento. Questo dato sarà inserito nelle avvertenze di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर या सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर से जिन मरीज़ों का इलाज चल रहा है, उनमें लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें इलाज बंद करने के बावजूद लक्षण बने रहते हैं। यह बात इन दवाओं की चेतावनियों में जोड़ी जाएगी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name escitalopram.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Escitalopram nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo escitalopram.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita escitalopram pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif escitalopram.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo escitalopram.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें एस्सिटालोप्राम का नाम नहीं है।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Escena® oxalato de escitalopram: bula para o profissional de saúde",
            "lang": "pt-BR",
            "product": {
              "name": "Escena",
              "form": "comprimidos revestidos 10 mg e 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/369/bula-profissional",
            "fetchedUrl": null,
            "textDate": "2026-06-11",
            "textDateKind": "change-history",
            "textDateAsPrinted": "11/06/2026"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios psiquiátricos",
                "Comum"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Ansiedade, inquietude, sonhos anormais, diminuição da libido, anorgasmia feminina",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, restlessness, abnormal dreams, decreased libido, female anorgasmia",
                  "by": "ours"
                },
                "de": {
                  "text": "Ängstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido, Anorgasmie bei Frauen",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, inquietud, sueños anormales, disminución de la libido, anorgasmia femenina",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, impatiences, rêves anormaux, baisse de la libido, anorgasmie chez la femme",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, irrequietezza, sogni anomali, riduzione della libido, anorgasmia femminile",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, बेचैनी (restlessness), असामान्य सपने, कामेच्छा में कमी, महिलाओं में ऑर्गेज़्म न हो पाना (anorgasmia)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios do sistema reprodutor e mama",
                "Comum"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Homens: distúrbios da ejaculação e impotência",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Men: ejaculation disorders and impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Männer: Ejakulationsstörungen und Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "Hombres: trastornos de la eyaculación e impotencia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez l’homme : troubles de l’éjaculation et impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "Uomini: disturbi di eiaculazione e impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "पुरुष: स्खलन की गड़बड़ियाँ और स्तंभन दोष (impotence)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Distúrbios do sistema reprodutor e mama",
                "Desconhecido"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Galactorreia Mulheres: hemorragia pós-parto3 Homens: priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Women: postpartum haemorrhage3 Men: priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhö Frauen: postpartale Hämorrhagie3 Männer: Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Mujeres: hemorragia posparto3 Hombres: priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Chez la femme : hémorragie du post-partum3 Chez l’homme : priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Donne: emorragia postpartum3 Uomini: priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) महिलाएँ: प्रसव के बाद खून बहना (postpartum haemorrhage)3 पुरुष: लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "9. REAÇÕES ADVERSAS"
              ],
              "since": null,
              "qualifies": "listed-reproductive-2",
              "lang": "pt-BR",
              "text": "As reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Adverse reactions are most frequent during the first or second week of treatment and generally decrease in intensity and frequency as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen sind in der ersten oder zweiten Behandlungswoche am häufigsten und nehmen im weiteren Verlauf der Behandlung in der Regel an Stärke und Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas son más frecuentes durante la primera o la segunda semana de tratamiento y, generalmente, disminuyen en intensidad y frecuencia al continuar el tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont plus fréquents pendant la première ou la deuxième semaine de traitement et, généralement, diminuent en intensité et en fréquence avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse sono più frequenti durante la prima o la seconda settimana di trattamento e, generalmente, diminuiscono di intensità e frequenza con il proseguimento del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट इलाज के पहले या दूसरे हफ़्ते में ज़्यादा होते हैं, और इलाज जारी रहने के साथ आम तौर पर इनकी तीव्रता घटती है और ये कम बार होते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "originatorNotOpened",
              "text": {
                "en": "The originator product's text could not be opened. This is the text of another product, the one named in this row.",
                "de": "Der Text des Originalpräparats ließ sich nicht öffnen. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "El texto del producto original no se pudo abrir. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Não foi possível abrir o texto do produto original. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Le texte du produit d’origine n’a pas pu être ouvert. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Non è stato possibile aprire il testo del medicinale originatore. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "दवा के मूल (originator) उत्पाद का दस्तावेज़ खोला नहीं जा सका। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-br-leaflet-escena",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-br-leaflet-escena",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Escena® oxalato de escitalopram: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Escena",
              "form": "comprimidos revestidos 10 mg e 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/369/bula-paciente",
            "fetchedUrl": null,
            "textDate": "2026-06-11",
            "textDateKind": "change-history",
            "textDateAsPrinted": "11/06/2026"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Distúrbios sexuais (retardo ejaculatório, dificuldades de ereção, diminuição do desejo sexual e, em mulheres, dificuldades para chegar ao orgasmo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disorders (delayed ejaculation, erection difficulties, reduced sexual desire and, in women, difficulty reaching orgasm)",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsschwierigkeiten, vermindertes sexuelles Verlangen und bei Frauen Schwierigkeiten, zum Orgasmus zu kommen)",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos sexuales (retraso de la eyaculación, dificultades de erección, disminución del deseo sexual y, en las mujeres, dificultades para llegar al orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (éjaculation retardée, difficultés d’érection, baisse du désir sexuel et, chez la femme, difficultés à atteindre l’orgasme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali (eiaculazione ritardata, difficoltà di erezione, riduzione del desiderio sessuale e, nelle donne, difficoltà a raggiungere l’orgasmo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन में दिक्कत, यौन इच्छा में कमी और, महिलाओं में, ऑर्गेज़्म तक पहुँचने में दिक्कत)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Desconhecida (frequência não pode ser estimada a partir dos dados disponíveis):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Ereção dolorosa (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erection (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektion (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "Erección dolorosa (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érection douloureuse (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezione dolorosa (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "pt-BR",
              "text": "Os efeitos adversos são geralmente amenos e desaparecem espontaneamente após alguns dias de tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects are generally mild and disappear on their own after a few days of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen sind im Allgemeinen leicht und verschwinden nach einigen Behandlungstagen von selbst.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos son generalmente leves y desaparecen espontáneamente después de algunos días de tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement légers et disparaissent spontanément après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi sono generalmente lievi e scompaiono spontaneamente dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और कुछ दिनों के इलाज के बाद अपने आप चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-br-leaflet-espran",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-br-leaflet-espran",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ESPRAN® oxalato de escitalopram: bula para paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Espran",
              "form": "comprimidos revestidos 10 mg, 15 mg e 20 mg",
              "holder": "Torrent do Brasil Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Torrent do Brasil Ltda."
            },
            "url": "https://www.torrent.com.br/uploads/Espran_Bula_Paciente_BU-13%20(1).pdf",
            "fetchedUrl": null,
            "textDate": "2025-12-15",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi aprovada pela Anvisa em 15/12/2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Distúrbios sexuais (retardo ejaculatório, dificuldades de ereção, diminuição do desejo sexual e, em mulheres, dificuldades para chegar ao orgasmo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disorders (delayed ejaculation, erection difficulties, reduced sexual desire and, in women, difficulty reaching orgasm)",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsschwierigkeiten, vermindertes sexuelles Verlangen und bei Frauen Schwierigkeiten, zum Orgasmus zu kommen)",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos sexuales (retraso de la eyaculación, dificultades de erección, disminución del deseo sexual y, en las mujeres, dificultades para llegar al orgasmo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (éjaculation retardée, difficultés d’érection, baisse du désir sexuel et, chez la femme, difficultés à atteindre l’orgasme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali (eiaculazione ritardata, difficoltà di erezione, riduzione del desiderio sessuale e, nelle donne, difficoltà a raggiungere l’orgasmo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (स्खलन में देरी, इरेक्शन में दिक्कत, यौन इच्छा में कमी और, महिलाओं में, ऑर्गेज़्म तक पहुँचने में दिक्कत)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Desconhecida (frequência não pode ser estimada a partir dos dados disponíveis):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Ereção dolorosa (priapismo)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Painful erection (priapism)",
                  "by": "ours"
                },
                "de": {
                  "text": "Schmerzhafte Erektion (Priapismus)",
                  "by": "ours"
                },
                "es": {
                  "text": "Erección dolorosa (priapismo)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érection douloureuse (priapisme)",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezione dolorosa (priapismo)",
                  "by": "ours"
                },
                "hi": {
                  "text": "दर्दनाक इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "pt-BR",
              "text": "Os efeitos adversos são geralmente amenos e desaparecem espontaneamente após alguns dias de tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects are generally mild and disappear on their own after a few days of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen sind im Allgemeinen leicht und verschwinden nach einigen Behandlungstagen von selbst.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos son generalmente leves y desaparecen espontáneamente después de algunos días de tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement légers et disparaissent spontanément après quelques jours de traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi sono generalmente lievi e scompaiono spontaneamente dopo alcuni giorni di trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और कुछ दिनों के इलाज के बाद अपने आप चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "disfunção sexual, disfunções sexuais, longa duração, persist, continuaram, continua, após a interrupção, após a descontinuação, apesar da descontinuação, após parar, após a suspensão, sexual, libido, ejacul, orgasm, impot, ereç, eréti, priapismo, anorgasm, desejo",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-br-pro-lexapro",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-br-pro-lexapro",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Lexapro",
              "form": null,
              "holder": "Lundbeck Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=lexapro&page=1",
            "https://www.lundbeck.com/br/our-science/Products"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-br-leaflet-lexapro",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-br-leaflet-lexapro",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Lexapro",
              "form": null,
              "holder": "Lundbeck Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=lexapro&page=1",
            "https://www.lundbeck.com/br/our-science/Products"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "escitalopram-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "S-CITADEP Tablets",
            "lang": "en-IN",
            "product": {
              "name": "S-CITADEP",
              "form": "tablets",
              "holder": "Cipla Ltd."
            },
            "source": {
              "type": "holder",
              "name": "Cipla (ciplamed.com)"
            },
            "url": "https://www.ciplamed.com/product-index/s-citadep-tablets",
            "fetchedUrl": null,
            "textDate": "2021-12-14",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last updated: 14/December/2021"
          },
          "passages": [],
          "searched": "persist, long-lasting, long lasting, after stopping, after discontinu, continu, sexual, libido, ejacul, orgasm, impoten, erect, priapism, anorgasm, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyNoDatabase",
              "text": {
                "en": "This is the holder's own copy. This regulator publishes no database of such texts.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Diese Arzneimittelbehörde veröffentlicht keine Datenbank mit solchen Texten.",
                "es": "Es la copia del propio laboratorio titular. Esta agencia del medicamento no publica ninguna base de datos de estos textos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. Esta agência reguladora não publica um banco de dados com esses textos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. Cette agence ne publie aucune base de données de ces textes.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. Questa agenzia del farmaco non pubblica una banca dati di questi testi.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। इस देश का दवा नियामक ऐसे दस्तावेज़ों का कोई डेटाबेस प्रकाशित नहीं करता।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "escitalopram-in-pro-nexito",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#escitalopram-in-pro-nexito",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "holder-publishes-none",
            "no-public-database"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Nexito",
              "form": "5 mg, 10 mg, 15 mg, 20 mg tablets",
              "holder": "Sun Pharmaceutical Industries Ltd."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://sunpharma.com/india-products/",
            "https://sunpharma.com/india-prescribing-information/",
            "https://cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
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              "fields": [
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          ],
          "retired": null,
          "notes": []
        }
      ]
    },
    {
      "id": "fluoxetine",
      "inn": "fluoxetine",
      "names": {
        "en": "fluoxetine",
        "de": "Fluoxetin",
        "es": "fluoxetina",
        "pt-br": "fluoxetina",
        "fr": "fluoxétine",
        "it": "fluoxetina",
        "hi": "फ़्लुओक्सेटीन"
      },
      "class": "ssri",
      "classLabel": {
        "en": "SSRI antidepressant",
        "de": "SSRI-Antidepressivum",
        "es": "antidepresivo ISRS",
        "pt-br": "antidepressivo ISRS",
        "fr": "antidépresseur ISRS",
        "it": "antidepressivo SSRI",
        "hi": "SSRI एंटीडिप्रेसेंट"
      },
      "condition": "pssd",
      "lead": {
        "en": "For the SSRI antidepressant fluoxetine (Prozac), the product information we read in the United Kingdom, that of a generic product, says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, fluoxetine among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it. In the United States, the Prozac text for professionals says that symptoms of sexual dysfunction occasionally persist after fluoxetine is stopped. That sentence stands in the section on adverse reactions, not in a warning, and not every fluoxetine label there has it.",
        "de": "Zum SSRI-Antidepressivum Fluoxetin (Prozac) steht im Vereinigten Königreich in der Produktinformation eines Generikums, die wir gelesen haben, dass es Berichte über lang anhaltende sexuelle Funktionsstörungen gibt, bei denen die Symptome nach dem Absetzen von SSRI bestehen blieben. Das nennt man sexuelle Funktionsstörung nach SSRI-Einnahme (PSSD). Die Europäische Arzneimittel-Agentur (EMA) legte den Wortlaut dieses Warnhinweises 2019 für zehn Medikamente fest, darunter Fluoxetin. Laut einer Antwort der Regierung im britischen Parlament wurden die Produktinformationen für alle SSRI im Vereinigten Königreich 2019 um diesen Warnhinweis ergänzt. In den USA steht in der Fachinformation zu Prozac, dass Symptome einer sexuellen Funktionsstörung nach dem Absetzen von Fluoxetin gelegentlich fortbestehen. Dieser Satz steht im Abschnitt über Nebenwirkungen, nicht in einem Warnhinweis, und nicht jede FDA-Fachinformation zu Fluoxetin enthält ihn.",
        "es": "En el caso de la fluoxetina (Prozac), un antidepresivo ISRS, la información del producto que hemos leído en el Reino Unido, la de un medicamento genérico, dice que se han notificado casos de disfunción sexual de larga duración en los que los síntomas continuaron después de dejar los ISRS. Esto se conoce como disfunción sexual post-ISRS (PSSD). La Agencia Europea de Medicamentos (EMA) fijó en 2019 el texto de esta advertencia para diez medicamentos, entre ellos la fluoxetina, y una respuesta del Gobierno en el Parlamento dice que la información del producto de todos los ISRS en el Reino Unido se actualizó en 2019 para incluirla. En Estados Unidos, el texto de Prozac para profesionales dice que los síntomas de disfunción sexual ocasionalmente persisten después de dejar la fluoxetina. Esa frase está en el apartado de reacciones adversas, no en una advertencia, y no todas las fichas técnicas de fluoxetina de ese país la tienen.",
        "pt-br": "No caso do antidepressivo ISRS fluoxetina (Prozac), a bula que lemos no Reino Unido, a de um medicamento genérico, diz que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram depois da interrupção dos ISRS. Esse quadro é conhecido como disfunção sexual pós-ISRS (PSSD). A agência reguladora de medicamentos da UE definiu o texto desse alerta em 2019 para dez medicamentos, entre eles a fluoxetina. Uma resposta do governo no Parlamento diz que as bulas de todos os ISRS no Reino Unido foram atualizadas em 2019 para incluí-lo. Nos Estados Unidos, a bula do Prozac para o profissional de saúde diz que os sintomas de disfunção sexual ocasionalmente persistem depois da interrupção da fluoxetina. Essa frase está na seção de reações adversas, não em um alerta, e nem toda bula americana de fluoxetina a traz.",
        "fr": "Pour la fluoxétine (Prozac), un antidépresseur ISRS, les informations sur le produit que nous avons lues au Royaume-Uni, celles d’un médicament générique, indiquent que des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui ont persisté après l’arrêt des ISRS. C’est ce qu’on appelle la dysfonction sexuelle post-ISRS (PSSD). L’Agence européenne des médicaments (EMA) a fixé la formulation de cette mise en garde en 2019 pour dix médicaments, dont la fluoxétine. Selon une réponse du gouvernement britannique au Parlement, les informations sur le produit de tous les ISRS ont été mises à jour au Royaume-Uni en 2019 pour l’intégrer. Aux États-Unis, le texte du Prozac destiné aux professionnels indique que des symptômes de dysfonction sexuelle persistent parfois après l’arrêt de la fluoxétine. Cette phrase se trouve dans la rubrique des effets indésirables, et non dans une mise en garde ; elle ne figure pas sur toutes les notices de fluoxétine de ce pays.",
        "it": "Per l’antidepressivo SSRI fluoxetina (Prozac), le informazioni sul prodotto che abbiamo letto nel Regno Unito, quelle di un medicinale generico, dicono che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI. Questo quadro è noto come disfunzione sessuale post-SSRI (PSSD). L’agenzia del farmaco dell’UE ha fissato il testo di questa avvertenza nel 2019 per dieci medicinali, tra cui la fluoxetina. Una risposta del governo al Parlamento britannico dice che nel 2019 le informazioni sul prodotto britanniche di tutti gli SSRI sono state aggiornate per riportare questa avvertenza. Negli Stati Uniti, il testo di Prozac per i professionisti sanitari dice che i sintomi di disfunzione sessuale persistono occasionalmente dopo l’interruzione della fluoxetina. Quella frase si trova nella sezione sulle reazioni avverse, non in un’avvertenza, e non tutte le schede tecniche statunitensi della fluoxetina la riportano.",
        "hi": "SSRI एंटीडिप्रेसेंट फ़्लुओक्सेटीन (Prozac) के मामले में, ब्रिटेन में हमने दवा की जो आधिकारिक जानकारी (product information) पढ़ी, वह एक जेनेरिक उत्पाद की है। वह कहती है कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बाद भी लक्षण जारी रहे। इसे पोस्ट-SSRI सेक्शुअल डिस्फ़ंक्शन (PSSD) कहते हैं। यूरोपीय संघ (EU) के दवा नियामक ने 2019 में इस चेतावनी के शब्द दस दवाओं के लिए तय किए, जिनमें फ़्लुओक्सेटीन भी है। ब्रिटेन की संसद में सरकार का एक जवाब कहता है कि वहाँ सभी SSRI दवाओं की आधिकारिक जानकारी 2019 में अपडेट की गई, ताकि उसमें यह चेतावनी हो। अमेरिका में डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए Prozac का दस्तावेज़ कहता है कि फ़्लुओक्सेटीन बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के लक्षण कभी-कभी बने रहते हैं। यह वाक्य साइड इफ़ेक्ट (adverse reactions) वाले सेक्शन में है, किसी चेतावनी में नहीं, और वहाँ फ़्लुओक्सेटीन के कुछ लेबलों में यह वाक्य नहीं है।"
      },
      "brands": [
        {
          "name": "Prozac",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61885224/extrait",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000061330?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Olena",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2227",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prozep",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/2227",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fluox",
          "listings": [
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fluoxeren",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000017342?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Xeredien",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000034273?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Luramon",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=64970",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Daforin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fluoxetin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fluxene",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prozen",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Verotina",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Zyfloxin",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        }
      ],
      "leadBrands": [
        "Prozac"
      ],
      "cardSince": "fluoxetine-uk#persistence",
      "unknowns": [
        {
          "id": "frequency-pssd",
          "sourceUrl": "https://pubmed.ncbi.nlm.nih.gov/37294623/",
          "text": {
            "en": "No reliable figure exists for how often PSSD happens.",
            "de": "Eine verlässliche Zahl dazu, wie oft PSSD vorkommt, gibt es nicht.",
            "es": "No existe ninguna cifra fiable sobre la frecuencia con la que se produce la PSSD.",
            "pt-br": "Não existe um número confiável sobre a frequência com que a PSSD acontece.",
            "fr": "Il n’existe aucun chiffre fiable sur la fréquence de la PSSD.",
            "it": "Non esiste una cifra affidabile su quanto spesso si verifichi la PSSD.",
            "hi": "PSSD कितनी बार होता है, इसका कोई भरोसेमंद आँकड़ा नहीं है।"
          }
        },
        {
          "id": "estimate-men-pssd",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10122283/",
          "text": {
            "en": "One study of health records gives an estimate for men, counted through prescriptions for erection medicines.",
            "de": "Eine Studie auf der Grundlage von Krankenakten nennt eine Schätzung für Männer, gezählt anhand der Verordnungen von Erektionsmitteln.",
            "es": "Un estudio de historias clínicas da una estimación para hombres, calculada a partir de las recetas de medicamentos para la erección.",
            "pt-br": "Um estudo com dados de prontuários médicos traz uma estimativa para homens, calculada a partir das receitas de medicamentos para ereção.",
            "fr": "Une étude menée sur des dossiers médicaux donne une estimation pour les hommes, établie à partir des prescriptions de médicaments contre les troubles de l’érection.",
            "it": "Uno studio su cartelle cliniche dà una stima per gli uomini, calcolata attraverso le prescrizioni di farmaci per l’erezione.",
            "hi": "मेडिकल रिकॉर्ड पर आधारित एक अध्ययन पुरुषों के लिए एक अनुमान देता है, जो इरेक्शन की दवाओं की पर्चियों से गिना गया।"
          }
        },
        {
          "id": "course",
          "sourceUrl": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11450419/",
          "text": {
            "en": "It is not known how many people fully recover.",
            "de": "Es ist nicht bekannt, wie viele Menschen vollständig genesen.",
            "es": "No se sabe cuántas personas se recuperan por completo.",
            "pt-br": "Não se sabe quantas pessoas se recuperam por completo.",
            "fr": "On ne sait pas combien de personnes se rétablissent complètement.",
            "it": "Non si sa quante persone guariscano del tutto.",
            "hi": "यह पता नहीं है कि कितने लोग पूरी तरह ठीक हो जाते हैं।"
          }
        },
        {
          "id": "duration-pssd",
          "sourceUrl": "https://sidefxhub.com/label-wording-by-country/#fluoxetine",
          "text": {
            "en": "None of the product texts we read says how long the sexual dysfunction can last.",
            "de": "In keinem der Produkttexte, die wir gelesen haben, steht, wie lange die sexuelle Funktionsstörung anhalten kann.",
            "es": "Ninguno de los textos de producto que hemos leído dice cuánto puede durar la disfunción sexual.",
            "pt-br": "Nenhuma das bulas que lemos diz quanto tempo a disfunção sexual pode durar.",
            "fr": "Aucun des textes de produits que nous avons lus ne dit combien de temps la dysfonction sexuelle peut durer.",
            "it": "Nessuno dei testi dei prodotti che abbiamo letto dice quanto può durare la disfunzione sessuale.",
            "hi": "हमने दवा के जो दस्तावेज़ पढ़े, उनमें से कोई नहीं बताता कि सेक्शुअल डिस्फ़ंक्शन कितने समय तक रह सकता है।"
          }
        }
      ],
      "changed": "2026-10-14",
      "records": [
        {
          "id": "fluoxetine-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Fluoxetine 10 mg hard capsules",
            "lang": "en-GB",
            "product": {
              "name": "Fluoxetine",
              "form": "10 mg hard capsules",
              "holder": "Brown & Burk UK Ltd"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/15589/smpc",
            "fetchedUrl": null,
            "textDate": "2022-09-28",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 28/09/2022"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "fluoxetine-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Selective serotonin reuptake inhibitors (SSRI) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4.8). Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual (ver sección 4.8). Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual (ver seção 4.8). Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4.8). Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4.8). Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4.8 देखें)। लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "Psychiatric disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Anxiety Nervousness Restlessness Tension Libido decreased3 Sleep disorder Abnormal dreams4",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Angst Nervosität Ruhelosigkeit Angespanntheit Verminderte Libido3 Schlafstörung Abnormale Träume4",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad Nerviosismo Inquietud Tensión Disminución de la libido3 Trastornos del sueño Sueños anormales4",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade Nervosismo Inquietude Tensão Diminuição da libido3 Distúrbio do sono Sonhos anormais4",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété Nervosité Impatiences Tension Baisse de la libido3 Troubles du sommeil Rêves anormaux4",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia Nervosismo Irrequietezza Tensione Diminuzione della libido3 Disturbi del sonno Sogni anormali4",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी घबराहट बेचैनी (restlessness) तनाव कामेच्छा में कमी3 नींद की गड़बड़ी असामान्य सपने4",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "Psychiatric disorders",
                "Uncommon"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Depersonalisation Elevated mood Euphoric mood Thinking abnormal Orgasm abnormal5 Bruxism Suicidal thoughts and behaviour 6",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Depersonalisation Gehobene Stimmung Euphorische Stimmung Abnormales Denken Abnormaler Orgasmus5 Zähneknirschen Suizidale Gedanken und suizidales Verhalten 6",
                  "by": "ours"
                },
                "es": {
                  "text": "Despersonalización Estado elevado del ánimo Estado eufórico del ánimo Pensamiento anormal Orgasmo anormal5 Bruxismo Comportamientos y pensamientos suicidas 6",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização Humor elevado Humor eufórico Pensamento anormal Orgasmo anormal5 Bruxismo Pensamentos e comportamento suicidas 6",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dépersonnalisation Humeur exaltée Humeur euphorique Pensées anormales Orgasme anormal5 Bruxisme Pensées et comportement suicidaires 6",
                  "by": "ours"
                },
                "it": {
                  "text": "Depersonalizzazione Umore elevato Umore euforico Pensiero anormale Orgasmo anormale5 Bruxismo Ideazioni e comportamento suicidario 6",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना) मूड का ऊँचा रहना (elevated mood) बहुत ज़्यादा खुशी का मूड (euphoric mood) असामान्य सोच (thinking abnormal) ऑर्गेज़्म में गड़बड़ी5 दाँत पीसना (bruxism) आत्महत्या के विचार और व्यवहार 6",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "Reproductive system and breast disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Gynäkologische Blutung14 Erektile Dysfunktion Ejakulationsstörung15",
                  "by": "ours"
                },
                "es": {
                  "text": "Hemorragia ginecológica14 Disfunción eréctil Trastorno de la eyaculación15",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sangramento ginecológico14 Disfunção erétil Distúrbio da ejaculação15",
                  "by": "ours"
                },
                "fr": {
                  "text": "Saignements gynécologiques14 Dysfonction érectile Trouble de l’éjaculation15",
                  "by": "ours"
                },
                "it": {
                  "text": "Emorragia ginecologica14 Disfunzione erettile Disturbo dell’eiaculazione15",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding)14 स्तंभन दोष स्खलन की गड़बड़ी15",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "Reproductive system and breast disorders",
                "Uncommon"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Sexual dysfunction16",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Dysfunktion16",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual16",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual16",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction sexuelle16",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale16",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन16",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "footnote 16"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Occasionally persisting after treatment discontinuation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Gelegentlich anhaltend nach Absetzung der Therapie",
                  "by": "ours"
                },
                "es": {
                  "text": "Persiste ocasionalmente después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ocasionalmente persistindo após a descontinuação do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "Persistant parfois après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "Occasionalmente persistente dopo sospensione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कभी-कभी बना रहता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b) Tabulated list of adverse reactions",
                "Reproductive system and breast disorders",
                "Rare"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Galactorrhoea, Hyperprolactinaemia Priapism",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Galaktorrhoe, Hyperprolaktinämie Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea, Hiperprolactinemia Priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia, Hiperprolactinemia Priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée, Hyperprolactinémie Priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea, Iperprolattinemia Priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea), खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia) लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects",
                "a) Summary of the safety profile"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "en-GB",
              "text": "Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas pueden disminuir en intensidad y frecuencia con el tratamiento continuado y no conducen generalmente a la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis podem diminuir de intensidade e frequência com a continuação do tratamento e geralmente não levam à interrupção da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence avec la poursuite du traitement et n’entraînent généralement pas l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano ad una interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने के साथ साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "d) Paediatric population"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Isolated cases of adverse events potentially indicating delayed sexual maturation or sexual dysfunction have been reported from paediatric clinical use (see also section 5.3).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Einzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störung der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "Han sido notificados de la experiencia clínica en pediatría casos aislados de efectos adversos indicando potencialmente un retraso en la maduración sexual o disfunción sexual (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados, no uso clínico pediátrico, casos isolados de eventos adversos que potencialmente indicam atraso da maturação sexual ou disfunção sexual (ver também seção 5.3).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas isolés d’événements indésirables pouvant indiquer un retard de maturation sexuelle ou une dysfonction sexuelle ont été signalés lors de l’utilisation clinique en pédiatrie (voir également rubrique 5.3).",
                  "by": "ours"
                },
                "it": {
                  "text": "Nell’impiego clinico in pediatria sono stati riportati casi isolati di eventi avversi potenzialmente indicanti una ritardata maturazione sessuale o una disfunzione sessuale (vedere anche paragrafo 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल से प्रतिकूल घटनाओं (adverse events) के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा कर सकते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "productsDifferSearched",
              "text": {
                "en": "Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Wir haben sie nach Sätzen dazu durchsucht, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten, und sie nicht vollständig gelesen. Diese Zeile zeigt das genannte Produkt und kein anderes.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Hemos buscado en ellos frases sobre efectos secundarios sexuales que continúen después de dejar el medicamento, y no los hemos leído enteros. Esta fila muestra el producto que se nombra, y ningún otro.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. Procuramos nelas frases sobre efeitos colaterais sexuais que continuam depois de parar o medicamento, mas não as lemos por inteiro. Esta linha mostra o produto indicado, e nenhum outro.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Nous y avons cherché des phrases sur des effets secondaires sexuels qui persistent après l’arrêt, sans les lire en entier. Cette ligne montre le produit nommé, et aucun autre.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Vi abbiamo cercato frasi sugli effetti collaterali sessuali che continuano dopo l’interruzione e non li abbiamo letti per intero. Questa riga mostra il prodotto indicato, e nessun altro.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। हमने उनमें दवा बंद करने के बाद यौन साइड इफ़ेक्ट के बने रहने के बारे में वाक्य खोजे, और उन्हें पूरा नहीं पढ़ा। यह पंक्ति उसी उत्पाद की है, जिसका नाम दिया गया है, किसी और की नहीं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package Leaflet: Information for the patient. Fluoxetine 10 mg hard capsules. fluoxetine",
            "lang": "en-GB",
            "product": {
              "name": "Fluoxetine",
              "form": "10 mg hard capsules",
              "holder": "Brown & Burk UK Ltd"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.15589.pdf",
            "fetchedUrl": null,
            "textDate": "2022-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in 09/2022."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. What you need to know before you take Fluoxetine",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019",
                "scope": "jurisdiction",
                "basis": [
                  "fluoxetine-uk-regulator-parliament"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "Medicines like Fluoxetine (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Fluoxetin (so genannte SSRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt 4). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como fluoxetina (los llamados ISRS) pueden causar síntomas de disfunción sexual (ver sección 4). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como a fluoxetina (os chamados ISRS) podem causar sintomas de disfunção sexual (ver seção 4). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme la fluoxétine (appelés ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir rubrique 4). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Fluoxetine (i cosiddetti SSRI) possono causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Fluoxetine जैसी दवाओं (जिन्हें SSRI कहा जाता है) से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (सेक्शन 4 देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Some patients have had:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "prolonged and painful erection;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verlängerte und schmerzhafte Erektion;",
                  "by": "ours"
                },
                "es": {
                  "text": "erección prolongada y dolorosa;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereção prolongada e dolorosa;",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection prolongée et douloureuse ;",
                  "by": "ours"
                },
                "it": {
                  "text": "erezione prolungata e dolorosa;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Common (may affect up to 1 in 10 people)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes sexuelles Verlangen oder sexuelle Probleme (einschließlich Schwierigkeiten, eine Erektion für sexuelle Aktivität aufrechtzuerhalten)",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual o problemas sexuales (incluyendo dificultad para mantener una erección durante la actividad sexual)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual ou problemas sexuais (incluindo dificuldade para manter uma ereção para a atividade sexual)",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel ou troubles sexuels (y compris des difficultés à maintenir une érection pour une activité sexuelle)",
                  "by": "ours"
                },
                "it": {
                  "text": "ridotto desiderio sessuale o problemi sessuali (inclusa la difficoltà a mantenere un’erezione per l’attività sessuale)",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी या यौन समस्याएँ (जिनमें यौन क्रिया के लिए इरेक्शन बनाए रखने में दिक्कत भी शामिल है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Uncommon (may affect up to 1 in 100 people)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "sexual problems, including orgasm problems, occasionally persisting after treatment discontinuation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "sexuelle Probleme, einschließlich Orgasmusprobleme, die gelegentlich nach Beendigung der Behandlung bestehen bleiben",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas sexuales, incluyendo problemas de orgasmo, persistiendo ocasionalmente después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas sexuais, incluindo problemas de orgasmo, ocasionalmente persistindo após a descontinuação do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels, y compris des troubles de l’orgasme, persistant parfois après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi sessuali, inclusi problemi di orgasmo, occasionalmente persistenti dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ, जिनमें ऑर्गेज़्म की समस्याएँ भी शामिल हैं, जो इलाज बंद करने के बाद कभी-कभी बनी रहती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "en-GB",
              "text": "Most of these side effects are likely to disappear with continued treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die meisten dieser Nebenwirkungen gehen wahrscheinlich vorüber, während Sie Ihr Arzneimittel weiter einnehmen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de estos efectos adversos tienden a desaparecer con la continuación del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos colaterais provavelmente vai desaparecer com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart de ces effets indésirables disparaîtront probablement avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "È probabile che la maggior parte di questi effetti indesiderati sparisca continuando il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रखने पर इनमें से ज़्यादातर साइड इफ़ेक्ट के चले जाने की संभावना है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-uk-regulator-parliament",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-uk-regulator-parliament",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 50758, House of Commons: \"Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2025-05-07/50758",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/2025-05-07/50758",
            "textDate": "2025-05-13",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2025-05-13T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "sexual-persistence",
              "section": [
                "Answer"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die von der Medicines and Healthcare products Regulatory Agency (MHRA) genehmigten Produktinformationen, die medizinische Fachleute und Patientinnen und Patienten erhalten, wurden 2019 für alle selektiven Serotonin-Wiederaufnahmehemmer (SSRI) aktualisiert, um sie darüber zu informieren, dass Berichte über lang anhaltende sexuelle Funktionsstörungen eingegangen waren, bei denen die Symptome trotz Absetzen des SSRI anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto aprobada por la Medicines and Healthcare products Regulatory Agency (MHRA) que se facilita a profesionales sanitarios y pacientes para todos los inhibidores selectivos de la recaptación de serotonina (ISRS) se actualizó en 2019 para informarles de que se habían recibido notificaciones de disfunción sexual de larga duración en la que los síntomas continúan a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto aprovadas pela Medicines and Healthcare products Regulatory Agency (MHRA) e fornecidas a profissionais de saúde e pacientes para todos os inibidores seletivos da recaptação de serotonina (ISRS) foram atualizadas em 2019 para informá-los de que haviam sido recebidos relatos de disfunção sexual de longa duração em que os sintomas continuam apesar da descontinuação do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit approuvées par la Medicines and Healthcare products Regulatory Agency (MHRA) et fournies aux professionnels de santé et aux patients pour tous les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) ont été mises à jour en 2019 pour les informer que des signalements de dysfonction sexuelle durable, dans laquelle les symptômes persistent malgré l’arrêt de l’ISRS, avaient été reçus.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto approvate dalla Medicines and Healthcare products Regulatory Agency (MHRA) e fornite ai professionisti sanitari e ai pazienti per tutti gli inibitori selettivi della ricaptazione della serotonina (SSRI) sono state aggiornate nel 2019 per informarli che erano pervenute segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi continuano nonostante l’interruzione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Medicines and Healthcare products Regulatory Agency (MHRA) की मंज़ूर की हुई दवा की आधिकारिक जानकारी (product information), जो सभी सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं के लिए डॉक्टरों, दूसरे स्वास्थ्यकर्मियों और मरीज़ों को दी जाती है, 2019 में अपडेट की गई। मकसद उन्हें यह बताना था कि लंबे समय तक रहने वाले ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें मिली हैं, जिसमें SSRI बंद करने के बावजूद लक्षण जारी रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name fluoxetine.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Fluoxetin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo fluoxetina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita fluoxetina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif fluoxétine.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo fluoxetina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें फ़्लुओक्सेटीन का नाम नहीं है।"
              }
            },
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "fluoxetine-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Zusammenfassung der Merkmale des Arzneimittels",
                    "4.4. Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                    "Sexuelle Funktionsstörung"
                  ],
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Résumé des caractéristiques du produit",
                    "4.4. Mises en garde spéciales et précautions d’emploi",
                    "Dysfonction sexuelle"
                  ],
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Riassunto delle caratteristiche del prodotto",
                    "4.4. Avvertenze speciali e precauzioni d’impiego",
                    "Disfunzione sessuale"
                  ],
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Ficha técnica o resumen de las características del producto",
                    "4.4. Advertencias y precauciones especiales de empleo",
                    "Disfunción sexual"
                  ],
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Resumo das Características do Medicamento",
                    "4.4. Advertências e precauções especiais de utilização",
                    "Disfunção sexual"
                  ],
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS."
                }
              ],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "official"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual prolongada cujos sintomas persistiram apesar da descontinuação dos IRSN/ISRS.",
                  "by": "official"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "official"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "official"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": {
                "date": "2019-05-16",
                "scope": "jurisdiction",
                "basis": [
                  "fluoxetine-eu-regulator-prac201905"
                ]
              },
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "3. Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – Persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)",
                    "Packungsbeilage",
                    "2. Was sollten Sie vor der Einnahme von [Phantasiebezeichnung] beachten?",
                    "Warnhinweise und Vorsichtsmaßnahmen"
                  ],
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen."
                },
                {
                  "lang": "fr",
                  "section": [
                    "3. Inhibiteurs de la recapture de la sérotonine et de la noradrénaline (IRSN); inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) - Dysfonction sexuelle persistante après l’arrêt du médicament (EPITT nº 19277)",
                    "Notice",
                    "2. Quelles sont les informations à connaître avant de prendre [Nom de fantaisie]",
                    "Mises en garde et précautions"
                  ],
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement."
                },
                {
                  "lang": "it",
                  "section": [
                    "3. Inibitori della ricaptazione della serotonina e della noradrenalina (SNRI); inibitori selettivi della ricaptazione della serotonina (SSRI) – Disfunzione sessuale persistente dopo la sospensione del medicinale (EPITT n. 19277)",
                    "Foglio illustrativo",
                    "2. Cosa deve sapere prima di prendere [denominazione del medicinale]",
                    "Avvertenze e precauzioni"
                  ],
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento."
                },
                {
                  "lang": "es",
                  "section": [
                    "3. Inhibidores de la recaptación de serotonina y noradrenalina (IRSN); inhibidores selectivos de la recaptación de serotonina (ISRS) – Disfunción sexual persistente después de la retirada del fármaco (EPITT n.º 19 277)",
                    "Prospecto",
                    "2. Qué necesita saber antes de empezar a tomar [nombre de fantasía]",
                    "Advertencias y precauciones"
                  ],
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "3. Inibidores da recaptação da serotonina e noradrenalina (IRSN); inibidores seletivos da recaptação da serotonina (ISRS) – Disfunção sexual persistente após suspensão do tratamento (EPITT n.º 19277)",
                    "Folheto Informativo",
                    "2. O que precisa de saber antes de tomar [Nome do medicamento]",
                    "Advertências e precauções"
                  ],
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento."
                }
              ],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "official"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Em alguns casos, estes sintomas persistiram após a suspensão do tratamento.",
                  "by": "official"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "official"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "official"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen. Verabschiedet im Rahmen der PRAC-Sitzung vom 13. bis 16. Mai 2019",
              "url": "https://www.ema.europa.eu/de/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_de.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Nouveau texte des informations sur le produit – Extraits des recommandations du PRAC sur les signaux. Adopté les 13-16 mai 2019 par le PRAC",
              "url": "https://www.ema.europa.eu/fr/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_fr.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Nuovo testo delle informazioni sul prodotto – Estratti dalle raccomandazioni del PRAC in merito ai segnali. Adottato nella riunione del PRAC del 13-16 maggio 2019",
              "url": "https://www.ema.europa.eu/it/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_it.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "es",
              "name": "Recomendaciones del PRAC sobre señales: nuevo texto de información sobre el producto. Adoptadas por el PRAC el 13-16 de mayo de 2019",
              "url": "https://www.ema.europa.eu/es/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_es.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Novo texto da informação do medicamento – Extratos das recomendações do PRAC relativamente aos sinais. Adotado na reunião do PRAC de 13-16 de maio de 2019",
              "url": "https://www.ema.europa.eu/pt/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-may-2019-prac_pt.pdf",
              "textDateAsPrinted": null,
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            }
          ],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            },
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-eu-regulator-prac201905",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-eu-regulator-prac201905",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meeting",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-13-16-may-2019-prac-meeting_en.pdf",
            "fetchedUrl": null,
            "textDate": "2019-06-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "11 June 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Summary of product characteristics",
                "4.4. Special warnings and precautions for use",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-persistence",
              "section": [
                "1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal",
                "Package leaflet",
                "2. What you need to know before you take [Invented name]",
                "Warnings and precautions"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en",
              "text": "In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PROZAC (fluoxetine capsules) for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Prozac",
              "form": "capsules (\"Pulvules\") 10 mg, 20 mg and 40 mg",
              "holder": "Dista Products Company"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299",
            "fetchedUrl": null,
            "textDate": "2023-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 8/2023"
          },
          "passages": [
            {
              "key": "listed-warnings",
              "kind": "sexual-side-effects",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.17 Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Use of SSRIs, including PROZAC, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Anwendung von SSRI, einschließlich PROZAC, kann Symptome einer sexuellen Funktionsstörung verursachen [siehe Nebenwirkungen (6.1)]. Bei männlichen Patienten kann die Anwendung von SSRI zu verzögerter oder ausbleibender Ejakulation, verminderter Libido und erektiler Dysfunktion führen. Bei Patientinnen kann die Anwendung von SSRI zu verminderter Libido und verzögertem oder ausbleibendem Orgasmus führen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El uso de ISRS, incluido PROZAC, puede causar síntomas de disfunción sexual [ver Reacciones adversas (6.1)]. En los pacientes varones, el uso de ISRS puede dar lugar a retraso o insuficiencia de la eyaculación, disminución de la libido y disfunción eréctil. En las pacientes mujeres, el uso de ISRS puede dar lugar a disminución de la libido y a retraso o ausencia del orgasmo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O uso de ISRS, incluindo o PROZAC, pode causar sintomas de disfunção sexual [ver Reações adversas (6.1)]. Em pacientes do sexo masculino, o uso de ISRS pode resultar em retardo ou falha na ejaculação, diminuição da libido e disfunção erétil. Em pacientes do sexo feminino, o uso de ISRS pode resultar em diminuição da libido e em orgasmo retardado ou ausente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’utilisation des ISRS, dont PROZAC, peut causer des symptômes de dysfonction sexuelle [voir Effets indésirables (6.1)]. Chez les hommes, l’utilisation d’un ISRS peut entraîner un retard ou un échec de l’éjaculation, une diminution de la libido et une dysfonction érectile. Chez les femmes, l’utilisation d’un ISRS peut entraîner une diminution de la libido et un orgasme retardé ou absent.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’uso di SSRI, compreso PROZAC, può causare sintomi di disfunzione sessuale [vedere Reazioni avverse (6.1)]. Nei pazienti di sesso maschile, l’uso di SSRI può comportare eiaculazione ritardata o mancata, calo della libido e disfunzione erettile. Nelle pazienti di sesso femminile, l’uso di SSRI può comportare calo della libido e orgasmo ritardato o assente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "PROZAC समेत SSRI दवाओं के इस्तेमाल से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं [Adverse Reactions (6.1) देखें]। पुरुष मरीज़ों में SSRI के इस्तेमाल से स्खलन में देरी या स्खलन न हो पाना, कामेच्छा में कमी और स्तंभन दोष हो सकते हैं। महिला मरीज़ों में SSRI के इस्तेमाल से कामेच्छा में कमी हो सकती है, और ऑर्गेज़्म देर से हो सकता है या नहीं भी हो सकता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "other-causes",
              "kind": "qualification",
              "section": [
                "5 WARNINGS AND PRECAUTIONS",
                "5.17 Sexual Dysfunction"
              ],
              "since": null,
              "qualifies": "listed-warnings",
              "lang": "en-US",
              "text": "When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei der Beurteilung von Veränderungen der Sexualfunktion ist eine ausführliche Anamnese (einschließlich des zeitlichen Beginns der Symptome) wichtig, da sexuelle Symptome andere Ursachen haben können, einschließlich der zugrunde liegenden psychiatrischen Erkrankung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Al evaluar los cambios en la función sexual, es importante obtener una historia clínica detallada (incluido el momento en que aparecieron los síntomas), ya que los síntomas sexuales pueden tener otras causas, entre ellas el trastorno psiquiátrico subyacente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ao avaliar alterações na função sexual, é importante obter uma anamnese detalhada (incluindo o momento de início dos sintomas), porque os sintomas sexuais podem ter outras causas, entre elas o transtorno psiquiátrico subjacente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Lors de l’évaluation de changements de la fonction sexuelle, il est important de recueillir une anamnèse détaillée (y compris le moment d’apparition des symptômes), car les symptômes sexuels peuvent avoir d’autres causes, notamment le trouble psychiatrique sous-jacent.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nel valutare le alterazioni della funzione sessuale, è importante raccogliere un’anamnesi dettagliata (compreso il momento di insorgenza dei sintomi), perché i sintomi sessuali possono avere altre cause, tra cui il disturbo psichiatrico di base.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया में बदलावों का आकलन करते समय मरीज़ की विस्तृत मेडिकल हिस्ट्री लेना (जिसमें लक्षण शुरू होने का समय भी शामिल है) ज़रूरी है, क्योंकि यौन लक्षणों के दूसरे कारण भी हो सकते हैं, जिनमें पहले से मौजूद मानसिक बीमारी भी शामिल है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.1 Clinical Trials Experience",
                "Male and female sexual dysfunction with SSRIs"
              ],
              "since": {
                "date": "2011-06-15",
                "scope": "product",
                "basis": [
                  "fluoxetine-us-regulator-approval2011"
                ]
              },
              "inWarnings": false,
              "lang": "en-US",
              "text": "Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Symptome einer sexuellen Funktionsstörung bestehen nach dem Absetzen einer Fluoxetin-Behandlung gelegentlich fort.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los síntomas de disfunción sexual ocasionalmente persisten tras la interrupción del tratamiento con fluoxetina.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os sintomas de disfunção sexual ocasionalmente persistem após a descontinuação do tratamento com fluoxetina.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les symptômes de dysfonction sexuelle persistent parfois après l’arrêt du traitement par la fluoxétine.",
                  "by": "ours"
                },
                "it": {
                  "text": "I sintomi di disfunzione sessuale persistono occasionalmente dopo l’interruzione del trattamento con fluoxetina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के लक्षण फ़्लुओक्सेटीन से इलाज बंद करने के बाद कभी-कभी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "evidence",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.1 Clinical Trials Experience",
                "Male and female sexual dysfunction with SSRIs"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "There are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt keine angemessenen und gut kontrollierten Studien, die sexuelle Funktionsstörungen unter einer Behandlung mit Fluoxetin untersuchen.",
                  "by": "ours"
                },
                "es": {
                  "text": "No hay estudios adecuados y bien controlados que examinen la disfunción sexual con el tratamiento con fluoxetina.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Não há estudos adequados e bem controlados que examinem a disfunção sexual com o tratamento com fluoxetina.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il n’existe pas d’études adéquates et bien contrôlées portant sur la dysfonction sexuelle sous traitement par la fluoxétine.",
                  "by": "ours"
                },
                "it": {
                  "text": "Non esistono studi adeguati e ben controllati che abbiano esaminato la disfunzione sessuale durante il trattamento con fluoxetina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़्लुओक्सेटीन से इलाज के साथ सेक्शुअल डिस्फ़ंक्शन की जाँच करने वाले कोई पर्याप्त और अच्छी तरह नियंत्रित अध्ययन नहीं हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "sinceThisProduct",
              "text": {
                "en": "The date given is for this product. Texts for other products carry other dates.",
                "de": "Das angegebene Datum gilt für dieses Produkt. Texte zu anderen Produkten tragen andere Daten.",
                "es": "La fecha indicada es la de este producto. Los textos de otros productos llevan otras fechas.",
                "pt-br": "A data indicada vale para este produto. As bulas de outros produtos trazem outras datas.",
                "fr": "La date indiquée vaut pour ce produit. Les textes d’autres produits portent d’autres dates.",
                "it": "La data indicata vale per questo prodotto. I testi di altri prodotti riportano altre date.",
                "hi": "दी गई तारीख इस उत्पाद की है। दूसरे उत्पादों के दस्तावेज़ों पर दूसरी तारीखें हैं।"
              }
            },
            {
              "key": "marketingStopped",
              "text": {
                "en": "An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist dieses Produkt als eingestellt oder nicht mehr im Handel verzeichnet, und der Text in dieser Zeile ist weiterhin der eigene Text dieses Produkts.",
                "es": "En una lista oficial de medicamentos que hemos leído, este producto figura como discontinuado o como ya no comercializado, y el texto de esta fila sigue siendo el de este mismo producto.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra este produto como descontinuado ou não mais comercializado, e o texto desta linha continua sendo o do próprio produto.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente ce produit comme arrêté ou n’étant plus commercialisé, et le texte de cette ligne reste celui de ce produit.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica questo prodotto come dismesso o non più in commercio, e il testo di questa riga è comunque quello di questo stesso prodotto.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें इस उत्पाद को बंद या अब बाज़ार में उपलब्ध नहीं बताया गया है, और इस पंक्ति में दिया गया दस्तावेज़ अब भी इसी उत्पाद का अपना है।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "usLabelSearchFluoxetine",
              "text": {
                "en": "On 14 October 2026 we searched the labels in openFDA, the FDA's open database. The sentence about sexual dysfunction persisting after stopping, which this row shows, stood on 388 of the 439 labels in that database that contain fluoxetine. Five of the 388 are labels of the combination of olanzapine with fluoxetine. On those 388 labels the sentence stood among the adverse reactions and in no warnings section.",
                "de": "Am 14. Oktober 2026 haben wir die Fachinformationen in openFDA durchsucht, der offenen Datenbank der FDA. Der Satz in dieser Zeile, wonach sexuelle Funktionsstörungen nach dem Absetzen fortbestehen, stand in 388 der 439 Fachinformationen zu fluoxetinhaltigen Arzneimitteln in dieser Datenbank. Fünf der 388 sind Fachinformationen zur Kombination aus Olanzapin und Fluoxetin. In diesen 388 Fachinformationen stand der Satz unter den Nebenwirkungen und in keinem Abschnitt mit Warnhinweisen.",
                "es": "El 14 de octubre de 2026 buscamos en las fichas técnicas de openFDA, la base de datos abierta de la FDA. La frase sobre una disfunción sexual que persiste después de dejar el medicamento, la que muestra esta fila, figuraba en 388 de las 439 fichas técnicas de esa base de datos que contienen fluoxetina. Cinco de esas 388 son fichas técnicas de la combinación de olanzapina con fluoxetina. En esas 388 fichas técnicas, la frase figuraba entre las reacciones adversas y en ningún apartado de advertencias.",
                "pt-br": "Em 14 de outubro de 2026, pesquisamos as bulas no openFDA, o banco de dados aberto da FDA. A frase sobre disfunção sexual que persiste depois de parar o medicamento, que esta linha mostra, estava em 388 das 439 bulas desse banco de dados que contêm fluoxetina. Cinco dessas 388 são bulas da combinação de olanzapina com fluoxetina. Nessas 388 bulas, a frase estava entre as reações adversas e não aparecia em nenhuma seção de alertas.",
                "fr": "Le 14 octobre 2026, nous avons cherché dans les notices d’openFDA, la base de données ouverte de la FDA. La phrase sur une dysfonction sexuelle qui persiste après l’arrêt, que montre cette ligne, figurait sur 388 des 439 notices de cette base pour des produits contenant de la fluoxétine. Cinq de ces 388 notices sont celles de l’association d’olanzapine et de fluoxétine. Sur ces 388 notices, la phrase figurait parmi les effets indésirables et dans aucune rubrique de mises en garde.",
                "it": "Il 14 ottobre 2026 abbiamo cercato tra le schede tecniche in openFDA, la banca dati aperta della FDA. La frase sulla disfunzione sessuale che persiste dopo l’interruzione, mostrata in questa riga, compariva in 388 delle 439 schede tecniche di quella banca dati che contengono la fluoxetina. Cinque delle 388 sono schede tecniche dell’associazione di olanzapina e fluoxetina. In quelle 388 schede tecniche la frase si trovava tra le reazioni avverse e in nessuna sezione delle avvertenze.",
                "hi": "14 अक्टूबर 2026 को हमने FDA के खुले डेटाबेस openFDA में लेबल खोजे। उस डेटाबेस के जिन 439 लेबलों में फ़्लुओक्सेटीन है, उनमें से 388 पर दवा बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के बने रहने के बारे में वह वाक्य था, जो यह पंक्ति दिखाती है। इन 388 में से पाँच लेबल ओलानज़ापीन (olanzapine) और फ़्लुओक्सेटीन के मेल वाली दवा के हैं। इन 388 लेबलों पर यह वाक्य साइड इफ़ेक्ट (adverse reactions) के बीच था, किसी चेतावनी वाले सेक्शन में नहीं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-us-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-us-leaflet",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Medication Guide: PROZAC® (PRO-zac) (fluoxetine capsules) for oral use",
            "lang": "en-US",
            "product": {
              "name": "Prozac",
              "form": "capsules (\"Pulvules\") 10 mg, 20 mg and 40 mg",
              "holder": "Dista Products Company"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299",
            "fetchedUrl": null,
            "textDate": "2023-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Medication Guide revised August, 2023"
          },
          "passages": [
            {
              "key": "listed-problems",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including PROZAC, may cause sexual problems.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Probleme (Funktionsstörung). Die Einnahme von selektiven Serotonin-Wiederaufnahmehemmern (SSRI), einschließlich PROZAC, kann sexuelle Probleme verursachen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas sexuales (disfunción). Tomar inhibidores selectivos de la recaptación de serotonina (ISRS), incluido PROZAC, puede causar problemas sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas sexuais (disfunção). Tomar inibidores seletivos da recaptação de serotonina (ISRS), incluindo o PROZAC, pode causar problemas sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels (dysfonction). La prise d’inhibiteurs sélectifs de la recapture de la sérotonine (ISRS), dont PROZAC, peut causer des troubles sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi sessuali (disfunzione). L’assunzione di inibitori selettivi della ricaptazione della serotonina (SSRI), compreso PROZAC, può causare problemi sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ (डिस्फ़ंक्शन)। PROZAC समेत सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाएँ लेने से यौन समस्याएँ हो सकती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-1",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Delayed ejaculation or inability to have an ejaculation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Verzögerte Ejakulation oder Unfähigkeit zu ejakulieren",
                  "by": "ours"
                },
                "es": {
                  "text": "Eyaculación retardada o incapacidad para eyacular",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ejaculação retardada ou incapacidade de ter uma ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Éjaculation retardée ou incapacité à avoir une éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "Eiaculazione ritardata o incapacità di eiaculare",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में देरी या स्खलन न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-2",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-3",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?",
                "Sexual problems (dysfunction)",
                "Symptoms in males may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Problems getting or keeping an erection",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme, eine Erektion zu bekommen oder aufrechtzuerhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas para conseguir o mantener una erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas para ter ou manter uma ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’obtention ou de maintien d’une érection",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi a raggiungere o mantenere l’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-4",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Decreased sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-symptom-5",
              "kind": "sexual-side-effects",
              "section": [
                "What is the most important information I should know about PROZAC?",
                "Sexual problems (dysfunction)",
                "Symptoms in females may include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Delayed orgasm or inability to have an orgasm",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Verzögerter Orgasmus oder Unfähigkeit, zum Orgasmus zu kommen",
                  "by": "ours"
                },
                "es": {
                  "text": "Orgasmo retardado o incapacidad para tener un orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Orgasmo retardado ou incapacidade de ter um orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Orgasme retardé ou incapacité à avoir un orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "Orgasmo ritardato o incapacità di raggiungere l’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में देरी या ऑर्गेज़्म न हो पाना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROZAC?",
                "Common possible side effects in people who take PROZAC include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "sexual problems",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "sexuelle Probleme",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas sexuales",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas sexuais",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi sessuali",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, long-lasting, long lasting, enduring, irreversib, permanent, after discontinu, after stopping, after you stop, following discontinu, upon discontinu, despite, does not go away, continu, sexual, sex drive, libido, ejaculat, orgasm, erecti, impoten",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-us-regulator-approval2011",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-us-regulator-approval2011",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL: NDA 18-936/S-096, NDA 21-235/S-018",
            "lang": "en-US",
            "product": {
              "name": "Prozac",
              "form": "capsules for oral use",
              "holder": "Eli Lilly and Company"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2011-06-15",
            "textDateKind": "approval",
            "textDateAsPrinted": "06/15/2011"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "sexual-persistence",
              "section": [
                "ADVERSE REACTIONS",
                "section 6.1, Clinical Trials Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "Added text related to occasional persistence of sexual dysfunction following discontinuation of fluoxetine treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Text zum gelegentlichen Fortbestehen sexueller Funktionsstörungen nach dem Absetzen einer Fluoxetin-Behandlung hinzugefügt.",
                  "by": "ours"
                },
                "es": {
                  "text": "Texto añadido relativo a la persistencia ocasional de la disfunción sexual tras la interrupción del tratamiento con fluoxetina.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Acrescentado texto sobre a persistência ocasional da disfunção sexual após a descontinuação do tratamento com fluoxetina.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ajout d’un texte relatif à la persistance occasionnelle d’une dysfonction sexuelle après l’arrêt du traitement par la fluoxétine.",
                  "by": "ours"
                },
                "it": {
                  "text": "Aggiunto testo relativo alla persistenza occasionale della disfunzione sessuale dopo l’interruzione del trattamento con fluoxetina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़्लुओक्सेटीन से इलाज बंद करने के बाद सेक्शुअल डिस्फ़ंक्शन के कभी-कभी बने रहने से जुड़ा पाठ जोड़ा गया।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: APO-FLUOXETINE, Fluoxetine Capsules, Fluoxetine Oral Solution",
            "lang": "en-CA",
            "product": {
              "name": "APO-FLUOXETINE",
              "form": "capsules 10 mg and 20 mg and oral solution 20 mg/5 mL",
              "holder": "Apotex Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00078257.PDF",
            "fetchedUrl": null,
            "textDate": "2025-01-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: JAN 08, 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see 8.2 Clinical Trial Adverse Reactions). Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Selektive Serotonin-Wiederaufnahmehemmer (SSRI) können Symptome einer sexuellen Funktionsstörung verursachen (siehe 8.2 Nebenwirkungen in klinischen Studien). Patientinnen und Patienten sollten darüber informiert werden, dass lang anhaltende sexuelle Funktionsstörungen berichtet wurden, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los inhibidores selectivos de la recaptación de serotonina (ISRS) pueden causar síntomas de disfunción sexual (ver 8.2 Reacciones adversas en los ensayos clínicos). Se debe informar a los pacientes de que se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado a pesar de la suspensión del ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os inibidores seletivos da recaptação de serotonina (ISRS) podem causar sintomas de disfunção sexual (ver 8.2 Reações adversas em ensaios clínicos). Os pacientes devem ser informados de que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les inhibiteurs sélectifs de la recapture de la sérotonine (ISRS) peuvent causer des symptômes de dysfonction sexuelle (voir 8.2 Effets indésirables observés au cours des études cliniques). Les patients doivent être informés que des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli inibitori selettivi della ricaptazione della serotonina (SSRI) possono causare sintomi di disfunzione sessuale (vedere 8.2 Reazioni avverse negli studi clinici). I pazienti devono essere informati che sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर (SSRI) दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (8.2 Clinical Trial Adverse Reactions देखें)। मरीज़ों को बताया जाना चाहिए कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-8-2",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Symptoms of sexual dysfunction occasionally persisting after discontinuation of fluoxetine treatment have been observed in spontaneous reports.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Symptome einer sexuellen Funktionsstörung, die nach dem Absetzen einer Fluoxetin-Behandlung gelegentlich fortbestanden, wurden in Spontanberichten beobachtet.",
                  "by": "ours"
                },
                "es": {
                  "text": "En notificaciones espontáneas se han observado síntomas de disfunción sexual que ocasionalmente persisten tras la interrupción del tratamiento con fluoxetina.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sintomas de disfunção sexual que ocasionalmente persistem após a descontinuação do tratamento com fluoxetina foram observados em relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des symptômes de dysfonction sexuelle persistant parfois après l’arrêt du traitement par la fluoxétine ont été observés dans des signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nelle segnalazioni spontanee sono stati osservati sintomi di disfunzione sessuale che occasionalmente persistono dopo l’interruzione del trattamento con fluoxetina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "अपनी ओर से भेजी गई रिपोर्टों (spontaneous reports) में सेक्शुअल डिस्फ़ंक्शन के ऐसे लक्षण देखे गए हैं, जो फ़्लुओक्सेटीन से इलाज बंद करने के बाद कभी-कभी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "evidence",
              "kind": "qualification",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions",
                "Male and Female Sexual Dysfunction with SSRIs"
              ],
              "since": null,
              "qualifies": "persistence-8-2",
              "lang": "en-CA",
              "text": "There are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt keine angemessenen und gut kontrollierten Studien, die sexuelle Funktionsstörungen unter einer Behandlung mit Fluoxetin untersuchen.",
                  "by": "ours"
                },
                "es": {
                  "text": "No hay estudios adecuados y bien controlados que examinen la disfunción sexual con el tratamiento con fluoxetina.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Não há estudos adequados e bem controlados que examinem a disfunção sexual com o tratamento com fluoxetina.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il n’existe pas d’études adéquates et bien contrôlées portant sur la dysfonction sexuelle sous traitement par la fluoxétine.",
                  "by": "ours"
                },
                "it": {
                  "text": "Non esistono studi adeguati e ben controllati che abbiano esaminato la disfunzione sessuale durante il trattamento con fluoxetina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़्लुओक्सेटीन से इलाज के साथ सेक्शुअल डिस्फ़ंक्शन की जाँच करने वाले कोई पर्याप्त और अच्छी तरह नियंत्रित अध्ययन नहीं हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-ca-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-ca-leaflet",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: APO-FLUOXETINE, Fluoxetine Capsules, Fluoxetine Oral Solution",
            "lang": "en-CA",
            "product": {
              "name": "APO-FLUOXETINE",
              "form": "capsules 10 mg and 20 mg and oral solution 20 mg/5 mL",
              "holder": "Apotex Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00078257.PDF",
            "fetchedUrl": null,
            "textDate": "2025-01-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: January 08, 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "Effects on Sexual Function: Taking medicines like APO-FLUOXETINE may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping APO-FLUOXETINE treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Auswirkungen auf die Sexualfunktion: Die Einnahme von Arzneimitteln wie APO-FLUOXETINE kann Symptome einer sexuellen Funktionsstörung verursachen. In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung mit APO-FLUOXETINE bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Efectos sobre la función sexual: tomar medicamentos como APO-FLUOXETINE puede causar síntomas de disfunción sexual. En algunos casos, estos síntomas han continuado después de suspender el tratamiento con APO-FLUOXETINE.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Efeitos sobre a função sexual: tomar medicamentos como o APO-FLUOXETINE pode causar sintomas de disfunção sexual. Em alguns casos, esses sintomas continuaram após a interrupção do tratamento com APO-FLUOXETINE.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Effets sur la fonction sexuelle : la prise de médicaments comme APO-FLUOXETINE peut causer des symptômes de dysfonction sexuelle. Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement par APO-FLUOXETINE.",
                  "by": "ours"
                },
                "it": {
                  "text": "Effetti sulla funzione sessuale: l’assunzione di medicinali quali APO-FLUOXETINE può causare sintomi di disfunzione sessuale. In alcuni casi si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento con APO-FLUOXETINE.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया पर असर: APO-FLUOXETINE जैसी दवाएँ लेने से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं। कुछ मामलों में ये लक्षण APO-FLUOXETINE से इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-common",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using APO-FLUOXETINE?",
                "What are possible side effects from using APO-FLUOXETINE?"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "low sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "geringes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "deseo sexual bajo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "desejo sexual baixo",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "riduzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-serious",
              "kind": "sexual-side-effects",
              "section": [
                "Serious side effects and what to do about them",
                "UNKNOWN"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Increase in the hormone prolactin: In women: breast discomfort, leakage of milk from the breasts, missed periods, or other problems with your menstrual cycle. In men: decreased body and facial hair, breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Anstieg des Hormons Prolaktin: Bei Frauen: Beschwerden in der Brust, Austreten von Milch aus der Brust, ausbleibende Monatsblutungen oder andere Probleme mit Ihrem Menstruationszyklus. Bei Männern: weniger Körper- und Gesichtsbehaarung, Brustschwellung, Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten, oder andere sexuelle Funktionsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "Aumento de la hormona prolactina: en las mujeres, molestias en las mamas, salida de leche por las mamas, falta de la regla u otros problemas del ciclo menstrual. En los hombres, disminución del vello corporal y facial, hinchazón de las mamas, dificultad para conseguir o mantener erecciones u otra disfunción sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Aumento do hormônio prolactina: nas mulheres: desconforto nas mamas, saída de leite pelas mamas, falta de menstruação ou outros problemas com o seu ciclo menstrual. Nos homens: diminuição dos pelos do corpo e do rosto, inchaço das mamas, dificuldade para ter ou manter ereções ou outra disfunção sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Augmentation de l’hormone prolactine : Chez la femme : gêne mammaire, écoulement de lait par les seins, absence de règles ou autres troubles du cycle menstruel. Chez l’homme : diminution de la pilosité du corps et du visage, gonflement des seins, difficultés à obtenir ou à maintenir une érection, ou autre dysfonction sexuelle",
                  "by": "ours"
                },
                "it": {
                  "text": "Aumento dell’ormone prolattina: nelle donne: fastidio al seno, perdita di latte dal seno, mestruazioni saltate o altri problemi del ciclo mestruale. Negli uomini: riduzione dei peli del corpo e del viso, gonfiore del seno, difficoltà a ottenere o mantenere l’erezione o altre disfunzioni sessuali",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रोलैक्टिन हार्मोन का बढ़ना: महिलाओं में: स्तनों में तकलीफ़, स्तनों से दूध रिसना, माहवारी न आना, या माहवारी चक्र से जुड़ी दूसरी समस्याएँ। पुरुषों में: शरीर और चेहरे के बाल कम होना, स्तनों में सूजन, इरेक्शन होने या बनाए रखने में दिक्कत, या दूसरा सेक्शुअल डिस्फ़ंक्शन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-ca-regulator-review2021",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-ca-regulator-review2021",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00254",
            "fetchedUrl": null,
            "textDate": "2021-01-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Issued: 2021-01-06"
          },
          "passages": [
            {
              "key": "action",
              "kind": "sexual-persistence",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die Sicherheitsinformationen zu allen SSRI und SNRI zu aktualisieren, um zu empfehlen, dass medizinische Fachleute ihre Patientinnen und Patienten über das mögliche Risiko lang anhaltender (möglicherweise Wochen bis Jahre) sexueller Symptome informieren, die nach dem Absetzen einer SSRI- oder SNRI-Behandlung fortbestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para actualizar la información de seguridad del producto de todos los ISRS e IRSN, con el fin de recomendar que los profesionales sanitarios informen a los pacientes del posible riesgo de síntomas sexuales de larga duración (posiblemente de semanas a años) que persisten después de suspender el tratamiento con ISRS o IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para atualizar as informações de segurança do produto de todos os ISRS e IRSN, a fim de recomendar que os profissionais de saúde informem os pacientes sobre o risco potencial de sintomas sexuais de longa duração (possivelmente de semanas a anos) que persistem após a interrupção do tratamento com ISRS ou IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour mettre à jour les informations de sécurité des produits pour tous les ISRS et IRSN, afin de recommander aux professionnels de santé d’informer les patients du risque potentiel de symptômes sexuels durables (peut-être de plusieurs semaines à plusieurs années) qui persistent après l’arrêt d’un traitement par ISRS ou IRSN.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per aggiornare le informazioni di sicurezza sul prodotto di tutti gli SSRI e gli SNRI, in modo da raccomandare ai professionisti sanitari di informare i pazienti del potenziale rischio di sintomi sessuali a lungo termine (forse da settimane ad anni) che persistono dopo l’interruzione del trattamento con SSRI o SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada दवा बनाने वाली कंपनियों के साथ मिलकर सभी SSRI और SNRI दवाओं की सुरक्षा जानकारी अपडेट करेगा। उसमें यह सिफ़ारिश होगी कि डॉक्टर और दूसरे स्वास्थ्यकर्मी मरीज़ों को इस संभावित जोखिम के बारे में बताएँ कि SSRI या SNRI से इलाज बंद करने के बाद यौन लक्षण लंबे समय तक (शायद हफ़्तों से लेकर सालों तक) बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "Health Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a interrupção do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names fluoxetine among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Fluoxetin.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo fluoxetina.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita fluoxetina entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif fluoxétine.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo fluoxetina.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें फ़्लुओक्सेटीन का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-ca-regulator-infowatch202112",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-ca-regulator-infowatch202112",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, December 2021",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2021/sc-hc/H167-1-2021-12-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2021-12",
            "textDateKind": "publication",
            "textDateAsPrinted": "December 2021"
          },
          "passages": [
            {
              "key": "update",
              "kind": "sexual-persistence",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der Abschnitt Warnhinweise und Vorsichtsmaßnahmen der kanadischen Fachinformationen zu SSRI (Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Vilazodon und Vortioxetin) und SNRI (Desvenlafaxin, Duloxetin, Levomilnacipran und Venlafaxin) wurde oder wird um neue Sicherheitsinformationen zu Berichten über lang anhaltende sexuelle Funktionsstörungen ergänzt, bei denen die Symptome trotz Absetzen der Behandlung fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "El apartado de advertencias y precauciones de las monografías de producto canadienses de los ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona y vortioxetina) y de los IRSN (desvenlafaxina, duloxetina, levomilnaciprán y venlafaxina) se ha actualizado, o se actualizará, con nueva información de seguridad relativa a notificaciones de disfunción sexual de larga duración en la que los síntomas han continuado a pesar de la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A seção Advertências e Precauções das monografias de produto canadenses dos ISRS (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodona e vortioxetina) e dos IRSN (desvenlafaxina, duloxetina, levomilnaciprana e venlafaxina) foi, ou será, atualizada com novas informações de segurança sobre relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La section Mises en garde et précautions des monographies de produit canadiennes des ISRS (citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, vilazodone et vortioxétine) et des IRSN (desvenlafaxine, duloxétine, lévomilnacipran et venlafaxine) a été, ou sera, mise à jour avec de nouvelles informations de sécurité concernant des signalements de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La sezione Avvertenze e precauzioni delle monografie di prodotto canadesi degli SSRI (citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, vilazodone e vortioxetina) e degli SNRI (desvenlafaxina, duloxetina, levomilnacipran e venlafaxina) è stata, o sarà, aggiornata con nuove informazioni di sicurezza relative a segnalazioni di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कनाडा में SSRI दवाओं (सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, विलाज़ोडोन और वोर्टिऑक्सेटीन) और SNRI दवाओं (डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, लेवोमिल्नासिप्रान और वेनलाफ़ैक्सीन) की आधिकारिक जानकारी (product monograph) के Warnings and Precautions सेक्शन को नई सुरक्षा जानकारी के साथ अपडेट कर दिया गया है, या किया जाएगा। यह जानकारी लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की उन रिपोर्टों के बारे में है, जिनमें इलाज बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Product monograph updates",
                "Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)",
                "Key messages for healthcare professionals:"
              ],
              "since": null,
              "qualifies": "update",
              "lang": "en-CA",
              "text": "Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung von Health Canada konnte einen ursächlichen Zusammenhang zwischen dem Absetzen einer SSRI- oder SNRI-Behandlung und anhaltenden sexuellen Funktionsstörungen weder bestätigen noch ausschließen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de Health Canada no pudo confirmar ni descartar una relación causal entre la suspensión del tratamiento con ISRS o IRSN y la disfunción sexual persistente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão da Health Canada não pôde confirmar nem descartar uma ligação causal entre a descontinuação do tratamento com ISRS ou IRSN e a disfunção sexual persistente.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de Santé Canada n’a pu ni confirmer ni exclure un lien de causalité entre l’arrêt d’un traitement par ISRS ou IRSN et une dysfonction sexuelle persistante.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione di Health Canada non ha potuto confermare, né escludere, un nesso causale tra l’interruzione del trattamento con SSRI o SNRI e la disfunzione sessuale persistente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada की समीक्षा SSRI या SNRI से इलाज बंद करने और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के बीच कारण और असर के संबंध की न तो पुष्टि कर सकी, न ही उसे खारिज कर सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassNamed",
              "text": {
                "en": "This document is about a whole class of medicines and names fluoxetine among them.",
                "de": "Dieses Dokument betrifft eine ganze Wirkstoffklasse und nennt darunter Fluoxetin.",
                "es": "Este documento trata de toda una clase de medicamentos y nombra entre ellos el principio activo fluoxetina.",
                "pt-br": "Este documento trata de toda uma classe de medicamentos e cita fluoxetina entre eles.",
                "fr": "Ce document porte sur toute une classe de médicaments et y nomme le principe actif fluoxétine.",
                "it": "Questo documento riguarda un’intera classe di medicinali e nomina, tra gli altri, il principio attivo fluoxetina.",
                "hi": "यह दस्तावेज़ दवाओं के एक पूरे समूह के बारे में है, और उनमें फ़्लुओक्सेटीन का नाम भी है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION APO-FLUOXETINE (FLUOXETINE HYDROCHLORIDE)",
            "lang": "en-AU",
            "product": {
              "name": "APO-FLUOXETINE",
              "form": null,
              "holder": "Arrotex Pharmaceuticals Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-02363-1",
            "textDate": "2026-03-25",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.4",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Section 4.4 of Australia's product information for APO-Fluoxetine has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.",
                "de": "Abschnitt 4.4 der australischen Fachinformation zu APO-Fluoxetine enthält einen Warnhinweis mit der Überschrift sexuelle Funktionsstörung. Dort heißt es, es gebe Berichte über sexuelle Funktionsstörungen, die lange andauerten und bei denen die Symptome nach dem Absetzen von SSRI oder SNRI weitergingen.",
                "es": "La sección 4.4 de la información del producto australiana de APO-Fluoxetine tiene una advertencia titulada disfunción sexual. Dice que hay notificaciones de disfunción sexual que duró mucho tiempo, con síntomas que siguieron después de dejar los ISRS o los IRSN.",
                "pt-br": "A seção 4.4 da bula australiana do APO-Fluoxetine para o profissional de saúde tem um alerta com o título disfunção sexual. Ela diz que há relatos de disfunção sexual que durou muito tempo, com sintomas que continuaram depois que os ISRS ou IRSN foram interrompidos.",
                "fr": "En Australie, la rubrique 4.4 des informations sur le produit d’APO-Fluoxetine contient une mise en garde qui a pour titre la dysfonction sexuelle. Elle indique que des cas de dysfonction sexuelle ayant duré longtemps ont été signalés, avec des symptômes qui ont continué après l’arrêt des ISRS ou des IRSN.",
                "it": "La sezione 4.4 delle informazioni sul prodotto australiane di APO-Fluoxetine ha un’avvertenza intitolata disfunzione sessuale. Dice che ci sono segnalazioni di disfunzione sessuale durata a lungo, con sintomi proseguiti dopo l’interruzione degli SSRI o degli SNRI.",
                "hi": "ऑस्ट्रेलिया में APO-Fluoxetine की आधिकारिक जानकारी (product information) के सेक्शन 4.4 में सेक्शुअल डिस्फ़ंक्शन के शीर्षक से एक चेतावनी है। वह कहती है कि ऐसे सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें हैं, जो लंबे समय तक रहा और जिसमें SSRI या SNRI दवाएँ बंद करने के बाद भी लक्षण चलते रहे।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "persistence-4-8",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.8",
                "Urogenital System",
                "Uncommon"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "In section 4.8, the list of side effects of the urogenital system has sexual dysfunction among the uncommon ones, and adds in brackets that it occasionally persists after treatment is stopped.",
                "de": "In Abschnitt 4.8 führt die Liste der Nebenwirkungen des Urogenitalsystems die sexuelle Funktionsstörung unter den gelegentlichen Nebenwirkungen auf und ergänzt in Klammern, dass sie nach dem Absetzen der Behandlung gelegentlich anhält.",
                "es": "En la sección 4.8, la lista de efectos secundarios del sistema urogenital incluye la disfunción sexual entre los poco frecuentes y añade entre paréntesis que ocasionalmente persiste después de terminar el tratamiento.",
                "pt-br": "Na seção 4.8, a lista de efeitos colaterais do sistema urogenital traz a disfunção sexual entre os incomuns e acrescenta, entre parênteses, que ela ocasionalmente persiste depois da interrupção do tratamento.",
                "fr": "Dans la rubrique 4.8, la liste des effets secondaires touchant l’appareil urogénital cite la dysfonction sexuelle parmi les effets peu fréquents et ajoute entre parenthèses qu’elle persiste parfois après l’arrêt du traitement.",
                "it": "Nella sezione 4.8, l’elenco degli effetti collaterali dell’apparato urogenitale riporta la disfunzione sessuale tra quelli non comuni, e aggiunge tra parentesi che occasionalmente persiste dopo l’interruzione del trattamento.",
                "hi": "सेक्शन 4.8 में मूत्र और जननांग तंत्र (urogenital system) के साइड इफ़ेक्ट की सूची सेक्शुअल डिस्फ़ंक्शन को कम आम साइड इफ़ेक्ट में गिनाती है, और ब्रैकेट में जोड़ती है कि यह इलाज बंद होने के बाद कभी-कभी बना रहता है।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            },
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "APO-FLUOXETINE Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "APO-FLUOXETINE",
              "form": null,
              "holder": "Arrotex Pharmaceuticals Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-02364-1",
            "textDate": "2024-09",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 6",
                "Less serious side effects",
                "General symptoms:"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "Australia's consumer medicine information for APO-Fluoxetine lists sexual problems among its side effects: a lower sex drive, and trouble with erection, ejaculation or orgasm. It says that in some cases these have carried on after treatment stopped.",
                "de": "Die australische Packungsbeilage zu APO-Fluoxetine führt sexuelle Probleme unter den Nebenwirkungen auf: weniger sexuelles Verlangen sowie Schwierigkeiten mit der Erektion, der Ejakulation oder dem Orgasmus. Dort heißt es, in manchen Fällen seien diese nach dem Ende der Behandlung weitergegangen.",
                "es": "El prospecto australiano de APO-Fluoxetine (Consumer Medicine Information) recoge problemas sexuales entre sus efectos secundarios: menor deseo sexual y dificultades con la erección, la eyaculación o el orgasmo. Dice que, en algunos casos, estos han seguido después de terminar el tratamiento.",
                "pt-br": "A bula australiana do APO-Fluoxetine para pacientes lista problemas sexuais entre os efeitos colaterais: queda do desejo sexual e dificuldades com a ereção, a ejaculação ou o orgasmo. Ela diz que, em alguns casos, eles continuaram depois do fim do tratamento.",
                "fr": "En Australie, la notice d’APO-Fluoxetine destinée aux patients cite des troubles sexuels parmi ses effets secondaires : une baisse du désir sexuel et des difficultés d’érection, d’éjaculation ou d’orgasme. Elle indique que, dans certains cas, ceux-ci ont continué après l’arrêt du traitement.",
                "it": "Il foglio illustrativo australiano di APO-Fluoxetine (Consumer Medicine Information) elenca i problemi sessuali tra i suoi effetti collaterali: calo del desiderio sessuale e difficoltà con l’erezione, l’eiaculazione o l’orgasmo. Dice che in alcuni casi questi sono proseguiti dopo la fine del trattamento.",
                "hi": "ऑस्ट्रेलिया में APO-Fluoxetine का मरीज़ों वाला लीफ़लेट (consumer medicine information) अपने साइड इफ़ेक्ट में यौन समस्याएँ गिनाता है: कामेच्छा में कमी, और इरेक्शन, स्खलन या ऑर्गेज़्म में दिक्कत। वह कहता है कि कुछ मामलों में ये इलाज बंद होने के बाद भी चलती रहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            },
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, Arrow - Fluoxetine",
            "lang": "en-NZ",
            "product": {
              "name": "Arrow - Fluoxetine",
              "form": "20 mg capsules",
              "holder": "Teva Pharma (New Zealand) Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/a/arrowfluoxetinetab.pdf",
            "fetchedUrl": null,
            "textDate": "2026-08-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT 10 August 2026"
          },
          "passages": [
            {
              "key": "listed-nervous-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "b. Adverse reactions from clinical trials",
                "Nervous system disorders",
                "Common"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "abnormal dreams, libido decreased, sleep disorder, thinking abnormal, chills;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "abnormale Träume, verminderte Libido, Schlafstörung, abnormales Denken, Schüttelfrost;",
                  "by": "ours"
                },
                "es": {
                  "text": "sueños anormales, disminución de la libido, trastorno del sueño, pensamiento anormal, escalofríos;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "sonhos anormais, diminuição da libido, distúrbio do sono, pensamento anormal, calafrios;",
                  "by": "ours"
                },
                "fr": {
                  "text": "rêves anormaux, baisse de la libido, troubles du sommeil, pensées anormales, frissons ;",
                  "by": "ours"
                },
                "it": {
                  "text": "sogni anormali, diminuzione della libido, disturbi del sonno, pensiero anormale, brividi;",
                  "by": "ours"
                },
                "hi": {
                  "text": "असामान्य सपने, कामेच्छा में कमी, नींद की गड़बड़ी, असामान्य सोच (thinking abnormal), ठंड लगना (chills);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "b. Adverse reactions from clinical trials",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "Common: abnormal ejaculation (male only), gynaecological bleeding (female only), impotence (male only); Uncommon: anorgasmia, breast pain, sexual dysfunction (occasionally persisting after treatment discontinuation); Rare: priapism (male only).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Häufig: abnormale Ejakulation (nur Männer), gynäkologische Blutung (nur Frauen), Impotenz (nur Männer); Gelegentlich: Anorgasmie, Brustschmerzen, sexuelle Dysfunktion (gelegentlich anhaltend nach Absetzung der Therapie); Selten: Priapismus (nur Männer).",
                  "by": "ours"
                },
                "es": {
                  "text": "Frecuentes: eyaculación anormal (solo hombres), hemorragia ginecológica (solo mujeres), impotencia (solo hombres); Poco frecuentes: anorgasmia, dolor mamario, disfunción sexual (que persiste ocasionalmente después de la interrupción del tratamiento); Raras: priapismo (solo hombres).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Comuns: ejaculação anormal (somente homens), sangramento ginecológico (somente mulheres), impotência (somente homens); Incomuns: anorgasmia, dor nas mamas, disfunção sexual (ocasionalmente persistindo após a descontinuação do tratamento); Raras: priapismo (somente homens).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Fréquent : éjaculation anormale (chez l’homme uniquement), saignements gynécologiques (chez la femme uniquement), impuissance (chez l’homme uniquement) ; Peu fréquent : anorgasmie, douleur mammaire, dysfonction sexuelle (persistant parfois après l’arrêt du traitement) ; Rare : priapisme (chez l’homme uniquement).",
                  "by": "ours"
                },
                "it": {
                  "text": "Comune: eiaculazione anormale (solo uomini), emorragia ginecologica (solo donne), impotenza (solo uomini); Non comune: anorgasmia, dolore mammario, disfunzione sessuale (occasionalmente persistente dopo la sospensione del trattamento); Raro: priapismo (solo uomini).",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम (common): स्खलन में गड़बड़ी (सिर्फ़ पुरुषों में), महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding) (सिर्फ़ महिलाओं में), स्तंभन दोष (impotence) (सिर्फ़ पुरुषों में); कम आम (uncommon): ऑर्गेज़्म न हो पाना (anorgasmia), स्तनों में दर्द, सेक्शुअल डिस्फ़ंक्शन (इलाज बंद करने के बाद कभी-कभी बना रहता है); दुर्लभ (rare): लंबे समय तक बना रहने वाला इरेक्शन (priapism) (सिर्फ़ पुरुषों में)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "not-necessarily-caused",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects",
                "b. Adverse reactions from clinical trials"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "en-NZ",
              "text": "It is important to emphasise that, although the events reported did occur during treatment with fluoxetine, they were not necessarily caused by it.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es ist wichtig zu betonen, dass die gemeldeten Ereignisse zwar während der Behandlung mit Fluoxetin auftraten, aber nicht unbedingt durch Fluoxetin verursacht wurden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Es importante subrayar que, aunque los acontecimientos notificados sí se produjeron durante el tratamiento con fluoxetina, no fueron necesariamente causados por ella.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "É importante ressaltar que, embora os eventos relatados tenham de fato ocorrido durante o tratamento com fluoxetina, eles não foram necessariamente causados por ela.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il est important de souligner que, bien que les événements signalés se soient produits pendant le traitement par la fluoxétine, ils n’ont pas nécessairement été causés par celle-ci.",
                  "by": "ours"
                },
                "it": {
                  "text": "È importante sottolineare che, sebbene gli eventi segnalati si siano effettivamente verificati durante il trattamento con fluoxetina, non sono stati necessariamente causati da essa.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस बात पर ज़ोर देना ज़रूरी है कि रिपोर्ट की गई घटनाएँ भले ही फ़्लुओक्सेटीन से इलाज के दौरान हुईं, पर यह ज़रूरी नहीं कि वे इसी की वजह से हुई हों।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information, Arrow-Fluoxetine",
            "lang": "en-NZ",
            "product": {
              "name": "Arrow-Fluoxetine",
              "form": "capsules 20 mg and dispersible tablets",
              "holder": "Teva Pharma (New Zealand) Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/Consumers/CMI/a/arrowfluoxetine.pdf",
            "fetchedUrl": null,
            "textDate": "2026-08-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Information 10 August 2026 (based on data sheet dated10 August 2026)"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Side effects"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "sexual disturbances (decreased sexual drive, problems with orgasm, ejaculation or erection). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Störungen der Sexualfunktion (vermindertes sexuelles Verlangen, Probleme mit dem Orgasmus, der Ejakulation oder der Erektion). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "alteraciones sexuales (disminución del deseo sexual, problemas con el orgasmo, la eyaculación o la erección). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais (diminuição do desejo sexual, problemas de orgasmo, de ejaculação ou de ereção). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels (baisse du désir sexuel, troubles de l’orgasme, de l’éjaculation ou de l’érection). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi sessuali (riduzione del desiderio sessuale, problemi di orgasmo, di eiaculazione o di erezione). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ (कामेच्छा में कमी, ऑर्गेज़्म, स्खलन या इरेक्शन की समस्याएँ)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "Side effects"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-NZ",
              "text": "Side effects vary from patient to patient and often lessen with continued use.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Nebenwirkungen sind bei jeder Patientin und jedem Patienten anders und lassen bei fortgesetzter Anwendung oft nach.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios varían de un paciente a otro y a menudo disminuyen al continuar el uso.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais variam de paciente para paciente e muitas vezes diminuem com o uso contínuo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables varient d’un patient à l’autre et s’atténuent souvent avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati variano da paziente a paziente e spesso si attenuano con l’uso continuato.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट हर मरीज़ में अलग होते हैं और दवा लेते रहने पर अक्सर कम हो जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "productsDifferNamed",
              "text": {
                "en": "Another product's leaflet reads differently. This row shows the product named, and no other.",
                "de": "Die Packungsbeilage eines anderen Produkts lautet anders. Diese Zeile zeigt das genannte Produkt und kein anderes.",
                "es": "El prospecto de otro producto dice otra cosa. Esta fila muestra el producto que se nombra, y ningún otro.",
                "pt-br": "A bula de outro produto diz outra coisa. Esta linha mostra o produto indicado, e nenhum outro.",
                "fr": "La notice d’un autre produit est rédigée différemment. Cette ligne montre le produit nommé, et aucun autre.",
                "it": "Il foglio illustrativo di un altro prodotto dice una cosa diversa. Questa riga mostra il prodotto indicato, e nessun altro.",
                "hi": "एक दूसरे उत्पाद का लीफ़लेट कुछ और कहता है। यह पंक्ति उसी उत्पाद की है, जिसका नाम दिया गया है, किसी और की नहीं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-nz-pro-fluox",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-nz-pro-fluox",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, FLUOX",
            "lang": "en-NZ",
            "product": {
              "name": "Fluox",
              "form": "capsules and dispersible tablets (20 mg fluoxetine)",
              "holder": "Viatris Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/f/fluoxcaptab.pdf",
            "fetchedUrl": null,
            "textDate": "2026-05-28",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of Revision of the Text 28 May 2026"
          },
          "passages": [
            {
              "key": "listed-nervous-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Nervous system disorders",
                "Common:"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "abnormal dreams, libido decreased, sleep disorder, thinking abnormal, chills",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "abnormale Träume, verminderte Libido, Schlafstörung, abnormales Denken, Schüttelfrost",
                  "by": "ours"
                },
                "es": {
                  "text": "sueños anormales, disminución de la libido, trastorno del sueño, pensamiento anormal, escalofríos",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "sonhos anormais, diminuição da libido, distúrbio do sono, pensamento anormal, calafrios",
                  "by": "ours"
                },
                "fr": {
                  "text": "rêves anormaux, baisse de la libido, troubles du sommeil, pensées anormales, frissons",
                  "by": "ours"
                },
                "it": {
                  "text": "sogni anormali, diminuzione della libido, disturbi del sonno, pensiero anormale, brividi",
                  "by": "ours"
                },
                "hi": {
                  "text": "असामान्य सपने, कामेच्छा में कमी, नींद की गड़बड़ी, असामान्य सोच (thinking abnormal), ठंड लगना (chills)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "abnormal ejaculation (male only), gynaecological bleeding (female only), impotence (male only) anorgasmia, breast pain, sexual dysfunction (occasionally persisting after treatment discontinuation) priapism (male only)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "abnormale Ejakulation (nur Männer), gynäkologische Blutung (nur Frauen), Impotenz (nur Männer) Anorgasmie, Brustschmerzen, sexuelle Dysfunktion (gelegentlich anhaltend nach Absetzung der Therapie) Priapismus (nur Männer)",
                  "by": "ours"
                },
                "es": {
                  "text": "eyaculación anormal (solo hombres), hemorragia ginecológica (solo mujeres), impotencia (solo hombres) anorgasmia, dolor mamario, disfunción sexual (que persiste ocasionalmente después de la interrupción del tratamiento) priapismo (solo hombres)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ejaculação anormal (somente homens), sangramento ginecológico (somente mulheres), impotência (somente homens) anorgasmia, dor nas mamas, disfunção sexual (ocasionalmente persistindo após a descontinuação do tratamento) priapismo (somente homens)",
                  "by": "ours"
                },
                "fr": {
                  "text": "éjaculation anormale (chez l’homme uniquement), saignements gynécologiques (chez la femme uniquement), impuissance (chez l’homme uniquement) anorgasmie, douleur mammaire, dysfonction sexuelle (persistant parfois après l’arrêt du traitement) priapisme (chez l’homme uniquement)",
                  "by": "ours"
                },
                "it": {
                  "text": "eiaculazione anormale (solo uomini), emorragia ginecologica (solo donne), impotenza (solo uomini) anorgasmia, dolore mammario, disfunzione sessuale (occasionalmente persistente dopo la sospensione del trattamento) priapismo (solo uomini)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में गड़बड़ी (सिर्फ़ पुरुषों में), महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding) (सिर्फ़ महिलाओं में), स्तंभन दोष (impotence) (सिर्फ़ पुरुषों में) ऑर्गेज़्म न हो पाना (anorgasmia), स्तनों में दर्द, सेक्शुअल डिस्फ़ंक्शन (इलाज बंद करने के बाद कभी-कभी बना रहता है) लंबे समय तक बना रहने वाला इरेक्शन (priapism) (सिर्फ़ पुरुषों में)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "not-necessarily-caused",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "en-NZ",
              "text": "It is important to emphasise that, although the events reported did occur during treatment with fluoxetine, they were not necessarily caused by it.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es ist wichtig zu betonen, dass die gemeldeten Ereignisse zwar während der Behandlung mit Fluoxetin auftraten, aber nicht unbedingt durch Fluoxetin verursacht wurden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Es importante subrayar que, aunque los acontecimientos notificados sí se produjeron durante el tratamiento con fluoxetina, no fueron necesariamente causados por ella.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "É importante ressaltar que, embora os eventos relatados tenham de fato ocorrido durante o tratamento com fluoxetina, eles não foram necessariamente causados por ela.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il est important de souligner que, bien que les événements signalés se soient produits pendant le traitement par la fluoxétine, ils n’ont pas nécessairement été causés par celle-ci.",
                  "by": "ours"
                },
                "it": {
                  "text": "È importante sottolineare che, sebbene gli eventi segnalati si siano effettivamente verificati durante il trattamento con fluoxetina, non sono stati necessariamente causati da essa.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस बात पर ज़ोर देना ज़रूरी है कि रिपोर्ट की गई घटनाएँ भले ही फ़्लुओक्सेटीन से इलाज के दौरान हुईं, पर यह ज़रूरी नहीं कि वे इसी की वजह से हुई हों।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-nz-leaflet-fluox",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-nz-leaflet-fluox",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Consumer Medicine Information, FLUOX",
            "lang": "en-NZ",
            "product": {
              "name": "Fluox",
              "form": "capsules 20 mg and dispersible tablets 20 mg",
              "holder": "Viatris Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/Consumers/CMI/f/fluox.pdf",
            "fetchedUrl": null,
            "textDate": "2026-05-28",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Information 28 May 2026 (Based on datasheet dated 28 May 2026)"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Before you take Fluox",
                "Before you start to take it:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Medicines like Fluox may cause symptoms of sexual dysfunction (see Side Effects section). In some cases, these symptoms have continued after stopping treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittel wie Fluox können Symptome einer sexuellen Funktionsstörung verursachen (siehe Abschnitt Nebenwirkungen). In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los medicamentos como Fluox pueden causar síntomas de disfunción sexual (ver el apartado Efectos secundarios). En algunos casos, estos síntomas han continuado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Medicamentos como o Fluox podem causar sintomas de disfunção sexual (ver a seção Efeitos colaterais). Em alguns casos, esses sintomas continuaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les médicaments comme Fluox peuvent causer des symptômes de dysfonction sexuelle (voir la rubrique Effets indésirables). Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Medicinali quali Fluox possono causare sintomi di disfunzione sessuale (vedere il paragrafo «Effetti indesiderati»). In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Fluox जैसी दवाओं से सेक्शुअल डिस्फ़ंक्शन के लक्षण हो सकते हैं (Side Effects सेक्शन देखें)। कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "Side effects"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "sexual function problems: such as delayed ejaculation, problems with erection, decreased sex drive or difficulties achieving orgasm (In some cases, these symptoms have continued after stopping treatment)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit der Sexualfunktion: etwa verzögerte Ejakulation, Probleme mit der Erektion, vermindertes sexuelles Verlangen oder Schwierigkeiten, zum Orgasmus zu kommen (In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen)",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas de la función sexual: como retraso de la eyaculación, problemas con la erección, disminución del deseo sexual o dificultades para alcanzar el orgasmo (En algunos casos, estos síntomas han continuado después de suspender el tratamiento)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas da função sexual: como ejaculação retardada, problemas de ereção, diminuição do desejo sexual ou dificuldades para chegar ao orgasmo (Em alguns casos, esses sintomas continuaram após a interrupção do tratamento)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de la fonction sexuelle : tels qu’une éjaculation retardée, des troubles de l’érection, une baisse du désir sexuel ou des difficultés à atteindre l’orgasme (Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement)",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi della funzione sessuale: come eiaculazione ritardata, problemi di erezione, riduzione del desiderio sessuale o difficoltà a raggiungere l’orgasmo (In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की समस्याएँ: जैसे स्खलन में देरी, इरेक्शन की समस्याएँ, कामेच्छा में कमी या ऑर्गेज़्म तक पहुँचने में दिक्कत (कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहे हैं)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "Side effects"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "en-NZ",
              "text": "This medicine may have unwanted side effects in a few people.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dieses Arzneimittel kann bei einigen wenigen Menschen unerwünschte Nebenwirkungen haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Este medicamento puede tener efectos secundarios no deseados en unas pocas personas.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Este medicamento pode ter efeitos colaterais indesejados em algumas pessoas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ce médicament peut avoir des effets indésirables chez quelques personnes.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questo medicinale può avere effetti indesiderati in alcune persone.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस दवा से कुछ लोगों में अनचाहे साइड इफ़ेक्ट हो सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation",
            "lang": "de",
            "product": {
              "name": "Fluoxetin-ratiopharm®",
              "form": "20 mg Hartkapseln",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/label/Fluoxetin-ratiopharm%2020%20mg%20Hartkapseln%20-%205.pdf?pzn=7536040",
            "fetchedUrl": null,
            "textDate": "2026-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. STAND DER INFORMATION Mai 2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung",
                "Sexuelle Funktionsstörung"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione degli SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाएँ बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Angst, Nervosität Ruhelosigkeit Angespanntheit verminderte Libido3 Schlafstörung abnormale Träume4",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety, nervousness restlessness tension decreased libido3 sleep disorder abnormal dreams4",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad, nerviosismo inquietud tensión disminución de la libido3 trastorno del sueño sueños anormales4",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade, nervosismo inquietude tensão diminuição da libido3 distúrbio do sono sonhos anormais4",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété, nervosité impatiences tension baisse de la libido3 troubles du sommeil rêves anormaux4",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia, nervosismo Irrequietezza Tensione Diminuzione della libido3 Disturbi del sonno Sogni anormali4",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, घबराहट बेचैनी (restlessness) तनाव कामेच्छा में कमी3 नींद की गड़बड़ी असामान्य सपने4",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Gelegentlich"
              ],
              "since": null,
              "lang": "de",
              "text": "Depersonalisation, gehobene Stimmung, euphorische Stimmung, abnormales Denken abnormaler Orgasmus5 Zähneknirschen, suizidale Gedanken und suizidales Verhalten6",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depersonalisation, elevated mood, euphoric mood, abnormal thinking abnormal orgasm5 teeth grinding, suicidal thoughts and suicidal behaviour6",
                  "by": "ours"
                },
                "es": {
                  "text": "Despersonalización, estado elevado del ánimo, estado eufórico del ánimo, pensamiento anormal orgasmo anormal5 rechinar de dientes, pensamientos suicidas y comportamiento suicida6",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização, humor elevado, humor eufórico, pensamento anormal orgasmo anormal5 ranger de dentes, pensamentos suicidas e comportamento suicida6",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dépersonnalisation, humeur exaltée, humeur euphorique, pensées anormales orgasme anormal5 grincement de dents, pensées suicidaires et comportement suicidaire6",
                  "by": "ours"
                },
                "it": {
                  "text": "Depersonalizzazione, umore elevato, umore euforico, pensiero anormale Orgasmo anormale5 Digrignamento dei denti, pensieri suicidi e comportamento suicida6",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना), मूड का ऊँचा रहना (elevated mood), बहुत ज़्यादा खुशी का मूड (euphoric mood), असामान्य सोच (abnormal thinking) ऑर्गेज़्म में गड़बड़ी5 दाँत पीसना (bruxism), आत्महत्या के विचार और आत्महत्या से जुड़ा व्यवहार6",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "gynäkologische Blutung14 Erektile Dysfunktion Ejakulationsstörung15",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15",
                  "by": "ours"
                },
                "es": {
                  "text": "hemorragia ginecológica14 Disfunción eréctil Trastorno de la eyaculación15",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "sangramento ginecológico14 Disfunção erétil Distúrbio da ejaculação15",
                  "by": "ours"
                },
                "fr": {
                  "text": "saignements gynécologiques14 Dysfonction érectile Trouble de l’éjaculation15",
                  "by": "ours"
                },
                "it": {
                  "text": "Emorragia ginecologica14 Disfunzione erettile Disturbo dell’eiaculazione15",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding)14 स्तंभन दोष स्खलन की गड़बड़ी15",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Gelegentlich"
              ],
              "since": null,
              "lang": "de",
              "text": "sexuelle Dysfunktion16",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual dysfunction16",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual16",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual16",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle16",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale16",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन16",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Nebenwirkungen",
                "Tabellarische Zusammenfassung der Nebenwirkungen",
                "Fußnote 16"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Gelegentlich anhaltend nach Absetzung der Therapie",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Occasionally persisting after the therapy is stopped",
                  "by": "ours"
                },
                "es": {
                  "text": "Persiste ocasionalmente después de la suspensión del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ocasionalmente persistente após a descontinuação da terapia",
                  "by": "ours"
                },
                "fr": {
                  "text": "Persistant parfois après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "Occasionalmente persistente dopo la sospensione della terapia",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कभी-कभी बना रहता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Selten"
              ],
              "since": null,
              "lang": "de",
              "text": "Galaktorrhoe, Hyperprolaktinämie, Priapismus",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea, hyperprolactinaemia, priapism",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea, hiperprolactinemia, priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia, hiperprolactinemia, priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée, hyperprolactinémie, priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea, iperprolattinemia, priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea), खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia), लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Nebenwirkungen",
                "Zusammenfassung des Sicherheitsprofils"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "de",
              "text": "Schweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The severity and frequency of side effects may decrease in the course of treatment and do not generally lead to treatment being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "La gravedad y la frecuencia de los efectos secundarios pueden disminuir en el curso del tratamiento y, por lo general, no llevan a interrumpirlo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A intensidade e a frequência dos efeitos colaterais podem diminuir ao longo do tratamento e, em geral, não levam à interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La gravité et la fréquence des effets indésirables peuvent diminuer au cours du traitement et n’entraînent généralement pas l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La gravità e la frequenza degli effetti indesiderati possono diminuire nel corso del trattamento e in genere non portano a un’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज के दौरान साइड इफ़ेक्ट की गंभीरता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Kinder und Jugendliche"
              ],
              "since": null,
              "lang": "de",
              "text": "Einzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störung der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Isolated cases of side effects that may point to delayed sexual development or a disorder of sexual function were reported during clinical use in children and adolescents (see also section 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "Durante el uso clínico en la infancia y la adolescencia se han notificado casos aislados de efectos secundarios que podrían indicar un retraso del desarrollo sexual o un trastorno de la función sexual (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Casos isolados de efeitos colaterais que possivelmente indicam um atraso do desenvolvimento sexual ou um distúrbio da função sexual foram relatados durante o uso clínico em crianças e adolescentes (ver também seção 5.3).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas isolés d’effets indésirables pouvant indiquer un retard du développement sexuel ou un trouble de la fonction sexuelle ont été signalés lors de l’utilisation clinique chez l’enfant et l’adolescent (voir également rubrique 5.3).",
                  "by": "ours"
                },
                "it": {
                  "text": "Durante l’impiego clinico in bambini e adolescenti sono stati segnalati casi isolati di effetti indesiderati che potrebbero indicare un ritardo dello sviluppo sessuale o un disturbo della funzione sessuale (vedere anche paragrafo 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल के दौरान साइड इफ़ेक्ट के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए, जो शायद यौन विकास में देरी या यौन क्रिया की गड़बड़ी की ओर इशारा करते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "originatorNotOpened",
              "text": {
                "en": "The originator product's text could not be opened. This is the text of another product, the one named in this row.",
                "de": "Der Text des Originalpräparats ließ sich nicht öffnen. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "El texto del producto original no se pudo abrir. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Não foi possível abrir o texto do produto original. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Le texte du produit d’origine n’a pas pu être ouvert. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Non è stato possibile aprire il testo del medicinale originatore. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "दवा के मूल (originator) उत्पाद का दस्तावेज़ खोला नहीं जा सका। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-de-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-de-leaflet",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Patienten",
            "lang": "de",
            "product": {
              "name": "Fluoxetin-ratiopharm®",
              "form": "20 mg Hartkapseln",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/pkg_insert/Fluoxetin-ratiopharm%2020%20mg%20Hartkapseln%20-%203.pdf?pzn=7536040",
            "fetchedUrl": null,
            "textDate": "2026-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im Mai 2026."
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Was sollten Sie vor der Einnahme von Fluoxetin-ratiopharm® beachten?",
                "Warnhinweise und Vorsichtsmaßnahmen",
                "Sexuelle Funktionsstörung"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "de",
              "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In certain cases these symptoms continued after treatment was ended.",
                  "by": "ours"
                },
                "es": {
                  "text": "En determinados casos, estos síntomas persistieron después de finalizar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em certos casos, esses sintomas permaneceram após o término do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In determinati casi questi sintomi sono persistiti dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में ये लक्षण इलाज खत्म होने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Einige Patienten hatten"
              ],
              "since": null,
              "lang": "de",
              "text": "verlängerte und schmerzhafte Erektion;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "prolonged and painful erection;",
                  "by": "ours"
                },
                "es": {
                  "text": "erección prolongada y dolorosa;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereção prolongada e dolorosa;",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection prolongée et douloureuse ;",
                  "by": "ours"
                },
                "it": {
                  "text": "erezione prolungata e dolorosa;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Häufig (kann bis zu 1 von 10 Behandelten betreffen)"
              ],
              "since": null,
              "lang": "de",
              "text": "Verminderter Sexualtrieb oder sexuelle Probleme (einschließlich Schwierigkeit, eine Erektion zur sexuellen Aktivität aufrecht zu halten)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Reduced sex drive or sexual problems (including difficulty keeping an erection for sexual activity)",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual o problemas sexuales (incluida la dificultad para mantener una erección durante la actividad sexual)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual ou problemas sexuais (incluindo dificuldade para manter uma ereção para a atividade sexual)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel ou troubles sexuels (y compris des difficultés à maintenir une érection pour une activité sexuelle)",
                  "by": "ours"
                },
                "it": {
                  "text": "Ridotto desiderio sessuale o problemi sessuali (inclusa la difficoltà a mantenere un’erezione per l’attività sessuale)",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी या यौन समस्याएँ (जिनमें यौन क्रिया के लिए इरेक्शन बनाए रखने में दिक्कत भी शामिल है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Sexuelle Funktionsstörungen, einschließlich Orgasmusprobleme, die gelegentlich nach Beendigung der Behandlung bestehen bleiben",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction, including orgasm problems, which occasionally persists after treatment has ended",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos de la función sexual, incluidos problemas de orgasmo, que ocasionalmente persisten después de finalizar el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunções sexuais, incluindo problemas de orgasmo, que ocasionalmente permanecem após o término do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de la fonction sexuelle, y compris des troubles de l’orgasme, qui persistent parfois après la fin du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi della funzione sessuale, inclusi problemi di orgasmo, che occasionalmente persistono dopo la fine del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की गड़बड़ियाँ, जिनमें ऑर्गेज़्म की समस्याएँ भी शामिल हैं, जो इलाज खत्म होने के बाद कभी-कभी बनी रहती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "de",
              "text": "Die meisten dieser Nebenwirkungen gehen wahrscheinlich vorüber, während Sie Ihr Arzneimittel weiter einnehmen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these side effects are likely to pass while you go on taking your medicine.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de estos efectos secundarios probablemente desaparecerán mientras siga tomando el medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos colaterais provavelmente vai passar enquanto você continua tomando o seu medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart de ces effets indésirables disparaîtront probablement pendant que vous continuez à prendre votre médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte di questi effetti indesiderati probabilmente passerà mentre continua a prendere il medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आप अपनी दवा लेते रहें, तो इनमें से ज़्यादातर साइड इफ़ेक्ट के चले जाने की संभावना है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "originatorNotOpened",
              "text": {
                "en": "The originator product's text could not be opened. This is the text of another product, the one named in this row.",
                "de": "Der Text des Originalpräparats ließ sich nicht öffnen. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "El texto del producto original no se pudo abrir. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Não foi possível abrir o texto do produto original. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Le texte du produit d’origine n’a pas pu être ouvert. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Non è stato possibile aprire il testo del medicinale originatore. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "दवा के मूल (originator) उत्पाद का दस्तावेज़ खोला नहीं जा सका। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-de-pro-fluctin",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-de-pro-fluctin",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "holder-publishes-none",
            "login"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Fluctin",
              "form": null,
              "holder": "Lilly"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.lilly.com/de/arzneimittel/aktuell",
            "https://www.gebrauchsinformation4-0.de",
            "https://www.fachinfo.de/",
            "https://portal.bfarm.de/amguifree/"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-de-leaflet-fluctin",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-de-leaflet-fluctin",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "holder-publishes-none",
            "login"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Fluctin",
              "form": null,
              "holder": "Lilly"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.lilly.com/de/arzneimittel/aktuell",
            "https://www.gebrauchsinformation4-0.de",
            "https://www.fachinfo.de/",
            "https://portal.bfarm.de/amguifree/"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-de-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-de-regulator",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Bulletin/2019/2-2019.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2019-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Ausgabe 2 | Juni 2019"
          },
          "passages": [
            {
              "key": "wording",
              "kind": "sexual-persistence",
              "section": [
                "PRAC-Meldungen",
                "Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen",
                "Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persistieron a pesar de la suspensión de los ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatadas disfunções sexuais de longa duração em que os sintomas permaneceram apesar da descontinuação dos ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono persistiti nonostante l’interruzione di SSRI/SNRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI बंद करने के बावजूद लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "tenMedicines",
              "text": {
                "en": "The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.",
                "de": "Der Wortlaut gilt für zehn Medikamente: Citalopram, Escitalopram, Fluoxetin, Fluvoxamin, Paroxetin, Sertralin, Desvenlafaxin, Duloxetin, Milnacipran und Venlafaxin.",
                "es": "El texto es para diez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprán y venlafaxina.",
                "pt-br": "O texto vale para dez medicamentos: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnaciprana e venlafaxina.",
                "fr": "La formulation vaut pour dix médicaments : citalopram, escitalopram, fluoxétine, fluvoxamine, paroxétine, sertraline, desvenlafaxine, duloxétine, milnacipran et venlafaxine.",
                "it": "Il testo riguarda dieci medicinali: citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, desvenlafaxina, duloxetina, milnacipran e venlafaxina.",
                "hi": "ये शब्द दस दवाओं के लिए हैं: सिटालोप्राम, एस्सिटालोप्राम, फ़्लुओक्सेटीन, फ़्लुवोक्सामीन, पैरॉक्सेटीन, सर्ट्रालीन, डेसवेनलाफ़ैक्सीन, ड्यूलोक्सेटीन, मिल्नासिप्रान और वेनलाफ़ैक्सीन।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "PROZAC",
              "form": "20 mg, gélule",
              "holder": "LILLY France"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61885224/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61885224/extrait",
            "textDate": "2021-01-22",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 22/01/2021"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Mises en garde spéciales et précautions d'emploi",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von sexueller Funktionsstörung berichtet, bei denen die Symptome trotz Absetzen der Behandlung mit SSRI anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual cuyos síntomas se han prolongado a pesar de la suspensión del tratamiento con ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual cujos sintomas se prolongaram apesar da interrupção do tratamento com ISRS.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale i cui sintomi si sono protratti nonostante l’interruzione del trattamento con SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाओं से इलाज बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Anxiété. Nervosité. Impatiences. Tension. Baisse de la libido3. Troubles du sommeil. Rêves anormaux4.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety. Nervousness. Restlessness. Tension. Decreased libido3. Sleep disorders. Abnormal dreams4.",
                  "by": "ours"
                },
                "de": {
                  "text": "Angst. Nervosität. Ruhelosigkeit. Angespanntheit. Verminderte Libido3. Schlafstörungen. Abnormale Träume4.",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad. Nerviosismo. Inquietud. Tensión. Disminución de la libido3. Trastornos del sueño. Sueños anormales4.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade. Nervosismo. Inquietude. Tensão. Diminuição da libido3. Distúrbios do sono. Sonhos anormais4.",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia. Nervosismo. Irrequietezza. Tensione. Diminuzione della libido3. Disturbi del sonno. Sogni anormali4.",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी। घबराहट। बेचैनी (restlessness)। तनाव। कामेच्छा में कमी3। नींद की गड़बड़ियाँ। असामान्य सपने4।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Peu fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Dépersonnalisation. Exaltation. Euphorie. Pensées anormales. Orgasmes anormaux5. Bruxisme. Pensées et comportement suicidaires6.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depersonalisation. Elation. Euphoria. Abnormal thoughts. Abnormal orgasms5. Bruxism. Suicidal thoughts and behaviour6.",
                  "by": "ours"
                },
                "de": {
                  "text": "Depersonalisation. Gehobene Stimmung. Euphorie. Abnormale Gedanken. Abnormale Orgasmen5. Zähneknirschen. Suizidale Gedanken und suizidales Verhalten6.",
                  "by": "ours"
                },
                "es": {
                  "text": "Despersonalización. Exaltación. Euforia. Pensamientos anormales. Orgasmos anormales5. Bruxismo. Pensamientos y comportamiento suicidas6.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização. Exaltação. Euforia. Pensamentos anormais. Orgasmos anormais5. Bruxismo. Pensamentos e comportamento suicidas6.",
                  "by": "ours"
                },
                "it": {
                  "text": "Depersonalizzazione. Esaltazione. Euforia. Pensieri anormali. Orgasmi anormali5. Bruxismo. Pensieri e comportamento suicidari6.",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना)। मूड का ऊँचा रहना (elation)। बहुत ज़्यादा खुशी का मूड (euphoria)। असामान्य सोच (abnormal thoughts)। ऑर्गेज़्म में गड़बड़ी5। दाँत पीसना (bruxism)। आत्महत्या के विचार और व्यवहार6।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Saignements gynécologiques14. Dysfonction érectile. Troubles de l’éjaculation15.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Gynaecological bleeding14. Erectile dysfunction. Ejaculation disorders15.",
                  "by": "ours"
                },
                "de": {
                  "text": "Gynäkologische Blutungen14. Erektile Dysfunktion. Ejakulationsstörungen15.",
                  "by": "ours"
                },
                "es": {
                  "text": "Hemorragias ginecológicas14. Disfunción eréctil. Trastornos de la eyaculación15.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sangramentos ginecológicos14. Disfunção erétil. Distúrbios da ejaculação15.",
                  "by": "ours"
                },
                "it": {
                  "text": "Emorragie ginecologiche14. Disfunzione erettile. Disturbi dell’eiaculazione15.",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding)14। स्तंभन दोष। स्खलन की गड़बड़ियाँ15।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Peu fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Troubles sexuels16.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disorders16.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion16.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos sexuales16.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios sexuais16.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali16.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ16।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Effets indésirables",
                "b. Tableau récapitulatif des effets indésirables",
                "note 16"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Pouvant parfois persister après arrêt du traitement",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "May sometimes persist after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "Kann manchmal nach dem Absetzen der Behandlung anhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "Pueden persistir a veces después de la suspensión del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Podendo às vezes persistir após a interrupção do tratamento",
                  "by": "ours"
                },
                "it": {
                  "text": "Possono talvolta persistere dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कभी-कभी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Rare"
              ],
              "since": null,
              "lang": "fr",
              "text": "Galactorrhée. Hyperprolactinémie Priapisme.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea. Hyperprolactinaemia Priapism.",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhoe. Hyperprolaktinämie Priapismus.",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea. Hiperprolactinemia Priapismo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia. Hiperprolactinemia Priapismo.",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea. Iperprolattinemia Priapismo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea)। खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia) लंबे समय तक बना रहने वाला इरेक्शन (priapism)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables",
                "a. Résumé du profil de sécurité"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "fr",
              "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence lors de la poursuite du traitement et ne nécessitent généralement pas l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects may decrease in intensity and frequency as treatment continues and do not generally require treatment to be stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen können bei fortgesetzter Behandlung an Stärke und Häufigkeit abnehmen und erfordern im Allgemeinen kein Absetzen der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos pueden disminuir en intensidad y en frecuencia al continuar el tratamiento y, por lo general, no requieren su suspensión.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos podem diminuir em intensidade e em frequência com a continuação do tratamento e geralmente não exigem a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati possono diminuire di intensità e frequenza con il proseguimento del trattamento e generalmente non richiedono l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद करना ज़रूरी नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "d. Population pédiatrique"
              ],
              "since": null,
              "lang": "fr",
              "text": "Des cas isolés d’effets indésirables suggérant des retards de maturation sexuelle ou une dysfonction sexuelle ont été rapportés lors de l’utilisation clinique en pédiatrie (voir également rubrique 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Isolated cases of adverse effects suggesting delayed sexual maturation or sexual dysfunction have been reported during paediatric clinical use (see also section 5.3).",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei der klinischen Anwendung bei Kindern und Jugendlichen wurden Einzelfälle von Nebenwirkungen berichtet, die auf eine verzögerte sexuelle Reifung oder eine sexuelle Funktionsstörung hindeuten (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos aislados de efectos adversos que sugieren retrasos de la maduración sexual o una disfunción sexual durante el uso clínico en pediatría (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos isolados de efeitos adversos que sugerem atrasos da maturação sexual ou disfunção sexual durante o uso clínico em pediatria (ver também a seção 5.3).",
                  "by": "ours"
                },
                "it": {
                  "text": "Nell’uso clinico in pediatria sono stati segnalati casi isolati di effetti indesiderati che suggeriscono ritardi della maturazione sessuale o una disfunzione sessuale (vedere anche paragrafo 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल के दौरान साइड इफ़ेक्ट के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा करते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "marketingStopped",
              "text": {
                "en": "An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist dieses Produkt als eingestellt oder nicht mehr im Handel verzeichnet, und der Text in dieser Zeile ist weiterhin der eigene Text dieses Produkts.",
                "es": "En una lista oficial de medicamentos que hemos leído, este producto figura como discontinuado o como ya no comercializado, y el texto de esta fila sigue siendo el de este mismo producto.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra este produto como descontinuado ou não mais comercializado, e o texto desta linha continua sendo o do próprio produto.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente ce produit comme arrêté ou n’étant plus commercialisé, et le texte de cette ligne reste celui de ce produit.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica questo prodotto come dismesso o non più in commercio, e il testo di questa riga è comunque quello di questo stesso prodotto.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें इस उत्पाद को बंद या अब बाज़ार में उपलब्ध नहीं बताया गया है, और इस पंक्ति में दिया गया दस्तावेज़ अब भी इसी उत्पाद का अपना है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-fr-leaflet",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "PROZAC",
              "form": "20 mg, gélule",
              "holder": "LILLY France"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61885224/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/61885224/extrait",
            "textDate": "2021-01-22",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 22/01/2021"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PROZAC 20 mg, gélule ?",
                "Avertissements et précautions",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms continued after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas se han prolongado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas se prolongaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi si sono protratti dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Certains patients ont présenté :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Une érection prolongée et douloureuse ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "A prolonged and painful erection;",
                  "by": "ours"
                },
                "de": {
                  "text": "Eine verlängerte und schmerzhafte Erektion;",
                  "by": "ours"
                },
                "es": {
                  "text": "Una erección prolongada y dolorosa;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereção prolongada e dolorosa;",
                  "by": "ours"
                },
                "it": {
                  "text": "Un’erezione prolungata e dolorosa;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquents (pouvant affecter jusqu’à 1 patient sur 10)"
              ],
              "since": null,
              "lang": "fr",
              "text": "baisse du désir sexuel ou problèmes sexuels (tels que difficultés à conserver une érection suffisante pour une activité sexuelle),",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire or sexual problems (such as difficulty keeping an erection sufficient for sexual activity),",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen oder sexuelle Probleme (etwa Schwierigkeiten, eine für sexuelle Aktivität ausreichende Erektion aufrechtzuerhalten),",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual o problemas sexuales (como dificultades para mantener una erección suficiente para la actividad sexual),",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual ou problemas sexuais (como dificuldades para manter uma ereção suficiente para uma atividade sexual),",
                  "by": "ours"
                },
                "it": {
                  "text": "calo del desiderio sessuale o problemi sessuali (come difficoltà a mantenere un’erezione sufficiente per un’attività sessuale),",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी या यौन समस्याएँ (जैसे यौन क्रिया के लिए काफ़ी इरेक्शन बनाए रखने में दिक्कत),",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "troubles sexuels, incluant des troubles de l’orgasme, pouvant parfois persister après arrêt du traitement",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual disorders, including orgasm disorders, which may sometimes persist after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Störungen, einschließlich Orgasmusstörungen, die manchmal nach dem Absetzen der Behandlung anhalten können",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos sexuales, incluidos trastornos del orgasmo, que a veces pueden persistir después de suspender el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais, incluindo distúrbios do orgasmo, que às vezes podem persistir após a interrupção do tratamento",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi sessuali, inclusi disturbi dell’orgasmo, che possono talvolta persistere dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ, जिनमें ऑर्गेज़्म की गड़बड़ियाँ भी शामिल हैं, जो इलाज बंद करने के बाद कभी-कभी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "fr",
              "text": "La plupart de ces effets indésirables disparaissent avec la poursuite du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these side effects disappear as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die meisten dieser Nebenwirkungen verschwinden bei fortgesetzter Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de estos efectos adversos desaparecen al continuar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos adversos desaparece com a continuação do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte di questi effetti indesiderati scompare con il proseguimento del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर इनमें से ज़्यादातर साइड इफ़ेक्ट चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "marketingStopped",
              "text": {
                "en": "An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist dieses Produkt als eingestellt oder nicht mehr im Handel verzeichnet, und der Text in dieser Zeile ist weiterhin der eigene Text dieses Produkts.",
                "es": "En una lista oficial de medicamentos que hemos leído, este producto figura como discontinuado o como ya no comercializado, y el texto de esta fila sigue siendo el de este mismo producto.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra este produto como descontinuado ou não mais comercializado, e o texto desta linha continua sendo o do próprio produto.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente ce produit comme arrêté ou n’étant plus commercialisé, et le texte de cette ligne reste celui de ce produit.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica questo prodotto come dismesso o non più in commercio, e il testo di questa riga è comunque quello di questo stesso prodotto.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें इस उत्पाद को बंद या अब बाज़ार में उपलब्ध नहीं बताया गया है, और इस पंक्ति में दिया गया दस्तावेज़ अब भी इसी उत्पाद का अपना है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-fr-pro-accord",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-fr-pro-accord",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "FLUOXETINE ACCORD",
              "form": "20 mg, gélule",
              "holder": "ACCORD HEALTHCARE France SAS"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63686057/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63686057/extrait",
            "textDate": "2024-01-29",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 29/01/2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Mises en garde spéciales et précautions d'emploi",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Des cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von sexueller Funktionsstörung berichtet, bei denen die Symptome trotz Absetzen der Behandlung mit SSRI anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual cuyos síntomas se han prolongado a pesar de la suspensión del tratamiento con ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual cujos sintomas se prolongaram apesar da interrupção do tratamento com ISRS.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale i cui sintomi si sono protratti nonostante l’interruzione del trattamento con SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाओं से इलाज बंद करने के बावजूद लक्षण जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Anxiété. Nervosité. Impatiences. Tension. Baisse de la libido3. Troubles du sommeil. Rêves anormaux4.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety. Nervousness. Restlessness. Tension. Decreased libido3. Sleep disorders. Abnormal dreams4.",
                  "by": "ours"
                },
                "de": {
                  "text": "Angst. Nervosität. Ruhelosigkeit. Angespanntheit. Verminderte Libido3. Schlafstörungen. Abnormale Träume4.",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad. Nerviosismo. Inquietud. Tensión. Disminución de la libido3. Trastornos del sueño. Sueños anormales4.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade. Nervosismo. Inquietude. Tensão. Diminuição da libido3. Distúrbios do sono. Sonhos anormais4.",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia. Nervosismo. Irrequietezza. Tensione. Diminuzione della libido3. Disturbi del sonno. Sogni anormali4.",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी। घबराहट। बेचैनी (restlessness)। तनाव। कामेच्छा में कमी3। नींद की गड़बड़ियाँ। असामान्य सपने4।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Peu fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Dépersonnalisation. Exaltation. Euphorie. Pensées anormales. Orgasmes anormaux5. Bruxisme. Pensées et comportement suicidaires6.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depersonalisation. Elation. Euphoria. Abnormal thoughts. Abnormal orgasms5. Bruxism. Suicidal thoughts and behaviour6.",
                  "by": "ours"
                },
                "de": {
                  "text": "Depersonalisation. Gehobene Stimmung. Euphorie. Abnormale Gedanken. Abnormale Orgasmen5. Zähneknirschen. Suizidale Gedanken und suizidales Verhalten6.",
                  "by": "ours"
                },
                "es": {
                  "text": "Despersonalización. Exaltación. Euforia. Pensamientos anormales. Orgasmos anormales5. Bruxismo. Pensamientos y comportamiento suicidas6.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização. Exaltação. Euforia. Pensamentos anormais. Orgasmos anormais5. Bruxismo. Pensamentos e comportamento suicidas6.",
                  "by": "ours"
                },
                "it": {
                  "text": "Depersonalizzazione. Esaltazione. Euforia. Pensieri anormali. Orgasmi anormali5. Bruxismo. Pensieri e comportamento suicidari6.",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना)। मूड का ऊँचा रहना (elation)। बहुत ज़्यादा खुशी का मूड (euphoria)। असामान्य सोच (abnormal thoughts)। ऑर्गेज़्म में गड़बड़ी5। दाँत पीसना (bruxism)। आत्महत्या के विचार और व्यवहार6।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Saignements gynécologiques14. Dysfonction érectile. Troubles de l’éjaculation15.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Gynaecological bleeding14. Erectile dysfunction. Ejaculation disorders15.",
                  "by": "ours"
                },
                "de": {
                  "text": "Gynäkologische Blutungen14. Erektile Dysfunktion. Ejakulationsstörungen15.",
                  "by": "ours"
                },
                "es": {
                  "text": "Hemorragias ginecológicas14. Disfunción eréctil. Trastornos de la eyaculación15.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sangramentos ginecológicos14. Disfunção erétil. Distúrbios da ejaculação15.",
                  "by": "ours"
                },
                "it": {
                  "text": "Emorragie ginecologiche14. Disfunzione erettile. Disturbi dell’eiaculazione15.",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding)14। स्तंभन दोष। स्खलन की गड़बड़ियाँ15।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Peu fréquent"
              ],
              "since": null,
              "lang": "fr",
              "text": "Troubles sexuels16.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual disorders16.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion16.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos sexuales16.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios sexuais16.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi sessuali16.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ16।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Effets indésirables",
                "b. Tableau récapitulatif des effets indésirables",
                "note 16"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Pouvant parfois persister après arrêt du traitement",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "May sometimes persist after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "Kann manchmal nach dem Absetzen der Behandlung anhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "Pueden persistir a veces después de la suspensión del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Podendo às vezes persistir após a interrupção do tratamento",
                  "by": "ours"
                },
                "it": {
                  "text": "Possono talvolta persistere dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कभी-कभी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Rare"
              ],
              "since": null,
              "lang": "fr",
              "text": "Galactorrhée. Hyperprolactinémie. Priapisme.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea. Hyperprolactinaemia. Priapism.",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhoe. Hyperprolaktinämie. Priapismus.",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea. Hiperprolactinemia. Priapismo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia. Hiperprolactinemia. Priapismo.",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea. Iperprolattinemia. Priapismo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea)। खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia)। लंबे समय तक बना रहने वाला इरेक्शन (priapism)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables",
                "a. Résumé du profil de sécurité"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "fr",
              "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence lors de la poursuite du traitement et ne nécessitent généralement pas l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects may decrease in intensity and frequency as treatment continues and do not generally require treatment to be stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen können bei fortgesetzter Behandlung an Stärke und Häufigkeit abnehmen und erfordern im Allgemeinen kein Absetzen der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos pueden disminuir en intensidad y en frecuencia al continuar el tratamiento y, por lo general, no requieren su suspensión.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos podem diminuir em intensidade e em frequência com a continuação do tratamento e geralmente não exigem a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati possono diminuire di intensità e frequenza con il proseguimento del trattamento e generalmente non richiedono l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद करना ज़रूरी नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "d. Population pédiatrique"
              ],
              "since": null,
              "lang": "fr",
              "text": "Des cas isolés d’effets indésirables suggérant des retards de maturation sexuelle ou une dysfonction sexuelle ont été rapportés lors de l’utilisation clinique en pédiatrie (voir également rubrique 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Isolated cases of adverse effects suggesting delayed sexual maturation or sexual dysfunction have been reported during paediatric clinical use (see also section 5.3).",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei der klinischen Anwendung bei Kindern und Jugendlichen wurden Einzelfälle von Nebenwirkungen berichtet, die auf eine verzögerte sexuelle Reifung oder eine sexuelle Funktionsstörung hindeuten (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos aislados de efectos adversos que sugieren retrasos de la maduración sexual o una disfunción sexual durante el uso clínico en pediatría (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos isolados de efeitos adversos que sugerem atrasos da maturação sexual ou disfunção sexual durante o uso clínico em pediatria (ver também a seção 5.3).",
                  "by": "ours"
                },
                "it": {
                  "text": "Nell’uso clinico in pediatria sono stati segnalati casi isolati di effetti indesiderati che suggeriscono ritardi della maturazione sessuale o una disfunzione sessuale (vedere anche paragrafo 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल के दौरान साइड इफ़ेक्ट के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा करते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-fr-leaflet-accord",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-fr-leaflet-accord",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "FLUOXETINE ACCORD",
              "form": "20 mg, gélule",
              "holder": "ACCORD HEALTHCARE France SAS"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63686057/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63686057/extrait",
            "textDate": "2024-01-29",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 29/01/2024"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE FLUOXETINE ACCORD 20 mg, gélule ?",
                "Avertissements et précautions",
                "Dysfonction sexuelle"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "fr",
              "text": "Dans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms continued after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, estos síntomas se han prolongado después de suspender el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas se prolongaram após a interrupção do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi si sono protratti dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी जारी रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Certains patients ont présenté :"
              ],
              "since": null,
              "lang": "fr",
              "text": "Une érection prolongée et douloureuse ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "A prolonged and painful erection;",
                  "by": "ours"
                },
                "de": {
                  "text": "Eine verlängerte und schmerzhafte Erektion;",
                  "by": "ours"
                },
                "es": {
                  "text": "Una erección prolongada y dolorosa;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereção prolongada e dolorosa;",
                  "by": "ours"
                },
                "it": {
                  "text": "Un’erezione prolungata e dolorosa;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquents (pouvant affecter jusqu’à 1 patient sur 10)"
              ],
              "since": null,
              "lang": "fr",
              "text": "baisse du désir sexuel ou problèmes sexuels (tels que difficultés à conserver une érection suffisante pour une activité sexuelle),",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire or sexual problems (such as difficulty keeping an erection sufficient for sexual activity),",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen oder sexuelle Probleme (etwa Schwierigkeiten, eine für sexuelle Aktivität ausreichende Erektion aufrechtzuerhalten),",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual o problemas sexuales (como dificultades para mantener una erección suficiente para la actividad sexual),",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual ou problemas sexuais (como dificuldades para manter uma ereção suficiente para uma atividade sexual),",
                  "by": "ours"
                },
                "it": {
                  "text": "calo del desiderio sessuale o problemi sessuali (come difficoltà a mantenere un’erezione sufficiente per un’attività sessuale),",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी या यौन समस्याएँ (जैसे यौन क्रिया के लिए काफ़ी इरेक्शन बनाए रखने में दिक्कत),",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "troubles sexuels, incluant des troubles de l’orgasme, pouvant parfois persister après arrêt du traitement,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual disorders, including orgasm disorders, which may sometimes persist after treatment is stopped,",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Störungen, einschließlich Orgasmusstörungen, die manchmal nach dem Absetzen der Behandlung anhalten können,",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos sexuales, incluidos trastornos del orgasmo, que a veces pueden persistir después de suspender el tratamiento,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios sexuais, incluindo distúrbios do orgasmo, que às vezes podem persistir após a interrupção do tratamento,",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi sessuali, inclusi disturbi dell’orgasmo, che possono talvolta persistere dopo l’interruzione del trattamento,",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन गड़बड़ियाँ, जिनमें ऑर्गेज़्म की गड़बड़ियाँ भी शामिल हैं, जो इलाज बंद करने के बाद कभी-कभी बनी रह सकती हैं,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "fr",
              "text": "La plupart de ces effets indésirables disparaissent avec la poursuite du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these side effects disappear as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die meisten dieser Nebenwirkungen verschwinden bei fortgesetzter Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de estos efectos adversos desaparecen al continuar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos adversos desaparece com a continuação do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte di questi effetti indesiderati scompare con il proseguimento del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर इनमें से ज़्यादातर साइड इफ़ेक्ट चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Prozac",
              "form": "20 mg capsule rigide",
              "holder": "Eli Lilly Italia S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1277/farmaci/25970/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2020-01-08",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 08/01/2020"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Avvertenze speciali e precauzioni di impiego",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome nach dem Absetzen von SSRI fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual a largo plazo con persistencia de los síntomas tras la interrupción del uso de ISRS.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual de longo prazo, com persistência dos sintomas após a interrupção do uso de ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle à long terme ont été signalés, avec persistance des symptômes après l’arrêt de l’utilisation des ISRS.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI दवाओं का इस्तेमाल बंद करने के बाद भी लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "Disturbi psichiatrici",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Ansia Nervosismo Irrequietezza Tensione Diminuzione della libido3 Disturbi del sonno Sogni anormali4",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety Nervousness Restlessness Tension Decreased libido3 Sleep disorders Abnormal dreams4",
                  "by": "ours"
                },
                "de": {
                  "text": "Angst Nervosität Ruhelosigkeit Angespanntheit Verminderte Libido3 Schlafstörungen Abnormale Träume4",
                  "by": "ours"
                },
                "es": {
                  "text": "Ansiedad Nerviosismo Inquietud Tensión Disminución de la libido3 Trastornos del sueño Sueños anormales4",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade Nervosismo Inquietude Tensão Diminuição da libido3 Distúrbios do sono Sonhos anormais4",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété Nervosité Impatiences Tension Baisse de la libido3 Troubles du sommeil Rêves anormaux4",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी घबराहट बेचैनी (restlessness) तनाव कामेच्छा में कमी3 नींद की गड़बड़ियाँ असामान्य सपने4",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "Disturbi psichiatrici",
                "Non comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Depersonalizzazione Umore elevato Umore euforico Pensiero anormale Orgasmo anormale5 Bruxismo Ideazioni e comportamento suicidario6",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depersonalisation Elevated mood Euphoric mood Abnormal thinking Abnormal orgasm5 Bruxism Suicidal ideation and behaviour6",
                  "by": "ours"
                },
                "de": {
                  "text": "Depersonalisation Gehobene Stimmung Euphorische Stimmung Abnormales Denken Abnormaler Orgasmus5 Zähneknirschen Suizidale Gedanken und suizidales Verhalten6",
                  "by": "ours"
                },
                "es": {
                  "text": "Despersonalización Estado elevado del ánimo Estado eufórico del ánimo Pensamiento anormal Orgasmo anormal5 Bruxismo Ideación y comportamiento suicidas6",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização Humor elevado Humor eufórico Pensamento anormal Orgasmo anormal5 Bruxismo Ideação e comportamento suicidas6",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dépersonnalisation Humeur exaltée Humeur euphorique Pensées anormales Orgasme anormal5 Bruxisme Idées et comportement suicidaires6",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना) मूड का ऊँचा रहना (elevated mood) बहुत ज़्यादा खुशी का मूड (euphoric mood) असामान्य सोच (abnormal thinking) ऑर्गेज़्म में गड़बड़ी5 दाँत पीसना (bruxism) आत्महत्या के विचार और व्यवहार6",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "Patologie dell'apparato riproduttivo e della mammella",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Sanguinamento a carico dell'apparato riproduttivo femminile14 Disfunzione erettile Disturbo dell’eiaculazione15",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Bleeding of the female reproductive system14 Erectile dysfunction Ejaculation disorder15",
                  "by": "ours"
                },
                "de": {
                  "text": "Blutungen der weiblichen Geschlechtsorgane14 Erektile Dysfunktion Ejakulationsstörung15",
                  "by": "ours"
                },
                "es": {
                  "text": "Sangrado del aparato reproductor femenino14 Disfunción eréctil Trastorno de la eyaculación15",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sangramento do sistema reprodutor feminino14 Disfunção erétil Distúrbio da ejaculação15",
                  "by": "ours"
                },
                "fr": {
                  "text": "Saignement de l’appareil reproducteur féminin14 Dysfonction érectile Trouble de l’éjaculation15",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना14 स्तंभन दोष स्खलन की गड़बड़ी15",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "Patologie dell'apparato riproduttivo e della mammella",
                "Non comune"
              ],
              "since": null,
              "lang": "it",
              "text": "Disfunzione di natura sessuale16",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Dysfunction of a sexual nature16",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion16",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción de naturaleza sexual16",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção de natureza sexual16",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction de nature sexuelle16",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन प्रकृति का डिस्फ़ंक्शन16",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "nota 16"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "Occasionalmente persistente dopo sospensione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Occasionally persistent after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Gelegentlich anhaltend nach Absetzung der Therapie.",
                  "by": "ours"
                },
                "es": {
                  "text": "Ocasionalmente persistente tras la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ocasionalmente persistente após a suspensão do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Persistant parfois après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कभी-कभी बना रहता है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b. Tabella riassuntiva delle reazioni avverse",
                "Patologie dell'apparato riproduttivo e della mammella",
                "Raro"
              ],
              "since": null,
              "lang": "it",
              "text": "Galattorrea Iperprolattinemia Priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Hyperprolactinaemia Priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhoe Hyperprolaktinämie Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "Galactorrea Hiperprolactinemia Priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Hiperprolactinemia Priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Hyperprolactinémie Priapisme",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia) लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati",
                "a. Sommario del profilo di sicurezza"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "it",
              "text": "Gli effetti indesiderati possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano ad una interruzione della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to therapy being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos pueden disminuir en intensidad y frecuencia con el tratamiento continuado y, por lo general, no llevan a interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos podem diminuir de intensidade e frequência com a continuação do tratamento e geralmente não levam à interrupção da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence avec la poursuite du traitement et n’entraînent généralement pas l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "d. Popolazione pediatrica (vedere paragrafi 4.4 e 5.1)"
              ],
              "since": null,
              "lang": "it",
              "text": "Nell’impiego clinico in pediatria sono stati riportati casi isolati di eventi avversi potenzialmente indicanti una ritardata maturazione sessuale o una disfunzione sessuale (vedere anche paragrafo 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In paediatric clinical use, isolated cases have been reported of adverse events potentially indicating delayed sexual maturation or sexual dysfunction (see also section 5.3).",
                  "by": "ours"
                },
                "de": {
                  "text": "Einzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störung der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "En el uso clínico en pediatría se han notificado casos aislados de acontecimientos adversos que podrían indicar un retraso de la maduración sexual o una disfunción sexual (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "No uso clínico em pediatria, foram relatados casos isolados de eventos adversos que potencialmente indicam um atraso da maturação sexual ou uma disfunção sexual (ver também a seção 5.3).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Lors de l’utilisation clinique en pédiatrie, des cas isolés d’événements indésirables pouvant indiquer un retard de maturation sexuelle ou une dysfonction sexuelle ont été signalés (voir également rubrique 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल के दौरान प्रतिकूल घटनाओं (adverse events) के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा कर सकते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "marketingStopped",
              "text": {
                "en": "An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist dieses Produkt als eingestellt oder nicht mehr im Handel verzeichnet, und der Text in dieser Zeile ist weiterhin der eigene Text dieses Produkts.",
                "es": "En una lista oficial de medicamentos que hemos leído, este producto figura como discontinuado o como ya no comercializado, y el texto de esta fila sigue siendo el de este mismo producto.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra este produto como descontinuado ou não mais comercializado, e o texto desta linha continua sendo o do próprio produto.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente ce produit comme arrêté ou n’étant plus commercialisé, et le texte de cette ligne reste celui de ce produit.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica questo prodotto come dismesso o non più in commercio, e il testo di questa riga è comunque quello di questo stesso prodotto.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें इस उत्पाद को बंद या अब बाज़ार में उपलब्ध नहीं बताया गया है, और इस पंक्ति में दिया गया दस्तावेज़ अब भी इसी उत्पाद का अपना है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
            "lang": "it",
            "product": {
              "name": "Prozac",
              "form": "20 mg capsule rigide",
              "holder": "Eli Lilly Italia S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1277/farmaci/25970/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2020-01-08",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 08/01/2020"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Cosa deve sapere prima di prendere Prozac capsule rigide",
                "Avvertenze e precauzioni",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms have been seen to persist after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, se ha observado la persistencia de estos síntomas tras la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, observou-se a persistência desses sintomas após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la persistance de ces symptômes a été observée après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में देखा गया है कि ये लक्षण इलाज बंद करने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Alcuni pazienti hanno presentato:"
              ],
              "since": null,
              "lang": "it",
              "text": "erezione prolungata e dolorosa;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "prolonged and painful erection;",
                  "by": "ours"
                },
                "de": {
                  "text": "verlängerte und schmerzhafte Erektion;",
                  "by": "ours"
                },
                "es": {
                  "text": "erección prolongada y dolorosa;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereção prolongada e dolorosa;",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection prolongée et douloureuse ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Comuni (che possono interessare fino a 1 paziente su 10)"
              ],
              "since": null,
              "lang": "it",
              "text": "ridotto desiderio sessuale e problemi sessuali (inclusa la difficoltà a mantenere un’erezione per l’attività sessuale)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "reduced sexual desire and sexual problems (including difficulty keeping an erection for sexual activity)",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen und sexuelle Probleme (einschließlich Schwierigkeiten, eine Erektion für die sexuelle Aktivität aufrechtzuerhalten)",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual y problemas sexuales (incluida la dificultad para mantener una erección durante la actividad sexual)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "redução do desejo sexual e problemas sexuais (incluindo a dificuldade para manter uma ereção para a atividade sexual)",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse du désir sexuel et troubles sexuels (y compris la difficulté à maintenir une érection pour l’activité sexuelle)",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी और यौन समस्याएँ (जिनमें यौन क्रिया के लिए इरेक्शन बनाए रखने में दिक्कत भी शामिल है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non comuni (che possono interessare fino a 1 paziente su 100)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "problemi sessuali, inclusi problemi di orgasmo, occasionalmente persistenti dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual problems, including orgasm problems, occasionally persisting after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Probleme, einschließlich Orgasmusprobleme, die gelegentlich nach Beendigung der Behandlung bestehen bleiben",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas sexuales, incluidos problemas de orgasmo, ocasionalmente persistentes tras la interrupción del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas sexuais, incluindo problemas de orgasmo, ocasionalmente persistentes após a interrupção do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels, y compris des troubles de l’orgasme, persistant parfois après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ, जिनमें ऑर्गेज़्म की समस्याएँ भी शामिल हैं, जो इलाज बंद करने के बाद कभी-कभी बनी रहती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "it",
              "text": "È probabile che la maggior parte di questi effetti indesiderati sparisca continuando il trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these side effects are likely to disappear as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die meisten dieser Nebenwirkungen gehen wahrscheinlich vorüber, wenn die Behandlung fortgesetzt wird.",
                  "by": "ours"
                },
                "es": {
                  "text": "Es probable que la mayoría de estos efectos adversos desaparezcan al continuar el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "É provável que a maioria desses efeitos adversos desapareça com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart de ces effets indésirables disparaîtront probablement avec la poursuite du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रखने पर इनमें से ज़्यादातर साइड इफ़ेक्ट के चले जाने की संभावना है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "marketingStopped",
              "text": {
                "en": "An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist dieses Produkt als eingestellt oder nicht mehr im Handel verzeichnet, und der Text in dieser Zeile ist weiterhin der eigene Text dieses Produkts.",
                "es": "En una lista oficial de medicamentos que hemos leído, este producto figura como discontinuado o como ya no comercializado, y el texto de esta fila sigue siendo el de este mismo producto.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra este produto como descontinuado ou não mais comercializado, e o texto desta linha continua sendo o do próprio produto.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente ce produit comme arrêté ou n’étant plus commercialisé, et le texte de cette ligne reste celui de ce produit.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica questo prodotto come dismesso o non più in commercio, e il testo di questa riga è comunque quello di questo stesso prodotto.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें इस उत्पाद को बंद या अब बाज़ार में उपलब्ध नहीं बताया गया है, और इस पंक्ति में दिया गया दस्तावेज़ अब भी इसी उत्पाद का अपना है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-it-pro-eg",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-it-pro-eg",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Fluoxetina EG",
              "form": "20 mg capsule rigide",
              "holder": "EG S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1561/farmaci/34207/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2025-07-09",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 09/07/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Avvertenze speciali e precauzioni d’impiego",
                "Disfunzione sessuale"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome nach dem Absetzen von SSRI/SNRI fortbestanden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual a largo plazo con persistencia de los síntomas tras la interrupción del uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual de longo prazo, com persistência dos sintomas após a interrupção do uso de ISRS/IRSN.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle à long terme ont été signalés, avec persistance des symptômes après l’arrêt de l’utilisation des ISRS/IRSN.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI/SNRI का इस्तेमाल बंद करने के बाद भी लक्षण बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b) Elenco delle reazioni avverse",
                "Disturbi psichiatrici",
                "Comune:"
              ],
              "since": null,
              "lang": "it",
              "text": "ansia, nervosismo, irrequietezza, tensione, diminuzione della libido 3, disturbi del sonno, sogni anormali 4",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "anxiety, nervousness, restlessness, tension, decreased libido 3, sleep disorders, abnormal dreams 4",
                  "by": "ours"
                },
                "de": {
                  "text": "Angst, Nervosität, Ruhelosigkeit, Angespanntheit, verminderte Libido 3, Schlafstörungen, abnormale Träume 4",
                  "by": "ours"
                },
                "es": {
                  "text": "ansiedad, nerviosismo, inquietud, tensión, disminución de la libido 3, trastornos del sueño, sueños anormales 4",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ansiedade, nervosismo, inquietude, tensão, diminuição da libido 3, distúrbios do sono, sonhos anormais 4",
                  "by": "ours"
                },
                "fr": {
                  "text": "anxiété, nervosité, impatiences, tension, baisse de la libido 3, troubles du sommeil, rêves anormaux 4",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी, घबराहट, बेचैनी (restlessness), तनाव, कामेच्छा में कमी 3, नींद की गड़बड़ियाँ, असामान्य सपने 4",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b) Elenco delle reazioni avverse",
                "Disturbi psichiatrici",
                "Non comune:"
              ],
              "since": null,
              "lang": "it",
              "text": "depersonalizzazione, alterazioni del pensiero, umore elevato, euforia, orgasmo anormale 5, bruxismo, idea suicida e comportamento suicida 6",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "depersonalisation, changes in thinking, elevated mood, euphoria, abnormal orgasm 5, bruxism, suicidal ideas and suicidal behaviour 6",
                  "by": "ours"
                },
                "de": {
                  "text": "Depersonalisation, Denkstörungen, gehobene Stimmung, Euphorie, abnormaler Orgasmus 5, Zähneknirschen, Suizidgedanken und suizidales Verhalten 6",
                  "by": "ours"
                },
                "es": {
                  "text": "despersonalización, alteraciones del pensamiento, estado elevado del ánimo, euforia, orgasmo anormal 5, bruxismo, idea suicida y comportamiento suicida 6",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "despersonalização, alterações do pensamento, humor elevado, euforia, orgasmo anormal 5, bruxismo, ideia suicida e comportamento suicida 6",
                  "by": "ours"
                },
                "fr": {
                  "text": "dépersonnalisation, altérations de la pensée, humeur exaltée, euphorie, orgasme anormal 5, bruxisme, idées suicidaires et comportement suicidaire 6",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना), सोच में बदलाव (changes in thinking), मूड का ऊँचा रहना (elevated mood), बहुत ज़्यादा खुशी का मूड (euphoria), ऑर्गेज़्म में गड़बड़ी 5, दाँत पीसना (bruxism), आत्महत्या का विचार और आत्महत्या से जुड़ा व्यवहार 6",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b) Elenco delle reazioni avverse",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Comune:"
              ],
              "since": null,
              "lang": "it",
              "text": "emorragia ginecologica 13, disfunzione erettile, problemi nell’eiaculazione 14",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "gynaecological bleeding 13, erectile dysfunction, ejaculation problems 14",
                  "by": "ours"
                },
                "de": {
                  "text": "gynäkologische Blutung 13, erektile Dysfunktion, Ejakulationsprobleme 14",
                  "by": "ours"
                },
                "es": {
                  "text": "hemorragia ginecológica 13, disfunción eréctil, problemas en la eyaculación 14",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "hemorragia ginecológica 13, disfunção erétil, problemas na ejaculação 14",
                  "by": "ours"
                },
                "fr": {
                  "text": "hémorragie gynécologique 13, dysfonction érectile, problèmes d’éjaculation 14",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding) 13, स्तंभन दोष, स्खलन की समस्याएँ 14",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b) Elenco delle reazioni avverse",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Non comune:"
              ],
              "since": null,
              "lang": "it",
              "text": "disfunzione sessuale",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual dysfunction",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Dysfunktion",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "b) Elenco delle reazioni avverse",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Raro:"
              ],
              "since": null,
              "lang": "it",
              "text": "galattorrea, iperprolattinemia, priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "galactorrhoea, hyperprolactinaemia, priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhoe, Hyperprolaktinämie, Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "galactorrea, hiperprolactinemia, priapismo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "galactorreia, hiperprolactinemia, priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "galactorrhée, hyperprolactinémie, priapisme",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea), खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia), लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati",
                "a) Sintesi del profilo di sicurezza"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "it",
              "text": "Gli effetti indesiderati possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano ad una interruzione della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to therapy being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos pueden disminuir en intensidad y frecuencia con el tratamiento continuado y, por lo general, no llevan a interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos podem diminuir de intensidade e frequência com a continuação do tratamento e geralmente não levam à interrupção da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence avec la poursuite du traitement et n’entraînent généralement pas l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "d) Popolazione pediatrica (vedere paragrafi 4.4 e 5.1)"
              ],
              "since": null,
              "lang": "it",
              "text": "Nell’uso clinico pediatrico sono stati riportati casi isolati di eventi avversi che potenzialmente indicano ritardo della maturazione sessuale o disfunzioni sessuali (vedere anche paragrafo 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In paediatric clinical use, isolated cases have been reported of adverse events that potentially indicate delayed sexual maturation or sexual dysfunction (see also section 5.3).",
                  "by": "ours"
                },
                "de": {
                  "text": "Einzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störungen der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "es": {
                  "text": "En el uso clínico pediátrico se han notificado casos aislados de acontecimientos adversos que podrían indicar un retraso de la maduración sexual o disfunciones sexuales (ver también sección 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "No uso clínico pediátrico, foram relatados casos isolados de eventos adversos que potencialmente indicam atraso da maturação sexual ou disfunções sexuais (ver também a seção 5.3).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Lors de l’utilisation clinique en pédiatrie, des cas isolés d’événements indésirables pouvant indiquer un retard de la maturation sexuelle ou des dysfonctions sexuelles ont été signalés (voir également rubrique 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल इस्तेमाल में प्रतिकूल घटनाओं (adverse events) के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा कर सकते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-it-leaflet-eg",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-it-leaflet-eg",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
            "lang": "it",
            "product": {
              "name": "Fluoxetina EG",
              "form": "20 mg capsule rigide",
              "holder": "EG S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1561/farmaci/34207/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2025-07-09",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 09/07/2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Cosa deve sapere prima di prendere Fluoxetina EG",
                "Avvertenze e precauzioni"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "it",
              "text": "In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms have been seen to persist after treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, se ha observado la persistencia de estos síntomas tras la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, observou-se a persistência desses sintomas após a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la persistance de ces symptômes a été observée après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में देखा गया है कि ये लक्षण इलाज बंद करने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati comuni (possono interessare fino a 1 persona su 10):"
              ],
              "since": null,
              "lang": "it",
              "text": "problemi sessuali, tra cui difficoltà a mantenere l'erezione per un'attività sessuale (disfunzione erettile), eiaculazione precoce o eiaculazione ritardata (disturbi dell'eiaculazione), diminuzione del desiderio sessuale (libido diminuita);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual problems, including difficulty keeping an erection for sexual activity (erectile dysfunction), premature or delayed ejaculation (ejaculation disorders), decreased sexual desire (decreased libido);",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Probleme, darunter Schwierigkeiten, die Erektion für sexuelle Aktivität aufrechtzuerhalten (erektile Dysfunktion), vorzeitige oder verzögerte Ejakulation (Ejakulationsstörungen), vermindertes sexuelles Verlangen (verminderte Libido);",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas sexuales, entre ellos dificultad para mantener la erección durante una actividad sexual (disfunción eréctil), eyaculación precoz o eyaculación retardada (trastornos de la eyaculación), disminución del deseo sexual (libido disminuida);",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas sexuais, entre eles dificuldade para manter a ereção para uma atividade sexual (disfunção erétil), ejaculação precoce ou ejaculação retardada (distúrbios da ejaculação), diminuição do desejo sexual (libido diminuída);",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles sexuels, dont une difficulté à maintenir une érection pour une activité sexuelle (dysfonction érectile), une éjaculation précoce ou retardée (troubles de l’éjaculation), une baisse du désir sexuel (baisse de la libido) ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ, जिनमें ये शामिल हैं: यौन क्रिया के लिए इरेक्शन बनाए रखने में दिक्कत (स्तंभन दोष), समय से पहले स्खलन या स्खलन में देरी (स्खलन की गड़बड़ियाँ), यौन इच्छा में कमी (कामेच्छा में कमी);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100):"
              ],
              "since": null,
              "lang": "it",
              "text": "problemi di orgasmo;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "orgasm problems;",
                  "by": "ours"
                },
                "de": {
                  "text": "Orgasmusprobleme;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas de orgasmo;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas de orgasmo;",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’orgasme ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म की समस्याएँ;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100):"
              ],
              "since": null,
              "lang": "it",
              "text": "problemi nell’attività sessuali (disfunzione sessuale);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with sexual activity (sexual dysfunction);",
                  "by": "ours"
                },
                "de": {
                  "text": "Probleme bei sexueller Aktivität (sexuelle Dysfunktion);",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas en la actividad sexual (disfunción sexual);",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas na atividade sexual (disfunção sexual);",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’activité sexuelle (dysfonction sexuelle) ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया में समस्याएँ (सेक्शुअल डिस्फ़ंक्शन);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati rari (possono interessare fino a 1 persona su 1.000):"
              ],
              "since": null,
              "lang": "it",
              "text": "erezione dolorosa persistente (priapismo);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent painful erection (priapism);",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende schmerzhafte Erektion (Priapismus);",
                  "by": "ours"
                },
                "es": {
                  "text": "erección dolorosa persistente (priapismo);",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "ereção dolorosa persistente (priapismo);",
                  "by": "ours"
                },
                "fr": {
                  "text": "érection douloureuse persistante (priapisme) ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला दर्दनाक इरेक्शन (priapism);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-5",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Uso nei bambini e negli adolescenti al di sotto di 18 anni d’età"
              ],
              "since": null,
              "lang": "it",
              "text": "maturità sessuale ritardata o disfunzione sessuale;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "delayed sexual maturity or sexual dysfunction;",
                  "by": "ours"
                },
                "de": {
                  "text": "verzögerte Geschlechtsreife oder sexuelle Dysfunktion;",
                  "by": "ours"
                },
                "es": {
                  "text": "madurez sexual retrasada o disfunción sexual;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "maturidade sexual retardada ou disfunção sexual;",
                  "by": "ours"
                },
                "fr": {
                  "text": "retard de la maturité sexuelle ou dysfonction sexuelle ;",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-es",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "fluoxetina cinfa",
              "form": "20 mg cápsulas duras EFG",
              "holder": "Laboratorios Cinfa, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/63499/FT_63499.html",
            "fetchedUrl": null,
            "textDate": "2021-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO Mayo 2021"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Advertencias y precauciones especiales de empleo",
                "Disfunción sexual"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen des SSRI fortbestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da suspensão do ISRS.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’arrêt de l’ISRS, ont été signalés.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante la sospensione dell’SSRI.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें SSRI बंद करने के बावजूद लक्षण बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen tabulado de reacciones adversas",
                "Trastornos psiquiátricos",
                "Frecuentes"
              ],
              "since": null,
              "lang": "es",
              "text": "Ansiedad Nerviosismo Inquietud Tensión Disminución de la libido3 Trastornos del sueño Sueños anormales4",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Anxiety Nervousness Restlessness Tension Decreased libido3 Sleep disorders Abnormal dreams4",
                  "by": "ours"
                },
                "de": {
                  "text": "Angst Nervosität Ruhelosigkeit Angespanntheit Verminderte Libido3 Schlafstörungen Abnormale Träume4",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ansiedade Nervosismo Inquietude Tensão Diminuição da libido3 Distúrbios do sono Sonhos anormais4",
                  "by": "ours"
                },
                "fr": {
                  "text": "Anxiété Nervosité Impatiences Tension Baisse de la libido3 Troubles du sommeil Rêves anormaux4",
                  "by": "ours"
                },
                "it": {
                  "text": "Ansia Nervosismo Irrequietezza Tensione Diminuzione della libido3 Disturbi del sonno Sogni anormali4",
                  "by": "ours"
                },
                "hi": {
                  "text": "एंग्ज़ायटी घबराहट बेचैनी (restlessness) तनाव कामेच्छा में कमी3 नींद की गड़बड़ियाँ असामान्य सपने4",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen tabulado de reacciones adversas",
                "Trastornos psiquiátricos",
                "Poco frecuentes"
              ],
              "since": null,
              "lang": "es",
              "text": "Despersonalización Estado elevado del ánimo Estado eufórico del ánimo Pensamiento anormal Orgasmo normal5 Bruxismo Comportamientos y pensamientos suicidas6",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depersonalisation Elevated mood Euphoric mood Abnormal thinking Abnormal orgasm5 Bruxism Suicidal behaviour and thoughts6",
                  "by": "ours"
                },
                "de": {
                  "text": "Depersonalisation Gehobene Stimmung Euphorische Stimmung Abnormales Denken Abnormaler Orgasmus5 Zähneknirschen Suizidales Verhalten und suizidale Gedanken6",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Despersonalização Estado de ânimo elevado Estado de ânimo eufórico Pensamento anormal Orgasmo anormal5 Bruxismo Comportamentos e pensamentos suicidas6",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dépersonnalisation Humeur exaltée Humeur euphorique Pensées anormales Orgasme anormal5 Bruxisme Comportements et pensées suicidaires6",
                  "by": "ours"
                },
                "it": {
                  "text": "Depersonalizzazione Umore elevato Umore euforico Pensiero anormale Orgasmo anormale5 Bruxismo Comportamenti e pensieri suicidi6",
                  "by": "ours"
                },
                "hi": {
                  "text": "डीपर्सनलाइज़ेशन (खुद से कटा हुआ महसूस करना) मूड का ऊँचा रहना (elevated mood) बहुत ज़्यादा खुशी का मूड (euphoric mood) असामान्य सोच (abnormal thinking) ऑर्गेज़्म में गड़बड़ी5 दाँत पीसना (bruxism) आत्महत्या से जुड़ा व्यवहार और विचार6",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen tabulado de reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuentes"
              ],
              "since": null,
              "lang": "es",
              "text": "Hemorragia ginecológica14 Disfunción eréctil Trastorno de la eyaculación15",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15",
                  "by": "ours"
                },
                "de": {
                  "text": "Gynäkologische Blutung14 Erektile Dysfunktion Ejakulationsstörung15",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Hemorragia ginecológica14 Disfunção erétil Distúrbio da ejaculação15",
                  "by": "ours"
                },
                "fr": {
                  "text": "Hémorragie gynécologique14 Dysfonction érectile Trouble de l’éjaculation15",
                  "by": "ours"
                },
                "it": {
                  "text": "Emorragia ginecologica14 Disfunzione erettile Disturbo dell’eiaculazione15",
                  "by": "ours"
                },
                "hi": {
                  "text": "महिलाओं के प्रजनन अंगों से खून आना (gynaecological bleeding)14 स्तंभन दोष स्खलन की गड़बड़ी15",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen tabulado de reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Poco frecuentes"
              ],
              "since": null,
              "lang": "es",
              "text": "Disfunción sexual",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction sexuelle",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-3",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen tabulado de reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Raras"
              ],
              "since": null,
              "lang": "es",
              "text": "Galactorrea Hiperprolactinemia Priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Galactorrhoea Hyperprolactinaemia Priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Galaktorrhoe Hyperprolaktinämie Priapismus",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Galactorreia Hiperprolactinemia Priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Galactorrhée Hyperprolactinémie Priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "Galattorrea Iperprolattinemia Priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों से दूध जैसा स्राव (galactorrhoea) खून में प्रोलैक्टिन हार्मोन का बढ़ना (hyperprolactinaemia) लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen del perfil de seguridad"
              ],
              "since": null,
              "qualifies": "listed-reproductive-3",
              "lang": "es",
              "text": "Las reacciones adversas pueden disminuir en intensidad y frecuencia con el tratamiento continuado y no conducen generalmente a la interrupción del tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse reactions may decrease in intensity and frequency with continued treatment and do not generally lead to treatment being stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas podem diminuir de intensidade e frequência com a continuação do tratamento e geralmente não levam à interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables peuvent diminuer en intensité et en fréquence avec la poursuite du traitement et n’entraînent généralement pas l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano all’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज जारी रहने पर साइड इफ़ेक्ट की तीव्रता घट सकती है और वे कम बार हो सकते हैं, और आम तौर पर इनकी वजह से इलाज बंद नहीं होता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-paediatric",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Población pediátrica (ver secciones 4.4 y 5.1)"
              ],
              "since": null,
              "lang": "es",
              "text": "Han sido notificados de la experiencia clínica en pediatría casos aislados de efectos adversos indicando potencialmente un retraso en la maduración sexual o disfunción sexual (ver también sección 5.3).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "From clinical experience in children, isolated cases have been reported of adverse effects potentially indicating delayed sexual maturation or sexual dysfunction (see also section 5.3).",
                  "by": "ours"
                },
                "de": {
                  "text": "Einzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störung der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram notificados, na experiência clínica em pediatria, casos isolados de efeitos adversos que potencialmente indicam um atraso na maturação sexual ou disfunção sexual (ver também seção 5.3).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas isolés d’effets indésirables pouvant indiquer un retard de la maturation sexuelle ou une dysfonction sexuelle ont été signalés dans le cadre de l’expérience clinique en pédiatrie (voir également rubrique 5.3).",
                  "by": "ours"
                },
                "it": {
                  "text": "Dall’esperienza clinica in pediatria sono stati segnalati casi isolati di effetti avversi potenzialmente indicativi di un ritardo della maturazione sessuale o di disfunzione sessuale (vedere anche paragrafo 5.3).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बच्चों और किशोरों में क्लिनिकल अनुभव से साइड इफ़ेक्ट के इक्का-दुक्का ऐसे मामले रिपोर्ट हुए हैं, जो यौन परिपक्वता में देरी या सेक्शुअल डिस्फ़ंक्शन की ओर इशारा कर सकते हैं (सेक्शन 5.3 भी देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "productsDifferSearched",
              "text": {
                "en": "Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Wir haben sie nach Sätzen dazu durchsucht, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten, und sie nicht vollständig gelesen. Diese Zeile zeigt das genannte Produkt und kein anderes.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Hemos buscado en ellos frases sobre efectos secundarios sexuales que continúen después de dejar el medicamento, y no los hemos leído enteros. Esta fila muestra el producto que se nombra, y ningún otro.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. Procuramos nelas frases sobre efeitos colaterais sexuais que continuam depois de parar o medicamento, mas não as lemos por inteiro. Esta linha mostra o produto indicado, e nenhum outro.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Nous y avons cherché des phrases sur des effets secondaires sexuels qui persistent après l’arrêt, sans les lire en entier. Cette ligne montre le produit nommé, et aucun autre.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Vi abbiamo cercato frasi sugli effetti collaterali sessuali che continuano dopo l’interruzione e non li abbiamo letti per intero. Questa riga mostra il prodotto indicato, e nessun altro.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। हमने उनमें दवा बंद करने के बाद यौन साइड इफ़ेक्ट के बने रहने के बारे में वाक्य खोजे, और उन्हें पूरा नहीं पढ़ा। यह पंक्ति उसी उत्पाद की है, जिसका नाम दिया गया है, किसी और की नहीं।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-es-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-es-leaflet",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: información para el usuario",
            "lang": "es",
            "product": {
              "name": "fluoxetina cinfa",
              "form": "20 mg cápsulas duras EFG",
              "holder": "Laboratorios Cinfa, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/63499/P_63499.html",
            "fetchedUrl": null,
            "textDate": "2021-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: Mayo 2021"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. Qué necesita saber antes de empezar a tomar fluoxetina cinfa",
                "Advertencias y precauciones",
                "Disfunción sexual"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "es",
              "text": "En algunos casos, estos síntomas persisten después de suspender el tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these symptoms persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "In bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses sintomas persistem depois de suspender o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces symptômes persistent après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi, questi sintomi persistono dopo la sospensione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, ये लक्षण इलाज बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Algunos pacientes han padecido:"
              ],
              "since": null,
              "lang": "es",
              "text": "Erección prolongada y dolorosa.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Prolonged and painful erection.",
                  "by": "ours"
                },
                "de": {
                  "text": "Verlängerte und schmerzhafte Erektion.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ereção prolongada e dolorosa.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Érection prolongée et douloureuse.",
                  "by": "ours"
                },
                "it": {
                  "text": "Erezione prolungata e dolorosa.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला और दर्दनाक इरेक्शन।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuentes (pueden afectar hasta 1 de cada 10 personas)"
              ],
              "since": null,
              "lang": "es",
              "text": "Disminución del deseo sexual o problemas sexuales (incluyendo dificultad para mantener una erección durante la actividad sexual).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decreased sexual desire or sexual problems (including difficulty keeping an erection during sexual activity).",
                  "by": "ours"
                },
                "de": {
                  "text": "Vermindertes sexuelles Verlangen oder sexuelle Probleme (einschließlich Schwierigkeiten, während der sexuellen Aktivität eine Erektion aufrechtzuerhalten).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual ou problemas sexuais (incluindo dificuldade para manter uma ereção durante a atividade sexual).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Baisse du désir sexuel ou troubles sexuels (y compris des difficultés à maintenir une érection pendant l’activité sexuelle).",
                  "by": "ours"
                },
                "it": {
                  "text": "Riduzione del desiderio sessuale o problemi sessuali (inclusa la difficoltà a mantenere un’erezione durante l’attività sessuale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी या यौन समस्याएँ (जिनमें यौन क्रिया के दौरान इरेक्शन बनाए रखने में दिक्कत भी शामिल है)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Poco frecuentes (pueden afectar hasta 1 de cada 100 personas)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "Problemas sexuales, incluyendo problemas de orgasmo, persistiendo ocasionalmente después de la interrupción del tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual problems, including orgasm problems, occasionally persisting after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Probleme, einschließlich Orgasmusprobleme, die gelegentlich nach Beendigung der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas sexuais, incluindo problemas de orgasmo, ocasionalmente persistindo depois da interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles sexuels, y compris des troubles de l’orgasme, persistant parfois après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi sessuali, inclusi problemi di orgasmo, che occasionalmente persistono dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन समस्याएँ, जिनमें ऑर्गेज़्म की समस्याएँ भी शामिल हैं, जो इलाज बंद करने के बाद कभी-कभी बनी रहती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Posibles efectos adversos"
              ],
              "since": null,
              "qualifies": "persistence-listed",
              "lang": "es",
              "text": "La mayoría de estos efectos adversos tienden a desaparecer con la continuación del tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these side effects tend to disappear as treatment continues.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die meisten dieser Nebenwirkungen verschwinden in der Regel bei fortgesetzter Behandlung.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos adversos tende a desaparecer com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart de ces effets indésirables tendent à disparaître avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte di questi effetti avversi tende a scomparire con la continuazione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इनमें से ज़्यादातर साइड इफ़ेक्ट इलाज जारी रहने पर आम तौर पर चले जाते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-es-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-es-regulator",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/boletines-aemps/boletinMensual/2019-boletinMensual/boletin-mensual-de-la-aemps-sobre-medicamentos-de-uso-humano-del-mes-de-mayo-de-2019/",
            "fetchedUrl": null,
            "textDate": "2019-06-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 26 de junio de 2019"
          },
          "passages": [
            {
              "key": "bulletin",
              "kind": "sexual-persistence",
              "section": [
                "Información sobre seguridad",
                "Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia",
                "Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexual"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "En pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.",
                  "by": "ours"
                },
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Serotonin-Noradrenalin-Wiederaufnahmehemmern oder mit selektiven Serotonin-Wiederaufnahmehemmern behandelt werden, wurden Fälle von lang anhaltender sexueller Funktionsstörung gemeldet, bei denen die Symptome trotz Absetzen der Behandlung fortbestehen. Diese Erkenntnis wird in die Warnhinweise dieser Medikamente aufgenommen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em pacientes em tratamento com inibidores da recaptação de serotonina e noradrenalina, ou com inibidores seletivos da recaptação de serotonina, foram notificados casos de disfunção sexual de longa duração em que os sintomas persistem apesar da interrupção do tratamento. Esse achado será incorporado às advertências desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Chez des patients traités par inhibiteurs de la recapture de la sérotonine et de la noradrénaline, ou par inhibiteurs sélectifs de la recapture de la sérotonine, des cas de dysfonction sexuelle de longue durée, dans lesquels les symptômes persistent malgré l’interruption du traitement, ont été signalés. Cette observation sera ajoutée aux mises en garde de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti in trattamento con inibitori della ricaptazione della serotonina e della noradrenalina, o con inibitori selettivi della ricaptazione della serotonina, sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi persistono nonostante l’interruzione del trattamento. Questo dato sarà inserito nelle avvertenze di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेरोटोनिन-नॉरएड्रेनालाईन रीअपटेक इनहिबिटर या सेलेक्टिव सेरोटोनिन रीअपटेक इनहिबिटर से जिन मरीज़ों का इलाज चल रहा है, उनमें लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन के ऐसे मामले रिपोर्ट हुए हैं, जिनमें इलाज बंद करने के बावजूद लक्षण बने रहते हैं। यह बात इन दवाओं की चेतावनियों में जोड़ी जाएगी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "coversClassOnly",
              "text": {
                "en": "That document is about the whole class of medicines. It does not name fluoxetine.",
                "de": "Dieses Dokument betrifft die ganze Wirkstoffklasse. Es nennt Fluoxetin nicht.",
                "es": "Ese documento trata de toda la clase de medicamentos. No nombra el principio activo fluoxetina.",
                "pt-br": "Esse documento trata de toda a classe de medicamentos. Não cita fluoxetina pelo nome.",
                "fr": "Ce document porte sur toute la classe de médicaments. Il ne nomme pas le principe actif fluoxétine.",
                "it": "Quel documento riguarda l’intera classe di medicinali. Non nomina il principio attivo fluoxetina.",
                "hi": "वह दस्तावेज़ दवाओं के पूरे समूह के बारे में है। उसमें फ़्लुओक्सेटीन का नाम नहीं है।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fluoxetin (cloridrato de fluoxetina): bula para o profissional de saúde",
            "lang": "pt-BR",
            "product": {
              "name": "Fluoxetin",
              "form": "cápsula dura 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/160/bula-profissional",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Reação comum (> 1/100 e < 1/10):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "diminuição da libido (incluindo perda da libido)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido (including loss of libido)",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido (einschließlich Libidoverlust)",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido (incluida la pérdida de la libido)",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse de la libido (y compris perte de libido)",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido (inclusa la perdita della libido)",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी (जिसमें कामेच्छा का खत्म होना भी शामिल है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Reação comum (> 1/100 e < 1/10):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "distúrbios da ejaculação (incluindo falha na ejaculação, disfunção da ejaculação, ejaculação precoce, retardo na ejaculação e ejaculação retrógrada)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders (including ejaculation failure, ejaculation dysfunction, premature ejaculation, delayed ejaculation and retrograde ejaculation)",
                  "by": "ours"
                },
                "de": {
                  "text": "Ejakulationsstörungen (einschließlich ausbleibender Ejakulation, Ejakulationsstörung, vorzeitiger Ejakulation, verzögerter Ejakulation und retrograder Ejakulation)",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación (incluidos insuficiencia eyaculatoria, disfunción de la eyaculación, eyaculación precoz, retraso de la eyaculación y eyaculación retrógrada)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation (y compris échec de l’éjaculation, dysfonction de l’éjaculation, éjaculation précoce, éjaculation retardée et éjaculation rétrograde)",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione (tra cui mancata eiaculazione, disfunzione dell’eiaculazione, eiaculazione precoce, eiaculazione ritardata ed eiaculazione retrograda)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की गड़बड़ियाँ (जिनमें स्खलन न हो पाना, स्खलन का ठीक से न होना (ejaculation dysfunction), समय से पहले स्खलन, स्खलन में देरी और उलटा स्खलन (retrograde ejaculation) शामिल हैं)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Reação comum (> 1/100 e < 1/10):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "disfunção erétil",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erectile dysfunction",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción eréctil",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction érectile",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione erettile",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Reação incomum (> 1/1.000 e <1/100):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "alteração do orgasmo (incluindo anorgasmia)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "change in orgasm (including anorgasmia)",
                  "by": "ours"
                },
                "de": {
                  "text": "Orgasmusstörung (einschließlich Anorgasmie)",
                  "by": "ours"
                },
                "es": {
                  "text": "alteración del orgasmo (incluida la anorgasmia)",
                  "by": "ours"
                },
                "fr": {
                  "text": "altération de l’orgasme (y compris anorgasmie)",
                  "by": "ours"
                },
                "it": {
                  "text": "alterazione dell’orgasmo (inclusa l’anorgasmia)",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में बदलाव (जिसमें ऑर्गेज़्म न हो पाना (anorgasmia) भी शामिल है)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-5",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Reação incomum (> 1/1.000 e <1/100):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "aumento da libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "increased libido",
                  "by": "ours"
                },
                "de": {
                  "text": "gesteigerte Libido",
                  "by": "ours"
                },
                "es": {
                  "text": "aumento de la libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "augmentation de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "aumento della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में बढ़ोतरी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-6",
              "kind": "sexual-side-effects",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Relatos pós-comercialização:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "priapismo",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "priapism",
                  "by": "ours"
                },
                "de": {
                  "text": "Priapismus",
                  "by": "ours"
                },
                "es": {
                  "text": "priapismo",
                  "by": "ours"
                },
                "fr": {
                  "text": "priapisme",
                  "by": "ours"
                },
                "it": {
                  "text": "priapismo",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक बना रहने वाला इरेक्शन (priapism)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "9. REAÇÕES ADVERSAS",
                "Relatos pós-comercialização:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "disfunção sexual (ocasionalmente persistindo após a descontinuação do uso)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual dysfunction (occasionally persisting after use is stopped)",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Dysfunktion (gelegentlich anhaltend nach Beendigung der Anwendung)",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual (que ocasionalmente persiste tras la suspensión del uso)",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle (persistant parfois après l’arrêt de l’utilisation)",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale (occasionalmente persistente dopo la sospensione dell’uso)",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन (दवा का इस्तेमाल बंद करने के बाद कभी-कभी बना रहता है)",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "originatorNotOpened",
              "text": {
                "en": "The originator product's text could not be opened. This is the text of another product, the one named in this row.",
                "de": "Der Text des Originalpräparats ließ sich nicht öffnen. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "El texto del producto original no se pudo abrir. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Não foi possível abrir o texto do produto original. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Le texte du produit d’origine n’a pas pu être ouvert. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Non è stato possibile aprire il testo del medicinale originatore. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "दवा के मूल (originator) उत्पाद का दस्तावेज़ खोला नहीं जा सका। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-br-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-br-leaflet",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fluoxetin (cloridrato de fluoxetina): bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Fluoxetin",
              "form": "cápsula dura 20 mg",
              "holder": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Cristália Produtos Químicos Farmacêuticos Ltda."
            },
            "url": "https://www.cristalia.com.br/produto/160/bula-paciente",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "diminuição da libido [incluindo perda da libido (desejo sexual)]",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido [including loss of libido (sexual desire)]",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido [einschließlich Verlust der Libido (sexuelles Verlangen)]",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido [incluida la pérdida de la libido (deseo sexual)]",
                  "by": "ours"
                },
                "fr": {
                  "text": "baisse de la libido [y compris perte de libido (désir sexuel)]",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido [inclusa la perdita della libido (desiderio sessuale)]",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी [जिसमें कामेच्छा (यौन इच्छा) का खत्म होना भी शामिल है]",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "distúrbios da ejaculação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders",
                  "by": "ours"
                },
                "de": {
                  "text": "Ejakulationsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की गड़बड़ियाँ",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "disfunção erétil (dificuldade de obtenção e/ou manutenção da ereção do pênis)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erectile dysfunction (difficulty getting and/or keeping an erection of the penis)",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion (Schwierigkeiten, eine Erektion des Penis zu bekommen und/oder aufrechtzuerhalten)",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción eréctil (dificultad para conseguir y/o mantener la erección del pene)",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction érectile (difficulté à obtenir et/ou à maintenir l’érection du pénis)",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione erettile (difficoltà a ottenere e/o mantenere l’erezione del pene)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (लिंग में इरेक्शन होने और/या उसे बनाए रखने में दिक्कत)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "alteração do orgasmo [incluindo anorgasmia (incapacidade de ter orgasmo)]",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "change in orgasm [including anorgasmia (inability to have an orgasm)]",
                  "by": "ours"
                },
                "de": {
                  "text": "Orgasmusstörung [einschließlich Anorgasmie (Unfähigkeit, einen Orgasmus zu haben)]",
                  "by": "ours"
                },
                "es": {
                  "text": "alteración del orgasmo [incluida la anorgasmia (incapacidad de tener un orgasmo)]",
                  "by": "ours"
                },
                "fr": {
                  "text": "altération de l’orgasme [y compris anorgasmie (incapacité à avoir un orgasme)]",
                  "by": "ours"
                },
                "it": {
                  "text": "alterazione dell’orgasmo [inclusa l’anorgasmia (incapacità di avere un orgasmo)]",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऑर्गेज़्म में बदलाव [जिसमें anorgasmia (ऑर्गेज़्म न हो पाना) भी शामिल है]",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-5",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "aumento da libido (aumento do desejo sexual)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "increased libido (increased sexual desire)",
                  "by": "ours"
                },
                "de": {
                  "text": "gesteigerte Libido (gesteigertes sexuelles Verlangen)",
                  "by": "ours"
                },
                "es": {
                  "text": "aumento de la libido (aumento del deseo sexual)",
                  "by": "ours"
                },
                "fr": {
                  "text": "augmentation de la libido (augmentation du désir sexuel)",
                  "by": "ours"
                },
                "it": {
                  "text": "aumento della libido (aumento del desiderio sessuale)",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में बढ़ोतरी (यौन इच्छा का बढ़ना)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-6",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Relatos pós-comercialização:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "priapismo (ereção do pênis prolongada ou dolorida)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "priapism (prolonged or painful erection of the penis)",
                  "by": "ours"
                },
                "de": {
                  "text": "Priapismus (verlängerte oder schmerzhafte Erektion des Penis)",
                  "by": "ours"
                },
                "es": {
                  "text": "priapismo (erección del pene prolongada o dolorosa)",
                  "by": "ours"
                },
                "fr": {
                  "text": "priapisme (érection du pénis prolongée ou douloureuse)",
                  "by": "ours"
                },
                "it": {
                  "text": "priapismo (erezione del pene prolungata o dolorosa)",
                  "by": "ours"
                },
                "hi": {
                  "text": "priapism (लिंग में लंबे समय तक बना रहने वाला या दर्दनाक इरेक्शन)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-listed",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Relatos pós-comercialização:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "disfunção sexual (ocasionalmente persistindo após a descontinuação do uso)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual dysfunction (occasionally persisting after use is stopped)",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Dysfunktion (gelegentlich anhaltend nach Beendigung der Anwendung)",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual (que ocasionalmente persiste tras la suspensión del uso)",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle (persistant parfois après l’arrêt de l’utilisation)",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale (occasionalmente persistente dopo la sospensione dell’uso)",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन (दवा का इस्तेमाल बंद करने के बाद कभी-कभी बना रहता है)",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "fluoxetine-br-pro-prozac",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-br-pro-prozac",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Prozac",
              "form": null,
              "holder": "Eli Lilly do Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=prozac&page=1",
            "https://www.lilly.com/br/medicamentos/disponiveis",
            "https://www.lilly.com/br/bulas"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-br-leaflet-prozac",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-br-leaflet-prozac",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "holder-publishes-none"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Prozac",
              "form": null,
              "holder": "Eli Lilly do Brasil Ltda."
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/api/consulta/bulario?count=20&filter%5BnomeProduto%5D=prozac&page=1",
            "https://www.lilly.com/br/medicamentos/disponiveis",
            "https://www.lilly.com/br/bulas"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
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              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "fluoxetine-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#fluoxetine-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "no-public-database"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": null,
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/",
            "https://sunpharma.com/india-products/",
            "https://sunpharma.com/india-prescribing-information/",
            "https://www.intaspharma.com/products/",
            "https://www.zyduslife.com/products.html",
            "https://www.zydushealthcare.com/brands/",
            "https://www.torrentpharma.com/pi/",
            "https://www.ciplamed.com/sitemap-pages.xml"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        }
      ]
    },
    {
      "id": "finasteride",
      "inn": "finasteride",
      "names": {
        "en": "finasteride",
        "de": "Finasterid",
        "es": "finasterida",
        "pt-br": "finasterida",
        "fr": "finastéride",
        "it": "finasteride",
        "hi": "फ़िनास्टेराइड"
      },
      "class": "5ari",
      "classLabel": {
        "en": "5α-reductase inhibitor",
        "de": "5-Alpha-Reduktase-Hemmer",
        "es": "inhibidor de la 5-alfa-reductasa",
        "pt-br": "inibidor da 5-alfa-redutase",
        "fr": "inhibiteur de la 5-alpha-réductase",
        "it": "inibitore della 5-alfa-reduttasi",
        "hi": "5-अल्फ़ा-रिडक्टेज़ इनहिबिटर"
      },
      "condition": "pfs",
      "lead": {
        "en": "For the 5α-reductase inhibitor finasteride (Propecia), the product information we read in the United Kingdom, in the United States, in Canada, in Australia, in New Zealand, in Germany, in France, in Italy, in Spain, in Brazil and in India, in some places that of another product, lists sexual dysfunction that continued after treatment was stopped. In each of those texts it stands among side effects reported once the medicine was in general use. Several add that these reports come from a group of unknown size, so how often this happens, and whether finasteride is the cause, cannot always be established. Patients call lasting effects after finasteride post-finasteride syndrome (PFS). The wording a European Commission decision set for the EU in 2025 is about mood and thoughts of suicide, and has no sentence about sexual side effects continuing after the medicine is stopped.",
        "de": "Zum 5-Alpha-Reduktase-Hemmer Finasterid (Propecia) führen die Produktinformationen, die wir im Vereinigten Königreich, in den USA, in Kanada, in Australien, in Neuseeland, in Deutschland, in Frankreich, in Italien, in Spanien, in Brasilien und in Indien gelesen haben, teils die eines anderen Produkts, sexuelle Funktionsstörungen auf, die nach dem Absetzen der Behandlung angehalten haben. In jedem dieser Texte steht dies unter den Nebenwirkungen, über die berichtet wurde, nachdem das Medikament allgemein angewendet wurde. Mehrere ergänzen, diese Berichte stammten aus einer Gruppe unbekannter Größe, weshalb sich nicht immer feststellen lasse, wie oft dies vorkommt und ob Finasterid die Ursache ist. Anhaltende Folgen nach Finasterid nennen Betroffene Post-Finasterid-Syndrom (PFS). Der Wortlaut, den ein Beschluss der Europäischen Kommission 2025 für die EU festgelegt hat, betrifft Stimmung und Suizidgedanken und enthält keinen Satz dazu, dass sexuelle Nebenwirkungen nach dem Absetzen des Medikaments anhalten.",
        "es": "En el caso de la finasterida (Propecia), un inhibidor de la 5-alfa-reductasa, la información del producto que hemos leído en el Reino Unido, en Estados Unidos, en Canadá, en Australia, en Nueva Zelanda, en Alemania, en Francia, en Italia, en España, en Brasil y en la India, en algunos casos la de otro producto, recoge disfunción sexual que continuó después de dejar el tratamiento. En cada uno de esos textos figura entre los efectos secundarios notificados cuando el medicamento ya se usaba de forma generalizada. Varios añaden que estas notificaciones proceden de un grupo de tamaño desconocido, por lo que no siempre puede establecerse con qué frecuencia ocurre ni si la finasterida es la causa. Los pacientes llaman síndrome post-finasterida (PFS) a los efectos duraderos tras la finasterida. El texto que fijó para la UE en 2025 una decisión de la Comisión Europea trata del estado de ánimo y de los pensamientos suicidas, y no tiene ninguna frase que diga que los efectos secundarios sexuales continúan después de dejar el medicamento.",
        "pt-br": "No caso do inibidor da 5-alfa-redutase finasterida (Propecia), as bulas que lemos no Reino Unido, nos Estados Unidos, no Canadá, na Austrália, na Nova Zelândia, na Alemanha, na França, na Itália, na Espanha, no Brasil e na Índia, em alguns lugares as de outro produto, listam disfunção sexual que continuou depois de parar o tratamento. Em cada um desses textos, ela aparece entre os efeitos colaterais relatados depois que o medicamento passou a ser de uso geral. Vários acrescentam que esses relatos vêm de um grupo de tamanho desconhecido, de modo que nem sempre é possível estabelecer com que frequência isso acontece, nem se a finasterida é a causa. Os pacientes chamam de síndrome pós-finasterida (PFS) os efeitos duradouros depois da finasterida. O texto que uma decisão da Comissão Europeia definiu para a UE em 2025 trata de humor e de pensamentos suicidas, e não tem nenhuma frase sobre efeitos colaterais sexuais que continuam depois de parar o medicamento.",
        "fr": "Pour le finastéride (Propecia), un inhibiteur de la 5-alpha-réductase, les informations sur le produit que nous avons lues au Royaume-Uni, aux États-Unis, au Canada, en Australie, en Nouvelle-Zélande, en Allemagne, en France, en Italie, en Espagne, au Brésil et en Inde, parfois celles d’un autre produit, citent une dysfonction sexuelle qui a persisté après l’arrêt du traitement. Dans chacun de ces textes, elle figure parmi les effets secondaires signalés depuis que le médicament est d’usage courant. Plusieurs ajoutent que ces signalements proviennent d’un groupe de taille inconnue : on ne peut donc pas toujours établir la fréquence du phénomène, ni si le finastéride en est la cause. Les patients appellent syndrome post-finastéride (PFS) les effets qui durent après le finastéride. La formulation fixée en 2025 pour l’UE par une décision de la Commission européenne porte sur l’humeur et les pensées suicidaires, et ne contient aucune phrase disant que des effets secondaires sexuels persistent après l’arrêt du médicament.",
        "it": "Per l’inibitore della 5-alfa-reduttasi finasteride (Propecia), le informazioni sul prodotto che abbiamo letto nel Regno Unito, negli Stati Uniti, in Canada, in Australia, in Nuova Zelanda, in Germania, in Francia, in Italia, in Spagna, in Brasile e in India, in alcuni casi quelle di un altro prodotto, elencano la disfunzione sessuale che è proseguita dopo l’interruzione del trattamento. In ciascuno di questi testi compare tra gli effetti indesiderati segnalati quando il medicinale era già in uso generale. Diversi aggiungono che queste segnalazioni provengono da un gruppo di dimensioni sconosciute, per cui non sempre è possibile stabilire con quale frequenza accada, né se la finasteride ne sia la causa. I pazienti chiamano sindrome post-finasteride (PFS) gli effetti che durano dopo la finasteride. Il testo fissato per l’UE da una decisione della Commissione europea nel 2025 riguarda l’umore e i pensieri suicidi, e non ha nessuna frase sugli effetti collaterali sessuali che continuano dopo l’interruzione del medicinale.",
        "hi": "5-अल्फ़ा-रिडक्टेज़ इनहिबिटर फ़िनास्टेराइड (Propecia) के मामले में, दवा की जो आधिकारिक जानकारी (product information) हमने पढ़ी, ब्रिटेन में, अमेरिका में, कनाडा में, ऑस्ट्रेलिया में, न्यूज़ीलैंड में, जर्मनी में, फ़्रांस में, इटली में, स्पेन में, ब्राज़ील में और भारत में, कुछ जगहों पर किसी दूसरे उत्पाद की, वह उस सेक्शुअल डिस्फ़ंक्शन को गिनाती है, जो इलाज बंद होने के बाद भी जारी रहा। इन ग्यारहों दस्तावेज़ों में से हर एक में वह उन साइड इफ़ेक्ट के बीच दर्ज है, जो दवा के आम उपयोग में आने के बाद रिपोर्ट हुए। कई दस्तावेज़ यह भी जोड़ते हैं कि ये रिपोर्टें अनिश्चित आकार के एक समूह से आती हैं, इसलिए यह हमेशा तय नहीं किया जा सकता कि ऐसा कितनी बार होता है, और कि इसका कारण फ़िनास्टेराइड है या नहीं। फ़िनास्टेराइड के बाद बने रहने वाले असर को मरीज़ पोस्ट-फ़िनास्टेराइड सिंड्रोम (PFS) कहते हैं। यूरोपीय आयोग (European Commission) के एक फ़ैसले ने 2025 में EU के लिए जो शब्द तय किए, वे मूड और आत्महत्या के विचारों के बारे में हैं, और उनमें दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने का कोई वाक्य नहीं है।"
      },
      "brands": [
        {
          "name": "Propecia",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/916",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=61606",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "BfArM",
              "sourceUrl": "https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/a-f/finasterid.html",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000061889?lang=it",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=62441",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Proscar",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/916",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=13370",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "BfArM",
              "sourceUrl": "https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/a-f/finasterid.html",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000022192?lang=it",
              "checked": "2026-10-14"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=59830",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Chibro-Proscar",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67859371/extrait",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Ricit",
          "listings": [
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prostide",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000022296?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Genaprost",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000022338?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finastid",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000022193?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Asterid",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041163?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Ridestin",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041164?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finestar",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041166?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Fendazel",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041094?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Stecur",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041221?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Sitas",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041616?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finacapil",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000042209?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Ormicton",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000041996?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Carefinast",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000042478?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finedor",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000043157?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Terip",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000043566?lang=it",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Alocare",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=73972",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Litace",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=69257",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Maxpil",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=70276",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Excalv",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finalop",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finarid",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Finastil",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        },
        {
          "name": "Prohair",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-14"
            }
          ]
        }
      ],
      "leadBrands": [
        "Propecia"
      ],
      "cardSince": null,
      "unknowns": [
        {
          "id": "frequency-pfs",
          "sourceUrl": "https://www.medicines.org.uk/emc/product/2194/smpc",
          "text": {
            "en": "How often PFS happens is unknown. The UK text for professionals says the frequency of the side effects reported after marketing, among them sexual dysfunction that persisted after treatment was stopped, “cannot be determined”, because they come from spontaneous reports.",
            "de": "Wie oft PFS vorkommt, ist unbekannt. Im britischen Text für Fachkreise heißt es zur Häufigkeit der nach der Markteinführung berichteten Nebenwirkungen, darunter sexuelle Funktionsstörungen, die nach dem Absetzen der Behandlung anhielten: „cannot be determined“ (auf Englisch). Der Grund: Sie stammen aus Spontanberichten.",
            "es": "No se sabe con qué frecuencia se produce el PFS. El texto británico para profesionales dice que la frecuencia de los efectos secundarios notificados después de la comercialización, entre ellos la disfunción sexual que persistió después de dejar el tratamiento, «cannot be determined», porque proceden de notificaciones espontáneas.",
            "pt-br": "Não se sabe com que frequência a PFS acontece. A bula britânica para o profissional de saúde diz que a frequência dos efeitos colaterais relatados depois da comercialização, entre eles a disfunção sexual que persistiu depois de parar o tratamento, “cannot be determined” (não pode ser determinada), porque eles vêm de relatos espontâneos.",
            "fr": "On ne sait pas à quelle fréquence le PFS survient. Le texte britannique destiné aux professionnels indique, en anglais, que la fréquence des effets secondaires signalés après la commercialisation, dont une dysfonction sexuelle qui a persisté après l’arrêt du traitement, « cannot be determined », parce qu’ils proviennent de signalements spontanés.",
            "it": "Non si sa con quale frequenza si verifichi la PFS. Il testo britannico per i professionisti sanitari dice che la frequenza degli effetti collaterali segnalati dopo la commercializzazione, tra cui la disfunzione sessuale che è proseguita dopo l’interruzione del trattamento, «cannot be determined», perché derivano da segnalazioni spontanee.",
            "hi": "PFS कितनी बार होता है, यह अज्ञात है। डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए बना ब्रिटेन का दस्तावेज़ कहता है कि बाज़ार में आने के बाद रिपोर्ट हुए साइड इफ़ेक्ट की आवृत्ति, जिनमें इलाज बंद होने के बाद भी बना रहा सेक्शुअल डिस्फ़ंक्शन भी है, “cannot be determined” है, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आते हैं।"
          }
        }
      ],
      "changed": "2026-10-14",
      "records": [
        {
          "id": "finasteride-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Propecia 1 mg Film-Coated Tablets",
            "lang": "en-GB",
            "product": {
              "name": "Propecia",
              "form": "1 mg film-coated tablets",
              "holder": "Organon Pharma (UK) Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/2194/smpc",
            "fetchedUrl": null,
            "textDate": "2026-06-29",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 29 June 2026"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders:",
                "Uncommon*:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Decreased libido.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Verminderte Libido.",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución de la libido.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição da libido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Diminution de la libido.",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione della libido.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders:",
                "Uncommon*:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Erektile Dysfunktion, Ejakulationsstörung (einschließlich vermindertes Ejakulatvolumen).",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção erétil, distúrbio da ejaculação (incluindo diminuição do volume do ejaculado).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de l’érection, troubles de l’éjaculation (y compris diminution du volume de l’éjaculat).",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato).",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, स्खलन विकार (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी सहित)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "In addition, the following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorder) after discontinuation of treatment with 'Propecia'; male breast cancer (see 4.4 Special warnings and precautions for use).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Nach Markteinführung wurde zusätzlich über Folgendes berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörung) nach dem Absetzen der Behandlung mit ‚Propecia‘; Brustkrebs beim Mann (siehe Abschnitt 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con «Propecia»; cáncer de mama en varones (ver 4.4 Advertencias y precauciones especiales de empleo).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, foram relatados no uso pós-comercialização: persistência da disfunção sexual (diminuição da libido, disfunção erétil e distúrbio da ejaculação) após a descontinuação do tratamento com 'Propecia'; câncer de mama masculino (ver 4.4 Advertências e precauções especiais de uso).",
                  "by": "ours"
                },
                "fr": {
                  "text": "De plus, les effets indésirables suivants ont été rapportés depuis la mise sur le marché : persistance de troubles de la fonction sexuelle (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) après l’arrêt du traitement par « Propecia » ; cancer du sein chez l’homme (voir rubrique 4.4 Mises en garde spéciales et précautions d’emploi).",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, durante l’uso post-marketing sono stati riportati: persistenza della disfunzione sessuale (diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con ‘Propecia’; cancro della mammella nell’uomo (vedere 4.4 Avvertenze speciali e precauzioni d’impiego).",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, बाज़ार में आने के बाद के उपयोग में ये रिपोर्ट हुए हैं: 'Propecia' से इलाज बंद करने के बाद भी सेक्शुअल डिस्फ़ंक्शन का बने रहना (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार); पुरुषों में स्तन कैंसर (देखें 4.4 उपयोग के लिए विशेष चेतावनियाँ और सावधानियाँ)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-GB",
              "text": "The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Häufigkeit der nach Markteinführung berichteten Nebenwirkungen kann nicht bestimmt werden, da es sich um Spontanberichte handelt.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de reacciones adversas notificada durante su uso después de la comercialización, no puede ser determinada, ya que derivan de informes espontáneos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência das reações adversas relatadas durante o uso pós-comercialização não pode ser determinada, pois elas derivam de relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence des effets indésirables rapportés depuis la mise sur le marché ne peut pas être déterminée, car ils proviennent de signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate durante l’uso post-marketing non può essere determinata, perché derivano da segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद के उपयोग में रिपोर्ट हुए प्रतिकूल प्रभावों की आवृत्ति तय नहीं की जा सकती, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-studies",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "In these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with 'Propecia': decreased libido ('Propecia', 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with 'Propecia' and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with 'Propecia' and in many who continued therapy. The effect of 'Propecia' on ejaculate volume was measured in a separate study and was not different from that seen with placebo.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In diesen Studien wurden bei ≥ 1 % der mit ‚Propecia‘ behandelten Männer die folgenden arzneimittelbedingten unerwünschten Ereignisse berichtet: verminderte Libido (‚Propecia‘ 1,8 % vs. Placebo 1,3 %) und erektile Dysfunktion (1,3 %, 0,7 %). Zusätzlich wurde bei 0,8 % der mit ‚Propecia‘ behandelten Männer und bei 0,4 % der mit Placebo behandelten Männer ein vermindertes Ejakulatvolumen berichtet. Diese Nebenwirkungen bildeten sich bei Männern zurück, die die Therapie mit ‚Propecia‘ abbrachen, und bei vielen, die die Therapie fortsetzten. Die Wirkung von ‚Propecia‘ auf das Ejakulatvolumen wurde in einer gesonderten Studie gemessen und unterschied sich nicht von der unter Placebo.",
                  "by": "ours"
                },
                "es": {
                  "text": "En estos estudios, se notificaron las siguientes experiencias adversas relacionadas con el medicamento en ≥1% de los varones tratados con «Propecia»: disminución de la libido («Propecia», 1,8% frente a placebo, 1,3%) y disfunción eréctil (1,3%, 0,7%). Además, se notificó una disminución del volumen de eyaculación en el 0,8% de los varones tratados con «Propecia» y en el 0,4% de los varones tratados con placebo. Estos efectos secundarios se resolvieron en los varones que interrumpieron el tratamiento con «Propecia» y en muchos de los que lo continuaron. El efecto de «Propecia» sobre el volumen de eyaculación se midió en un estudio aparte y no fue distinto del observado con placebo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Nestes estudos, as seguintes experiências adversas relacionadas ao medicamento foram relatadas em ≥1% dos homens tratados com 'Propecia': diminuição da libido ('Propecia', 1,8% vs. placebo, 1,3%) e disfunção erétil (1,3%, 0,7%). Além disso, diminuição do volume do ejaculado foi relatada em 0,8% dos homens tratados com 'Propecia' e em 0,4% dos homens tratados com placebo. A resolução desses efeitos colaterais ocorreu em homens que descontinuaram a terapia com 'Propecia' e em muitos que continuaram a terapia. O efeito de 'Propecia' sobre o volume do ejaculado foi medido em um estudo separado e não foi diferente do observado com placebo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans ces études, les effets indésirables suivants, liés au médicament, ont été rapportés chez au moins 1 % des hommes traités par « Propecia » : diminution de la libido (« Propecia » 1,8 % contre 1,3 % sous placebo) et troubles de l’érection (1,3 % contre 0,7 %). En outre, une diminution du volume de l’éjaculat a été rapportée chez 0,8 % des hommes traités par « Propecia » et 0,4 % de ceux sous placebo. Ces effets secondaires ont disparu chez les hommes qui ont arrêté le traitement par « Propecia » et chez beaucoup de ceux qui l’ont poursuivi. L’effet de « Propecia » sur le volume de l’éjaculat a été mesuré dans une étude distincte et ne différait pas de celui observé sous placebo.",
                  "by": "ours"
                },
                "it": {
                  "text": "In questi studi, le seguenti esperienze avverse correlate al medicinale sono state riportate nell’1% o più degli uomini trattati con ‘Propecia’: diminuzione della libido (‘Propecia’ 1,8% contro placebo 1,3%) e disfunzione erettile (1,3%, 0,7%). Inoltre, una diminuzione del volume dell’eiaculato è stata riportata nello 0,8% degli uomini trattati con ‘Propecia’ e nello 0,4% degli uomini trattati con placebo. La risoluzione di questi effetti indesiderati si è verificata negli uomini che hanno interrotto la terapia con ‘Propecia’ e in molti di quelli che l’hanno proseguita. L’effetto di ‘Propecia’ sul volume dell’eiaculato è stato misurato in uno studio separato e non è risultato diverso da quello osservato con il placebo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन अध्ययनों में 'Propecia' से इलाज किए गए ≥1% पुरुषों में दवा से जुड़े ये प्रतिकूल अनुभव रिपोर्ट हुए: कामेच्छा में कमी ('Propecia' में 1.8%, प्लेसीबो में 1.3%) और स्तंभन दोष (1.3%, 0.7%)। इसके अलावा, 'Propecia' से इलाज किए गए 0.8% पुरुषों में और प्लेसीबो वाले 0.4% पुरुषों में स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी रिपोर्ट हुई। जिन पुरुषों ने 'Propecia' से इलाज बंद किया, उनमें और इलाज जारी रखने वाले कई पुरुषों में भी ये साइड इफ़ेक्ट ठीक हो गए। वीर्य की मात्रा पर 'Propecia' के असर को एक अलग अध्ययन में मापा गया और वह प्लेसीबो से अलग नहीं था।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-drug-related",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Drug-related sexual undesirable effects were more common in the finasteride 1 mg-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% in finasteride 1 mg-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug-related sexual adverse experiences in the first 12 months, and the incidence declined thereafter.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Arzneimittelbedingte sexuelle Nebenwirkungen waren bei den mit Finasterid 1 mg behandelten Männern häufiger als bei den mit Placebo behandelten Männern, mit Häufigkeiten von 3,8 % bzw. 2,1 % während der ersten 12 Monate. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid 1 mg behandelten Männern im Laufe der folgenden vier Jahre auf 0,6 %. Etwa 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung in den ersten 12 Monaten aufgrund arzneimittelbedingter sexueller Nebenwirkungen, danach nahm die Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida 1 mg que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida 1 mg durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis sexuais relacionados ao medicamento foram mais comuns nos homens tratados com finasterida 1 mg do que nos tratados com placebo, com frequências durante os primeiros 12 meses de 3,8% vs 2,1%, respectivamente. A incidência desses efeitos diminuiu para 0,6% nos homens tratados com finasterida 1 mg ao longo dos quatro anos seguintes. Aproximadamente 1% dos homens de cada grupo de tratamento interrompeu o tratamento por experiências adversas sexuais relacionadas ao medicamento nos primeiros 12 meses, e a incidência diminuiu depois disso.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sexuels liés au médicament ont été plus fréquents chez les hommes traités par finastéride 1 mg que chez ceux sous placebo, avec des fréquences respectives de 3,8 % contre 2,1 % au cours des 12 premiers mois. L’incidence de ces effets a diminué à 0,6 % chez les hommes traités par finastéride 1 mg au cours des quatre années suivantes. Environ 1 % des hommes de chaque groupe de traitement ont arrêté le traitement au cours des 12 premiers mois en raison d’effets indésirables sexuels liés au médicament, et l’incidence a diminué par la suite.",
                  "by": "ours"
                },
                "it": {
                  "text": "Effetti indesiderati della sfera sessuale correlati al medicinale sono stati più comuni negli uomini trattati con finasteride 1 mg che in quelli trattati con placebo, con frequenze nei primi 12 mesi rispettivamente del 3,8% contro il 2,1%. L’incidenza di tali effetti è diminuita allo 0,6% negli uomini trattati con finasteride 1 mg nel corso dei quattro anni successivi. Circa l’1% degli uomini di ciascun gruppo di trattamento ha interrotto la terapia a causa di esperienze avverse della sfera sessuale correlate al medicinale nei primi 12 mesi, e l’incidenza è poi diminuita.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा से जुड़े यौन प्रतिकूल प्रभाव फ़िनास्टेराइड 1 mg से इलाज किए गए पुरुषों में प्लेसीबो वाले पुरुषों से ज़्यादा आम थे; पहले 12 महीनों में उनकी आवृत्ति क्रमशः 3.8% बनाम 2.1% थी। अगले चार सालों में फ़िनास्टेराइड 1 mg से इलाज किए गए पुरुषों में इन प्रभावों की दर घटकर 0.6% हो गई। हर इलाज समूह के लगभग 1% पुरुषों ने पहले 12 महीनों में दवा से जुड़े यौन प्रतिकूल अनुभवों के कारण इलाज बंद किया, और उसके बाद यह दर घटती गई।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package Leaflet: Information for the user. Propecia® 1 mg film-coated Tablets. finasteride",
            "lang": "en-GB",
            "product": {
              "name": "Propecia",
              "form": "1 mg film-coated tablets",
              "holder": "Organon Pharma (UK) Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.2194.pdf",
            "fetchedUrl": null,
            "textDate": "2026-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in May 2026."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Uncommon: may affect up to 1 in 100 people"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "you may be unable to have an erection (impotence)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sie können möglicherweise keine Erektion bekommen (Impotenz)",
                  "by": "ours"
                },
                "es": {
                  "text": "puede no ser capaz de tener una erección (impotencia)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "você pode ficar incapaz de ter uma ereção (impotência)",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez être incapable d’avoir une érection (impuissance)",
                  "by": "ours"
                },
                "it": {
                  "text": "potrebbe non riuscire ad avere un’erezione (impotenza)",
                  "by": "ours"
                },
                "hi": {
                  "text": "आप इरेक्शन नहीं कर पाएँ (स्तंभन दोष)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Uncommon: may affect up to 1 in 100 people"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "you may have less desire to have sex",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sie haben möglicherweise weniger Lust auf Sex",
                  "by": "ours"
                },
                "es": {
                  "text": "puede tener menos deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "você pode ter menos desejo de fazer sexo",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez avoir moins de désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "potrebbe avere meno desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपमें सेक्स की इच्छा कम हो सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Uncommon: may affect up to 1 in 100 people"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "you may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es können Probleme mit dem Samenerguss auftreten, zum Beispiel eine Abnahme der beim Sex abgegebenen Samenmenge. Diese Abnahme der Samenmenge scheint die normale Sexualfunktion nicht zu beeinträchtigen",
                  "by": "ours"
                },
                "es": {
                  "text": "puede tener problemas con la eyaculación, por ejemplo una disminución de la cantidad de semen expulsado en el acto sexual. Esta disminución de la cantidad de semen no parece alterar el funcionamiento sexual normal.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "você pode ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de sêmen liberada durante o sexo. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez avoir des problèmes d’éjaculation, par exemple une diminution de la quantité de sperme émise pendant les rapports sexuels. Cette diminution de la quantité de sperme ne semble pas affecter la fonction sexuelle normale",
                  "by": "ours"
                },
                "it": {
                  "text": "potrebbe avere problemi con l’eiaculazione, per esempio una diminuzione della quantità di sperma emesso durante il rapporto sessuale. Questa diminuzione della quantità di sperma non sembra influire sulla normale funzione sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपको स्खलन में दिक्कत हो सकती है, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी। वीर्य की मात्रा में यह कमी सामान्य यौन क्रिया पर असर डालती नहीं लगती",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "en-GB",
              "text": "Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Einige der Nebenwirkungen sind bei fortgesetzter Behandlung vorübergehend oder verschwinden, wenn die Behandlung beendet wird.",
                  "by": "ours"
                },
                "es": {
                  "text": "Algunos de los efectos secundarios son pasajeros con el tratamiento continuado o desaparecen cuando se interrumpe el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Alguns dos efeitos colaterais são temporários com a continuação do tratamento ou desapareceram quando o tratamento foi interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Certains de ces effets secondaires sont temporaires si le traitement est poursuivi, ou ont disparu à l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Alcuni degli effetti indesiderati sono temporanei con la prosecuzione del trattamento o sono scomparsi quando il trattamento è stato interrotto.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इनमें से कुछ साइड इफ़ेक्ट इलाज जारी रखने पर अस्थायी होते हैं, या इलाज बंद करने पर खत्म हो गए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Frequency unknown:"
              ],
              "since": {
                "date": "2010",
                "scope": "jurisdiction",
                "basis": [
                  "finasteride-uk-regulator-par202404"
                ]
              },
              "inWarnings": false,
              "lang": "en-GB",
              "text": "persistent difficulty having an erection after discontinuation of treatment",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "anhaltende Schwierigkeiten bei der Erektion nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad persistente para tener erección después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade persistente de ter ereção depois da interrupção do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté persistante à avoir une érection après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà persistente ad avere un’erezione dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी इरेक्शन होने में बनी रहने वाली दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Frequency unknown:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "persistent decrease in sex drive after discontinuation of treatment",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "anhaltende Abnahme des sexuellen Verlangens nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución persistente en el deseo sexual después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição persistente do desejo sexual depois da interrupção do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution persistante du désir sexuel après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी सेक्स की इच्छा में बनी रहने वाली कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Frequency unknown:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "persistent problems with ejaculation after discontinuation of treatment",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "anhaltende Ejakulationsschwierigkeiten nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas persistentes de eyaculación después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas persistentes de ejaculação depois da interrupção do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation persistants après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी स्खलन में बनी रहने वाली दिक्कतें",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-pro-proscar",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Proscar 5mg film-coated Tablets",
            "lang": "en-GB",
            "product": {
              "name": "Proscar",
              "form": "5 mg film-coated tablets",
              "holder": "Organon Pharma (UK) Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/1008/smpc",
            "fetchedUrl": null,
            "textDate": "2024-12-20",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 20 December 2024"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas mais frequentes são impotência e diminuição da libido. Essas reações adversas ocorrem no início da terapia e desaparecem com a continuação do tratamento na maioria dos pacientes.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables les plus fréquents sont l’impuissance et la diminution de la libido. Ces effets indésirables apparaissent au début du traitement et disparaissent avec la poursuite du traitement chez la majorité des patients.",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza e diminuzione della libido sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सबसे आम प्रतिकूल प्रभाव स्तंभन दोष और कामेच्छा में कमी हैं। ये प्रभाव इलाज की शुरुआत में होते हैं और ज़्यादातर मरीज़ों में इलाज जारी रखने पर ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders",
                "Common:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "decreased libido",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verminderte Libido",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders",
                "Unknown:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "decreased libido that may continue after discontinuation of therapy, depression, anxiety, suicidal ideation",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verminderte Libido, die auch nach dem Absetzen der Therapie andauern kann, Depression, Angst, Suizidgedanken",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido que puede continuar después de la interrupción del tratamiento, depresión, ansiedad, ideación suicida",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido que pode continuar após a descontinuação da terapia, depressão, ansiedade, ideação suicida",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido pouvant se poursuivre après l’arrêt du traitement, dépression, anxiété, idées suicidaires",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido che può proseguire dopo l’interruzione della terapia, depressione, ansia, ideazione suicidaria",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी, जो इलाज बंद करने के बाद भी बनी रह सकती है, डिप्रेशन, चिंता, आत्महत्या के विचार",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Common:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "impotence",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Uncommon:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "ejaculation disorder, breast tenderness, breast enlargement.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ejakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der Brust.",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación, hipersensibilidad mamaria, crecimiento mamario.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbio da ejaculação, sensibilidade nas mamas, aumento das mamas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation, sensibilité des seins, augmentation du volume des seins.",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार, स्तनों में कोमलता (छूने पर दर्द), स्तनों का बढ़ना।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders",
                "Unknown:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "testicular pain, haematospermia, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Hodenschmerzen, Hämatospermie, sexuelle Funktionsstörung (erektile Dysfunktion und Ejakulationsstörung), die nach dem Absetzen der Behandlung andauern kann; Infertilität bei Männern und/oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet.",
                  "by": "ours"
                },
                "es": {
                  "text": "dolor testicular, hematospermia, disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que puede continuar después de la interrupción del tratamiento; infertilidad masculina y/o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dor testicular, hematospermia, disfunção sexual (disfunção erétil e distúrbio da ejaculação) que pode continuar após a descontinuação do tratamento; infertilidade masculina e/ou má qualidade do sêmen. Foi relatada normalização ou melhora da qualidade do sêmen após a descontinuação da finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "douleur testiculaire, hématospermie, dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) pouvant se poursuivre après l’arrêt du traitement ; infertilité masculine et/ou mauvaise qualité du sperme. Une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "dolore testicolare, ematospermia, disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che può proseguire dopo l’interruzione del trattamento; infertilità maschile e/o scarsa qualità del liquido seminale. Normalizzazione o miglioramento della qualità del liquido seminale è stata riportata dopo l’interruzione della finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "अंडकोष में दर्द, वीर्य में खून (हीमैटोस्पर्मिया), सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार), जो इलाज बंद करने के बाद भी बना रह सकता है; पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता। फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-GB",
              "text": "The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Häufigkeit der nach Markteinführung berichteten Nebenwirkungen kann nicht bestimmt werden, da es sich um Spontanberichte handelt.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de reacciones adversas notificada durante su uso después de la comercialización, no puede ser determinada, ya que derivan de informes espontáneos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência das reações adversas relatadas durante o uso pós-comercialização não pode ser determinada, pois elas derivam de relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence des effets indésirables rapportés depuis la mise sur le marché ne peut pas être déterminée, car ils proviennent de signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate durante l’uso post-marketing non può essere determinata, perché derivano da segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद के उपयोग में रिपोर्ट हुए प्रतिकूल प्रभावों की आवृत्ति तय नहीं की जा सकती, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-investigations-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Investigations",
                "Common:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "decreased volume of ejaculate",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes Ejakulatvolumen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del volumen de eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de l’éjaculat",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del volume dell’eiaculato",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-mtops",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Medical Therapy of Prostatic Symptoms (MTOPS)"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737). In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. The incidence of ejaculation disorder in patients receiving combination therapy was comparable to the sum of incidences of this adverse experience for the two monotherapies.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In der MTOPS-Studie wurden Finasterid 5 mg/Tag (n = 768), Doxazosin 4 oder 8 mg/Tag (n = 756), die Kombinationstherapie aus Finasterid 5 mg/Tag und Doxazosin 4 oder 8 mg/Tag (n = 786) und Placebo (n = 737) verglichen. In dieser Studie stimmten das Sicherheits- und das Verträglichkeitsprofil der Kombinationstherapie im Allgemeinen mit den Profilen der einzelnen Bestandteile überein. Die Häufigkeit von Ejakulationsstörungen bei Patienten unter Kombinationstherapie entsprach der Summe der Häufigkeiten dieses unerwünschten Ereignisses unter den beiden Monotherapien.",
                  "by": "ours"
                },
                "es": {
                  "text": "El estudio MTOPS comparó finasterida 5 mg/día (n=768), doxazosina 4 u 8 mg/día (n=756), el tratamiento combinado de finasterida 5 mg/día y doxazosina 4 u 8 mg/día (n=786) y placebo (n=737). En este estudio, el perfil de seguridad y tolerabilidad del tratamiento combinado fue en general coherente con el de cada uno de sus componentes. La incidencia del trastorno de eyaculación en pacientes recibiendo tratamiento combinado fue comparable a la suma de las incidencias de esta experiencia adversa para las dos monoterapias.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O estudo MTOPS comparou finasterida 5 mg/dia (n=768), doxazosina 4 ou 8 mg/dia (n=756), terapia combinada de finasterida 5 mg/dia e doxazosina 4 ou 8 mg/dia (n=786) e placebo (n=737). Neste estudo, o perfil de segurança e tolerabilidade da terapia combinada foi em geral coerente com os perfis dos componentes individuais. A incidência de distúrbio da ejaculação em pacientes que receberam a terapia combinada foi comparável à soma das incidências dessa experiência adversa nas duas monoterapias.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’étude MTOPS a comparé le finastéride 5 mg/jour (n = 768), la doxazosine 4 ou 8 mg/jour (n = 756), l’association du finastéride 5 mg/jour et de la doxazosine 4 ou 8 mg/jour (n = 786) et un placebo (n = 737). Dans cette étude, le profil de sécurité et de tolérance de l’association était globalement conforme à celui de ses composants pris séparément. L’incidence des troubles de l’éjaculation chez les patients recevant l’association était comparable à la somme des incidences de cet effet indésirable pour les deux monothérapies.",
                  "by": "ours"
                },
                "it": {
                  "text": "Lo studio MTOPS ha confrontato finasteride 5 mg/die (n=768), doxazosin 4 o 8 mg/die (n=756), la terapia di associazione di finasteride 5 mg/die e doxazosin 4 o 8 mg/die (n=786) e placebo (n=737). In questo studio il profilo di sicurezza e tollerabilità della terapia di associazione è risultato in generale coerente con i profili dei singoli componenti. L’incidenza di disturbi dell’eiaculazione nei pazienti trattati con l’associazione è risultata paragonabile alla somma delle incidenze di tale esperienza avversa per le due monoterapie.",
                  "by": "ours"
                },
                "hi": {
                  "text": "MTOPS अध्ययन में फ़िनास्टेराइड 5 mg/दिन (n=768), डॉक्साज़ोसिन 4 या 8 mg/दिन (n=756), फ़िनास्टेराइड 5 mg/दिन और डॉक्साज़ोसिन 4 या 8 mg/दिन का संयुक्त इलाज (n=786), और प्लेसीबो (n=737) की तुलना की गई। इस अध्ययन में संयुक्त इलाज की सुरक्षा और सहनशीलता की तस्वीर आम तौर पर अलग-अलग दवाओं की तस्वीर से मेल खाती थी। संयुक्त इलाज लेने वाले मरीज़ों में स्खलन विकार की दर इस प्रतिकूल अनुभव की दोनों अलग-अलग इलाजों की दरों के जोड़ के बराबर थी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-leaflet-proscar",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PACKAGE LEAFLET: INFORMATION FOR THE USER. PROSCAR® 5 mg film-coated tablets (finasteride)",
            "lang": "en-GB",
            "product": {
              "name": "Proscar",
              "form": "5 mg film-coated tablets",
              "holder": "Organon Pharma (UK) Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/files/pil.1008.pdf",
            "fetchedUrl": null,
            "textDate": "2024-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in August 2024."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Other side effects may include:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "You may be unable to have an erection (impotence)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sie können möglicherweise keine Erektion bekommen (Impotenz)",
                  "by": "ours"
                },
                "es": {
                  "text": "Puede no ser capaz de tener una erección (impotencia)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Você pode ficar incapaz de ter uma ereção (impotência)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Vous pouvez être incapable d’avoir une érection (impuissance)",
                  "by": "ours"
                },
                "it": {
                  "text": "Potrebbe non riuscire ad avere un’erezione (impotenza)",
                  "by": "ours"
                },
                "hi": {
                  "text": "आप इरेक्शन नहीं कर पाएँ (स्तंभन दोष)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Other side effects may include:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "You may have less desire to have sex",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sie haben möglicherweise weniger Lust auf Sex",
                  "by": "ours"
                },
                "es": {
                  "text": "Puede tener menos deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Você pode ter menos desejo de fazer sexo",
                  "by": "ours"
                },
                "fr": {
                  "text": "Vous pouvez avoir moins de désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "Potrebbe avere meno desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपमें सेक्स की इच्छा कम हो सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Other side effects may include:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es können Probleme mit dem Samenerguss auftreten, zum Beispiel eine Abnahme der beim Sex abgegebenen Samenmenge. Diese Abnahme der Samenmenge scheint die normale Sexualfunktion nicht zu beeinträchtigen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Puede tener problemas con la eyaculación, por ejemplo una disminución de la cantidad de semen expulsado en el acto sexual. Esta disminución de la cantidad de semen no parece alterar el funcionamiento sexual normal.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Você pode ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de sêmen liberada durante o sexo. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Vous pouvez avoir des problèmes d’éjaculation, par exemple une diminution de la quantité de sperme émise pendant les rapports sexuels. Cette diminution de la quantité de sperme ne semble pas affecter la fonction sexuelle normale.",
                  "by": "ours"
                },
                "it": {
                  "text": "Potrebbe avere problemi con l’eiaculazione, per esempio una diminuzione della quantità di sperma emesso durante il rapporto sessuale. Questa diminuzione della quantità di sperma non sembra influire sulla normale funzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपको स्खलन में दिक्कत हो सकती है, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी। वीर्य की मात्रा में यह कमी सामान्य यौन क्रिया पर असर डालती नहीं लगती।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "en-GB",
              "text": "These side effects above may disappear after a while if you continue taking Proscar. If not, they usually resolve after stopping Proscar.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die oben genannten Nebenwirkungen können nach einiger Zeit verschwinden, wenn Sie Proscar weiter einnehmen. Wenn nicht, klingen sie nach dem Absetzen von Proscar in der Regel ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos secundarios pueden desaparecer pasado un tiempo si sigue tomando Proscar. Si no, por lo general desaparecen al dejar de tomar Proscar.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses efeitos colaterais acima podem desaparecer depois de algum tempo se você continuar tomando Proscar. Se não, geralmente desaparecem depois de parar de tomar Proscar.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces effets secondaires peuvent disparaître au bout d’un moment si vous continuez à prendre Proscar. Sinon, ils disparaissent généralement à l’arrêt de Proscar.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi effetti indesiderati possono scomparire dopo un po’ di tempo se continua a prendere Proscar. In caso contrario, di solito si risolvono dopo l’interruzione di Proscar.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऊपर के ये साइड इफ़ेक्ट Proscar लेते रहने पर कुछ समय बाद खत्म हो सकते हैं। अगर नहीं, तो Proscar बंद करने के बाद वे आम तौर पर ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Other side effects reported in some men are:"
              ],
              "since": {
                "date": "2010",
                "scope": "jurisdiction",
                "basis": [
                  "finasteride-uk-regulator-par202404"
                ]
              },
              "inWarnings": false,
              "lang": "en-GB",
              "text": "An inability to have an erection which may continue after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Unfähigkeit, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "Imposibilidad de tener una erección que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Uma incapacidade de ter uma ereção que pode continuar depois de parar a medicação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une incapacité à avoir une érection qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Incapacità di avere un’erezione che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना, जो दवा बंद करने के बाद भी बना रह सकता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Other side effects reported in some men are:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Decrease in sex drive that may continue after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição do desejo sexual que pode continuar depois de parar a medicação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une diminution du désir sexuel qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione del desiderio sessuale che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी बनी रह सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Possible side effects",
                "Other side effects reported in some men are:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Problems with ejaculation that may continue after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauern können",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas con la eyaculación que pueden continuar después de dejar la medicación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas com a ejaculação que podem continuar depois de parar a medicação",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des problèmes d’éjaculation qui peuvent se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi di eiaculazione che possono proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जो दवा बंद करने के बाद भी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-par202404",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-par202404",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Safety review of Finasteride. Public Assessment Report",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://assets.publishing.service.gov.uk/media/6825bc05a4c1a40fde4e63e7/Finasteride_PAR_Accessible_1206.pdf",
            "fetchedUrl": null,
            "textDate": "2024-04",
            "textDateKind": "publication",
            "textDateAsPrinted": "April 2024"
          },
          "passages": [
            {
              "key": "updates",
              "kind": "regulator-statement",
              "section": [
                "3.3 Warnings on sexual and psychiatric risks in the product information",
                "Sexual side effects and finasteride"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "In 2010, the product information was updated to clarify that persistence of erectile dysfunction after stopping treatment had been reported in post-marketing use. In 2013, the product information was further updated to include ‘decreased libido’ and ‘ejaculation disorder’.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "2010 wurde die Produktinformation aktualisiert, um klarzustellen, dass nach Markteinführung über eine Persistenz der erektilen Dysfunktion nach dem Absetzen der Behandlung berichtet worden war. 2013 wurde die Produktinformation um „verminderte Libido“ und „Ejakulationsstörung“ ergänzt.",
                  "by": "ours"
                },
                "es": {
                  "text": "En 2010, la información del producto se actualizó para aclarar que, durante su uso después de la comercialización, se había notificado la persistencia de la disfunción eréctil después de interrumpir el tratamiento. En 2013, la información del producto se actualizó de nuevo para incluir «disminución de la libido» y «trastorno de la eyaculación».",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em 2010, as informações do produto foram atualizadas para esclarecer que a persistência da disfunção erétil depois de parar o tratamento havia sido relatada no uso pós-comercialização. Em 2013, as informações do produto foram atualizadas de novo para incluir ‘diminuição da libido’ e ‘distúrbio da ejaculação’.",
                  "by": "ours"
                },
                "fr": {
                  "text": "En 2010, les informations sur le produit ont été mises à jour pour préciser que la persistance de troubles de l’érection après l’arrêt du traitement avait été rapportée depuis la mise sur le marché. En 2013, elles ont été de nouveau mises à jour pour ajouter « diminution de la libido » et « troubles de l’éjaculation ».",
                  "by": "ours"
                },
                "it": {
                  "text": "Nel 2010 le informazioni sul prodotto sono state aggiornate per chiarire che nell’uso post-marketing era stata riportata la persistenza della disfunzione erettile dopo l’interruzione del trattamento. Nel 2013 le informazioni sul prodotto sono state ulteriormente aggiornate per includere ‘diminuzione della libido’ e ‘disturbi dell’eiaculazione’.",
                  "by": "ours"
                },
                "hi": {
                  "text": "2010 में दवा की आधिकारिक जानकारी को अपडेट किया गया, ताकि यह साफ़ हो कि बाज़ार में आने के बाद के उपयोग में इलाज बंद करने के बाद भी स्तंभन दोष के बने रहने की रिपोर्ट हुई थी। 2013 में आधिकारिक जानकारी को और अपडेट करके उसमें ‘कामेच्छा में कमी’ और ‘स्खलन विकार’ जोड़े गए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "card-1mg",
              "kind": "sexual-persistence",
              "section": [
                "10. Annexes",
                "Annex 1",
                "Patient card for finasteride 1mg:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Decreased sex drive and erectile dysfunction have also been reported (which in some cases continued after treatment was stopped).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Auch über ein vermindertes sexuelles Verlangen und über erektile Dysfunktion wurde berichtet (die in einigen Fällen nach dem Absetzen der Behandlung andauerten).",
                  "by": "ours"
                },
                "es": {
                  "text": "También se han notificado disminución del deseo sexual y disfunción eréctil (que en algunos casos continuaron después de interrumpir el tratamiento).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Também foram relatadas diminuição do desejo sexual e disfunção erétil (que em alguns casos continuaram depois de o tratamento ser interrompido).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une diminution du désir sexuel et des troubles de l’érection ont aussi été rapportés (qui, dans certains cas, ont continué après l’arrêt du traitement).",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono state riportate anche diminuzione del desiderio sessuale e disfunzione erettile (che in alcuni casi sono proseguite dopo l’interruzione del trattamento).",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी और स्तंभन दोष की भी रिपोर्टें आई हैं (जो कुछ मामलों में इलाज बंद होने के बाद भी जारी रहीं)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "card-5mg",
              "kind": "sexual-persistence",
              "section": [
                "10. Annexes",
                "Annex 1",
                "Patient card for finasteride 5mg:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Decreased sex drive and erectile dysfunction have also been reported (which in some cases continued after treatment was stopped).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Auch über ein vermindertes sexuelles Verlangen und über erektile Dysfunktion wurde berichtet (die in einigen Fällen nach dem Absetzen der Behandlung andauerten).",
                  "by": "ours"
                },
                "es": {
                  "text": "También se han notificado disminución del deseo sexual y disfunción eréctil (que en algunos casos continuaron después de interrumpir el tratamiento).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Também foram relatadas diminuição do desejo sexual e disfunção erétil (que em alguns casos continuaram depois de o tratamento ser interrompido).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une diminution du désir sexuel et des troubles de l’érection ont aussi été rapportés (qui, dans certains cas, ont continué après l’arrêt du traitement).",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono state riportate anche diminuzione del desiderio sessuale e disfunzione erettile (che in alcuni casi sono proseguite dopo l’interruzione del trattamento).",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी और स्तंभन दोष की भी रिपोर्टें आई हैं (जो कुछ मामलों में इलाज बंद होने के बाद भी जारी रहीं)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-dsu202605",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-dsu202605",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Drug Safety Update: \"Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/finasteride-and-dutasteride-updated-safety-warnings-for-psychiatric-side-effects-and-sexual-dysfunction",
            "fetchedUrl": null,
            "textDate": "2026-05-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 11 May 2026"
          },
          "passages": [
            {
              "key": "advice",
              "kind": "sexual-persistence",
              "section": [
                "Advice for Healthcare Professionals:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "finasteride is associated with depression, suicidal ideation and sexual dysfunction which may persist after treatment is stopped",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Finasterid wird mit Depression, Suizidgedanken und sexueller Dysfunktion in Verbindung gebracht, die nach dem Absetzen der Behandlung andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "la finasterida se asocia a depresión, ideación suicida y disfunción sexual que puede persistir después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "a finasterida está associada a depressão, ideação suicida e disfunção sexual que pode persistir depois de o tratamento ser interrompido",
                  "by": "ours"
                },
                "fr": {
                  "text": "le finastéride est associé à la dépression, aux idées suicidaires et à une dysfonction sexuelle qui peut persister après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "la finasteride è associata a depressione, ideazione suicidaria e disfunzione sessuale che possono persistere dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड डिप्रेशन, आत्महत्या के विचारों और ऐसे सेक्शुअल डिस्फ़ंक्शन से जुड़ा है, जो इलाज बंद होने के बाद भी बना रह सकता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "cards",
              "kind": "regulator-statement",
              "section": [
                "Advice for Healthcare Professionals:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "inform patients of the risks at point of prescribing and advise patients to read the Finasteride patient cards and the patient leaflet for finasteride which are both supplied in the 1 mg and 5 mg packs",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Patientinnen und Patienten bei der Verschreibung über die Risiken informieren und ihnen raten, die Patientenkarten zu Finasterid und die Packungsbeilage zu Finasterid zu lesen, die beide den Packungen mit 1 mg und mit 5 mg beiliegen",
                  "by": "ours"
                },
                "es": {
                  "text": "informen a los pacientes de los riesgos en el momento de la prescripción y les aconsejen leer las tarjetas para el paciente de finasterida y el prospecto de finasterida, que se suministran ambos en los envases de 1 mg y de 5 mg",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "informar os pacientes sobre os riscos no momento da prescrição e aconselhá-los a ler os cartões do paciente da finasterida e a bula da finasterida, que são fornecidos juntos nas embalagens de 1 mg e de 5 mg",
                  "by": "ours"
                },
                "fr": {
                  "text": "informer les patients des risques au moment de la prescription et leur conseiller de lire les cartes patient du finastéride et la notice du finastéride, toutes deux fournies dans les boîtes de 1 mg et de 5 mg",
                  "by": "ours"
                },
                "it": {
                  "text": "informare i pazienti dei rischi al momento della prescrizione e consigliare loro di leggere le schede per il paziente sulla finasteride e il foglio illustrativo della finasteride, entrambi forniti nelle confezioni da 1 mg e da 5 mg",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों को लिखते समय जोखिम बताएँ, और उन्हें सलाह दें कि वे फ़िनास्टेराइड के मरीज़ कार्ड और फ़िनास्टेराइड के मरीज़ लीफ़लेट पढ़ें, जो दोनों 1 mg और 5 mg के पैक में दिए जाते हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "update",
              "kind": "regulator-statement",
              "section": [
                "Advice for Healthcare Professionals:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "the product information for finasteride 1 mg will be updated with a warning that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported without mood alterations",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Produktinformation für Finasterid 1 mg wird um einen Warnhinweis ergänzt werden, dass sexuelle Dysfunktion zu Stimmungsstörungen beitragen kann und dass sexuelle Dysfunktion auch ohne Stimmungsveränderungen berichtet wurde",
                  "by": "ours"
                },
                "es": {
                  "text": "la información del producto de finasterida 1 mg se actualizará con una advertencia de que la disfunción sexual puede contribuir a los trastornos del estado de ánimo, y de que también se ha notificado disfunción sexual sin alteraciones del estado de ánimo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "as informações do produto da finasterida 1 mg serão atualizadas com um alerta de que a disfunção sexual pode contribuir para transtornos de humor, e de que também foi relatada disfunção sexual sem alterações de humor",
                  "by": "ours"
                },
                "fr": {
                  "text": "les informations sur le produit du finastéride 1 mg seront mises à jour avec une mise en garde indiquant que la dysfonction sexuelle peut contribuer à des troubles de l’humeur, et que des cas de dysfonction sexuelle ont aussi été rapportés sans altération de l’humeur",
                  "by": "ours"
                },
                "it": {
                  "text": "le informazioni sul prodotto per finasteride 1 mg saranno aggiornate con un’avvertenza secondo cui la disfunzione sessuale può contribuire ai disturbi dell’umore, e che la disfunzione sessuale è stata riportata anche senza alterazioni dell’umore",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड 1 mg की आधिकारिक जानकारी में यह चेतावनी जोड़ी जाएगी कि सेक्शुअल डिस्फ़ंक्शन मूड के विकारों में योगदान दे सकता है, और यह भी कि सेक्शुअल डिस्फ़ंक्शन मूड में बदलाव के बिना भी रिपोर्ट हुआ है",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-dsu202404",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-dsu202404",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Drug Safety Update: \"Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/finasteride-reminder-of-the-risk-psychiatric-side-effects-and-of-sexual-side-effects-which-may-persist-after-discontinuation-of-treatment",
            "fetchedUrl": null,
            "textDate": "2024-04-29",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 29 April 2024"
          },
          "passages": [
            {
              "key": "review",
              "kind": "regulator-statement",
              "section": [
                "Review of persistent sexual dysfunction and psychiatric side effects with finasteride"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The PEAG noted that the product information for finasteride contains information regarding the potential for persistent sexual side effects after discontinuation with finasteride and depression and suicidal ideation. However, these side effects are not well known by prescribers and patients and therefore a Drug Safety Update article was recommended.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die PEAG stellte fest, dass die Produktinformation für Finasterid Angaben zur Möglichkeit anhaltender sexueller Nebenwirkungen nach dem Absetzen von Finasterid sowie zu Depression und Suizidgedanken enthält. Diese Nebenwirkungen sind Verschreibenden sowie Patientinnen und Patienten jedoch nicht gut bekannt, weshalb ein Artikel im Drug Safety Update empfohlen wurde.",
                  "by": "ours"
                },
                "es": {
                  "text": "El PEAG señaló que la información del producto de finasterida contiene datos sobre la posibilidad de efectos secundarios sexuales persistentes después de interrumpir la finasterida, y sobre depresión e ideación suicida. Sin embargo, quienes prescriben y los pacientes no conocen bien estos efectos secundarios, por lo que se recomendó un artículo en el Drug Safety Update.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O PEAG observou que as informações do produto da finasterida trazem informações sobre o potencial de efeitos colaterais sexuais persistentes depois da descontinuação da finasterida, e sobre depressão e ideação suicida. No entanto, esses efeitos colaterais não são bem conhecidos por quem prescreve nem pelos pacientes, e por isso foi recomendado um artigo do Drug Safety Update.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le PEAG a noté que les informations sur le produit du finastéride contiennent des renseignements sur la possibilité d’effets secondaires sexuels persistants après l’arrêt du finastéride, ainsi que sur la dépression et les idées suicidaires. Toutefois, ces effets secondaires sont mal connus des prescripteurs et des patients, et la publication d’un article du Drug Safety Update a donc été recommandée.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il PEAG ha osservato che le informazioni sul prodotto per la finasteride contengono indicazioni sulla possibilità di effetti indesiderati sessuali persistenti dopo l’interruzione della finasteride e su depressione e ideazione suicidaria. Tuttavia, questi effetti indesiderati non sono ben noti a chi prescrive e ai pazienti, e per questo è stato raccomandato un articolo del Drug Safety Update.",
                  "by": "ours"
                },
                "hi": {
                  "text": "PEAG ने नोट किया कि फ़िनास्टेराइड की आधिकारिक जानकारी में इलाज बंद करने के बाद भी बने रहने वाले यौन साइड इफ़ेक्ट की संभावना के बारे में, और डिप्रेशन तथा आत्महत्या के विचारों के बारे में जानकारी है। लेकिन ये साइड इफ़ेक्ट दवा लिखने वालों और मरीज़ों को ठीक से पता नहीं हैं, इसलिए Drug Safety Update लेख की सिफ़ारिश की गई।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persisted",
              "kind": "sexual-persistence",
              "section": [
                "Advice for healthcare professionals:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "patients have reported that sexual dysfunction (including decreased libido and erectile dysfunction) has persisted even after treatment was stopped",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Patientinnen und Patienten haben berichtet, dass sexuelle Dysfunktion (einschließlich verminderter Libido und erektiler Dysfunktion) auch nach dem Absetzen der Behandlung angehalten hat",
                  "by": "ours"
                },
                "es": {
                  "text": "los pacientes han notificado que la disfunción sexual (incluidas la disminución de la libido y la disfunción eréctil) ha persistido incluso después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "pacientes relataram que a disfunção sexual (incluindo diminuição da libido e disfunção erétil) persistiu mesmo depois de o tratamento ser interrompido",
                  "by": "ours"
                },
                "fr": {
                  "text": "des patients ont rapporté que la dysfonction sexuelle (y compris la diminution de la libido et les troubles de l’érection) avait persisté même après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "i pazienti hanno riportato che la disfunzione sessuale (compresi diminuzione della libido e disfunzione erettile) è persistita anche dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों ने बताया है कि सेक्शुअल डिस्फ़ंक्शन (कामेच्छा में कमी और स्तंभन दोष सहित) इलाज बंद होने के बाद भी बना रहा",
                  "by": "ours"
                }
              }
            },
            {
              "key": "card",
              "kind": "regulator-statement",
              "section": [
                "Advice for healthcare professionals:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "a patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In allen Finasterid-Packungen wird eine Patientenkarte eingeführt werden, die auf das Risiko sexueller und psychiatrischer Nebenwirkungen unter Finasterid hinweisen wird, um das Bewusstsein bei Patientinnen und Patienten sowie Verschreibenden zu erhöhen",
                  "by": "ours"
                },
                "es": {
                  "text": "se introducirá una tarjeta para el paciente en todos los envases de finasterida, que destacará el riesgo de efectos secundarios sexuales y psiquiátricos notificados con la finasterida, para aumentar la concienciación entre los pacientes y quienes prescriben",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "um cartão do paciente será introduzido em todas as embalagens de finasterida, destacando o risco de efeitos colaterais sexuais e psiquiátricos relatados com a finasterida, para aumentar a conscientização entre pacientes e quem prescreve",
                  "by": "ours"
                },
                "fr": {
                  "text": "une carte patient sera introduite dans toutes les boîtes de finastéride ; elle mettra en avant le risque d’effets secondaires sexuels et psychiatriques rapportés avec le finastéride, afin de mieux sensibiliser les patients et les prescripteurs",
                  "by": "ours"
                },
                "it": {
                  "text": "in tutte le confezioni di finasteride sarà introdotta una scheda per il paziente, che metterà in evidenza il rischio di effetti indesiderati sessuali e psichiatrici riportati con la finasteride, per aumentare la consapevolezza di pazienti e prescrittori",
                  "by": "ours"
                },
                "hi": {
                  "text": "सभी फ़िनास्टेराइड पैक में एक मरीज़ कार्ड शुरू किया जाएगा, जो फ़िनास्टेराइड से रिपोर्ट हुए यौन साइड इफ़ेक्ट और मानसिक साइड इफ़ेक्ट के जोखिम को उभारेगा, ताकि मरीज़ों और दवा लिखने वालों में जागरूकता बढ़े",
                  "by": "ours"
                }
              }
            },
            {
              "key": "for-patients",
              "kind": "sexual-persistence",
              "section": [
                "Advice for healthcare professionals to give to patients and caregivers:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "in some cases sexual dysfunction has persisted in patients even after they have stopped taking finasteride",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "in einigen Fällen hat die sexuelle Dysfunktion bei Patientinnen und Patienten auch nach dem Absetzen von Finasterid angehalten",
                  "by": "ours"
                },
                "es": {
                  "text": "en algunos casos la disfunción sexual ha persistido en los pacientes incluso después de haber dejado de tomar finasterida",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "em alguns casos, a disfunção sexual persistiu em pacientes mesmo depois de eles terem parado de tomar finasterida",
                  "by": "ours"
                },
                "fr": {
                  "text": "dans certains cas, la dysfonction sexuelle a persisté chez des patients même après qu’ils ont arrêté de prendre du finastéride",
                  "by": "ours"
                },
                "it": {
                  "text": "in alcuni casi la disfunzione sessuale è persistita nei pazienti anche dopo che avevano smesso di prendere la finasteride",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में मरीज़ों में फ़िनास्टेराइड बंद करने के बाद भी सेक्शुअल डिस्फ़ंक्शन बना रहा है",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-dsu201705",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-dsu201705",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Drug Safety Update: \"Finasteride: rare reports of depression and suicidal thoughts\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/finasteride-rare-reports-of-depression-and-suicidal-thoughts",
            "fetchedUrl": null,
            "textDate": "2017-05-24",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 24 May 2017"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Sexual dysfunction"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Healthcare professionals are reminded that adverse reactions related to sexual function have been reported in association with finasteride. These include decreased libido, erectile dysfunction, and ejaculation disorders (such as decreased volume of ejaculate).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Angehörige der Gesundheitsberufe werden daran erinnert, dass im Zusammenhang mit Finasterid Nebenwirkungen auf die Sexualfunktion berichtet wurden. Dazu gehören verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen (etwa vermindertes Ejakulatvolumen).",
                  "by": "ours"
                },
                "es": {
                  "text": "Se recuerda a los profesionales sanitarios que se han notificado reacciones adversas relacionadas con la función sexual en asociación con la finasterida. Entre ellas figuran la disminución de la libido, la disfunción eréctil y los trastornos de la eyaculación (como la disminución del volumen de eyaculación).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os profissionais de saúde são lembrados de que foram relatadas reações adversas relacionadas à função sexual em associação com a finasterida. Elas incluem diminuição da libido, disfunção erétil e distúrbios da ejaculação (como diminuição do volume do ejaculado).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il est rappelé aux professionnels de santé que des effets indésirables touchant la fonction sexuelle ont été rapportés avec le finastéride. Il s’agit notamment de la diminution de la libido, des troubles de l’érection et des troubles de l’éjaculation (tels que la diminution du volume de l’éjaculat).",
                  "by": "ours"
                },
                "it": {
                  "text": "Si ricorda ai professionisti sanitari che con la finasteride sono state riportate reazioni avverse relative alla funzione sessuale. Tra queste, diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione (come diminuzione del volume dell’eiaculato).",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्वास्थ्यकर्मियों को याद दिलाया जाता है कि फ़िनास्टेराइड के साथ यौन क्रिया से जुड़े प्रतिकूल प्रभाव रिपोर्ट हुए हैं। इनमें कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार (जैसे स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी) शामिल हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the paragraph under the heading on sexual dysfunction was read whole; it lists sexual side effects and says nothing about them continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "markedSuperseded",
              "text": {
                "en": "The regulator has marked this document as superseded.",
                "de": "Die Arzneimittelbehörde hat dieses Dokument als ersetzt gekennzeichnet.",
                "es": "La agencia del medicamento ha marcado este documento como sustituido.",
                "pt-br": "A agência reguladora marcou este documento como substituído.",
                "fr": "L’agence du médicament indique que ce document a été remplacé.",
                "it": "L’agenzia del farmaco ha contrassegnato questo documento come superato.",
                "hi": "नियामक ने इस दस्तावेज़ पर दर्ज किया है कि इसकी जगह नया दस्तावेज़ आ चुका है (superseded)।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-regulator-press202404",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-press202404",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Press release: \"Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/government/news/men-on-finasteride-asked-to-stay-vigilant-for-possible-psychiatric-and-sexual-side-effects",
            "fetchedUrl": null,
            "textDate": "2024-04-29",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 29 April 2024"
          },
          "passages": [
            {
              "key": "persisted",
              "kind": "sexual-persistence",
              "section": [
                "Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "In some cases, sexual dysfunction has persisted in patients even after they have stopped taking finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In einigen Fällen hat die sexuelle Dysfunktion bei Patientinnen und Patienten auch nach dem Absetzen von Finasterid angehalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos, la disfunción sexual ha persistido en los pacientes incluso después de haber dejado de tomar finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, a disfunção sexual persistiu em pacientes mesmo depois de eles terem parado de tomar finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, la dysfonction sexuelle a persisté chez des patients même après qu’ils ont arrêté de prendre du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi la disfunzione sessuale è persistita nei pazienti anche dopo che avevano smesso di prendere la finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में मरीज़ों में फ़िनास्टेराइड बंद करने के बाद भी सेक्शुअल डिस्फ़ंक्शन बना रहा है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-press202605",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-press202605",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Press release: \"MHRA strengthens safety warnings for finasteride and dutasteride\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/government/news/mhra-strengthens-safety-warnings-for-finasteride-and-dutasteride",
            "fetchedUrl": null,
            "textDate": "2026-05-11",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 11 May 2026"
          },
          "passages": [
            {
              "key": "cards",
              "kind": "regulator-statement",
              "section": [
                "MHRA strengthens safety warnings for finasteride and dutasteride"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Existing UK patient alert cards for finasteride, introduced in 2024, remain in place. These cards highlight the risks of sexual dysfunction, depression and suicidal thoughts and advise patients on what action to take if side effects occur.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die 2024 eingeführten britischen Patientenwarnkarten für Finasterid bleiben bestehen. Diese Karten weisen auf die Risiken sexueller Dysfunktion, Depression und Suizidgedanken hin und raten Patientinnen und Patienten, was sie tun sollen, wenn Nebenwirkungen auftreten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las tarjetas de alerta para el paciente de finasterida que ya existen en el Reino Unido, introducidas en 2024, siguen vigentes. Estas tarjetas destacan los riesgos de disfunción sexual, depresión y pensamientos suicidas y aconsejan a los pacientes qué hacer si aparecen efectos secundarios.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os cartões de alerta do paciente do Reino Unido para a finasterida, introduzidos em 2024, continuam em vigor. Esses cartões destacam os riscos de disfunção sexual, depressão e pensamentos suicidas e orientam os pacientes sobre o que fazer se ocorrerem efeitos colaterais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les cartes d’alerte patient existantes pour le finastéride au Royaume-Uni, introduites en 2024, restent en place. Ces cartes mettent en avant les risques de dysfonction sexuelle, de dépression et de pensées suicidaires, et indiquent aux patients quoi faire en cas d’effets secondaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le schede di allerta per il paziente già in uso nel Regno Unito per la finasteride, introdotte nel 2024, restano in vigore. Queste schede mettono in evidenza i rischi di disfunzione sessuale, depressione e pensieri suicidi e indicano ai pazienti che cosa fare se compaiono effetti indesiderati.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड के लिए ब्रिटेन के मौजूदा मरीज़ अलर्ट कार्ड, जो 2024 में शुरू किए गए थे, बने हुए हैं। ये कार्ड सेक्शुअल डिस्फ़ंक्शन, डिप्रेशन और आत्महत्या के विचारों के जोखिम को उभारते हैं और बताते हैं कि साइड इफ़ेक्ट होने पर मरीज़ों को क्या करना चाहिए।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the press release was read whole and checked by machine for the words persist, after stopping, after treatment and discontinu; it has no sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-uk-regulator-dhpc202608",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-dhpc202608",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Direct Healthcare Professional Communication (DHPC): \"Finasteride and dutasteride - Updated safety warnings for psychiatric side effects and sexual dysfunction\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://assets.publishing.service.gov.uk/media/6a8d4c0408705e34a95daa99/finasteride-dutasteride_DHPC_-_updated_safety_warnings_for_psychiatric_side_effects_and_sexual_dysfunction.pdf",
            "fetchedUrl": null,
            "textDate": "2026-08-17",
            "textDateKind": "publication",
            "textDateAsPrinted": "17th August 2026"
          },
          "passages": [
            {
              "key": "card",
              "kind": "regulator-statement",
              "section": [
                "Summary of the safety concern:"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "A Patient Alert Card is available in the package of medicinal products containing finasteride to highlight the risks of depressed mood, depression, suicidal ideation and sexual dysfunction reported with finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In der Packung von Arzneimitteln, die Finasterid enthalten, liegt eine Patientenwarnkarte bei, die auf die mit Finasterid berichteten Risiken von gedrückter Stimmung, Depression, Suizidgedanken und sexueller Dysfunktion hinweist.",
                  "by": "ours"
                },
                "es": {
                  "text": "En el envase de los medicamentos que contienen finasterida hay una tarjeta de alerta para el paciente que destaca los riesgos de estado de ánimo deprimido, depresión, ideación suicida y disfunción sexual notificados con la finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Um Cartão de Alerta do Paciente está disponível na embalagem dos medicamentos que contêm finasterida para destacar os riscos de humor deprimido, depressão, ideação suicida e disfunção sexual relatados com a finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une carte d’alerte patient est disponible dans l’emballage des médicaments contenant du finastéride pour mettre en avant les risques d’humeur dépressive, de dépression, d’idées suicidaires et de dysfonction sexuelle rapportés avec le finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nella confezione dei medicinali contenenti finasteride è disponibile una scheda di allerta per il paziente, per mettere in evidenza i rischi di umore depresso, depressione, ideazione suicidaria e disfunzione sessuale riportati con la finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड वाली दवाओं के पैकेज में एक मरीज़ अलर्ट कार्ड उपलब्ध है, जो फ़िनास्टेराइड से रिपोर्ट हुए उदास मूड, डिप्रेशन, आत्महत्या के विचारों और सेक्शुअल डिस्फ़ंक्शन के जोखिमों को उभारता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the letter was read whole and checked by machine for the words persist, after stopping and after discontinu; it has no sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-regulator-parliament202412",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-parliament202412",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 20625, House of Commons: \"Finasteride\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2024-12-17/20625",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/1750573",
            "textDate": "2024-12-31",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2024-12-31T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "regulator-statement",
              "section": [
                "Answer"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The MHRA has recently completed an extensive safety review into finasteride, with the subsequent updates to the product information having been implemented, and the development of a patient alert card is underway.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die MHRA hat kürzlich eine umfassende Sicherheitsüberprüfung zu Finasterid abgeschlossen; die daraus folgenden Aktualisierungen der Produktinformation wurden umgesetzt, und die Entwicklung einer Patientenwarnkarte läuft.",
                  "by": "ours"
                },
                "es": {
                  "text": "La MHRA ha completado recientemente una amplia revisión de seguridad de la finasterida; las actualizaciones posteriores de la información del producto ya se han aplicado y se está elaborando una tarjeta de alerta para el paciente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A MHRA concluiu recentemente uma extensa revisão de segurança da finasterida, com as atualizações subsequentes das informações do produto já implementadas, e o desenvolvimento de um cartão de alerta do paciente está em andamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La MHRA a récemment terminé un examen approfondi de la sécurité du finastéride ; les mises à jour des informations sur le produit qui en découlent ont été mises en œuvre, et l’élaboration d’une carte d’alerte patient est en cours.",
                  "by": "ours"
                },
                "it": {
                  "text": "La MHRA ha recentemente concluso un’ampia revisione di sicurezza sulla finasteride; i successivi aggiornamenti delle informazioni sul prodotto sono stati attuati e l’elaborazione di una scheda di allerta per il paziente è in corso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "MHRA ने हाल ही में फ़िनास्टेराइड की एक व्यापक सुरक्षा समीक्षा पूरी की है, जिसके बाद आधिकारिक जानकारी में अपडेट लागू किए जा चुके हैं, और मरीज़ अलर्ट कार्ड का विकास जारी है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the answer was read whole; it has no sentence about side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-regulator-parliament202501",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-parliament202501",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN 23846, House of Commons: \"Antidepressants: Side Effects\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
            },
            "url": "https://questions-statements.parliament.uk/written-questions/detail/2025-01-14/23846",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/1755236",
            "textDate": "2025-01-22",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2025-01-22T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "sexual-persistence",
              "section": [
                "Answer"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The MHRA is currently reviewing the existing warnings in relation to sexual dysfunction which may continue after stopping anti-depressant medication, and recently completed an extensive safety review of finasteride and persistent sexual dysfunction, including after stopping treatment with finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die MHRA überprüft derzeit die bestehenden Warnhinweise zu sexueller Dysfunktion, die nach dem Absetzen von Antidepressiva anhalten kann, und hat kürzlich eine umfassende Sicherheitsüberprüfung zu Finasterid und anhaltender sexueller Dysfunktion abgeschlossen, auch nach dem Absetzen der Behandlung mit Finasterid.",
                  "by": "ours"
                },
                "es": {
                  "text": "La MHRA está revisando actualmente las advertencias existentes sobre la disfunción sexual que puede continuar después de dejar los medicamentos antidepresivos, y ha completado recientemente una amplia revisión de seguridad de la finasterida y de la disfunción sexual persistente, incluida la que aparece después de dejar el tratamiento con finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A MHRA está revisando atualmente os alertas existentes sobre a disfunção sexual que pode continuar depois de parar os medicamentos antidepressivos, e concluiu recentemente uma extensa revisão de segurança da finasterida e da disfunção sexual persistente, inclusive depois de parar o tratamento com finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La MHRA examine actuellement les mises en garde existantes sur la dysfonction sexuelle qui peut se poursuivre après l’arrêt d’un médicament antidépresseur, et a récemment terminé un examen approfondi de la sécurité du finastéride et de la dysfonction sexuelle persistante, y compris après l’arrêt du traitement par finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "La MHRA sta attualmente rivedendo le avvertenze esistenti relative alla disfunzione sessuale che può proseguire dopo l’interruzione dei medicinali antidepressivi, e ha recentemente concluso un’ampia revisione di sicurezza sulla finasteride e sulla disfunzione sessuale persistente, anche dopo l’interruzione del trattamento con finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "MHRA अभी एंटीडिप्रेसेंट दवाएँ बंद करने के बाद भी जारी रह सकने वाले सेक्शुअल डिस्फ़ंक्शन से जुड़ी मौजूदा चेतावनियों की समीक्षा कर रही है, और उसने हाल ही में फ़िनास्टेराइड और बने रहने वाले सेक्शुअल डिस्फ़ंक्शन की, फ़िनास्टेराइड से इलाज बंद करने के बाद के मामलों सहित, एक व्यापक सुरक्षा समीक्षा पूरी की है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
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              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-uk-regulator-parliament202609",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-uk-regulator-parliament202609",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "government",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Written question UIN HL2471, House of Lords: \"Finasteride: Side Effects\"",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "parliament",
              "name": "UK Parliament"
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            "url": "https://questions-statements.parliament.uk/written-questions/detail/2026-07-22/HL2471",
            "fetchedUrl": "https://questions-statements-api.parliament.uk/api/writtenquestions/questions/1929613",
            "textDate": "2026-09-09",
            "textDateKind": "answer",
            "textDateAsPrinted": "dateAnswered: 2026-09-09T00:00:00"
          },
          "passages": [
            {
              "key": "answer",
              "kind": "regulator-statement",
              "section": [
                "Answer"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Patient alert cards are being introduced in all finasteride packs to reiterate these warnings.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Patientenwarnkarten werden in allen Finasterid-Packungen eingeführt, um diese Warnhinweise zu bekräftigen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se están introduciendo tarjetas de alerta para el paciente en todos los envases de finasterida para reiterar estas advertencias.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Cartões de alerta do paciente estão sendo introduzidos em todas as embalagens de finasterida para reiterar esses alertas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cartes d’alerte patient sont introduites dans toutes les boîtes de finastéride pour rappeler ces mises en garde.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le schede di allerta per il paziente vengono introdotte in tutte le confezioni di finasteride per ribadire queste avvertenze.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन चेतावनियों को दोहराने के लिए सभी फ़िनास्टेराइड पैक में मरीज़ अलर्ट कार्ड शुरू किए जा रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the answer was read whole; it has no sentence about side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
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          "changed": "2026-10-14",
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          },
          "history": [
            {
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              "fields": [
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              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "parliamentaryInformation",
              "text": {
                "en": "Contains Parliamentary information licensed under the Open Parliament Licence v3.0.",
                "de": "Enthält Informationen des britischen Parlaments, lizenziert unter der Open Parliament Licence v3.0.",
                "es": "Contiene información parlamentaria con la licencia Open Parliament Licence v3.0.",
                "pt-br": "Contém informações do Parlamento britânico licenciadas sob a Open Parliament Licence v3.0.",
                "fr": "Contient des informations parlementaires publiées sous l’Open Parliament Licence v3.0.",
                "it": "Contiene informazioni parlamentari concesse in licenza con la Open Parliament Licence v3.0.",
                "hi": "इसमें संसद की जानकारी है, जिस पर Open Parliament Licence v3.0 लागू है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Annex III Amendments to relevant sections of the Product Information",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_en.pdf",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": "the annex was read whole, in English and in its German, French, Italian, Spanish and Portuguese versions, part A (finasteride 1 mg) and part B (finasteride 5 mg); it has no sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [
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              "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Anhang III Änderungen der relevanten Abschnitte der Produktinformation",
              "url": "https://www.ema.europa.eu/de/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_de.pdf",
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              "url": "https://www.ema.europa.eu/fr/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_fr.pdf",
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              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Allegato III Modifiche ai paragrafi rilevanti delle informazioni sul prodotto",
              "url": "https://www.ema.europa.eu/it/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_it.pdf",
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              "checked": "2026-10-14",
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              "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Anexo III Modificaciones para incluir en las secciones relevantes de la información del producto",
              "url": "https://www.ema.europa.eu/es/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_es.pdf",
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            },
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              "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: ANEXO III Alterações às secções relevantes da Informação do Medicamento",
              "url": "https://www.ema.europa.eu/pt/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-iii_pt.pdf",
              "textDateAsPrinted": null,
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              "checked": "2026-10-14",
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          ],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
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                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-eu-regulator-ema202508",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-eu-regulator-ema202508",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_en.pdf",
            "fetchedUrl": null,
            "textDate": "2025-08-22",
            "textDateKind": "publication",
            "textDateAsPrinted": "22 August 2025"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "regulator-statement",
              "section": [
                "Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines"
              ],
              "since": null,
              "lang": "en",
              "text": "The product information for finasteride 1 mg tablets will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes.",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "Maßnahmen zur Minimierung des Risikos für Suizidgedanken bei Anwendung von Finasterid und Dutasterid enthaltenden Arzneimitteln"
                  ],
                  "text": "Die Produktinformation für Finasterid 1 mg Tabletten wird Patienten nun auch darauf hinweisen, dass sie ärztliche Hilfe in Anspruch nehmen müssen, wenn sie Probleme mit der Sexualfunktion (wie verminderte Libido oder Erektionsstörung) haben, die bekannte Nebenwirkungen des Arzneimittels sind und zu Stimmungsschwankungen beitragen können."
                },
                {
                  "lang": "fr",
                  "section": [
                    "Mesures visant à réduire au minimum le risque de pensées suicidaires associé aux médicaments contenant du finastéride ou du dutastéride"
                  ],
                  "text": "Les notices des comprimés de finastéride 1 mg alerteront désormais aussi les patients sur la nécessité de consulter un médecin en cas de problèmes de fonction sexuelle (tels qu’une diminution de la libido ou des troubles de l’érection), qui sont des effets indésirables connus du médicament et peuvent contribuer aux changements d’humeur."
                },
                {
                  "lang": "it",
                  "section": [
                    "Misure per ridurre al minimo il rischio di pensieri suicidi con i medicinali a base di finasteride e dutasteride"
                  ],
                  "text": "Le informazioni sul prodotto relative a finasteride 1 mg compresse segnaleranno inoltre ora ai pazienti la necessità di consultare un medico nel caso in cui presentino problemi relativi alla funzione sessuale (quali diminuzione dell’impulso sessuale o disfunzione erettile), che sono effetti indesiderati noti del medicinale e possono contribuire a cambiamenti di umore."
                },
                {
                  "lang": "es",
                  "section": [
                    "Medidas para minimizar el riesgo de pensamientos suicidas con medicamentos que contienen finasterida y dutasterida"
                  ],
                  "text": "La información sobre el producto de los comprimidos de 1 mg de finasterida también alertará ahora a los pacientes sobre la necesidad de consultar a un médico si experimentan problemas de la función sexual (como disminución del impulso sexual o disfunción eréctil), que son efectos adversos conocidos del medicamento y pueden contribuir a cambios en el estado de ánimo."
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "Medidas para minimizar o risco de pensamentos suicidas com medicamentos que contêm finasterida e dutasterida"
                  ],
                  "text": "A informação do medicamento dos comprimidos de 1 mg de finasterida irá agora também alertar os doentes para a necessidade de procurar aconselhamento médico se tiverem problemas com a função sexual (tais como diminuição da libido ou disfunção erétil), que são efeitos indesejáveis conhecidos do medicamento e podem contribuir para as alterações de humor."
                }
              ],
              "translations": {
                "de": {
                  "text": "Die Produktinformation für Finasterid 1 mg Tabletten wird Patienten nun auch darauf hinweisen, dass sie ärztliche Hilfe in Anspruch nehmen müssen, wenn sie Probleme mit der Sexualfunktion (wie verminderte Libido oder Erektionsstörung) haben, die bekannte Nebenwirkungen des Arzneimittels sind und zu Stimmungsschwankungen beitragen können.",
                  "by": "official"
                },
                "es": {
                  "text": "La información sobre el producto de los comprimidos de 1 mg de finasterida también alertará ahora a los pacientes sobre la necesidad de consultar a un médico si experimentan problemas de la función sexual (como disminución del impulso sexual o disfunción eréctil), que son efectos adversos conocidos del medicamento y pueden contribuir a cambios en el estado de ánimo.",
                  "by": "official"
                },
                "pt-br": {
                  "text": "A informação do medicamento dos comprimidos de 1 mg de finasterida irá agora também alertar os doentes para a necessidade de procurar aconselhamento médico se tiverem problemas com a função sexual (tais como diminuição da libido ou disfunção erétil), que são efeitos indesejáveis conhecidos do medicamento e podem contribuir para as alterações de humor.",
                  "by": "official"
                },
                "fr": {
                  "text": "Les notices des comprimés de finastéride 1 mg alerteront désormais aussi les patients sur la nécessité de consulter un médecin en cas de problèmes de fonction sexuelle (tels qu’une diminution de la libido ou des troubles de l’érection), qui sont des effets indésirables connus du médicament et peuvent contribuer aux changements d’humeur.",
                  "by": "official"
                },
                "it": {
                  "text": "Le informazioni sul prodotto relative a finasteride 1 mg compresse segnaleranno inoltre ora ai pazienti la necessità di consultare un medico nel caso in cui presentino problemi relativi alla funzione sessuale (quali diminuzione dell’impulso sessuale o disfunzione erettile), che sono effetti indesiderati noti del medicinale e possono contribuire a cambiamenti di umore.",
                  "by": "official"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड 1 mg की गोलियों की आधिकारिक जानकारी अब मरीज़ों को यह भी सचेत करेगी कि अगर उन्हें यौन क्रिया में समस्याएँ (जैसे सेक्स की इच्छा में कमी या स्तंभन दोष) हों, जो दवा के जाने-माने साइड इफ़ेक्ट हैं और मूड में बदलाव में योगदान दे सकते हैं, तो वे डॉक्टर की सलाह लें।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the communication was read whole in English; what it says about sexual function is the sentence shown, and it has no sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Maßnahmen zur Minimierung des Risikos für Suizidgedanken bei Anwendung von Finasterid und Dutasterid enthaltenden Arzneimitteln",
              "url": "https://www.ema.europa.eu/de/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_de.pdf",
              "textDateAsPrinted": "22. August 2025",
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Mesures visant à réduire au minimum le risque de pensées suicidaires associé aux médicaments contenant du finastéride ou du dutastéride",
              "url": "https://www.ema.europa.eu/fr/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_fr.pdf",
              "textDateAsPrinted": "22 août 2025",
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Misure per ridurre al minimo il rischio di pensieri suicidi con i medicinali a base di finasteride e dutasteride",
              "url": "https://www.ema.europa.eu/it/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_it.pdf",
              "textDateAsPrinted": "22 agosto 2025",
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "es",
              "name": "Medidas para minimizar el riesgo de pensamientos suicidas con medicamentos que contienen finasterida y dutasterida",
              "url": "https://www.ema.europa.eu/es/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_es.pdf",
              "textDateAsPrinted": "22 de agosto de 2025",
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Medidas para minimizar o risco de pensamentos suicidas com medicamentos que contêm finasterida e dutasterida",
              "url": "https://www.ema.europa.eu/pt/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts_pt.pdf",
              "textDateAsPrinted": "22 de agosto de 2025",
              "dateDiffers": false,
              "checked": "2026-10-14",
              "verified": {
                "date": "2026-10-14",
                "result": "exact"
              }
            }
          ],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-eu-regulator-annex2",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-eu-regulator-annex2",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Annex II Scientific conclusions",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-annex-ii_en.pdf",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "grounds",
              "kind": "regulator-statement",
              "section": [
                "Scientific conclusions",
                "Grounds for PRAC recommendation"
              ],
              "since": null,
              "lang": "en",
              "text": "PRAC concluded that sexual dysfunction (a known adverse drug reaction of finasteride) may have a potential contributory role in suicidal ideation in some patients being treated with finasteride 1 mg for oral use and recommended this to be reflected in the product information of these medicinal products.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Der PRAC kam zu dem Schluss, dass sexuelle Dysfunktion (eine bekannte Nebenwirkung von Finasterid) bei einigen Patienten, die mit Finasterid 1 mg zum Einnehmen behandelt werden, möglicherweise zu Suizidgedanken beitragen kann, und empfahl, dies in der Produktinformation dieser Arzneimittel zu berücksichtigen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El PRAC concluyó que la disfunción sexual (una reacción adversa conocida de la finasterida) puede tener un posible papel contribuyente en la ideación suicida en algunos pacientes tratados con finasterida 1 mg por vía oral y recomendó que esto se reflejara en la información del producto de estos medicamentos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O PRAC concluiu que a disfunção sexual (uma reação adversa conhecida da finasterida) pode ter um papel contribuinte potencial na ideação suicida em alguns pacientes tratados com finasterida 1 mg por via oral, e recomendou que isso fosse refletido nas informações do produto desses medicamentos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le PRAC a conclu que la dysfonction sexuelle (un effet indésirable connu du finastéride) pouvait jouer un rôle contributif potentiel dans les idées suicidaires chez certains patients traités par finastéride 1 mg par voie orale, et a recommandé que cela soit reflété dans les informations sur le produit de ces médicaments.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il PRAC ha concluso che la disfunzione sessuale (una reazione avversa nota della finasteride) può avere un potenziale ruolo contributivo nell’ideazione suicidaria in alcuni pazienti trattati con finasteride 1 mg per uso orale, e ha raccomandato di riflettere questo aspetto nelle informazioni sul prodotto di questi medicinali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "PRAC इस नतीजे पर पहुँचा कि सेक्शुअल डिस्फ़ंक्शन (फ़िनास्टेराइड की एक जानी-मानी प्रतिकूल दवा प्रतिक्रिया) मुँह से ली जाने वाली फ़िनास्टेराइड 1 mg से इलाज किए जा रहे कुछ मरीज़ों में आत्महत्या के विचारों में संभावित योगदान दे सकता है, और उसने सिफ़ारिश की कि यह इन दवाओं की आधिकारिक जानकारी में दिखे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the point of the grounds that speaks of sexual dysfunction was read whole; it says nothing about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PROPECIA® (finasteride) tablets for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Propecia",
              "form": "tablets 1 mg",
              "holder": "Organon LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36",
            "fetchedUrl": null,
            "textDate": "2022-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 8/2022"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.2 Postmarketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain; hematospermia.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Fortpflanzungssystem: sexuelle Dysfunktion, die nach dem Absetzen der Behandlung andauerte, darunter erektile Dysfunktion, Libidostörungen, Ejakulationsstörungen und Orgasmusstörungen; Infertilität bei Männern und/oder schlechte Spermienqualität (eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet); Hodenschmerzen; Hämatospermie.",
                  "by": "ours"
                },
                "es": {
                  "text": "Aparato reproductor: disfunción sexual que continuó después de la interrupción del tratamiento, incluidas disfunción eréctil, trastornos de la libido, trastornos de la eyaculación y trastornos del orgasmo; infertilidad masculina y/o calidad seminal pobre (se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida); dolor testicular; hematospermia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sistema reprodutor: disfunção sexual que continuou depois da descontinuação do tratamento, incluindo disfunção erétil, distúrbios da libido, distúrbios da ejaculação e distúrbios do orgasmo; infertilidade masculina e/ou má qualidade do sêmen (foi relatada normalização ou melhora da qualidade do sêmen depois da descontinuação da finasterida); dor testicular; hematospermia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Appareil reproducteur : dysfonction sexuelle qui a continué après l’arrêt du traitement, notamment troubles de l’érection, troubles de la libido, troubles de l’éjaculation et troubles de l’orgasme ; infertilité masculine et/ou mauvaise qualité du sperme (une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride) ; douleur testiculaire ; hématospermie.",
                  "by": "ours"
                },
                "it": {
                  "text": "Apparato riproduttivo: disfunzione sessuale che è proseguita dopo l’interruzione del trattamento, comprese disfunzione erettile, disturbi della libido, disturbi dell’eiaculazione e disturbi dell’orgasmo; infertilità maschile e/o scarsa qualità del liquido seminale (normalizzazione o miglioramento della qualità del liquido seminale sono stati riportati dopo l’interruzione della finasteride); dolore testicolare; ematospermia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र: इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष, कामेच्छा के विकार, स्खलन विकार और ऑर्गेज़्म विकार शामिल हैं; पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता (फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है); अंडकोष में दर्द; वीर्य में खून (हीमैटोस्पर्मिया)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.2 Postmarketing Experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "The following adverse reactions have been identified during post approval use of PROPECIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Nach der Zulassung wurden bei der Anwendung von PROPECIA die folgenden Nebenwirkungen festgestellt. Da diese Reaktionen freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han identificado las siguientes reacciones adversas durante el uso de PROPECIA después de su aprobación. Como estas reacciones se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento:",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir foram identificadas durante o uso após a aprovação do PROPECIA. Como essas reações são relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência delas nem estabelecer uma relação causal com a exposição ao medicamento:",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants ont été identifiés lors de l’utilisation de PROPECIA après son approbation. Comme ces réactions sont rapportées volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament :",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse sono state identificate durante l’uso successivo all’approvazione di PROPECIA. Poiché queste reazioni sono riportate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale:",
                  "by": "ours"
                },
                "hi": {
                  "text": "PROPECIA के मंज़ूरी के बाद के उपयोग में ये प्रतिकूल प्रतिक्रियाएँ पहचानी गई हैं। क्योंकि ये प्रतिक्रियाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं:",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "usLabelSearchFinasteride",
              "text": {
                "en": "On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence that sexual dysfunction continued after treatment was stopped stood on 151 of the 181 labels in that database that name finasteride, and on each of them among the adverse reactions, in no warnings section. Of the 30 without it, 10 are hair products with labels in the Drug Facts style, 5 are listings of compounded solutions for the skin, 2 have no text on adverse reactions, and 13 are older labels of 5 mg tablets with an earlier list of adverse reactions.",
                "de": "Am 14. Oktober 2026 haben wir die Fachinformationen in openFDA durchsucht, der offenen Datenbank der FDA. Ein Satz dazu, dass sexuelle Funktionsstörungen nach dem Absetzen der Behandlung anhielten, stand in 151 der 181 Fachinformationen in dieser Datenbank, die Finasterid nennen, und zwar in jeder von ihnen unter den Nebenwirkungen, in keinem Abschnitt mit Warnhinweisen. Von den 30 ohne diesen Satz sind 10 Haarprodukte mit Etiketten im Stil der „Drug Facts“, 5 Einträge zu individuell hergestellten Lösungen zur Anwendung auf der Haut, 2 haben keinen Text zu Nebenwirkungen, und 13 sind ältere Fachinformationen zu 5-mg-Tabletten mit einer früheren Liste der Nebenwirkungen.",
                "es": "El 14 de octubre de 2026 buscamos en las fichas técnicas de openFDA, la base de datos abierta de la FDA. Una frase que decía que la disfunción sexual continuó después de dejar el tratamiento figuraba en 151 de las 181 fichas técnicas de esa base de datos que nombran la finasterida, y en cada una de ellas entre las reacciones adversas, en ningún apartado de advertencias. De las 30 que no la tienen, 10 son productos para el cabello con fichas técnicas al estilo de Drug Facts, 5 son listados de soluciones magistrales para la piel, 2 no tienen texto sobre reacciones adversas y 13 son fichas técnicas antiguas de comprimidos de 5 mg con una lista anterior de reacciones adversas.",
                "pt-br": "Em 14 de outubro de 2026, pesquisamos as bulas no openFDA, o banco de dados aberto da FDA. Uma frase dizendo que a disfunção sexual continuou depois de parar o tratamento estava em 151 das 181 bulas desse banco de dados que citam finasterida e, em cada uma delas, entre as reações adversas, em nenhuma seção de alertas. Das 30 sem essa frase, 10 são produtos para o cabelo com bulas no estilo Drug Facts, 5 são listagens de soluções manipuladas para a pele, 2 não têm texto sobre reações adversas e 13 são bulas mais antigas de comprimidos de 5 mg, com uma lista anterior de reações adversas.",
                "fr": "Le 14 octobre 2026, nous avons cherché dans les notices d’openFDA, la base de données ouverte de la FDA. Une phrase disant qu’une dysfonction sexuelle a continué après l’arrêt du traitement figurait sur 151 des 181 notices de cette base qui nomment le finastéride, et sur chacune d’elles parmi les effets indésirables, dans aucune rubrique de mises en garde. Sur les 30 qui ne la contenaient pas, 10 sont des produits capillaires dont la notice suit le format Drug Facts, 5 sont des fiches de solutions préparées par des pharmacies pour la peau, 2 n’ont aucun texte sur les effets indésirables, et 13 sont d’anciennes notices de comprimés de 5 mg avec une liste plus ancienne d’effets indésirables.",
                "it": "Il 14 ottobre 2026 abbiamo cercato tra le schede tecniche in openFDA, la banca dati aperta della FDA. Una frase secondo cui la disfunzione sessuale è proseguita dopo l’interruzione del trattamento compariva in 151 delle 181 schede tecniche di quella banca dati che nominano la finasteride, e in ciascuna di esse tra le reazioni avverse, in nessuna sezione delle avvertenze. Delle 30 che non l’hanno, 10 sono prodotti per i capelli con schede nello stile Drug Facts, 5 sono elenchi di soluzioni galeniche per la pelle, 2 non hanno testo sulle reazioni avverse e 13 sono schede più vecchie di compresse da 5 mg con un elenco precedente di reazioni avverse.",
                "hi": "14 अक्टूबर 2026 को हमने FDA के खुले डेटाबेस openFDA में लेबल खोजे। उस डेटाबेस के जिन 181 लेबलों में फ़िनास्टेराइड का नाम है, उनमें से 151 पर यह वाक्य था कि इलाज बंद होने के बाद भी सेक्शुअल डिस्फ़ंक्शन जारी रहा, और उन सभी पर वह प्रतिकूल प्रतिक्रियाओं (adverse reactions) के बीच था, किसी चेतावनी वाले सेक्शन में नहीं। बिना इस वाक्य वाले 30 लेबलों में से 10 बालों के उत्पाद हैं, जिनके लेबल Drug Facts शैली के हैं, 5 त्वचा पर लगाने वाले कंपाउंड किए गए घोलों की सूचियाँ हैं, 2 में प्रतिकूल प्रतिक्रियाओं पर कोई पाठ नहीं है, और 13 5 mg की गोलियों के पुराने लेबल हैं, जिनमें प्रतिकूल प्रतिक्रियाओं की पहले वाली सूची है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-us-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-leaflet",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Patient Information PROPECIA (Pro-pee-sha) (finasteride) Tablets",
            "lang": "en-US",
            "product": {
              "name": "Propecia",
              "form": "tablets 1 mg",
              "holder": "Organon LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36",
            "fetchedUrl": null,
            "textDate": "2023-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 11/2023"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The most common side effects of PROPECIA include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decrease in sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Abnahme des sexuellen Verlangens",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The most common side effects of PROPECIA include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "trouble getting or keeping an erection",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas para conseguir o mantener una erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter ou manter uma ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir ou à maintenir une érection",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà ad avere o mantenere un’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बने रहने में दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The most common side effects of PROPECIA include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "a decrease in the amount of semen",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "eine Abnahme der Samenmenge",
                  "by": "ours"
                },
                "es": {
                  "text": "una disminución de la cantidad de semen",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da quantidade de sêmen",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la quantité de sperme",
                  "by": "ours"
                },
                "it": {
                  "text": "una diminuzione della quantità di sperma",
                  "by": "ours"
                },
                "hi": {
                  "text": "वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The following have been reported in general use with PROPECIA:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "decrease in sex drive that continued after stopping the medication;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen des Arzneimittels andauerte;",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual que continuó después de dejar el medicamento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual que continuou depois de parar o medicamento;",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel qui a continué après l’arrêt du médicament ;",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale che è proseguita dopo l’interruzione del medicinale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी जारी रही;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The following have been reported in general use with PROPECIA:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "problems with ejaculation that continued after stopping medication;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauerten;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continuaron después de dejar el medicamento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação que continuaram depois de parar o medicamento;",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui ont continué après l’arrêt du médicament ;",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che sono proseguiti dopo l’interruzione del medicinale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जो दवा बंद करने के बाद भी जारी रहीं;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROPECIA?",
                "The following have been reported in general use with PROPECIA:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "difficulty in achieving an erection that continued after stopping the medication;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauerten;",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para conseguir una erección que continuó después de dejar el medicamento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter uma ereção que continuou depois de parar o medicamento;",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir une érection qui a continué après l’arrêt du médicament ;",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà a ottenere un’erezione che è proseguita dopo l’interruzione del medicinale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत, जो दवा बंद करने के बाद भी जारी रही;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-pro-proscar",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PROSCAR® (finasteride) Tablets: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Proscar",
              "form": "tablets 5 mg",
              "holder": "Organon LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b",
            "fetchedUrl": null,
            "textDate": "2026-03",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 3/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.2 Postmarketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume). These events were reported rarely in men taking PROSCAR for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of PROSCAR in these events is unknown.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "sexuelle Dysfunktion, die nach dem Absetzen der Behandlung andauerte, darunter erektile Dysfunktion, verminderte Libido und Ejakulationsstörungen (z. B. vermindertes Ejakulatvolumen). Diese Ereignisse wurden bei Männern, die PROSCAR zur Behandlung der BPH einnahmen, selten berichtet. Die meisten Männer waren älter und nahmen Begleitmedikation ein und/oder hatten Begleiterkrankungen. Die eigenständige Rolle von PROSCAR bei diesen Ereignissen ist unbekannt.",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual que continuó después de la interrupción del tratamiento, incluidas disfunción eréctil, disminución de la libido y trastornos de la eyaculación (p. ej., volumen de eyaculación reducido). Estos acontecimientos se notificaron raramente en varones que tomaban PROSCAR para el tratamiento de la HBP. La mayoría de los varones eran de edad avanzada y tomaban medicamentos concomitantes o tenían enfermedades concomitantes. Se desconoce el papel independiente de PROSCAR en estos acontecimientos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual que continuou depois da descontinuação do tratamento, incluindo disfunção erétil, diminuição da libido e distúrbios da ejaculação (por exemplo, volume de ejaculado reduzido). Esses eventos foram relatados raramente em homens que tomavam PROSCAR para o tratamento da HPB. A maioria dos homens era mais velha e tomava medicamentos concomitantes e/ou tinha outras condições de saúde. O papel independente do PROSCAR nesses eventos é desconhecido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle qui a continué après l’arrêt du traitement, notamment troubles de l’érection, diminution de la libido et troubles de l’éjaculation (par ex. réduction du volume de l’éjaculat). Ces événements ont été rapportés rarement chez des hommes prenant PROSCAR pour traiter une HBP. La plupart étaient plus âgés et prenaient d’autres médicaments et/ou avaient d’autres maladies. Le rôle propre de PROSCAR dans ces événements est inconnu.",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale che è proseguita dopo l’interruzione del trattamento, comprese disfunzione erettile, diminuzione della libido e disturbi dell’eiaculazione (ad es. volume ridotto dell’eiaculato). Questi eventi sono stati riportati raramente negli uomini che assumevano PROSCAR per il trattamento dell’IPB. La maggior parte degli uomini era di età più avanzata e assumeva medicinali concomitanti e/o aveva patologie concomitanti. Il ruolo indipendente di PROSCAR in questi eventi non è noto.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष, कामेच्छा में कमी और स्खलन विकार (जैसे वीर्य की मात्रा में कमी) शामिल हैं। प्रोस्टेट के बढ़ने (BPH) के इलाज के लिए PROSCAR लेने वाले पुरुषों में ये घटनाएँ कभी-कभार ही रिपोर्ट हुईं। ज़्यादातर पुरुष उम्रदराज़ थे और साथ में दूसरी दवाएँ ले रहे थे और/या उन्हें साथ की दूसरी बीमारियाँ थीं। इन घटनाओं में PROSCAR की अपनी अलग भूमिका अज्ञात है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.2 Postmarketing Experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "The following additional adverse events have been reported in postmarketing experience with PROSCAR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Nach Markteinführung wurden bei der Anwendung von PROSCAR die folgenden zusätzlichen unerwünschten Ereignisse berichtet. Da diese Ereignisse freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado los siguientes acontecimientos adversos adicionales en la experiencia poscomercialización con PROSCAR. Como estos acontecimientos se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento:",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os seguintes eventos adversos adicionais foram relatados na experiência pós-comercialização com o PROSCAR. Como esses eventos são relatados voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência deles nem estabelecer uma relação causal com a exposição ao medicamento:",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les événements indésirables supplémentaires suivants ont été rapportés depuis la commercialisation de PROSCAR. Comme ces événements sont rapportés volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament :",
                  "by": "ours"
                },
                "it": {
                  "text": "I seguenti ulteriori eventi avversi sono stati riportati nell’esperienza post-marketing con PROSCAR. Poiché questi eventi sono riportati volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale:",
                  "by": "ours"
                },
                "hi": {
                  "text": "PROSCAR के मंज़ूरी के बाद के अनुभव में ये अतिरिक्त प्रतिकूल घटनाएँ रिपोर्ट हुई हैं। क्योंकि ये घटनाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं:",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-lower-doses",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "6.2 Postmarketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:\norgasm disorders",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Das folgende zusätzliche unerwünschte Ereignis im Zusammenhang mit sexueller Dysfunktion, die nach dem Absetzen der Behandlung andauerte, wurde nach Markteinführung bei Finasterid in den niedrigeren Dosierungen berichtet, die zur Behandlung des erblich bedingten Haarausfalls bei Männern angewendet werden. Da das Ereignis freiwillig aus einer Population unbekannter Größe gemeldet wird, ist es nicht immer möglich, seine Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen:\nOrgasmusstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado el siguiente acontecimiento adverso adicional relacionado con la disfunción sexual que continuó después de la interrupción del tratamiento en la experiencia poscomercialización con finasterida en las dosis más bajas utilizadas para tratar la alopecia masculina androgénica. Como el acontecimiento se notifica voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento:\ntrastornos del orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O seguinte evento adverso adicional relacionado à disfunção sexual que continuou depois da descontinuação do tratamento foi relatado na experiência pós-comercialização com a finasterida em doses menores, usadas para tratar a calvície masculina. Como o evento é relatado voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência dele nem estabelecer uma relação causal com a exposição ao medicamento:\ndistúrbios do orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’événement indésirable supplémentaire suivant, lié à une dysfonction sexuelle qui a continué après l’arrêt du traitement, a été rapporté depuis la commercialisation du finastéride aux doses plus faibles utilisées pour traiter la calvitie masculine. Comme cet événement est rapporté volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable sa fréquence ni d’établir un lien de causalité avec l’exposition au médicament :\ntroubles de l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "Il seguente ulteriore evento avverso relativo alla disfunzione sessuale che è proseguita dopo l’interruzione del trattamento è stato riportato nell’esperienza post-marketing con la finasteride a dosi più basse, usate per trattare la calvizie maschile. Poiché l’evento è riportato volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale:\ndisturbi dell’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "गंजेपन के इलाज में इस्तेमाल होने वाली कम डोज़ की फ़िनास्टेराइड के मंज़ूरी के बाद के अनुभव में, इलाज बंद करने के बाद भी जारी रहने वाले सेक्शुअल डिस्फ़ंक्शन से जुड़ी यह अतिरिक्त प्रतिकूल घटना रिपोर्ट हुई है। क्योंकि यह घटना अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती है, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि यह कितनी बार होती है:\nऑर्गेज़्म विकार",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-us-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-leaflet-proscar",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Patient Information about PROSCAR® (Prahs-car)",
            "lang": "en-US",
            "product": {
              "name": "Proscar",
              "form": "tablets 5 mg",
              "holder": "Organon LLC"
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b",
            "fetchedUrl": null,
            "textDate": "2026-03",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 03/2026"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The most common side effects of PROSCAR include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "trouble getting or keeping an erection (impotence)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten (Impotenz)",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas para conseguir o mantener una erección (impotencia)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter ou manter uma ereção (impotência)",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir ou à maintenir une érection (impuissance)",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà ad avere o mantenere un’erezione (impotenza)",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बने रहने में दिक्कत (स्तंभन दोष)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The most common side effects of PROSCAR include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decrease in sex drive",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Abnahme des sexuellen Verlangens",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The most common side effects of PROSCAR include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "decreased volume of ejaculate",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "vermindertes Ejakulatvolumen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del volumen de eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de l’éjaculat",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del volume dell’eiaculato",
                  "by": "ours"
                },
                "hi": {
                  "text": "वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The most common side effects of PROSCAR include:"
              ],
              "since": null,
              "lang": "en-US",
              "text": "ejaculation disorders",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ejakulationsstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The following have been reported in general use with PROSCAR and/or finasteride at lower doses:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "trouble getting or keeping an erection that continued after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten, die nach dem Absetzen des Arzneimittels andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas para conseguir o mantener una erección que continuaron después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter ou manter uma ereção que continuou depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir ou à maintenir une érection qui a continué après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà ad avere o mantenere un’erezione che è proseguita dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बने रहने में दिक्कत, जो दवा बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The following have been reported in general use with PROSCAR and/or finasteride at lower doses:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "problems with ejaculation that continued after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continuaron después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação que continuaram depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui ont continué après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che sono proseguiti dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जो दवा बंद करने के बाद भी जारी रहीं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "What are the possible side effects of PROSCAR?",
                "The following have been reported in general use with PROSCAR and/or finasteride at lower doses:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "decrease in sex drive that continued after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen des Arzneimittels andauerte",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual que continuó después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual que continuou depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel qui a continué après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale che è proseguita dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-regulator-approval201204propecia",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-regulator-approval201204propecia",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL: NDA 020788/S-020, S-021, S-023",
            "lang": "en-US",
            "product": {
              "name": "Propecia",
              "form": "Tablet, 1 mg",
              "holder": "Merck Sharp & Dohme Corp."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2012-04-11",
            "textDateKind": "approval",
            "textDateAsPrinted": "04/11/2012"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "sexual-persistence",
              "section": [
                "SUPPLEMENT APPROVAL"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "S-021 is a “Changes Being Effected” sNDA that provides for the addition of the adverse reaction “erectile dysfunction that continued after discontinuation of treatment”, to the Postmarketing Experience section of the package insert and to the patient labeling.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "S-021 ist ein „Changes Being Effected“-sNDA, mit dem die Nebenwirkung „erektile Dysfunktion, die nach dem Absetzen der Behandlung andauerte“ in den Abschnitt „Postmarketing Experience“ (Erfahrungen nach Markteinführung) der Fachinformation und in die Patienteninformation aufgenommen wird.",
                  "by": "ours"
                },
                "es": {
                  "text": "S-021 es una sNDA de tipo «Changes Being Effected» que prevé añadir la reacción adversa «disfunción eréctil que continuó después de la interrupción del tratamiento» a la sección de experiencia poscomercialización del prospecto del envase y a la información para el paciente.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O S-021 é um sNDA do tipo “Changes Being Effected” que prevê o acréscimo da reação adversa “disfunção erétil que continuou depois da descontinuação do tratamento” à seção de Experiência pós-comercialização da bula e à rotulagem para pacientes.",
                  "by": "ours"
                },
                "fr": {
                  "text": "S-021 est une demande supplémentaire d’autorisation de nouveau médicament (sNDA) de type « Changes Being Effected », qui prévoit l’ajout de l’effet indésirable « troubles de l’érection qui ont continué après l’arrêt du traitement » à la rubrique Expérience depuis la commercialisation de la notice du produit et à l’information destinée aux patients.",
                  "by": "ours"
                },
                "it": {
                  "text": "S-021 è una sNDA «Changes Being Effected» che prevede l’aggiunta della reazione avversa «disfunzione erettile che è proseguita dopo l’interruzione del trattamento» alla sezione Postmarketing Experience del foglio illustrativo per i professionisti e all’etichettatura per il paziente.",
                  "by": "ours"
                },
                "hi": {
                  "text": "S-021 एक “Changes Being Effected” sNDA है, जो पैकेज इनसर्ट और मरीज़ों के लिए लेबल के Postmarketing Experience सेक्शन में प्रतिकूल प्रतिक्रिया “इलाज बंद करने के बाद भी जारी रहने वाला स्तंभन दोष” जोड़ने का प्रावधान करता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-regulator-approval201204proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-regulator-approval201204proscar",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL: NDA 020180/S-040, S-041, S-042",
            "lang": "en-US",
            "product": {
              "name": "Proscar",
              "form": "5 mg Tablets",
              "holder": "Merck Sharp & Dohme Corp."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2012-04-11",
            "textDateKind": "approval",
            "textDateAsPrinted": "04/11/2012"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "regulator-statement",
              "section": [
                "SUPPLEMENT APPROVAL"
              ],
              "since": null,
              "lang": "en-US",
              "text": "These supplemental new drug applications, provides for revisions to the ADVERSE REACTIONS, Postmarketing Experience section of the labeling related to depression, erectile dysfunction, decreased libido, and male infertility and/or poor seminal quality, as well as a modification of the WARNINGS and PRECAUTIONS section concerning the consideration of other urological conditions when prescribing Proscar.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese ergänzenden Zulassungsanträge (supplemental new drug applications) sehen Änderungen im Abschnitt „ADVERSE REACTIONS, Postmarketing Experience“ der Fachinformation zu Depression, erektiler Dysfunktion, verminderter Libido sowie männlicher Infertilität und/oder schlechter Spermienqualität vor, außerdem eine Änderung des Abschnitts „WARNINGS and PRECAUTIONS“ zur Berücksichtigung anderer urologischer Erkrankungen bei der Verordnung von Proscar.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estas solicitudes suplementarias de nuevo medicamento prevén revisiones de la sección REACCIONES ADVERSAS, Experiencia poscomercialización, de la ficha relacionadas con depresión, disfunción eréctil, disminución de la libido e infertilidad masculina y/o calidad seminal pobre, así como una modificación de la sección ADVERTENCIAS Y PRECAUCIONES sobre la consideración de otras afecciones urológicas al recetar Proscar.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Estes pedidos suplementares de novo medicamento preveem revisões da seção REAÇÕES ADVERSAS, Experiência pós-comercialização, da rotulagem, relacionadas a depressão, disfunção erétil, diminuição da libido e infertilidade masculina e/ou má qualidade do sêmen, bem como uma modificação da seção ADVERTÊNCIAS e PRECAUÇÕES sobre a consideração de outras condições urológicas ao prescrever o Proscar.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces demandes supplémentaires d’autorisation de nouveau médicament prévoient des révisions de la rubrique EFFETS INDÉSIRABLES, Expérience depuis la commercialisation, concernant la dépression, les troubles de l’érection, la diminution de la libido et l’infertilité masculine et/ou la mauvaise qualité du sperme, ainsi qu’une modification de la rubrique MISES EN GARDE et PRÉCAUTIONS concernant la prise en compte d’autres affections urologiques lors de la prescription de Proscar.",
                  "by": "ours"
                },
                "it": {
                  "text": "Queste domande supplementari di nuovo farmaco prevedono modifiche alla sezione ADVERSE REACTIONS, Postmarketing Experience dell’etichettatura relative a depressione, disfunzione erettile, diminuzione della libido e infertilità maschile e/o scarsa qualità del liquido seminale, nonché una modifica della sezione WARNINGS and PRECAUTIONS riguardo alla considerazione di altre condizioni urologiche quando si prescrive Proscar.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये पूरक नई दवा आवेदन (supplemental new drug applications) लेबल के ADVERSE REACTIONS, Postmarketing Experience सेक्शन में डिप्रेशन, स्तंभन दोष, कामेच्छा में कमी, और पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता से जुड़े संशोधनों का, और साथ ही Proscar लिखते समय मूत्र संबंधी दूसरी स्थितियों पर विचार करने से जुड़े WARNINGS and PRECAUTIONS सेक्शन में बदलाव का प्रावधान करते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the letter was read in full; it names the changes to the postmarketing section of the label and does not itself say that any side effect continued after the medicine was stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-regulator-approval201301proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-regulator-approval201301proscar",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL: NDA 020180/S-043",
            "lang": "en-US",
            "product": {
              "name": "Proscar",
              "form": "5 mg Tablets",
              "holder": "Merck Sharp & Dohme Corp."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020180Orig1s043ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2013-01-16",
            "textDateKind": "approval",
            "textDateAsPrinted": "01/16/2013"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "sexual-persistence",
              "section": [
                "SUPPLEMENT APPROVAL"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "This “Prior Approval” supplemental new drug application provides for changes to the ADVERSE REACTIONS, Postmarketing Experience section of the labeling related to sexual dysfunction that continued after discontinuation of treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dieser ergänzende Zulassungsantrag („Prior Approval“) sieht Änderungen im Abschnitt „ADVERSE REACTIONS, Postmarketing Experience“ der Fachinformation zu sexueller Dysfunktion vor, die nach dem Absetzen der Behandlung andauerte.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esta solicitud suplementaria de nuevo medicamento de «aprobación previa» prevé cambios en la sección REACCIONES ADVERSAS, Experiencia poscomercialización, de la ficha relacionados con la disfunción sexual que continuó después de la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Este pedido suplementar de novo medicamento do tipo “Prior Approval” prevê mudanças na seção REAÇÕES ADVERSAS, Experiência pós-comercialização, da rotulagem, relacionadas à disfunção sexual que continuou depois da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cette demande supplémentaire d’autorisation de nouveau médicament, de type « Prior Approval », prévoit des modifications de la rubrique EFFETS INDÉSIRABLES, Expérience depuis la commercialisation, concernant la dysfonction sexuelle qui a continué après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questa domanda supplementare di nuovo farmaco di tipo «Prior Approval» prevede modifiche alla sezione ADVERSE REACTIONS, Postmarketing Experience dell’etichettatura relative alla disfunzione sessuale che è proseguita dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह “Prior Approval” पूरक नई दवा आवेदन लेबल के ADVERSE REACTIONS, Postmarketing Experience सेक्शन में इलाज बंद करने के बाद भी जारी रहने वाले सेक्शुअल डिस्फ़ंक्शन से जुड़े बदलावों का प्रावधान करता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-regulator-approval202208propecia",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-regulator-approval202208propecia",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL: NDA 020788/S-030",
            "lang": "en-US",
            "product": {
              "name": "Propecia",
              "form": "tablets, 1mg",
              "holder": "Organon LLC"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020788Orig1s030ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2022-08-01",
            "textDateKind": "approval",
            "textDateAsPrinted": "08/01/2022"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "regulator-statement",
              "section": [
                "SUPPLEMENT APPROVAL"
              ],
              "since": null,
              "lang": "en-US",
              "text": "This information pertains to the risk of suicidal ideation and behavior, additional risk of sexual dysfunction and psychoneurocognitive adverse events with use of Propecia.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Information betrifft das Risiko von Suizidgedanken und suizidalem Verhalten, ein zusätzliches Risiko sexueller Dysfunktion und psychoneurokognitive Nebenwirkungen bei der Anwendung von Propecia.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esta información se refiere al riesgo de ideación y comportamiento suicidas, al riesgo adicional de disfunción sexual y a los acontecimientos adversos psiconeurocognitivos con el uso de Propecia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esta informação se refere ao risco de ideação e comportamento suicida, ao risco adicional de disfunção sexual e a eventos adversos psiconeurocognitivos com o uso do Propecia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cette information concerne le risque d’idées et de comportements suicidaires, le risque supplémentaire de dysfonction sexuelle et les événements indésirables psychoneurocognitifs liés à l’utilisation de Propecia.",
                  "by": "ours"
                },
                "it": {
                  "text": "Queste informazioni riguardano il rischio di ideazione e comportamento suicidari, il rischio aggiuntivo di disfunzione sessuale e gli eventi avversi psiconeurocognitivi con l’uso di Propecia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह जानकारी Propecia के उपयोग के साथ आत्महत्या के विचारों और व्यवहार के जोखिम, सेक्शुअल डिस्फ़ंक्शन के अतिरिक्त जोखिम और psychoneurocognitive प्रतिकूल घटनाओं से जुड़ी है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the letter was read in full; it names the risks the new information pertains to and does not itself say that any side effect continued after the medicine was stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-us-regulator-alert202504",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-us-regulator-alert202504",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products",
            "lang": "en-US",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "U.S. Food and Drug Administration"
            },
            "url": "https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-consumers-potential-risks-associated-compounded",
            "fetchedUrl": null,
            "textDate": "2025-04-22",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "Content current as of: 04/22/2025"
          },
          "passages": [
            {
              "key": "reports",
              "kind": "general-persistence",
              "section": [
                "Review and discussion"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Most of the reports FDA has received state the adverse events continued to persist after product discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die meisten der bei der FDA eingegangenen Meldungen geben an, dass die unerwünschten Ereignisse nach dem Absetzen des Produkts weiterhin anhielten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de las notificaciones que ha recibido la FDA indican que los acontecimientos adversos continuaron persistiendo después de suspender el producto.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria dos relatos que a FDA recebeu informa que os eventos adversos continuaram a persistir depois da descontinuação do produto.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart des signalements reçus par la FDA indiquent que les événements indésirables ont continué après l’arrêt du produit.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte delle segnalazioni ricevute dalla FDA riferisce che gli eventi avversi hanno continuato a persistere dopo l’interruzione del prodotto.",
                  "by": "ours"
                },
                "hi": {
                  "text": "FDA को मिली ज़्यादातर रिपोर्टें कहती हैं कि प्रतिकूल घटनाएँ उत्पाद बंद करने के बाद भी जारी रहीं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "events-reported",
              "kind": "qualification",
              "section": [
                "Review and discussion"
              ],
              "since": null,
              "qualifies": "reports",
              "lang": "en-US",
              "text": "There were 32 cases reported to the FDA Adverse Event Reporting System between 2019 and 2024. Absorption of finasteride through the skin into the bloodstream is expected, and the reports describe adverse events that are consistent with those reported in association with the approved oral finasteride products, such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain following the use of compounded topical products with finasteride alone or in combination with other active ingredients.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Zwischen 2019 und 2024 wurden dem FDA Adverse Event Reporting System 32 Fälle gemeldet. Die Aufnahme von Finasterid über die Haut in den Blutkreislauf ist zu erwarten, und die Meldungen beschreiben unerwünschte Ereignisse, die mit den im Zusammenhang mit den zugelassenen oralen Finasterid-Produkten berichteten übereinstimmen, etwa erektile Dysfunktion, Angst, Suizidgedanken, Brain Fog, Depression, Erschöpfung, Schlaflosigkeit, verminderte Libido und Hodenschmerzen, nach der Anwendung individuell zubereiteter (compounded) topischer Produkte mit Finasterid allein oder in Kombination mit anderen Wirkstoffen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Entre 2019 y 2024 se notificaron 32 casos al Sistema de Notificación de Acontecimientos Adversos de la FDA. Se espera que la finasterida se absorba a través de la piel hacia el torrente sanguíneo, y las notificaciones describen acontecimientos adversos coherentes con los notificados en asociación con los productos orales de finasterida autorizados, como disfunción eréctil, ansiedad, ideación suicida, niebla mental, depresión, fatiga, insomnio, disminución de la libido y dolor testicular tras el uso de productos tópicos magistrales con finasterida sola o combinada con otros principios activos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados 32 casos ao Sistema de Notificação de Eventos Adversos da FDA (FAERS) entre 2019 e 2024. A absorção da finasterida pela pele para a corrente sanguínea é esperada, e os relatos descrevem eventos adversos compatíveis com os relatados em associação com os produtos aprovados de finasterida oral, como disfunção erétil, ansiedade, ideação suicida, confusão mental (brain fog), depressão, fadiga, insônia, diminuição da libido e dor testicular após o uso de produtos tópicos manipulados com finasterida isolada ou em combinação com outros princípios ativos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Entre 2019 et 2024, 32 cas ont été signalés au système de signalement des événements indésirables de la FDA (FAERS). Une absorption du finastéride par la peau vers la circulation sanguine est attendue, et les signalements décrivent des événements indésirables conformes à ceux rapportés avec les produits approuvés de finastéride par voie orale, tels que troubles de l’érection, anxiété, idées suicidaires, brouillard mental, dépression, fatigue, insomnie, diminution de la libido et douleur testiculaire, après l’utilisation de produits topiques préparés par des pharmacies contenant du finastéride seul ou associé à d’autres principes actifs.",
                  "by": "ours"
                },
                "it": {
                  "text": "Tra il 2019 e il 2024 sono stati segnalati 32 casi al FDA Adverse Event Reporting System. L’assorbimento della finasteride attraverso la pelle nel flusso sanguigno è previsto, e le segnalazioni descrivono eventi avversi coerenti con quelli riportati in associazione ai prodotti orali a base di finasteride approvati, come disfunzione erettile, ansia, ideazione suicidaria, nebbia mentale, depressione, affaticamento, insonnia, diminuzione della libido e dolore testicolare, in seguito all’uso di prodotti topici galenici contenenti finasteride da sola o in combinazione con altri principi attivi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "2019 से 2024 के बीच FDA Adverse Event Reporting System में 32 मामले रिपोर्ट हुए। फ़िनास्टेराइड के त्वचा के रास्ते खून में पहुँचने की अपेक्षा की जाती है, और रिपोर्टें ऐसी प्रतिकूल घटनाओं का वर्णन करती हैं जो मंज़ूर मुँह से ली जाने वाली फ़िनास्टेराइड के साथ रिपोर्ट हुई घटनाओं से मेल खाती हैं, जैसे अकेली फ़िनास्टेराइड, या दूसरे सक्रिय तत्वों के साथ उसके कंपाउंड किए गए त्वचा पर लगाने वाले उत्पादों के उपयोग के बाद स्तंभन दोष, चिंता, आत्महत्या के विचार, ब्रेन फ़ॉग, डिप्रेशन, थकान, अनिद्रा, कामेच्छा में कमी और अंडकोष में दर्द।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the alert was read whole; its sentence about adverse events continuing after the product was stopped names no sexual function itself; the sentence before it lists the events reported, sexual ones among them",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: PrPROPECIA® finasteride tablets, Film-coated Tablets 1 mg, USP",
            "lang": "en-CA",
            "product": {
              "name": "Propecia",
              "form": "film-coated tablets 1 mg",
              "holder": "Organon Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00073610.PDF",
            "fetchedUrl": null,
            "textDate": "2023-11-24",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: NOV 24, 2023"
          },
          "passages": [
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Psychiatric disorders: mood alterations and depression, decreased libido that continued after discontinuation of treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Psychiatrische Erkrankungen: Stimmungsveränderungen und Depression, verminderte Libido, die nach dem Absetzen der Behandlung andauerte.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos psiquiátricos: alteraciones del estado de ánimo y depresión, disminución de la libido que continuó después de la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Transtornos psiquiátricos: alterações de humor e depressão, diminuição da libido que continuou depois da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles psychiatriques : altérations de l’humeur et dépression, diminution de la libido qui a continué après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi psichiatrici: alterazioni dell’umore e depressione, diminuzione della libido che è proseguita dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मानसिक विकार: मूड में बदलाव और डिप्रेशन, कामेच्छा में कमी जो इलाज बंद करने के बाद भी जारी रही।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, breast tenderness and enlargement, male breast cancer, testicular pain, hematospermia, male infertility and/or poor seminal quality.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Erkrankungen der Geschlechtsorgane und der Brustdrüse: sexuelle Dysfunktion (erektile Dysfunktion und Ejakulationsstörungen), die nach dem Absetzen der Behandlung andauerte, Berührungsempfindlichkeit und Vergrößerung der Brust, Brustkrebs beim Mann, Hodenschmerzen, Hämatospermie, Infertilität bei Männern und/oder schlechte Spermienqualität.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos del aparato reproductor y de la mama: disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó después de la interrupción del tratamiento, hipersensibilidad y crecimiento mamarios, cáncer de mama en varones, dolor testicular, hematospermia, infertilidad masculina y/o calidad seminal pobre.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Transtornos do sistema reprodutor e das mamas: disfunção sexual (disfunção erétil e distúrbios da ejaculação) que continuou depois da descontinuação do tratamento, sensibilidade e aumento das mamas, câncer de mama masculino, dor testicular, hematospermia, infertilidade masculina e/ou má qualidade do sêmen.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de l’appareil reproducteur et du sein : dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) qui a continué après l’arrêt du traitement, sensibilité et augmentation du volume des seins, cancer du sein chez l’homme, douleur testiculaire, hématospermie, infertilité masculine et/ou mauvaise qualité du sperme.",
                  "by": "ours"
                },
                "it": {
                  "text": "Patologie dell’apparato riproduttivo e della mammella: disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che è proseguita dopo l’interruzione del trattamento, tensione e aumento di volume della mammella, cancro della mammella nell’uomo, dolore testicolare, ematospermia, infertilità maschile e/o scarsa qualità del liquido seminale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र और स्तन के विकार: इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार), स्तनों में कोमलता और उनका बढ़ना, पुरुषों में स्तन कैंसर, अंडकोष में दर्द, वीर्य में खून (हीमैटोस्पर्मिया), पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-CA",
              "text": "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Da diese Reaktionen freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Como estas reacciones se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable la frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Como essas reações são relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência delas nem estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Comme ces réactions sont rapportées volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Poiché queste reazioni sono riportate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्योंकि ये प्रतिक्रियाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-ca-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca-leaflet",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: PrPROPECIA® Finasteride tablets",
            "lang": "en-CA",
            "product": {
              "name": "Propecia",
              "form": "film-coated tablets 1 mg",
              "holder": "Organon Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00073610.PDF",
            "fetchedUrl": null,
            "textDate": "2023-11-24",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: NOV 24, 2023"
          },
          "passages": [
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "What are possible side effects from using PROPECIA?",
                "Side effects may include:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "difficulty in achieving an erection that continued after stopping the medication;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauerten;",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para conseguir una erección que continuó después de dejar el medicamento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter uma ereção que continuou depois de parar o medicamento;",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir une érection qui a continué après l’arrêt du médicament ;",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà a ottenere un’erezione che è proseguita dopo l’interruzione del medicinale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत, जो दवा बंद करने के बाद भी जारी रही;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROPECIA?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "difficulty in achieving an erection;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen;",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para conseguir una erección;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter uma ereção;",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir une érection ;",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà a ottenere un’erezione;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROPECIA?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "less desire to have sex;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "weniger Lust auf Sex;",
                  "by": "ours"
                },
                "es": {
                  "text": "menos deseo sexual;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "menos desejo de fazer sexo;",
                  "by": "ours"
                },
                "fr": {
                  "text": "moins de désir sexuel ;",
                  "by": "ours"
                },
                "it": {
                  "text": "minore desiderio sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROPECIA?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "problems with ejaculation, such as a decrease in the amount of semen released during sex;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, etwa eine Abnahme der beim Sex abgegebenen Samenmenge;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación, como una disminución de la cantidad de semen expulsado durante el acto sexual;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação, como uma diminuição na quantidade de sêmen liberada durante o sexo;",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation, comme une diminution de la quantité de sperme émise pendant les rapports sexuels ;",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione, come una diminuzione della quantità di sperma emesso durante il rapporto sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-ca-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca-pro-proscar",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: PrPROSCAR® finasteride tablets, Film-coated Tablets 5 mg, USP",
            "lang": "en-CA",
            "product": {
              "name": "Proscar",
              "form": "film-coated tablets 5 mg",
              "holder": "Organon Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00073712.PDF",
            "fetchedUrl": null,
            "textDate": "2023-11-24",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: NOV 24, 2023"
          },
          "passages": [
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Psychiatric disorders: mood alterations and depression, decreased libido that continued after discontinuation of treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Psychiatrische Erkrankungen: Stimmungsveränderungen und Depression, verminderte Libido, die nach dem Absetzen der Behandlung andauerte.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos psiquiátricos: alteraciones del estado de ánimo y depresión, disminución de la libido que continuó después de la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Transtornos psiquiátricos: alterações de humor e depressão, diminuição da libido que continuou depois da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles psychiatriques : altérations de l’humeur et dépression, diminution de la libido qui a continué après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi psichiatrici: alterazioni dell’umore e depressione, diminuzione della libido che è proseguita dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मानसिक विकार: मूड में बदलाव और डिप्रेशन, कामेच्छा में कमी जो इलाज बंद करने के बाद भी जारी रही।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, male breast cancer, testicular pain, hematospermia, male infertility and/or poor seminal quality.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Erkrankungen der Geschlechtsorgane und der Brustdrüse: sexuelle Dysfunktion (erektile Dysfunktion und Ejakulationsstörungen), die nach dem Absetzen der Behandlung andauerte, Brustkrebs beim Mann, Hodenschmerzen, Hämatospermie, Infertilität bei Männern und/oder schlechte Spermienqualität.",
                  "by": "ours"
                },
                "es": {
                  "text": "Trastornos del aparato reproductor y de la mama: disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó después de la interrupción del tratamiento, cáncer de mama en varones, dolor testicular, hematospermia, infertilidad masculina y/o calidad seminal pobre.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Transtornos do sistema reprodutor e das mamas: disfunção sexual (disfunção erétil e distúrbios da ejaculação) que continuou depois da descontinuação do tratamento, câncer de mama masculino, dor testicular, hematospermia, infertilidade masculina e/ou má qualidade do sêmen.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de l’appareil reproducteur et du sein : dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) qui a continué après l’arrêt du traitement, cancer du sein chez l’homme, douleur testiculaire, hématospermie, infertilité masculine et/ou mauvaise qualité du sperme.",
                  "by": "ours"
                },
                "it": {
                  "text": "Patologie dell’apparato riproduttivo e della mammella: disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che è proseguita dopo l’interruzione del trattamento, cancro della mammella nell’uomo, dolore testicolare, ematospermia, infertilità maschile e/o scarsa qualità del liquido seminale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र और स्तन के विकार: इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार), पुरुषों में स्तन कैंसर, अंडकोष में दर्द, वीर्य में खून (हीमैटोस्पर्मिया), पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-CA",
              "text": "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Da diese Reaktionen freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Como estas reacciones se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable la frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Como essas reações são relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência delas nem estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Comme ces réactions sont rapportées volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Poiché queste reazioni sono riportate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्योंकि ये प्रतिक्रियाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-ca-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca-leaflet-proscar",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: PrPROSCAR® Finasteride tablets",
            "lang": "en-CA",
            "product": {
              "name": "Proscar",
              "form": "film-coated tablets 5 mg",
              "holder": "Organon Canada Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00073712.PDF",
            "fetchedUrl": null,
            "textDate": "2023-11-24",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: NOV 24, 2023"
          },
          "passages": [
            {
              "key": "listed-warnings",
              "kind": "sexual-side-effects",
              "section": [
                "Other warnings you should know about"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Combination therapy of PROSCAR and doxazosin may increase the chances of dizziness, postural hypotension (dizziness upon standing), weakness, impotence and abnormal ejaculation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Eine Kombinationstherapie aus PROSCAR und Doxazosin kann die Wahrscheinlichkeit für Schwindel, Blutdruckabfall beim Aufstehen (Schwindel beim Aufstehen), Schwäche, Impotenz und abnorme Ejakulation erhöhen.",
                  "by": "ours"
                },
                "es": {
                  "text": "El tratamiento combinado de PROSCAR y doxazosina puede aumentar las probabilidades de mareo, hipotensión postural (mareo al ponerse de pie), debilidad, impotencia y eyaculación anormal.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A terapia combinada de PROSCAR e doxazosina pode aumentar as chances de tontura, hipotensão postural (tontura ao ficar de pé), fraqueza, impotência e ejaculação anormal.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’association de PROSCAR et de doxazosine peut augmenter le risque de vertiges, d’hypotension orthostatique (vertiges en position debout), de faiblesse, d’impuissance et d’éjaculation anormale.",
                  "by": "ours"
                },
                "it": {
                  "text": "La terapia di associazione di PROSCAR e doxazosin può aumentare la probabilità di capogiro, ipotensione posturale (capogiro quando ci si alza in piedi), debolezza, impotenza ed eiaculazione anomala.",
                  "by": "ours"
                },
                "hi": {
                  "text": "PROSCAR और डॉक्साज़ोसिन का संयुक्त इलाज चक्कर आने, खड़े होने पर रक्तचाप गिरने (खड़े होने पर चक्कर आना), कमज़ोरी, स्तंभन दोष और असामान्य स्खलन की संभावना बढ़ा सकता है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROSCAR?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "impotence (an inability to have an erection);",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Impotenz (Unfähigkeit, eine Erektion zu bekommen);",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia (imposibilidad de tener una erección);",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência (incapacidade de ter uma ereção);",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance (incapacité à avoir une érection) ;",
                  "by": "ours"
                },
                "it": {
                  "text": "impotenza (incapacità di avere un’erezione);",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (इरेक्शन न कर पाना);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROSCAR?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "less desire to have sex;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "weniger Lust auf Sex;",
                  "by": "ours"
                },
                "es": {
                  "text": "menos deseo sexual;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "menos desejo de fazer sexo;",
                  "by": "ours"
                },
                "fr": {
                  "text": "moins de désir sexuel ;",
                  "by": "ours"
                },
                "it": {
                  "text": "minore desiderio sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "What are possible side effects from using PROSCAR?",
                "Side effects may include:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "problems with ejaculation that continued after stopping the medication;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauerten;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continuaron después de dejar el medicamento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação que continuaram depois de parar o medicamento;",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui ont continué après l’arrêt du médicament ;",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che sono proseguiti dopo l’interruzione del medicinale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जो दवा बंद करने के बाद भी जारी रहीं;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "What are possible side effects from using PROSCAR?",
                "Side effects may include:"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "problems with ejaculation, such as a decrease in the amount of semen released during sex;",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, etwa eine Abnahme der beim Sex abgegebenen Samenmenge;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación, como una disminución de la cantidad de semen expulsado durante el acto sexual;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação, como uma diminuição na quantidade de sêmen liberada durante o sexo;",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation, comme une diminution de la quantité de sperme émise pendant les rapports sexuels ;",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione, come una diminuzione della quantità di sperma emesso durante il rapporto sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-ca-regulator-review2026",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca-regulator-review2026",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Finasteride and Dutasteride - Assessing the Potential Risk of Sexual Dysfunction",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1778504746731",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "action",
              "kind": "regulator-statement",
              "section": [
                "Key Messages"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Health Canada will work with the manufacturers to enhance the existing product safety information in the Canadian product monograph (CPM) for all finasteride-containing products and dutasteride-containing products to also include a warning about the risk of sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die bestehenden Sicherheitsinformationen in der kanadischen Produktmonografie (Canadian Product Monograph, CPM) für alle finasterid- und dutasteridhaltigen Produkte um einen Warnhinweis zum Risiko sexueller Dysfunktion zu ergänzen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para reforzar la información de seguridad existente en la monografía de producto canadiense (CPM) de todos los productos que contienen finasterida y dutasterida, a fin de incluir también una advertencia sobre el riesgo de disfunción sexual.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para reforçar as informações de segurança existentes na monografia de produto canadense (CPM) de todos os produtos que contêm finasterida e dutasterida, para incluir também um alerta sobre o risco de disfunção sexual.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour renforcer les informations de sécurité existantes de la monographie de produit canadienne (MPC) de tous les produits contenant du finastéride et du dutastéride, afin d’y inclure aussi une mise en garde sur le risque de dysfonction sexuelle.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per rafforzare le informazioni di sicurezza esistenti nella monografia di prodotto canadese (CPM) di tutti i prodotti contenenti finasteride e dutasteride, includendovi anche un’avvertenza sul rischio di disfunzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada निर्माताओं के साथ मिलकर फ़िनास्टेराइड वाले सभी उत्पादों और ड्यूटास्टेराइड वाले सभी उत्पादों के कैनेडियन प्रोडक्ट मोनोग्राफ़ (CPM) में मौजूद सुरक्षा जानकारी को बेहतर बनाने का काम करेगी, ताकि उसमें सेक्शुअल डिस्फ़ंक्शन के जोखिम की चेतावनी भी शामिल हो।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "already-labelled",
              "kind": "qualification",
              "section": [
                "Overview"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "The risk of sexual dysfunction with the use of finasteride and dutasteride is known and labelled in the CPM for all finasteride-containing products and dutasteride-containing products.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Das Risiko sexueller Dysfunktion unter Finasterid und Dutasterid ist bekannt und in der CPM für alle finasterid- und dutasteridhaltigen Produkte angegeben.",
                  "by": "ours"
                },
                "es": {
                  "text": "El riesgo de disfunción sexual con el uso de finasterida y dutasterida es conocido y figura en la CPM de todos los productos que contienen finasterida y dutasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O risco de disfunção sexual com o uso de finasterida e dutasterida é conhecido e consta da CPM de todos os produtos que contêm finasterida e dutasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le risque de dysfonction sexuelle lié à l’utilisation du finastéride et du dutastéride est connu et figure dans la MPC de tous les produits contenant du finastéride et du dutastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "Il rischio di disfunzione sessuale con l’uso di finasteride e dutasteride è noto ed è indicato nella CPM di tutti i prodotti contenenti finasteride e dutasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड और ड्यूटास्टेराइड के उपयोग से सेक्शुअल डिस्फ़ंक्शन का जोखिम जाना-माना है, और फ़िनास्टेराइड वाले सभी उत्पादों और ड्यूटास्टेराइड वाले सभी उत्पादों के CPM में दर्ज है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, continu, after stopping, discontinu, long-lasting, irreversib, permanent, resolv, reversib, stop",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-ca-regulator-infowatch202606",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-ca-regulator-infowatch202606",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, June 2026",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2026/sc-hc/H167-1-2026-6-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2026-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "June 2026"
          },
          "passages": [
            {
              "key": "action",
              "kind": "regulator-statement",
              "section": [
                "MONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION",
                "Finasteride and dutasteride"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Health Canada will work with the manufacturers to enhance the product safety information in the Canadian product monograph for all finasteride-containing products and dutasteride-containing products to include a warning about the risk of sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Health Canada wird mit den Herstellern daran arbeiten, die Sicherheitsinformationen in der kanadischen Produktmonografie für alle finasterid- und dutasteridhaltigen Produkte um einen Warnhinweis zum Risiko sexueller Dysfunktion zu ergänzen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Health Canada trabajará con los fabricantes para reforzar la información de seguridad del producto en la monografía de producto canadiense de todos los productos que contienen finasterida y dutasterida, a fin de incluir una advertencia sobre el riesgo de disfunción sexual.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A Health Canada vai trabalhar com os fabricantes para reforçar as informações de segurança do produto na monografia de produto canadense de todos os produtos que contêm finasterida e dutasterida, para incluir um alerta sobre o risco de disfunção sexual.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Santé Canada travaillera avec les fabricants pour renforcer les informations de sécurité de la monographie de produit canadienne de tous les produits contenant du finastéride et du dutastéride, afin d’y inclure une mise en garde sur le risque de dysfonction sexuelle.",
                  "by": "ours"
                },
                "it": {
                  "text": "Health Canada collaborerà con i produttori per rafforzare le informazioni di sicurezza sul prodotto nella monografia di prodotto canadese di tutti i prodotti contenenti finasteride e dutasteride, includendovi un’avvertenza sul rischio di disfunzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Health Canada निर्माताओं के साथ मिलकर फ़िनास्टेराइड वाले सभी उत्पादों और ड्यूटास्टेराइड वाले सभी उत्पादों के कैनेडियन प्रोडक्ट मोनोग्राफ़ में मौजूद उत्पाद सुरक्षा जानकारी को बेहतर बनाने का काम करेगी, ताकि उसमें सेक्शुअल डिस्फ़ंक्शन के जोखिम की चेतावनी शामिल हो।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "published-may-2026",
              "kind": "qualification",
              "section": [
                "MONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION"
              ],
              "since": null,
              "qualifies": "action",
              "lang": "en-CA",
              "text": "The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in May 2026 by Health Canada.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es folgt eine Liste der Gesundheitsproduktwarnungen, der Arzneimittelrückrufe vom Typ I und der Zusammenfassungen abgeschlossener Sicherheitsüberprüfungen, die Health Canada im Mai 2026 veröffentlicht hat.",
                  "by": "ours"
                },
                "es": {
                  "text": "A continuación figura una lista de avisos sobre productos sanitarios, retiradas de medicamentos de tipo I y resúmenes de revisiones de seguridad finalizadas que Health Canada publicó en mayo de 2026.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A seguir, uma lista de avisos sobre produtos de saúde, recalls de medicamentos do tipo I e resumos de revisões de segurança concluídas, publicados em maio de 2026 pela Health Canada.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Voici la liste des avis sur les produits de santé, des rappels de médicaments de type I et des résumés d’examens de sécurité terminés, publiés en mai 2026 par Santé Canada.",
                  "by": "ours"
                },
                "it": {
                  "text": "Segue un elenco di avvisi sui prodotti sanitari, di ritiri di farmaci di tipo I e di sintesi di revisioni di sicurezza concluse, pubblicati a maggio 2026 da Health Canada.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह Health Canada द्वारा मई 2026 में प्रकाशित स्वास्थ्य उत्पाद एडवाइज़री, टाइप I दवा रिकॉल और पूरी हो चुकी सुरक्षा समीक्षाओं के सारांशों की सूची है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the recap item on finasteride and dutasteride was read whole; it has no sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION PROPECIA (finasteride) Tablets",
            "lang": "en-AU",
            "product": {
              "name": "PROPECIA",
              "form": null,
              "holder": "Organon Pharma Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-03381-3",
            "textDate": "2026-09-02",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.8",
                "Post-marketing experience"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "In section 4.8, under post-marketing experience, Australia's product information for Propecia lists a lower sex drive, and sexual dysfunction (erection and ejaculation problems), each as having gone on after the treatment was stopped.",
                "de": "In Abschnitt 4.8 führt die australische Fachinformation zu Propecia unter den Erfahrungen nach der Markteinführung ein vermindertes sexuelles Verlangen und sexuelle Funktionsstörungen (Erektions- und Ejakulationsstörungen) auf, jeweils als nach dem Absetzen der Behandlung anhaltend.",
                "es": "En la sección 4.8, en el apartado de experiencia poscomercialización, la información del producto australiana de Propecia recoge la disminución de la libido y la disfunción sexual (problemas de erección y de eyaculación), cada una como algo que continuó después de dejar el tratamiento.",
                "pt-br": "Na seção 4.8, em experiência pós-comercialização, a bula australiana do Propecia para o profissional de saúde lista diminuição do desejo sexual e disfunção sexual (problemas de ereção e de ejaculação), cada um como tendo continuado depois de parar o tratamento.",
                "fr": "À la rubrique 4.8, dans la partie consacrée à l’expérience depuis la commercialisation, les informations australiennes sur le produit Propecia citent une baisse du désir sexuel et une dysfonction sexuelle (troubles de l’érection et de l’éjaculation), chacune comme ayant continué après l’arrêt du traitement.",
                "it": "Nella sezione 4.8, sotto l’esperienza post-marketing, le informazioni sul prodotto di Propecia in Australia elencano una diminuzione del desiderio sessuale e una disfunzione sessuale (problemi di erezione e di eiaculazione), ciascuna come proseguita dopo l’interruzione del trattamento.",
                "hi": "सेक्शन 4.8 में, मार्केटिंग के बाद के अनुभव (post-marketing experience) के तहत, ऑस्ट्रेलिया में Propecia की प्रोडक्ट जानकारी कामेच्छा में कमी और सेक्शुअल डिस्फ़ंक्शन (इरेक्शन और स्खलन की समस्याएँ) को गिनाती है, और हर एक को ऐसी चीज़ बताती है जो इलाज बंद होने के बाद भी चलती रही।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "Section 4.8",
                "Post-marketing experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "summary": {
                "en": "The text says these reports come from a group of unknown size, so how often this happens, and whether the medicine is the cause, cannot always be established.",
                "de": "Der Text sagt, diese Berichte stammten aus einer Gruppe unbekannter Größe, weshalb sich nicht immer feststellen lasse, wie oft dies vorkommt und ob das Medikament die Ursache ist.",
                "es": "El texto dice que estas notificaciones proceden de un grupo de tamaño desconocido, por lo que no siempre puede establecerse con qué frecuencia ocurre ni si el medicamento es la causa.",
                "pt-br": "O texto diz que esses relatos vêm de um grupo de tamanho desconhecido, de modo que nem sempre é possível estabelecer com que frequência isso acontece, nem se o medicamento é a causa.",
                "fr": "Le texte indique que ces signalements proviennent d’un groupe de taille inconnue : on ne peut donc pas toujours établir la fréquence du phénomène, ni si le médicament en est la cause.",
                "it": "Il testo dice che queste segnalazioni provengono da un gruppo di dimensioni sconosciute, per cui non sempre è possibile stabilire con quale frequenza accada, né se il medicinale ne sia la causa.",
                "hi": "दस्तावेज़ कहता है कि ये रिपोर्टें अनिश्चित आकार के एक समूह से आती हैं, इसलिए यह हमेशा तय नहीं किया जा सकता कि ऐसा कितनी बार होता है, और कि दवा इसका कारण है या नहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PROPECIA Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "PROPECIA",
              "form": null,
              "holder": "Organon Pharma Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-04753-3",
            "textDate": "2026-09",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 6",
                "Less serious side effects"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "Australia's consumer medicine information for Propecia lists trouble getting an erection and a lower sex drive as side effects that go on after the medicine is stopped. In the same list it says that in clinical trials these effects went away in men who stopped taking it, and in many who carried on, and that ejaculation problems that go on after stopping are reported, though not often.",
                "de": "Die australische Packungsbeilage zu Propecia führt Schwierigkeiten, eine Erektion zu bekommen, und weniger sexuelles Verlangen als Nebenwirkungen auf, die nach dem Absetzen des Medikaments anhalten. In derselben Liste heißt es, in klinischen Studien seien diese Wirkungen bei Männern verschwunden, die das Medikament absetzten, und bei vielen, die es weiter einnahmen, und es werde berichtet, dass Ejakulationsstörungen nach dem Absetzen anhalten, wenn auch nicht oft.",
                "es": "El prospecto australiano de Propecia (Consumer Medicine Information) recoge la dificultad para tener una erección y la disminución de la libido como efectos secundarios que continúan después de dejar el medicamento. En la misma lista dice que, en los ensayos clínicos, estos efectos desaparecieron en los hombres que dejaron de tomarlo y en muchos de los que siguieron tomándolo, y que se han notificado problemas de eyaculación que continúan después de dejarlo, aunque no con frecuencia.",
                "pt-br": "A bula australiana do Propecia para pacientes lista dificuldade de ter ereção e diminuição do desejo sexual como efeitos colaterais que continuam depois de parar o medicamento. Na mesma lista, diz que, em estudos clínicos, esses efeitos desapareceram em homens que pararam de tomar e em muitos que continuaram, e que são relatados problemas de ejaculação que continuam depois de parar, embora não com frequência.",
                "fr": "En Australie, la notice de Propecia destinée aux patients cite les difficultés à obtenir une érection et la baisse du désir sexuel parmi les effets secondaires qui continuent après l’arrêt du médicament. Dans la même liste, elle indique que, dans les essais cliniques, ces effets ont disparu chez les hommes qui ont arrêté de le prendre, et chez beaucoup de ceux qui ont poursuivi le traitement, et que des troubles de l’éjaculation qui continuent après l’arrêt sont signalés, mais peu souvent.",
                "it": "Il foglio illustrativo australiano di Propecia (Consumer Medicine Information) elenca la difficoltà ad avere un’erezione e il calo del desiderio sessuale tra gli effetti collaterali che proseguono dopo l’interruzione del medicinale. Nello stesso elenco dice che negli studi clinici questi effetti sono scomparsi negli uomini che hanno smesso di prenderlo, e in molti di quelli che hanno proseguito, e che vengono segnalati, anche se non spesso, problemi di eiaculazione che proseguono dopo l’interruzione.",
                "hi": "ऑस्ट्रेलिया में Propecia का मरीज़ों वाला लीफ़लेट (consumer medicine information) इरेक्शन में दिक्कत और कामेच्छा में कमी को ऐसे साइड इफ़ेक्ट में गिनाता है, जो दवा बंद करने के बाद भी चलते रहते हैं। उसी सूची में वह कहता है कि क्लिनिकल ट्रायल में ये असर उन पुरुषों में खत्म हो गए जिन्होंने दवा लेना बंद किया, और दवा लेते रहने वाले कई पुरुषों में भी, और कि दवा बंद करने के बाद भी जारी रहने वाली स्खलन की समस्याएँ रिपोर्ट हुई हैं, हालाँकि अक्सर नहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-au-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-au-pro-proscar",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION PROSCAR (finasteride) Tablets",
            "lang": "en-AU",
            "product": {
              "name": "PROSCAR",
              "form": null,
              "holder": "Organon Pharma Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-03378-3",
            "textDate": "2026-09-02",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.8",
                "Post-Marketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "In section 4.8, under post-marketing experience, Australia's product information for Proscar lists a lower sex drive, and sexual dysfunction (erection and ejaculation problems), each as having gone on after the treatment was stopped.",
                "de": "In Abschnitt 4.8 führt die australische Fachinformation zu Proscar unter den Erfahrungen nach der Markteinführung ein vermindertes sexuelles Verlangen und sexuelle Funktionsstörungen (Erektions- und Ejakulationsstörungen) auf, jeweils als nach dem Absetzen der Behandlung anhaltend.",
                "es": "En la sección 4.8, en el apartado de experiencia poscomercialización, la información del producto australiana de Proscar recoge la disminución de la libido y la disfunción sexual (problemas de erección y de eyaculación), cada una como algo que continuó después de dejar el tratamiento.",
                "pt-br": "Na seção 4.8, em experiência pós-comercialização, a bula australiana do Proscar para o profissional de saúde lista diminuição do desejo sexual e disfunção sexual (problemas de ereção e de ejaculação), cada um como tendo continuado depois de parar o tratamento.",
                "fr": "À la rubrique 4.8, dans la partie consacrée à l’expérience depuis la commercialisation, les informations australiennes sur le produit Proscar citent une baisse du désir sexuel et une dysfonction sexuelle (troubles de l’érection et de l’éjaculation), chacune comme ayant continué après l’arrêt du traitement.",
                "it": "Nella sezione 4.8, sotto l’esperienza post-marketing, le informazioni sul prodotto di Proscar in Australia elencano una diminuzione del desiderio sessuale e una disfunzione sessuale (problemi di erezione e di eiaculazione), ciascuna come proseguita dopo l’interruzione del trattamento.",
                "hi": "सेक्शन 4.8 में, मार्केटिंग के बाद के अनुभव (post-marketing experience) के तहत, ऑस्ट्रेलिया में Proscar की प्रोडक्ट जानकारी कामेच्छा में कमी और सेक्शुअल डिस्फ़ंक्शन (इरेक्शन और स्खलन की समस्याएँ) को गिनाती है, और हर एक को ऐसी चीज़ बताती है जो इलाज बंद होने के बाद भी चलती रही।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "Section 4.8",
                "Post-Marketing Experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "summary": {
                "en": "The text says these reports are for Proscar or for finasteride at lower doses, and come from a group of unknown size, so how often this happens, and whether the medicine is the cause, cannot always be established.",
                "de": "Der Text sagt, diese Berichte beträfen Proscar oder Finasterid in niedrigeren Dosierungen und stammten aus einer Gruppe unbekannter Größe, weshalb sich nicht immer feststellen lasse, wie oft dies vorkommt und ob das Medikament die Ursache ist.",
                "es": "El texto dice que estas notificaciones corresponden a Proscar o a la finasterida en dosis más bajas y que proceden de un grupo de tamaño desconocido, por lo que no siempre puede establecerse con qué frecuencia ocurre ni si el medicamento es la causa.",
                "pt-br": "O texto diz que esses relatos são do Proscar ou da finasterida em doses menores e vêm de um grupo de tamanho desconhecido, de modo que nem sempre é possível estabelecer com que frequência isso acontece, nem se o medicamento é a causa.",
                "fr": "Le texte indique que ces signalements concernent Proscar ou le finastéride à doses plus faibles, et proviennent d’un groupe de taille inconnue : on ne peut donc pas toujours établir la fréquence du phénomène, ni si le médicament en est la cause.",
                "it": "Il testo dice che queste segnalazioni riguardano Proscar o la finasteride a dosi più basse, e provengono da un gruppo di dimensioni sconosciute, per cui non sempre è possibile stabilire con quale frequenza accada, né se il medicinale ne sia la causa.",
                "hi": "दस्तावेज़ कहता है कि ये रिपोर्टें Proscar या कम डोज़ की फ़िनास्टेराइड के लिए हैं और अनिश्चित आकार के एक समूह से आती हैं, इसलिए यह हमेशा तय नहीं किया जा सकता कि ऐसा कितनी बार होता है, और कि दवा इसका कारण है या नहीं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            },
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-au-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-au-leaflet-proscar",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PROSCAR Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "PROSCAR",
              "form": null,
              "holder": "Organon Pharma Pty Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-04754-3",
            "textDate": "2026-09",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 6",
                "Less serious side effects"
              ],
              "since": null,
              "inWarnings": false,
              "summary": {
                "en": "Australia's consumer medicine information for Proscar lists impotence, a lower sex drive and ejaculation problems as side effects that go on after the medicine is stopped. In the same list it says that in some cases these went away while the patient kept taking it, and that if they lasted they usually went away when the tablets were stopped.",
                "de": "Die australische Packungsbeilage zu Proscar führt Impotenz, weniger sexuelles Verlangen und Ejakulationsstörungen als Nebenwirkungen auf, die nach dem Absetzen des Medikaments anhalten. In derselben Liste heißt es, in einigen Fällen seien diese verschwunden, während der Patient das Medikament weiter einnahm, und wenn sie anhielten, seien sie in der Regel nach dem Absetzen der Tabletten verschwunden.",
                "es": "El prospecto australiano de Proscar (Consumer Medicine Information) recoge la impotencia, la disminución de la libido y los problemas de eyaculación como efectos secundarios que continúan después de dejar el medicamento. En la misma lista dice que, en algunos casos, estos desaparecieron mientras el paciente seguía tomándolo, y que, cuando duraron, por lo general desaparecieron al dejar de tomar los comprimidos.",
                "pt-br": "A bula australiana do Proscar para pacientes lista impotência, diminuição do desejo sexual e problemas de ejaculação como efeitos colaterais que continuam depois de parar o medicamento. Na mesma lista, diz que em alguns casos eles desapareceram enquanto o paciente continuava tomando, e que, quando duraram, geralmente desapareceram ao parar de tomar os comprimidos.",
                "fr": "En Australie, la notice de Proscar destinée aux patients cite l’impuissance, la baisse du désir sexuel et les troubles de l’éjaculation parmi les effets secondaires qui continuent après l’arrêt du médicament. Dans la même liste, elle indique que, dans certains cas, ils ont disparu alors que le patient continuait à prendre le médicament, et que, lorsqu’ils duraient, ils disparaissaient généralement à l’arrêt des comprimés.",
                "it": "Il foglio illustrativo australiano di Proscar (Consumer Medicine Information) elenca impotenza, calo del desiderio sessuale e problemi di eiaculazione tra gli effetti collaterali che proseguono dopo l’interruzione del medicinale. Nello stesso elenco dice che in alcuni casi questi sono scomparsi mentre il paziente continuava a prenderlo, e che, se sono durati, di solito sono scomparsi dopo la sospensione delle compresse.",
                "hi": "ऑस्ट्रेलिया में Proscar का मरीज़ों वाला लीफ़लेट (consumer medicine information) स्तंभन दोष (impotence), कामेच्छा में कमी और स्खलन की समस्याओं को ऐसे साइड इफ़ेक्ट में गिनाता है, जो दवा बंद करने के बाद भी चलते रहते हैं। उसी सूची में वह कहता है कि कुछ मामलों में ये तब खत्म हो गए जब मरीज़ दवा लेता रहा, और कि अगर ये बने रहे, तो गोलियाँ बंद करने पर आम तौर पर खत्म हो गए।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, PROPECIA",
            "lang": "en-NZ",
            "product": {
              "name": "Propecia",
              "form": "1 mg film coated tablet",
              "holder": "Organon (New Zealand) Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/p/Propeciatab.pdf",
            "fetchedUrl": null,
            "textDate": "2023-12-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT 11 December 2023"
          },
          "passages": [
            {
              "key": "listed-studies",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Adverse events identified during clinical trials"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "In these studies, the following medicine-related adverse experiences were reported in ≥ 1% of men treated with PROPECIA:\n• decreased libido (PROPECIA, 1.8% vs. placebo, 1.3%)\n• erectile dysfunction (1.3%, 0.7%).\nIn addition, decreased volume of ejaculate was reported in 0.8% of men treated with PROPECIA and 0.4% of men treated with placebo.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In diesen Studien wurden bei ≥ 1 % der mit PROPECIA behandelten Männer die folgenden arzneimittelbedingten unerwünschten Ereignisse berichtet:\n• verminderte Libido (PROPECIA 1,8 % vs. Placebo 1,3 %)\n• erektile Dysfunktion (1,3 %, 0,7 %).\nZusätzlich wurde bei 0,8 % der mit PROPECIA behandelten Männer und bei 0,4 % der mit Placebo behandelten Männer ein vermindertes Ejakulatvolumen berichtet.",
                  "by": "ours"
                },
                "es": {
                  "text": "En estos estudios, se notificaron las siguientes experiencias adversas relacionadas con el medicamento en ≥ 1% de los varones tratados con PROPECIA:\n• disminución de la libido (PROPECIA, 1,8% frente a placebo, 1,3%)\n• disfunción eréctil (1,3%, 0,7%).\nAdemás, se notificó una disminución del volumen de eyaculación en el 0,8% de los varones tratados con PROPECIA y en el 0,4% de los varones tratados con placebo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Nestes estudos, as seguintes experiências adversas relacionadas ao medicamento foram relatadas em ≥ 1% dos homens tratados com PROPECIA:\n• diminuição da libido (PROPECIA, 1,8% vs. placebo, 1,3%)\n• disfunção erétil (1,3%, 0,7%).\nAlém disso, diminuição do volume do ejaculado foi relatada em 0,8% dos homens tratados com PROPECIA e em 0,4% dos homens tratados com placebo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans ces études, les effets indésirables suivants, liés au médicament, ont été rapportés chez au moins 1 % des hommes traités par PROPECIA :\n• diminution de la libido (PROPECIA 1,8 % contre 1,3 % sous placebo)\n• troubles de l’érection (1,3 % contre 0,7 %).\nEn outre, une diminution du volume de l’éjaculat a été rapportée chez 0,8 % des hommes traités par PROPECIA et 0,4 % de ceux sous placebo.",
                  "by": "ours"
                },
                "it": {
                  "text": "In questi studi, le seguenti esperienze avverse correlate al medicinale sono state riportate nell’1% o più degli uomini trattati con PROPECIA:\n• diminuzione della libido (PROPECIA 1,8% contro placebo 1,3%)\n• disfunzione erettile (1,3%, 0,7%).\nInoltre, una diminuzione del volume dell’eiaculato è stata riportata nello 0,8% degli uomini trattati con PROPECIA e nello 0,4% degli uomini trattati con placebo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन अध्ययनों में PROPECIA से इलाज किए गए ≥ 1% पुरुषों में दवा से जुड़े ये प्रतिकूल अनुभव रिपोर्ट हुए:\n• कामेच्छा में कमी (PROPECIA में 1.8%, प्लेसीबो में 1.3%)\n• स्तंभन दोष (1.3%, 0.7%)।\nइसके अलावा, PROPECIA से इलाज किए गए 0.8% पुरुषों में और प्लेसीबो वाले 0.4% पुरुषों में स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी रिपोर्ट हुई।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "resolution",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects",
                "Adverse events identified during clinical trials"
              ],
              "since": null,
              "qualifies": "listed-studies",
              "lang": "en-NZ",
              "text": "Resolution of these adverse effects occurred in men who discontinued therapy with PROPECIA and in many who continued therapy. In a separate study, the effect of PROPECIA on ejaculate volume was measured and was not different from that seen with placebo. The incidence of each of the above adverse effects decreased to ≤ 0.3% by the fifth year of treatment with PROPECIA.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Nebenwirkungen bildeten sich bei Männern zurück, die die Therapie mit PROPECIA abbrachen, und bei vielen, die die Therapie fortsetzten. In einer gesonderten Studie wurde die Wirkung von PROPECIA auf das Ejakulatvolumen gemessen; sie unterschied sich nicht von der unter Placebo. Die Häufigkeit jeder der oben genannten Nebenwirkungen sank bis zum fünften Behandlungsjahr mit PROPECIA auf ≤ 0,3 %.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos adversos se resolvieron en los varones que interrumpieron el tratamiento con PROPECIA y en muchos de los que lo continuaron. En un estudio aparte se midió el efecto de PROPECIA sobre el volumen de eyaculación, que no fue distinto del observado con placebo. La incidencia de cada uno de los efectos adversos anteriores disminuyó hasta ≤ 0,3% en el quinto año de tratamiento con PROPECIA.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A resolução desses efeitos adversos ocorreu em homens que descontinuaram a terapia com PROPECIA e em muitos que continuaram a terapia. Em um estudo separado, o efeito do PROPECIA sobre o volume do ejaculado foi medido e não foi diferente do observado com placebo. A incidência de cada um dos efeitos adversos acima diminuiu para ≤ 0,3% até o quinto ano de tratamento com PROPECIA.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces effets indésirables ont disparu chez les hommes qui ont arrêté le traitement par PROPECIA et chez beaucoup de ceux qui l’ont poursuivi. Dans une étude distincte, l’effet de PROPECIA sur le volume de l’éjaculat a été mesuré et ne différait pas de celui observé sous placebo. L’incidence de chacun des effets indésirables ci-dessus a diminué à 0,3 % au plus à la cinquième année de traitement par PROPECIA.",
                  "by": "ours"
                },
                "it": {
                  "text": "La risoluzione di questi effetti avversi si è verificata negli uomini che hanno interrotto la terapia con PROPECIA e in molti di quelli che l’hanno proseguita. In uno studio separato è stato misurato l’effetto di PROPECIA sul volume dell’eiaculato, che non è risultato diverso da quello osservato con il placebo. L’incidenza di ciascuno degli effetti avversi sopra indicati è diminuita a ≤ 0,3% entro il quinto anno di trattamento con PROPECIA.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन प्रतिकूल प्रभावों में सुधार उन पुरुषों में हुआ जिन्होंने PROPECIA से इलाज बंद किया, और इलाज जारी रखने वाले कई पुरुषों में भी। एक अलग अध्ययन में वीर्य की मात्रा पर PROPECIA के असर को मापा गया और वह प्लेसीबो से अलग नहीं था। ऊपर के हर प्रतिकूल प्रभाव की दर PROPECIA से इलाज के पाँचवें साल तक घटकर ≤ 0.3% रह गई।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Adverse events identified during postmarketing experience",
                "Psychiatric disorders:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "decreased libido that continued after discontinuation of treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verminderte Libido, die nach dem Absetzen der Behandlung andauerte.",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido que continuó después de la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido que continuou depois da descontinuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido qui a continué après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido che è proseguita dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी, जो इलाज बंद करने के बाद भी जारी रही।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Adverse events identified during postmarketing experience",
                "Reproductive system and breast disorders:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "sexuelle Dysfunktion (erektile Dysfunktion und Ejakulationsstörungen), die nach dem Absetzen der Behandlung andauerte",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual (disfunção erétil e distúrbios da ejaculação) que continuou depois da descontinuação do tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) qui a continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che è proseguita dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार), जो इलाज बंद करने के बाद भी जारी रहा",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects",
                "Adverse events identified during postmarketing experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-NZ",
              "text": "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Da diese Reaktionen freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Como estas reacciones se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable la frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Como essas reações são relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência delas nem estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Comme ces réactions sont rapportées volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Poiché queste reazioni sono riportate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्योंकि ये प्रतिक्रियाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information (CMI), PROPECIA",
            "lang": "en-NZ",
            "product": {
              "name": "Propecia",
              "form": "1 mg tablet",
              "holder": "Organon New Zealand"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/Consumers/CMI/p/propecia.pdf",
            "fetchedUrl": null,
            "textDate": "2023-12",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was prepared in December 2023."
          },
          "passages": [
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "Adverse Effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "less desire for sex that continued after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "weniger Lust auf Sex, die nach dem Absetzen des Arzneimittels andauerte",
                  "by": "ours"
                },
                "es": {
                  "text": "menos deseo sexual que continuó después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "menos desejo de fazer sexo que continuou depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "moins de désir sexuel, qui a continué après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "minore desiderio sessuale che è proseguito dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "Adverse Effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "decreased amount of semen released during sex (this decrease does not appear to interfere with normal sexual function)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "verringerte beim Sex abgegebene Samenmenge (diese Abnahme scheint die normale Sexualfunktion nicht zu beeinträchtigen)",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la cantidad de semen expulsado durante el acto sexual (esta disminución no parece interferir con el funcionamiento sexual normal)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da quantidade de sêmen liberada durante o sexo (essa diminuição não parece interferir na função sexual normal)",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la quantité de sperme émise pendant les rapports sexuels (cette diminution ne semble pas gêner la fonction sexuelle normale)",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della quantità di sperma emesso durante il rapporto sessuale (questa diminuzione non sembra interferire con la normale funzione sessuale)",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी (यह कमी सामान्य यौन क्रिया में बाधा डालती नहीं लगती)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "Adverse Effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "problems with ejaculation that continue after stopping medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauern",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continúan después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação que continuam depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui continuent après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che continuano dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें, जो दवा बंद करने के बाद भी जारी रहती हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "Adverse Effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "difficulty in achieving an erection that continued after stopping the medication",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para conseguir una erección que continuó después de dejar el medicamento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter uma ereção que continuou depois de parar o medicamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir une érection qui a continué après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà a ottenere un’erezione che è proseguita dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत, जो दवा बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "Adverse Effects"
              ],
              "since": null,
              "qualifies": "persistence-erection",
              "lang": "en-NZ",
              "text": "Less desire for sex, difficulty in achieving an erection and decreased amount of semen released during sex occurred in less than two men in one hundred. It is important to understand that, in clinical trials, these unwanted effects disappeared in men who stopped taking PROPECIA, as well as in many men who continued treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Weniger Lust auf Sex, Schwierigkeiten, eine Erektion zu bekommen, und eine verringerte beim Sex abgegebene Samenmenge traten bei weniger als zwei von hundert Männern auf. Es ist wichtig zu verstehen, dass diese unerwünschten Wirkungen in klinischen Studien bei Männern verschwanden, die PROPECIA absetzten, und bei vielen Männern, die die Behandlung fortsetzten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Menos deseo sexual, dificultad para conseguir una erección y menor cantidad de semen expulsado durante el acto sexual se produjeron en menos de dos hombres de cada cien. Es importante entender que, en los ensayos clínicos, estos efectos no deseados desaparecieron en los hombres que dejaron de tomar PROPECIA, así como en muchos hombres que continuaron el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Menos desejo de fazer sexo, dificuldade de ter uma ereção e diminuição da quantidade de sêmen liberada durante o sexo ocorreram em menos de dois homens em cada cem. É importante entender que, em estudos clínicos, esses efeitos indesejados desapareceram em homens que pararam de tomar PROPECIA, assim como em muitos homens que continuaram o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Moins de désir sexuel, une difficulté à obtenir une érection et une diminution de la quantité de sperme émise pendant les rapports sexuels sont survenus chez moins de deux hommes sur cent. Il est important de comprendre que, dans les essais cliniques, ces effets indésirables ont disparu chez les hommes qui ont arrêté de prendre PROPECIA, ainsi que chez beaucoup d’hommes qui ont poursuivi le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Minore desiderio sessuale, difficoltà a ottenere un’erezione e diminuzione della quantità di sperma emesso durante il rapporto sessuale si sono verificati in meno di due uomini su cento. È importante capire che, negli studi clinici, questi effetti indesiderati sono scomparsi negli uomini che hanno smesso di prendere PROPECIA, come pure in molti uomini che hanno proseguito il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, इरेक्शन होने में दिक्कत और सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी सौ में से दो से कम पुरुषों में हुई। यह समझना ज़रूरी है कि क्लिनिकल ट्रायल में ये अनचाहे असर उन पुरुषों में खत्म हो गए जिन्होंने PROPECIA लेना बंद किया, और इलाज जारी रखने वाले कई पुरुषों में भी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-nz-pro-ricit",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-nz-pro-ricit",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Datasheet, Ricit",
            "lang": "en-NZ",
            "product": {
              "name": "Ricit",
              "form": "5 mg film coated tablets",
              "holder": "REX Medical Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/f/Finasteridetab.pdf",
            "fetchedUrl": null,
            "textDate": "2017-05-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT 5 May 2017"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas mais frequentes são impotência e diminuição da libido. Essas reações adversas ocorrem no início da terapia e desaparecem com a continuação do tratamento na maioria dos pacientes.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables les plus fréquents sont l’impuissance et la diminution de la libido. Ces effets indésirables apparaissent au début du traitement et disparaissent avec la poursuite du traitement chez la majorité des patients.",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza e diminuzione della libido sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सबसे आम प्रतिकूल प्रभाव स्तंभन दोष और कामेच्छा में कमी हैं। ये प्रभाव इलाज की शुरुआत में होते हैं और ज़्यादातर मरीज़ों में इलाज जारी रखने पर ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Psychiatric disorders"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "Common: decreased libido\nUnknown: decreased libido that may continue after discontinuation of therapy, depression",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Häufig: verminderte Libido\nNicht bekannt: verminderte Libido, die auch nach dem Absetzen der Therapie andauern kann, Depression",
                  "by": "ours"
                },
                "es": {
                  "text": "Frecuentes: disminución de la libido\nFrecuencia no conocida: disminución de la libido que puede continuar después de la interrupción del tratamiento, depresión",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Comum: diminuição da libido\nDesconhecida: diminuição da libido que pode continuar após a descontinuação da terapia, depressão",
                  "by": "ours"
                },
                "fr": {
                  "text": "Fréquent : diminution de la libido\nIndéterminée : diminution de la libido pouvant se poursuivre après l’arrêt du traitement, dépression",
                  "by": "ours"
                },
                "it": {
                  "text": "Comune: diminuzione della libido\nNon nota: diminuzione della libido che può proseguire dopo l’interruzione della terapia, depressione",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम: कामेच्छा में कमी\nअज्ञात: कामेच्छा में कमी, जो इलाज बंद करने के बाद भी बनी रह सकती है, डिप्रेशन",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "Common: impotence\nUncommon: ejaculation disorder, breast tenderness, breast enlargement.\nUnknown: testicular pain, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Häufig: Impotenz\nGelegentlich: Ejakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der Brust.\nNicht bekannt: Hodenschmerzen, sexuelle Funktionsstörung (erektile Dysfunktion und Ejakulationsstörung), die nach dem Absetzen der Behandlung andauern kann; Infertilität bei Männern und/oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet.",
                  "by": "ours"
                },
                "es": {
                  "text": "Frecuentes: impotencia\nPoco frecuentes: trastorno de la eyaculación, hipersensibilidad mamaria, crecimiento mamario.\nFrecuencia no conocida: dolor testicular, disfunción sexual (disfunción eréctil y trastorno de la eyaculación) que puede continuar después de la interrupción del tratamiento; infertilidad masculina y/o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Comum: impotência\nIncomum: distúrbio da ejaculação, sensibilidade nas mamas, aumento das mamas.\nDesconhecida: dor testicular, disfunção sexual (disfunção erétil e distúrbio da ejaculação) que pode continuar após a descontinuação do tratamento; infertilidade masculina e/ou má qualidade do sêmen. Foi relatada normalização ou melhora da qualidade do sêmen após a descontinuação da finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Fréquent : impuissance\nPeu fréquent : troubles de l’éjaculation, sensibilité des seins, augmentation du volume des seins.\nIndéterminée : douleur testiculaire, dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) pouvant se poursuivre après l’arrêt du traitement ; infertilité masculine et/ou mauvaise qualité du sperme. Une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "Comune: impotenza\nNon comune: disturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella.\nNon nota: dolore testicolare, disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che può proseguire dopo l’interruzione del trattamento; infertilità maschile e/o scarsa qualità del liquido seminale. Normalizzazione o miglioramento della qualità del liquido seminale è stata riportata dopo l’interruzione della finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम: स्तंभन दोष\nकम आम: स्खलन विकार, स्तनों में कोमलता, स्तनों का बढ़ना।\nअज्ञात: अंडकोष में दर्द, सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार), जो इलाज बंद करने के बाद भी बना रह सकता है; पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता। फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Undesirable effects"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-NZ",
              "text": "The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Häufigkeit der nach Markteinführung berichteten Nebenwirkungen kann nicht bestimmt werden, da es sich um Spontanberichte handelt.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de reacciones adversas notificada durante su uso después de la comercialización, no puede ser determinada, ya que derivan de informes espontáneos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência das reações adversas relatadas durante o uso pós-comercialização não pode ser determinada, pois elas derivam de relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence des effets indésirables rapportés depuis la mise sur le marché ne peut pas être déterminée, car ils proviennent de signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate durante l’uso post-marketing non può essere determinata, perché derivano da segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद के उपयोग में रिपोर्ट हुए प्रतिकूल प्रभावों की आवृत्ति तय नहीं की जा सकती, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-investigations",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Investigations"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "Common: decreased volume of ejaculate",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Häufig: vermindertes Ejakulatvolumen",
                  "by": "ours"
                },
                "es": {
                  "text": "Frecuentes: disminución del volumen de eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Comum: diminuição do volume do ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "Fréquent : diminution du volume de l’éjaculat",
                  "by": "ours"
                },
                "it": {
                  "text": "Comune: diminuzione del volume dell’eiaculato",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम: स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-nz-regulator-pu201603",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-nz-regulator-pu201603",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Post-Finasteride Syndrome",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/PUArticles/March2016/PostFinasterideSyndrome.htm",
            "fetchedUrl": null,
            "textDate": "2016-03-03",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 3 March 2016"
          },
          "passages": [
            {
              "key": "key-message",
              "kind": "sexual-persistence",
              "section": [
                "Key Messages"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "Symptoms (sexual, physical, and mental and neurological) often persist after the patient has stopped taking finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Symptome (sexuell, körperlich, psychisch und neurologisch) halten oft an, nachdem der Patient Finasterid abgesetzt hat.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los síntomas (sexuales, físicos, mentales y neurológicos) a menudo persisten después de que el paciente haya dejado de tomar finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sintomas (sexuais, físicos, mentais e neurológicos) muitas vezes persistem depois de o paciente parar de tomar finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les symptômes (sexuels, physiques, mentaux et neurologiques) persistent souvent après que le patient a arrêté de prendre du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "I sintomi (sessuali, fisici, mentali e neurologici) spesso persistono dopo che il paziente ha smesso di prendere la finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लक्षण (यौन, शारीरिक, और मानसिक व तंत्रिका संबंधी) अक्सर मरीज़ के फ़िनास्टेराइड लेना बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "in-some-men",
              "kind": "qualification",
              "section": [
                "Key Messages"
              ],
              "since": null,
              "qualifies": "key-message",
              "lang": "en-NZ",
              "text": "Post-Finasteride Syndrome can occur in some men who have taken finasteride.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Das Post-Finasterid-Syndrom kann bei einigen Männern auftreten, die Finasterid eingenommen haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "El síndrome post-finasterida puede aparecer en algunos hombres que han tomado finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A síndrome pós-finasterida pode ocorrer em alguns homens que tomaram finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Le syndrome post-finastéride peut survenir chez certains hommes qui ont pris du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "La sindrome post-finasteride può manifestarsi in alcuni uomini che hanno assunto la finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पोस्ट-फ़िनास्टेराइड सिंड्रोम (Post-Finasteride Syndrome) उन कुछ पुरुषों में हो सकता है जिन्होंने फ़िनास्टेराइड ली है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "markedOld",
              "text": {
                "en": "The regulator's page says this article is more than five years old and that some of its content may no longer be current.",
                "de": "Die Seite der Behörde gibt an, dieser Artikel sei mehr als fünf Jahre alt und manche Inhalte seien möglicherweise nicht mehr aktuell.",
                "es": "La página de la agencia del medicamento dice que este artículo tiene más de cinco años y que parte de su contenido puede no estar ya vigente.",
                "pt-br": "A página da agência reguladora diz que este artigo tem mais de cinco anos e que parte do conteúdo pode não estar mais atualizada.",
                "fr": "La page de l’agence du médicament indique que cet article date de plus de cinq ans et que certains de ses contenus ne sont peut-être plus à jour.",
                "it": "La pagina dell’agenzia del farmaco dice che questo articolo ha più di cinque anni e che parte del suo contenuto potrebbe non essere più attuale.",
                "hi": "नियामक का पेज कहता है कि यह लेख पाँच साल से ज़्यादा पुराना है और इसकी कुछ सामग्री शायद अब मौजूदा न हो।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation (Zusammenfassung der Merkmale des Arzneimittels)",
            "lang": "de",
            "product": {
              "name": "Propecia®",
              "form": "1 mg Filmtabletten",
              "holder": "Organon Healthcare GmbH"
            },
            "source": {
              "type": "holder",
              "name": "Organon Healthcare GmbH"
            },
            "url": "https://www.organon.com/germany/produkte/",
            "fetchedUrl": "https://www.fachinfo.de/webplugin/api/get?apiId=b74d0b8a64202a2173f1887c1e665671776f70b0",
            "textDate": "2025-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "09/2025"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen:",
                "Gelegentlich*"
              ],
              "since": null,
              "lang": "de",
              "text": "verminderte Libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse:",
                "Gelegentlich*"
              ],
              "since": null,
              "lang": "de",
              "text": "erektile Dysfunktion, Ejakulationsstörung (einschl. vermindertes Ejakulatvolumen)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção erétil, distúrbio da ejaculação (incluindo diminuição do volume do ejaculado)",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’érection, troubles de l’éjaculation (y compris diminution du volume de l’éjaculat)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, स्खलन विकार (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी सहित)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Nach Markteinführung wurde zusätzlich über Folgendes berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen von Finasterid; Brustkrebs beim Mann (siehe Abschnitt 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, the following has been reported after marketing: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after finasteride has been stopped; breast cancer in men (see section 4.4 Special warnings and precautions for use).",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasterida; cáncer de mama en varones (ver sección 4.4 Advertencias y precauciones especiales de empleo).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Depois da comercialização, também foi relatado o seguinte: persistência da disfunção sexual (diminuição da libido, disfunção erétil e distúrbios da ejaculação) depois de parar a finasterida; câncer de mama masculino (ver seção 4.4 Advertências e precauções especiais de uso).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Depuis la mise sur le marché, il a en outre été rapporté : persistance de troubles de la fonction sexuelle (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) après l’arrêt du finastéride ; cancer du sein chez l’homme (voir rubrique 4.4 Mises en garde spéciales et précautions d’emploi).",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, dopo la commercializzazione sono stati riportati: persistenza della disfunzione sessuale (diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione della finasteride; cancro della mammella nell’uomo (vedere paragrafo 4.4 Avvertenze speciali e precauzioni d’impiego).",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद इनकी भी रिपोर्ट हुई: फ़िनास्टेराइड बंद करने के बाद भी सेक्शुअल डिस्फ़ंक्शन का बने रहना (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार); पुरुषों में स्तन कैंसर (देखें सेक्शन 4.4 उपयोग के लिए विशेष चेतावनियाँ और सावधानियाँ)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "de",
              "text": "Die Häufigkeit der nach Markteinführung berichteten unerwünschten Ereignisse kann nicht bestimmt werden, da es sich um Spontanberichte handelt.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The frequency of the adverse events reported after marketing cannot be determined, as they come from spontaneous reports.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de reacciones adversas notificada durante su uso después de la comercialización, no puede ser determinada, ya que derivan de informes espontáneos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência dos eventos adversos relatados depois da comercialização não pode ser determinada, pois se trata de relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence des événements indésirables rapportés depuis la mise sur le marché ne peut pas être déterminée, car il s’agit de signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza degli eventi avversi riportati dopo la commercializzazione non può essere determinata, perché si tratta di segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद रिपोर्ट हुई अवांछित घटनाओं की आवृत्ति तय नहीं की जा सकती, क्योंकि वे स्वतःस्फूर्त रिपोर्टों पर आधारित हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-drug-related",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "lang": "de",
              "text": "Mit einer Häufigkeit von 3,8 % bzw. 2,1 % während der ersten 12 Monate waren sexuelle Nebenwirkungen bei den mit Finasterid behandelten Männern häufiger als bei den mit Placebo behandelten Männern. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern auf 0,6 % im Laufe der folgenden 4 Jahre. Ca. 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung aufgrund sexueller Nebenwirkungen während der ersten 12 Monate, danach nahm die Häufigkeit ab.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "With frequencies of 3.8% and 2.1% respectively during the first 12 months, sexual side effects were more common in men treated with finasteride than in men treated with placebo. The frequency of these side effects fell to 0.6% in men treated with finasteride over the following 4 years. About 1% of the men in each treatment group stopped treatment because of sexual side effects during the first 12 months; after that, the frequency decreased.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Com frequências de 3,8% e 2,1%, respectivamente, durante os primeiros 12 meses, os efeitos colaterais sexuais foram mais frequentes nos homens tratados com finasterida do que nos tratados com placebo. A frequência desses efeitos colaterais caiu para 0,6% nos homens tratados com finasterida ao longo dos 4 anos seguintes. Cerca de 1% dos homens de cada grupo de tratamento interrompeu o tratamento por efeitos colaterais sexuais durante os primeiros 12 meses; depois disso, a frequência diminuiu.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Avec des fréquences respectives de 3,8 % et 2,1 % au cours des 12 premiers mois, les effets indésirables sexuels ont été plus fréquents chez les hommes traités par finastéride que chez ceux traités par placebo. La fréquence de ces effets indésirables est descendue à 0,6 % chez les hommes traités par finastéride au cours des 4 années suivantes. Environ 1 % des hommes de chaque groupe de traitement ont arrêté le traitement en raison d’effets indésirables sexuels au cours des 12 premiers mois ; la fréquence a ensuite diminué.",
                  "by": "ours"
                },
                "it": {
                  "text": "Con frequenze rispettivamente del 3,8% e del 2,1% nei primi 12 mesi, gli effetti indesiderati sessuali sono stati più frequenti negli uomini trattati con finasteride che in quelli trattati con placebo. La frequenza di questi effetti indesiderati è scesa allo 0,6% negli uomini trattati con finasteride nel corso dei quattro anni successivi. Circa l’1% degli uomini di ciascun gruppo di trattamento ha interrotto il trattamento a causa di effetti indesiderati sessuali nei primi 12 mesi; in seguito la frequenza è diminuita.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पहले 12 महीनों में क्रमशः 3.8% और 2.1% की आवृत्ति के साथ, यौन साइड इफ़ेक्ट फ़िनास्टेराइड से इलाज किए गए पुरुषों में प्लेसीबो वाले पुरुषों से ज़्यादा आम थे। अगले 4 सालों में फ़िनास्टेराइड से इलाज किए गए पुरुषों में इन साइड इफ़ेक्ट की आवृत्ति घटकर 0.6% रह गई। हर इलाज समूह के लगभग 1% पुरुषों ने पहले 12 महीनों में यौन साइड इफ़ेक्ट के कारण इलाज बंद किया; उसके बाद आवृत्ति घटती गई।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-leaflet",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Anwender",
            "lang": "de",
            "product": {
              "name": "Propecia®",
              "form": "1 mg Filmtabletten",
              "holder": "Organon Healthcare GmbH"
            },
            "source": {
              "type": "holder",
              "name": "Organon Healthcare GmbH"
            },
            "url": "https://www.gebrauchsinformation4-0.de/pil/propecia-1-mg-filmtabletten~c4d01264-5931-5459-a524-9cb2bb3c3ecc/propecia-1-mg-filmtabletten~39ecaeb8-7d90-5700-9ba2-b92af48f7d54",
            "fetchedUrl": "https://www.gebrauchsinformation4-0.de/webplugin/api/get?apiId=0680569a7784c9cd4bf2bdd87bd502372eb22f14",
            "textDate": "2025-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Gebrauchsinformation wurde zuletzt überarbeitet im September 2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Gelegentlich: kann bis zu 1 von 100 Behandelten betreffen"
              ],
              "since": null,
              "lang": "de",
              "text": "vermindertes Verlangen nach Sex",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "reduced desire for sex",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "desejo sexual diminuído",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Gelegentlich: kann bis zu 1 von 100 Behandelten betreffen"
              ],
              "since": null,
              "lang": "de",
              "text": "Schwierigkeiten bei der Erektion",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty with erection",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades para lograr la erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficultés d’érection",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà nel raggiungimento dell’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन में दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Gelegentlich: kann bis zu 1 von 100 Behandelten betreffen"
              ],
              "since": null,
              "lang": "de",
              "text": "Störungen des Samenergusses einschließlich verminderter Samenergussmenge",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders, including a reduced amount of ejaculate",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación, incluida una disminución de la cantidad de semen eyaculado",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação, incluindo volume de ejaculado diminuído",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation, y compris diminution de la quantité de sperme éjaculée",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione, compresa una riduzione della quantità di sperma emesso",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में गड़बड़ी, जिसमें स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी भी शामिल है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "de",
              "text": "Die Nebenwirkungen waren während der Behandlung gewöhnlich vorübergehend oder verschwanden nach Abbruch der Behandlung.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects were usually temporary during treatment or disappeared when treatment was stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos han sido, normalmente, pasajeros con el tratamiento continuado o han desaparecido cuando el tratamiento se interrumpe.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais geralmente foram passageiros durante o tratamento ou desapareceram depois de interromper o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables étaient généralement passagers pendant le traitement ou ont disparu à l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono stati generalmente temporanei durante il trattamento o sono scomparsi dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर इलाज के दौरान अस्थायी थे, या इलाज बंद करने के बाद खत्म हो गए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-lead-in",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "nach dem Absetzen der Behandlung andauernde",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "lasting after treatment is stopped",
                  "by": "ours"
                },
                "es": {
                  "text": "persistentes después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "que continuam depois de parar o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "persistant après l’arrêt du traitement :",
                  "by": "ours"
                },
                "it": {
                  "text": "che continuano dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी जारी रहने वाली",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Schwierigkeiten bei der Erektion",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty with erection",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades para lograr la erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de ter ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficultés d’érection",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà nel raggiungimento dell’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन में दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Abnahme des sexuellen Verlangens",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decrease in sexual desire",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Ejakulationsschwierigkeiten",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty with ejaculation",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades con la eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldades de ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficultés d’éjaculation",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà di eiaculazione",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कतें",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-pro-proscar",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation (Zusammenfassung der Merkmale des Arzneimittels)",
            "lang": "de",
            "product": {
              "name": "PROSCAR®",
              "form": "5 mg Filmtabletten",
              "holder": "Organon Healthcare GmbH"
            },
            "source": {
              "type": "holder",
              "name": "Organon Healthcare GmbH"
            },
            "url": "https://www.organon.com/germany/produkte/",
            "fetchedUrl": "https://www.fachinfo.de/webplugin/api/get?apiId=1761230a02590aa56e7240f1e734e4d2f98985bf",
            "textDate": "2024-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "August 2024"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "lang": "de",
              "text": "Die häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The most common side effects are impotence and decreased libido. In most patients these side effects occur at the start of therapy and resolve as therapy continues.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais mais frequentes são impotência e diminuição da libido. Na maioria dos pacientes, esses efeitos colaterais aparecem no início da terapia e desaparecem no decorrer dela.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables les plus fréquents sont l’impuissance et la diminution de la libido. Chez la majorité des patients, ces effets indésirables apparaissent au début du traitement et disparaissent au cours du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza e diminuzione della libido sono gli effetti indesiderati più frequenti. Nella maggior parte dei pazienti questi effetti indesiderati si manifestano all’inizio della terapia e si risolvono nel corso della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सबसे आम साइड इफ़ेक्ट स्तंभन दोष और कामेच्छा में कमी हैं। ज़्यादातर मरीज़ों में ये साइड इफ़ेक्ट थेरेपी की शुरुआत में होते हैं और थेरेपी के दौरान ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "verminderte Libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Nebenwirkungen",
                "Psychiatrische Erkrankungen",
                "Nicht bekannt"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Depression; verminderte Libido, die auch nach dem Absetzen der Behandlung andauerte; Angst; Suizidgedanken",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Depression; decreased libido that continued even after treatment was stopped; anxiety; suicidal thoughts",
                  "by": "ours"
                },
                "es": {
                  "text": "depresión; disminución de la libido que continuó también después de interrumpir el tratamiento; ansiedad; ideación suicida",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Depressão; diminuição da libido que continuou mesmo depois de parar o tratamento; ansiedade; pensamentos suicidas",
                  "by": "ours"
                },
                "fr": {
                  "text": "dépression ; diminution de la libido qui a aussi persisté après l’arrêt du traitement ; anxiété ; idées suicidaires",
                  "by": "ours"
                },
                "it": {
                  "text": "Depressione; diminuzione della libido che è proseguita anche dopo l’interruzione del trattamento; ansia; ideazione suicidaria",
                  "by": "ours"
                },
                "hi": {
                  "text": "डिप्रेशन; कामेच्छा में कमी, जो इलाज बंद करने के बाद भी जारी रही; चिंता; आत्महत्या के विचार",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "Impotenz",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Gelegentlich"
              ],
              "since": null,
              "lang": "de",
              "text": "Ejakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der Brust",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Ejaculation disorders, breast tenderness, breast enlargement",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación, hipersensibilidad mamaria, crecimiento mamario",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação, sensibilidade ao toque nas mamas, aumento das mamas",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation, sensibilité des seins au toucher, augmentation du volume des seins",
                  "by": "ours"
                },
                "it": {
                  "text": "Disturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार, स्तनों को छूने पर संवेदनशीलता, स्तनों का बढ़ना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Nebenwirkungen",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Nicht bekannt"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Hodenschmerzen; Hämatospermie; sexuelle Funktionsstörungen (erektile Dysfunktion und Ejakulationsstörungen), die auch nach dem Absetzen der Behandlung andauerten; Infertilität bei Männern und/oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Testicular pain; haematospermia; sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued even after treatment was stopped; infertility in men and/or poor sperm quality. Normalisation or improvement of sperm quality has been reported after finasteride was stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "dolor testicular; hematospermia; disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó también después de interrumpir el tratamiento; infertilidad masculina y/o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Dor testicular; hematospermia; disfunções sexuais (disfunção erétil e distúrbios da ejaculação) que continuaram mesmo depois de parar o tratamento; infertilidade masculina e/ou má qualidade do sêmen. Foi relatada normalização ou melhora da qualidade do sêmen depois de parar a finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "douleur testiculaire ; hématospermie ; troubles de la fonction sexuelle (troubles de l’érection et troubles de l’éjaculation) qui ont aussi persisté après l’arrêt du traitement ; infertilité chez l’homme et/ou mauvaise qualité du sperme. Une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "Dolore testicolare; ematospermia; disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che è proseguita anche dopo l’interruzione del trattamento; infertilità maschile e/o scarsa qualità dello sperma. Normalizzazione o miglioramento della qualità dello sperma è stata riportata dopo l’interruzione della finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "अंडकोष में दर्द; वीर्य में खून (हीमैटोस्पर्मिया); यौन क्रिया के विकार (स्तंभन दोष और स्खलन विकार), जो इलाज बंद करने के बाद भी जारी रहे; पुरुषों में बाँझपन और/या वीर्य की खराब गुणवत्ता। फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Nebenwirkungen"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "de",
              "text": "Da die Nebenwirkungen, die nach Markteinführung für PROSCAR und/oder Finasterid in niedrigeren Dosierungen aus Spontanberichten aus einer Population unbestimmter Größe stammen, ist es nicht möglich, ihre Häufigkeit zuverlässig abzuschätzen bzw. einen Kausalzusammenhang mit der Anwendung des Arzneimittels nachzuweisen.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "As the side effects reported after marketing for PROSCAR and/or finasteride at lower doses come from spontaneous reports from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship with the use of the medicine.",
                  "by": "ours"
                },
                "es": {
                  "text": "Como las reacciones adversas notificadas después de la comercialización de PROSCAR y/o de finasterida en dosis más bajas proceden de notificaciones espontáneas de una población de tamaño indeterminado, no es posible estimar de forma fiable su frecuencia ni establecer una relación causal con el uso del medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Como os efeitos colaterais relatados depois da comercialização para o PROSCAR e/ou a finasterida em doses menores vêm de relatos espontâneos de uma população de tamanho indeterminado, não é possível estimar com segurança a frequência deles nem comprovar uma relação causal com o uso do medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables rapportés depuis la mise sur le marché pour PROSCAR et/ou pour le finastéride à doses plus faibles provenant de signalements spontanés d’une population de taille indéterminée, il n’est pas possible d’estimer leur fréquence de façon fiable ni de démontrer un lien de causalité avec l’utilisation du médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Poiché gli effetti indesiderati riportati dopo la commercializzazione per PROSCAR e/o per la finasteride a dosi più basse provengono da segnalazioni spontanee di una popolazione di dimensioni non definite, non è possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’uso del medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्योंकि बाज़ार में आने के बाद PROSCAR और/या कम डोज़ की फ़िनास्टेराइड के लिए रिपोर्ट हुए साइड इफ़ेक्ट अनिश्चित आकार की आबादी की स्वतःस्फूर्त रिपोर्टों से आते हैं, इसलिए उनकी आवृत्ति भरोसेमंद ढंग से आँकना, या दवा के उपयोग से कारण-संबंध साबित करना संभव नहीं है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-investigations-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Untersuchungen",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "vermindertes Ejakulatvolumen",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased volume of ejaculate",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del volumen de eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de l’éjaculat",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del volume dell’eiaculato",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-mtops",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Kombinationstherapie mit Doxazosin"
              ],
              "since": null,
              "lang": "de",
              "text": "Die folgenden Nebenwirkungen wurden häufiger berichtet, wenn PROSCAR zusammen mit dem alpha-Rezeptorenblocker Doxazosin angewendet wurde: Asthenie 16,8 % (Plazebo 7,1 %), posturale Hypotonie 17,8 % (Plazebo 8,0 %), Schwindel 23,2 % (Plazebo 8,1 %) und Ejakulationsstörungen 14,1 % (Plazebo 2,3 %).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The following side effects were reported more often when PROSCAR was used together with the alpha-blocker doxazosin: asthenia 16.8% (placebo 7.1%), postural hypotension 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%) and ejaculation disorders 14.1% (placebo 2.3%).",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas se notificaron con mayor frecuencia cuando PROSCAR se utilizó junto con el alfabloqueante doxazosina: astenia 16,8% (placebo 7,1%), hipotensión postural 17,8% (placebo 8,0%), mareo 23,2% (placebo 8,1%) y trastornos de la eyaculación 14,1% (placebo 2,3%).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais a seguir foram relatados com mais frequência quando o PROSCAR foi usado junto com o bloqueador alfa doxazosina: astenia 16,8% (placebo 7,1%), hipotensão postural 17,8% (placebo 8,0%), tontura 23,2% (placebo 8,1%) e distúrbios da ejaculação 14,1% (placebo 2,3%).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants ont été rapportés plus fréquemment lorsque PROSCAR était utilisé avec l’alphabloquant doxazosine : asthénie 16,8 % (placebo 7,1 %), hypotension orthostatique 17,8 % (placebo 8,0 %), vertiges 23,2 % (placebo 8,1 %) et troubles de l’éjaculation 14,1 % (placebo 2,3 %).",
                  "by": "ours"
                },
                "it": {
                  "text": "I seguenti effetti indesiderati sono stati riportati più spesso quando PROSCAR è stato usato insieme al bloccante alfa-adrenergico doxazosin: astenia 16,8% (placebo 7,1%), ipotensione posturale 17,8% (placebo 8,0%), capogiro 23,2% (placebo 8,1%) e disturbi dell’eiaculazione 14,1% (placebo 2,3%).",
                  "by": "ours"
                },
                "hi": {
                  "text": "जब PROSCAR को अल्फ़ा-रिसेप्टर ब्लॉकर डॉक्साज़ोसिन के साथ दिया गया, तब ये साइड इफ़ेक्ट ज़्यादा बार रिपोर्ट हुए: कमज़ोरी (एस्थीनिया) 16.8% (प्लेसीबो 7.1%), खड़े होने पर रक्तचाप गिरना 17.8% (प्लेसीबो 8.0%), चक्कर 23.2% (प्लेसीबो 8.1%) और स्खलन विकार 14.1% (प्लेसीबो 2.3%)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-leaflet-proscar",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Anwender",
            "lang": "de",
            "product": {
              "name": "PROSCAR®",
              "form": "5 mg Filmtabletten",
              "holder": "Organon Healthcare GmbH"
            },
            "source": {
              "type": "holder",
              "name": "Organon Healthcare GmbH"
            },
            "url": "https://www.gebrauchsinformation4-0.de/pil/proscar-5-mg-filmtabletten~0384d131-75fd-5700-b381-ba887f1d0121/proscar-5-mg-filmtabletten~64172cf6-9698-5db8-b7f9-2fb8c2285702",
            "fetchedUrl": "https://www.gebrauchsinformation4-0.de/webplugin/api/get?apiId=84a866cdd18e9f07687ac82b80c6cbc95a4a2524",
            "textDate": "2024-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im August 2024."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Häufig"
              ],
              "since": null,
              "lang": "de",
              "text": "verminderte Samenflüssigkeitsmenge (vermindertes Ejakulatvolumen), Störungen des sexuellen Reaktionsvermögens (Impotenz), verminderter Sexualtrieb (verminderte Libido).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "reduced amount of seminal fluid (decreased volume of ejaculate), disorders of sexual response (impotence), reduced sex drive (decreased libido).",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la cantidad de líquido seminal (disminución del volumen de eyaculación), alteraciones de la capacidad de respuesta sexual (impotencia), disminución del deseo sexual (disminución de la libido).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da quantidade de líquido seminal (diminuição do volume do ejaculado), distúrbios da capacidade de resposta sexual (impotência), diminuição do impulso sexual (diminuição da libido).",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la quantité de liquide séminal (diminution du volume de l’éjaculat), troubles de la réponse sexuelle (impuissance), diminution du désir sexuel (diminution de la libido).",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della quantità di liquido seminale (diminuzione del volume dell’eiaculato), disturbi della risposta sessuale (impotenza), diminuzione del desiderio sessuale (diminuzione della libido).",
                  "by": "ours"
                },
                "hi": {
                  "text": "वीर्य द्रव की मात्रा में कमी (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी), यौन प्रतिक्रिया में गड़बड़ी (स्तंभन दोष), यौन इच्छा में कमी (कामेच्छा में कमी)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Gelegentlich"
              ],
              "since": null,
              "lang": "de",
              "text": "Störungen des Samenergusses (Ejakulationsstörungen); Vergrößerung der Brust, Berührungsempfindlichkeit in der Brust, Hautausschlag.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "disorders of ejaculation (ejaculation disorders); breast enlargement, breast tenderness, skin rash.",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la expulsión del semen (trastornos de la eyaculación); crecimiento de la mama, hipersensibilidad en la mama, erupción cutánea.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação; aumento das mamas, sensibilidade ao toque nas mamas, erupção na pele.",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation ; augmentation du volume des seins, sensibilité des seins au toucher, éruption cutanée.",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’emissione del seme (disturbi dell’eiaculazione); aumento di volume della mammella, tensione della mammella, eruzione cutanea.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में गड़बड़ी (स्खलन विकार); स्तनों का बढ़ना, स्तनों में छूने पर संवेदनशीलता, त्वचा पर चकत्ते।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Nicht bekannt"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Juckreiz, erhöhte Leberwerte, Herzklopfen, Hodenschmerzen; Blut im Sperma, sexuelle Funktionsstörungen (Schwierigkeiten bei der Erektion und Störungen des Samenergusses), die auch nach dem Absetzen des Arzneimittels anhielten. Unfruchtbarkeit bei Männern und/oder eine schlechte Samenqualität. Nach dem Absetzen des Arzneimittels wurde über eine Verbesserung der Samenqualität berichtet. Depression; verminderter Sexualtrieb (verminderte Libido), der auch nach dem Absetzen der Behandlung andauerte; Angst; Selbstmordgedanken.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Itching, raised liver values, palpitations, testicular pain; blood in the sperm, sexual dysfunction (difficulty with erection and disorders of ejaculation) that persisted even after the medicine was stopped. Infertility in men and/or poor semen quality. An improvement in semen quality has been reported after the medicine was stopped. Depression; reduced sex drive (decreased libido) that continued even after treatment was stopped; anxiety; suicidal thoughts.",
                  "by": "ours"
                },
                "es": {
                  "text": "Picor, aumento de los valores hepáticos, palpitaciones, dolor testicular; sangre en el semen, disfunción sexual (dificultades con la erección y trastornos de la expulsión del semen) que continuó también después de dejar el medicamento. Infertilidad masculina y/o mala calidad seminal. Después de dejar el medicamento se notificó una mejora de la calidad seminal. Depresión; disminución del deseo sexual (disminución de la libido) que continuó también después de interrumpir el tratamiento; ansiedad; ideación suicida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Coceira, aumento das enzimas do fígado, palpitações, dor testicular; sangue no sêmen, disfunções sexuais (dificuldade de ter ereção e distúrbios da ejaculação) que continuaram mesmo depois de parar o medicamento. Infertilidade masculina e/ou má qualidade do sêmen. Depois de parar o medicamento, foi relatada melhora da qualidade do sêmen. Depressão; diminuição do impulso sexual (diminuição da libido) que continuou mesmo depois de parar o tratamento; ansiedade; pensamentos suicidas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Démangeaisons, augmentation des valeurs hépatiques, palpitations, douleur testiculaire ; sang dans le sperme, troubles de la fonction sexuelle (difficultés d’érection et troubles de l’éjaculation) qui ont aussi persisté après l’arrêt du médicament. Infertilité chez l’homme et/ou mauvaise qualité du sperme. Une amélioration de la qualité du sperme a été rapportée après l’arrêt du médicament. Dépression ; diminution du désir sexuel (diminution de la libido) qui a aussi persisté après l’arrêt du traitement ; anxiété ; pensées suicidaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "Prurito, aumento dei valori epatici, palpitazioni, dolore testicolare; sangue nello sperma, disfunzione sessuale (difficoltà nell’erezione e disturbi dell’emissione del seme) che è proseguita anche dopo l’interruzione del medicinale. Infertilità maschile e/o scarsa qualità del liquido seminale. Dopo l’interruzione del medicinale è stato riportato un miglioramento della qualità del liquido seminale. Depressione; diminuzione del desiderio sessuale (diminuzione della libido) che è proseguita anche dopo l’interruzione del trattamento; ansia; pensieri suicidi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "खुजली, लिवर एंज़ाइम का बढ़ना, दिल की धड़कन महसूस होना, अंडकोष में दर्द; वीर्य में खून, यौन क्रिया के विकार (इरेक्शन में दिक्कत और स्खलन में गड़बड़ी), जो दवा बंद करने के बाद भी बने रहे। पुरुषों में बाँझपन और/या वीर्य की खराब गुणवत्ता। दवा बंद करने के बाद वीर्य की गुणवत्ता में सुधार की रिपोर्ट हुई है। डिप्रेशन; यौन इच्छा में कमी (कामेच्छा में कमी), जो इलाज बंद करने के बाद भी जारी रही; चिंता; आत्महत्या के विचार।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Kombinationsbehandlung mit Doxazosin"
              ],
              "since": null,
              "lang": "de",
              "text": "Die folgenden Nebenwirkungen wurden häufiger berichtet, wenn PROSCAR zusammen mit dem alpha-Rezeptorenblocker Doxazosin angewendet wurde: Abgeschlagenheit 16,8 % (Scheinmedikament 7,1 %), Blutdruckabfall im Stehen 17,8 % (Scheinmedikament 8,0 %), Schwindel 23,2 % (Scheinmedikament 8,1 %) und Störungen des Samenergusses (Ejakulationsstörungen) 14,1 % (Scheinmedikament 2,3 %).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The following side effects were reported more often when PROSCAR was used together with the alpha-blocker doxazosin: tiredness 16.8% (dummy medicine 7.1%), drop in blood pressure on standing 17.8% (dummy medicine 8.0%), dizziness 23.2% (dummy medicine 8.1%) and disorders of ejaculation (ejaculation disorders) 14.1% (dummy medicine 2.3%).",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas se notificaron con mayor frecuencia cuando PROSCAR se utilizó junto con el alfabloqueante doxazosina: cansancio 16,8% (placebo 7,1%), bajada de la tensión arterial al ponerse de pie 17,8% (placebo 8,0%), mareo 23,2% (placebo 8,1%) y trastornos de la expulsión del semen (trastornos de la eyaculación) 14,1% (placebo 2,3%).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais a seguir foram relatados com mais frequência quando o PROSCAR foi usado junto com o bloqueador alfa doxazosina: cansaço 16,8% (medicamento simulado 7,1%), queda da pressão ao ficar de pé 17,8% (medicamento simulado 8,0%), tontura 23,2% (medicamento simulado 8,1%) e distúrbios da ejaculação 14,1% (medicamento simulado 2,3%).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants ont été rapportés plus fréquemment lorsque PROSCAR était utilisé avec l’alphabloquant doxazosine : fatigue 16,8 % (placebo 7,1 %), baisse de la tension en position debout 17,8 % (placebo 8,0 %), vertiges 23,2 % (placebo 8,1 %) et troubles de l’éjaculation 14,1 % (placebo 2,3 %).",
                  "by": "ours"
                },
                "it": {
                  "text": "I seguenti effetti indesiderati sono stati riportati più spesso quando PROSCAR è stato usato insieme al bloccante alfa-adrenergico doxazosin: stanchezza 16,8% (placebo 7,1%), calo di pressione in piedi 17,8% (placebo 8,0%), capogiro 23,2% (placebo 8,1%) e disturbi dell’emissione del seme (disturbi dell’eiaculazione) 14,1% (placebo 2,3%).",
                  "by": "ours"
                },
                "hi": {
                  "text": "जब PROSCAR को अल्फ़ा-रिसेप्टर ब्लॉकर डॉक्साज़ोसिन के साथ दिया गया, तब ये साइड इफ़ेक्ट ज़्यादा बार रिपोर्ट हुए: थकान 16.8% (डमी दवा 7.1%), खड़े होने पर रक्तचाप गिरना 17.8% (डमी दवा 8.0%), चक्कर 23.2% (डमी दवा 8.1%) और स्खलन में गड़बड़ी (स्खलन विकार) 14.1% (डमी दवा 2.3%)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-regulator-rhb201807",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-regulator-rhb201807",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Rote-Hand-Brief zu Finasterid: Risiko sexueller Dysfunktionen und psychischer Störungen",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RHB/2018/rhb-finasterid.html",
            "fetchedUrl": null,
            "textDate": "2018-07-05",
            "textDateKind": "publication",
            "textDateAsPrinted": "05.07.2018"
          },
          "passages": [
            {
              "key": "inform",
              "kind": "sexual-persistence",
              "section": [
                "Zusammenfassung"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Patienten sollten ebenfalls darüber informiert werden, dass sexuelle Dysfunktionen - basierend auf einzelnen Fallberichten über Patienten - auch nach Absetzen der Therapie länger als 10 Jahre fortbestehen können.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Patients should also be informed that, on the basis of individual case reports on patients, sexual dysfunction may persist for more than 10 years even after therapy has been stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "También debe informarse a los pacientes de que, según casos notificados de forma individual, la disfunción sexual puede persistir más de 10 años después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os pacientes também devem ser informados de que, com base em relatos de casos isolados, as disfunções sexuais podem persistir por mais de 10 anos depois de parar a terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les patients doivent aussi être informés que, d’après des cas isolés rapportés, une dysfonction sexuelle peut persister plus de 10 ans après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "I pazienti dovrebbero inoltre essere informati che, sulla base di segnalazioni di singoli casi, le disfunzioni sessuali possono persistere per più di 10 anni anche dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों को यह भी बताया जाना चाहिए कि अलग-अलग मरीज़ों के मामलों की रिपोर्टों के आधार पर, सेक्शुअल डिस्फ़ंक्शन थेरेपी बंद करने के बाद 10 साल से ज़्यादा समय तक भी बना रह सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-regulator-bulletin201809",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-regulator-bulletin201809",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bulletin zur Arzneimittelsicherheit, Ausgabe 3, September 2018: „Depressionen und sexuelle Funktionsstörungen unter Anwendung von Finasterid zur Behandlung der androgenetischen Alopezie“",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Bulletin/2018/3-2018.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2018-09",
            "textDateKind": "publication",
            "textDateAsPrinted": "Ausgabe 3 | September 2018"
          },
          "passages": [
            {
              "key": "product-information",
              "kind": "sexual-persistence",
              "section": [
                "AKTUELLE ANGABEN IN DEN PRODUKTINFORMATIONEN"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "de",
              "text": "Es wird darauf hingewiesen, dass sexuelle Dysfunktionen (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach Absetzen der Therapie persistieren können.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "It is pointed out that sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) may persist after therapy is stopped.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se señala que la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) puede persistir después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Chama-se a atenção para o fato de que as disfunções sexuais (diminuição da libido, disfunção erétil e distúrbios da ejaculação) podem persistir depois de parar a terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Il est précisé que des dysfonctions sexuelles (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Si segnala che le disfunzioni sessuali (diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione) possono persistere dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ध्यान दिलाया जाता है कि सेक्शुअल डिस्फ़ंक्शन (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार) थेरेपी बंद करने के बाद भी बना रह सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-de-regulator-rhb202509",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-regulator-rhb202509",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Rote-Hand-Brief zu Finasterid und Dutasterid: Neue Maßnahmen zur Minimierung des Risikos für Suizidgedanken",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RHB/2025/rhb-finasterid.html",
            "fetchedUrl": null,
            "textDate": "2025-09-15",
            "textDateKind": "publication",
            "textDateAsPrinted": "15.09.2025"
          },
          "passages": [],
          "searched": "and searched for \"andauer\", \"anhalt\", \"persist\", \"fortbesteh\", \"bestehen bleib\", \"nach dem Absetzen\", \"nach Absetzen\", \"nach Beendigung\": no hit in the letter or on the BfArM's page for it",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-de-leaflet-card",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-de-leaflet-card",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Patientenkarte zur sicheren Anwendung",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/EducationMaterial/Anlagen/a-f/finasterid-harmonisiert-patienten.pdf?__blob=publicationFile",
            "fetchedUrl": null,
            "textDate": "2025-10",
            "textDateKind": "publication",
            "textDateAsPrinted": "Version: 1.0, Stand: 10/2025"
          },
          "passages": [],
          "searched": ": it has NO sentence about sexual side effects continuing after stopping (no \"Absetzen\", \"andauer\", \"anhalt\", \"persist\")",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "FINASTERIDE ARROW LAB",
              "form": "1 mg, comprimé pelliculé",
              "holder": "ARROW GENERIQUES"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62120177/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62120177/extrait",
            "textDate": "2026-01-05",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 05/01/2026"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques",
                "Peu fréquent*"
              ],
              "since": null,
              "lang": "fr",
              "text": "baisse de la libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Peu fréquent*"
              ],
              "since": null,
              "lang": "fr",
              "text": "troubles de l'érection, troubles de l'éjaculation (y compris diminution du volume de l'éjaculat)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erection disorders, ejaculation disorders (including decreased volume of ejaculate)",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion, Ejakulationsstörungen (einschließlich vermindertes Ejakulatvolumen)",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ereção, distúrbios da ejaculação (incluindo diminuição do volume do ejaculado)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन की समस्याएँ, स्खलन की समस्याएँ (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी सहित)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "De plus, depuis la mise sur le marché, les effets indésirables suivants ont été rapportés : persistance des troubles de la fonction sexuelle (baisse de la libido, troubles de l'érection et de l'éjaculation) après l'arrêt du traitement par finastéride ; cancer du sein chez l'homme (voir rubrique 4.4 « Mises en garde spéciales et précautions d'emploi »).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, since marketing, the following adverse effects have been reported: persistence of sexual function disorders (decreased libido, erection and ejaculation disorders) after treatment with finasteride has been stopped; breast cancer in men (see section 4.4 “Special warnings and precautions for use”).",
                  "by": "ours"
                },
                "de": {
                  "text": "Außerdem wurden seit der Markteinführung die folgenden Nebenwirkungen berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen der Behandlung mit Finasterid; Brustkrebs beim Mann (siehe Abschnitt 4.4 „Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung“).",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasterida; cáncer de mama en varones (ver sección 4.4 Advertencias y precauciones especiales de empleo).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, desde a comercialização, os seguintes efeitos indesejáveis foram relatados: persistência dos distúrbios da função sexual (diminuição da libido, distúrbios da ereção e da ejaculação) depois de parar o tratamento com finasterida; câncer de mama no homem (ver seção 4.4 “Advertências especiais e precauções de uso”).",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, dopo la commercializzazione sono state riportate le seguenti reazioni avverse: persistenza della disfunzione sessuale (diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasteride; cancro della mammella nell’uomo (vedere paragrafo 4.4 «Avvertenze speciali e precauzioni d’impiego»).",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, बाज़ार में आने के बाद से ये साइड इफ़ेक्ट रिपोर्ट हुए हैं: फ़िनास्टेराइड से इलाज बंद करने के बाद भी यौन क्रिया की समस्याओं का बने रहना (कामेच्छा में कमी, इरेक्शन और स्खलन की समस्याएँ); पुरुषों में स्तन कैंसर (देखें सेक्शन 4.4 « विशेष चेतावनियाँ और उपयोग की सावधानियाँ »)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "fr",
              "text": "La fréquence des effets indésirables rapportés depuis la commercialisation ne peut être déterminée dans la mesure où elle découle de cas de pharmacovigilance spontanés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The frequency of the adverse effects reported since marketing cannot be determined, as it derives from spontaneous pharmacovigilance cases.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit der seit der Markteinführung berichteten Nebenwirkungen kann nicht bestimmt werden, da sie auf Spontanmeldungen aus der Pharmakovigilanz beruht.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de reacciones adversas notificada durante su uso después de la comercialización, no puede ser determinada, ya que derivan de informes espontáneos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência dos efeitos indesejáveis relatados desde a comercialização não pode ser determinada, na medida em que decorre de casos espontâneos de farmacovigilância.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate dopo la commercializzazione non può essere determinata, in quanto deriva da segnalazioni spontanee di farmacovigilanza.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद से रिपोर्ट हुए साइड इफ़ेक्ट की आवृत्ति तय नहीं की जा सकती, क्योंकि वह स्वतःस्फूर्त फ़ार्माकोविजिलेंस मामलों से आती है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-drug-related",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "lang": "fr",
              "text": "Les effets indésirables sexuels ont été plus fréquents chez les hommes traités par le finastéride que chez les hommes recevant le placebo, avec des fréquences respectives de 3,8 % vs 2,1 % pendant les 12 premiers mois. L'incidence de ces effets a diminué à 0,6 % chez les hommes traités par le finastéride au cours des quatre années suivantes. Environ 1 % des hommes (dans chaque groupe) ont arrêté le traitement au cours des 12 premiers mois en raison d'effets indésirables sexuels liés au traitement. Cette incidence a diminué par la suite.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual adverse effects were more frequent in men treated with finasteride than in men receiving placebo, with frequencies of 3.8% and 2.1% respectively during the first 12 months. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men (in each group) stopped treatment during the first 12 months because of treatment-related sexual adverse effects. This incidence decreased thereafter.",
                  "by": "ours"
                },
                "de": {
                  "text": "Arzneimittelbedingte sexuelle Nebenwirkungen waren bei den mit Finasterid behandelten Männern häufiger als bei den Männern, die Placebo erhielten, mit Häufigkeiten von 3,8 % bzw. 2,1 % während der ersten 12 Monate. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern im Laufe der folgenden vier Jahre auf 0,6 %. Etwa 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung in den ersten 12 Monaten aufgrund behandlungsbedingter sexueller Nebenwirkungen. Diese Häufigkeit nahm danach ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis sexuais foram mais frequentes nos homens tratados com finasterida do que nos que receberam placebo, com frequências respectivas de 3,8% vs 2,1% durante os 12 primeiros meses. A incidência desses efeitos diminuiu para 0,6% nos homens tratados com finasterida ao longo dos quatro anos seguintes. Cerca de 1% dos homens (em cada grupo) interrompeu o tratamento durante os 12 primeiros meses por efeitos indesejáveis sexuais ligados ao tratamento. Essa incidência diminuiu depois.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sessuali sono stati più frequenti negli uomini trattati con finasteride che in quelli trattati con placebo, con frequenze rispettivamente del 3,8% contro il 2,1% nei primi 12 mesi. L’incidenza di tali effetti è diminuita allo 0,6% negli uomini trattati con finasteride nel corso dei quattro anni successivi. Circa l’1% degli uomini (in ciascun gruppo) ha interrotto il trattamento nei primi 12 mesi a causa di effetti indesiderati sessuali correlati al trattamento. In seguito questa incidenza è diminuita.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पहले 12 महीनों में क्रमशः 3.8% बनाम 2.1% की आवृत्ति के साथ, यौन साइड इफ़ेक्ट फ़िनास्टेराइड से इलाज किए गए पुरुषों में प्लेसीबो लेने वाले पुरुषों से ज़्यादा आम थे। अगले चार सालों में फ़िनास्टेराइड से इलाज किए गए पुरुषों में इन प्रभावों की दर घटकर 0.6% रह गई। (हर समूह के) लगभग 1% पुरुषों ने पहले 12 महीनों में इलाज से जुड़े यौन साइड इफ़ेक्ट के कारण इलाज बंद किया। उसके बाद यह दर घटती गई।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-leaflet",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "FINASTERIDE ARROW LAB",
              "form": "1 mg, comprimé pelliculé",
              "holder": "ARROW GENERIQUES"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62120177/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62120177/extrait",
            "textDate": "2026-01-05",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 05/01/2026"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "diminution de la libido ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido;",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes Verlangen nach Sex;",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido;",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "troubles de l'érection ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erection problems;",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten bei der Erektion;",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades para lograr la erección;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ereção;",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà nel raggiungimento dell’erezione;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन की समस्याएँ;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :"
              ],
              "since": null,
              "lang": "fr",
              "text": "problèmes d'éjaculation, tels qu'une diminution du volume de l'éjaculat ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation problems, such as a decrease in the volume of ejaculate;",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, etwa eine verminderte Samenergussmenge;",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación, como una disminución del volumen de eyaculación;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas de ejaculação, como uma diminuição do volume do ejaculado;",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi con l’eiaculazione, quali una riduzione della quantità di sperma emesso;",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जैसे स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "fr",
              "text": "Les effets indésirables ont généralement été transitoires pendant le traitement ou ont disparu à l'arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects were generally temporary during treatment or disappeared when treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen waren während der Behandlung gewöhnlich vorübergehend oder verschwanden nach Abbruch der Behandlung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos han sido, normalmente, pasajeros con el tratamiento continuado o han desaparecido cuando el tratamiento se interrumpe.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis geralmente foram transitórios durante o tratamento ou desapareceram ao parar o tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono stati generalmente temporanei durante il trattamento o sono regrediti con l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर इलाज के दौरान अस्थायी रहे, या इलाज बंद करने पर खत्म हो गए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "persistance de difficultés à avoir des érections après l’arrêt du traitement ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent difficulty in having erections after treatment is stopped;",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Schwierigkeiten bei der Erektion nach dem Absetzen der Behandlung;",
                  "by": "ours"
                },
                "es": {
                  "text": "persistencia de dificultades para tener erección después de interrumpir el tratamiento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "persistência de dificuldades para ter ereções depois de parar o tratamento;",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà persistente ad avere una erezione dopo l’interruzione del trattamento;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी इरेक्शन होने में बनी रहने वाली दिक्कतें;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "diminution de la libido persistant après l’arrêt du traitement ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido persisting after treatment is stopped;",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen der Behandlung anhält;",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido que persiste después de interrumpir el tratamiento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido que persiste depois de parar o tratamento;",
                  "by": "ours"
                },
                "it": {
                  "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento;",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी, जो इलाज बंद करने के बाद भी बनी रही;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "persistance de troubles de l’éjaculation après l’arrêt du traitement ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent ejaculation problems after treatment is stopped;",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Ejakulationsschwierigkeiten nach dem Absetzen der Behandlung;",
                  "by": "ours"
                },
                "es": {
                  "text": "persistencia de trastornos de la eyaculación después de interrumpir el tratamiento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "persistência de distúrbios da ejaculação depois de parar o tratamento;",
                  "by": "ours"
                },
                "it": {
                  "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी स्खलन की समस्याओं का बने रहना;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-pro-proscar",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "CHIBRO-PROSCAR",
              "form": "5 mg, comprimé pelliculé",
              "holder": "ORGANON France"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67954321/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67954321/extrait",
            "textDate": "2024-07-19",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 19/07/2024"
          },
          "passages": [
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Effets indésirables",
                "Affections psychiatriques"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "diminution de la libido persistant à l'arrêt du traitement",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido persisting when treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido, die nach dem Absetzen der Behandlung anhält",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido que persiste al interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido que persiste ao parar o tratamento",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido persistente dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी, जो इलाज बंद करने पर भी बनी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Effets indésirables",
                "Affections des organes de reproduction et du sein"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "anomalies de la fonction sexuelle (troubles de l'érection et de l’éjaculation) persistant à l'arrêt du traitement",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "anomalies of sexual function (erection and ejaculation disorders) persisting when treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Funktionsstörungen (erektile Dysfunktion und Ejakulationsstörungen), die nach dem Absetzen der Behandlung anhalten",
                  "by": "ours"
                },
                "es": {
                  "text": "anomalías de la función sexual (trastornos de la erección y de la eyaculación) que persisten al interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "anomalias da função sexual (distúrbios da ereção e da ejaculação) que persistem ao parar o tratamento",
                  "by": "ours"
                },
                "it": {
                  "text": "anomalie della funzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) persistenti dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की गड़बड़ियाँ (इरेक्शन और स्खलन की समस्याएँ), जो इलाज बंद करने पर भी बनी रहीं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8. Effets indésirables"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "fr",
              "text": "La fréquence des effets indésirables rapportés depuis la mise sur le marché n'a pu être établie, car elle repose sur des signalements spontanés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The frequency of the adverse effects reported since marketing could not be established, as it rests on spontaneous reports.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit der seit der Markteinführung berichteten Nebenwirkungen konnte nicht ermittelt werden, da sie auf Spontanmeldungen beruht.",
                  "by": "ours"
                },
                "es": {
                  "text": "La frecuencia de las reacciones adversas notificadas desde la comercialización no ha podido establecerse, ya que se basa en notificaciones espontáneas.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência dos efeitos indesejáveis relatados desde a comercialização não pôde ser estabelecida, pois se baseia em notificações espontâneas.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate dopo l’immissione in commercio non ha potuto essere stabilita, perché si basa su segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद से रिपोर्ट हुए साइड इफ़ेक्ट की आवृत्ति तय नहीं की जा सकी, क्योंकि वह स्वतःस्फूर्त रिपोर्टों पर आधारित है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-leaflet-proscar",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "CHIBRO-PROSCAR",
              "form": "5 mg, comprimé pelliculé",
              "holder": "ORGANON France"
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67954321/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/67954321/extrait",
            "textDate": "2024-07-19",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 19/07/2024"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Les effets secondaires fréquemment rapportés :"
              ],
              "since": null,
              "lang": "fr",
              "text": "impuissance,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "impotence,",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz,",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência,",
                  "by": "ours"
                },
                "it": {
                  "text": "impotenza,",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Les effets secondaires fréquemment rapportés :"
              ],
              "since": null,
              "lang": "fr",
              "text": "diminution de la libido,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido,",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido,",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido,",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale,",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Les effets secondaires fréquemment rapportés :"
              ],
              "since": null,
              "lang": "fr",
              "text": "diminution du volume de l'éjaculat.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased volume of ejaculate.",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes Ejakulatvolumen.",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del volumen de eyaculación.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado.",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del volume di sperma.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Moins fréquemment, ont été rapportés :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "troubles de l'éjaculation persistant à l’arrêt du traitement,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation problems persisting when treatment is stopped,",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, die nach dem Absetzen der Behandlung anhalten,",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación que persisten al interrumpir el tratamiento,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação que persistem ao parar o tratamento,",
                  "by": "ours"
                },
                "it": {
                  "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento,",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जो इलाज बंद करने पर भी बनी रहीं,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Moins fréquemment, ont été rapportés :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "incapacité à avoir une érection persistante à l'arrêt du traitement,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "inability to have an erection, persisting when treatment is stopped,",
                  "by": "ours"
                },
                "de": {
                  "text": "Unfähigkeit, eine Erektion zu bekommen, die nach dem Absetzen der Behandlung anhält,",
                  "by": "ours"
                },
                "es": {
                  "text": "incapacidad para tener una erección que persiste al interrumpir el tratamiento,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "incapacidade de ter uma ereção que persiste ao parar o tratamento,",
                  "by": "ours"
                },
                "it": {
                  "text": "incapacità persistente di avere un’erezione dopo l’interruzione del trattamento,",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना, जो इलाज बंद करने पर भी बना रहा,",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Moins fréquemment, ont été rapportés :"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "diminution de la libido persistant à l'arrêt du traitement,",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido persisting when treatment is stopped,",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido, die nach dem Absetzen der Behandlung anhält,",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido que persiste al interrumpir el tratamiento,",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido que persiste ao parar o tratamento,",
                  "by": "ours"
                },
                "it": {
                  "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento,",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी, जो इलाज बंद करने पर भी बनी रही,",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr-regulator-ansm201203",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm201203",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Point d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondaires",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2022/07/06/finasteride-dans-le-traitement-de-la-calvitie-mars-2012-3.pdf",
            "fetchedUrl": null,
            "textDate": "2012-03-13",
            "textDateKind": "publication",
            "textDateAsPrinted": "Point d’Information du 13 mars 2012"
          },
          "passages": [
            {
              "key": "reported",
              "kind": "sexual-persistence",
              "section": [
                "Point d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondaires"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Depuis lors, des cas de troubles de l’érection persistant après l’arrêt du traitement et de cancer du sein chez l’homme ont été rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Since then, cases of erection problems persisting after treatment was stopped, and of breast cancer in men, have been reported.",
                  "by": "ours"
                },
                "de": {
                  "text": "Seitdem wurden Fälle von erektiler Dysfunktion, die nach dem Absetzen der Behandlung anhielt, und von Brustkrebs beim Mann berichtet.",
                  "by": "ours"
                },
                "es": {
                  "text": "Desde entonces se han notificado casos de trastornos de la erección que persisten después de interrumpir el tratamiento y de cáncer de mama en el varón.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Desde então, foram relatados casos de distúrbios da ereção que persistem depois de parar o tratamento e de câncer de mama no homem.",
                  "by": "ours"
                },
                "it": {
                  "text": "Da allora sono stati riportati casi di disfunzione erettile persistente dopo l’interruzione del trattamento e di cancro della mammella nell’uomo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "तब से, इलाज बंद करने के बाद भी इरेक्शन की समस्याओं के बने रहने और पुरुषों में स्तन कैंसर के मामले रिपोर्ट हुए हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Point d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondaires"
              ],
              "since": null,
              "qualifies": "reported",
              "lang": "fr",
              "text": "A ce jour le lien de causalité entre la prise de finastéride et la persistance des troubles de l’érection, après l’arrêt du traitement, n’est pas établi.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "To date, a causal link between taking finasteride and the persistence of erection problems after treatment is stopped has not been established.",
                  "by": "ours"
                },
                "de": {
                  "text": "Bis heute ist der ursächliche Zusammenhang zwischen der Einnahme von Finasterid und der Persistenz der erektilen Dysfunktion nach dem Absetzen der Behandlung nicht belegt.",
                  "by": "ours"
                },
                "es": {
                  "text": "A día de hoy, no se ha establecido el vínculo de causalidad entre la toma de finasterida y la persistencia de los trastornos de la erección después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Até hoje, o nexo causal entre o uso de finasterida e a persistência dos distúrbios da ereção depois de parar o tratamento não está estabelecido.",
                  "by": "ours"
                },
                "it": {
                  "text": "Ad oggi il nesso causale tra l’assunzione di finasteride e la persistenza della disfunzione erettile dopo l’interruzione del trattamento non è stabilito.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आज तक फ़िनास्टेराइड लेने और इलाज बंद करने के बाद इरेक्शन की समस्याओं के बने रहने के बीच कारण-संबंध स्थापित नहीं हुआ है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm201710",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm201710",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Point d’Information du 26 octobre 2017 : Finastéride : surveiller le risque de dépression et d’idées suicidaires",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2022/07/06/finasteride-surveiller-le-risque-de-depression-et-d-idees-suicidaires-oct-2017-3.pdf",
            "fetchedUrl": null,
            "textDate": "2017-10-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Point d’Information du 26 octobre 2017"
          },
          "passages": [
            {
              "key": "reminder",
              "kind": "sexual-persistence",
              "section": [
                "Rappel sur les troubles sexuels"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "L’ANSM rappelle qu’il est possible d’observer une persistance de troubles sexuels après l’arrêt d’un traitement par finastéride.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The ANSM points out that sexual problems may persist after treatment with finasteride has been stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die ANSM erinnert daran, dass nach dem Absetzen einer Behandlung mit Finasterid eine Persistenz sexueller Störungen beobachtet werden kann.",
                  "by": "ours"
                },
                "es": {
                  "text": "La ANSM recuerda que es posible observar una persistencia de trastornos sexuales después de interrumpir un tratamiento con finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A ANSM lembra que é possível observar uma persistência de distúrbios sexuais depois de parar um tratamento com finasterida.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’ANSM ricorda che è possibile osservare una persistenza dei disturbi sessuali dopo l’interruzione di un trattamento con finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ANSM याद दिलाती है कि फ़िनास्टेराइड से इलाज बंद करने के बाद भी यौन समस्याओं का बने रहना देखा जा सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm201902",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm201902",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finastéride : rappel sur les risques de troubles psychiatriques et de la fonction sexuelle",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/finasteride-rappel-sur-les-risques-de-troubles-psychiatriques-et-de-la-fonction-sexuelle",
            "fetchedUrl": null,
            "textDate": "2019-02-01",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 01/02/2019"
          },
          "passages": [
            {
              "key": "reminder",
              "kind": "sexual-persistence",
              "section": [
                "Troubles sexuels"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "L’ANSM rappelle qu’il est possible d’observer une persistance de ces troubles sexuels après l’arrêt d’un traitement par finastéride.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The ANSM points out that these sexual problems may persist after treatment with finasteride has been stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die ANSM erinnert daran, dass nach dem Absetzen einer Behandlung mit Finasterid eine Persistenz dieser sexuellen Störungen beobachtet werden kann.",
                  "by": "ours"
                },
                "es": {
                  "text": "La ANSM recuerda que es posible observar una persistencia de estos trastornos sexuales después de interrumpir un tratamiento con finasterida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A ANSM lembra que é possível observar uma persistência desses distúrbios sexuais depois de parar um tratamento com finasterida.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’ANSM ricorda che è possibile osservare una persistenza di questi disturbi sessuali dopo l’interruzione di un trattamento con finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ANSM याद दिलाती है कि फ़िनास्टेराइड से इलाज बंद करने के बाद भी इन यौन समस्याओं का बने रहना देखा जा सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-lettre201902",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-lettre201902",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Lettre aux professionnels de santé, Février 2019 : Finastéride (Propecia, Chibro-Proscar, génériques) : rappel sur les risques de troubles de la fonction sexuelle et de troubles psychiatriques",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2020/10/16/20201016-dhpc-190201-finasteride.pdf",
            "fetchedUrl": null,
            "textDate": "2019-02",
            "textDateKind": "publication",
            "textDateAsPrinted": "Février 2019"
          },
          "passages": [
            {
              "key": "summary",
              "kind": "sexual-persistence",
              "section": [
                "Résumé",
                "TROUBLES SEXUELS"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Les troubles de la fonction sexuelle, dans certains cas, peuvent persister après l'arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual function disorders may, in some cases, persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Störungen der Sexualfunktion können in manchen Fällen nach dem Absetzen der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los trastornos de la función sexual, en algunos casos, pueden persistir después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os distúrbios da função sexual, em alguns casos, podem persistir depois de parar o tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "I disturbi della funzione sessuale, in alcuni casi, possono persistere dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया की समस्याएँ कुछ मामलों में इलाज बंद करने के बाद भी बनी रह सकती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-fr-regulator-fiche202210",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-fiche202210",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FINASTERIDE 1 mg (Propecia® et génériques) Pour la chute des cheveux : information pour les patients",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2022/11/30/finasteride-fiche-info-patients.pdf",
            "fetchedUrl": null,
            "textDate": "2022-10",
            "textDateKind": "publication",
            "textDateAsPrinted": "Octobre 2022"
          },
          "passages": [
            {
              "key": "for-patients",
              "kind": "sexual-persistence",
              "section": [
                "QUELS SONT LES EFFETS INDÉSIRABLES DU FINASTÉRIDE",
                "LES TROUBLES DE LA SEXUALITE"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Des patients ont rapporté des troubles sexuels. Il peut s’agir de troubles de l’érection, de l’éjaculation, de douleurs testiculaires, d’une diminution de la libido. Il est possible que ces effets persistent après l’arrêt du traitement et ce, pour une durée indéterminée.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Patients have reported sexual problems. These may be problems with erection or ejaculation, testicular pain or decreased libido. These effects may persist after treatment is stopped, and for an undetermined length of time.",
                  "by": "ours"
                },
                "de": {
                  "text": "Patienten haben über sexuelle Störungen berichtet. Dabei kann es sich um erektile Dysfunktion, Ejakulationsstörungen, Hodenschmerzen oder eine verminderte Libido handeln. Diese Wirkungen können nach dem Absetzen der Behandlung anhalten, und zwar für eine unbestimmte Dauer.",
                  "by": "ours"
                },
                "es": {
                  "text": "Algunos pacientes han notificado trastornos sexuales. Puede tratarse de trastornos de la erección o de la eyaculación, de dolores testiculares o de una disminución de la libido. Es posible que estos efectos persistan después de interrumpir el tratamiento, y ello durante un periodo indeterminado.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Pacientes relataram distúrbios sexuais. Podem ser distúrbios da ereção, da ejaculação, dores testiculares, diminuição da libido. É possível que esses efeitos persistam depois de parar o tratamento, por um período indeterminado.",
                  "by": "ours"
                },
                "it": {
                  "text": "Alcuni pazienti hanno riportato disturbi sessuali. Può trattarsi di disturbi dell’erezione, dell’eiaculazione, di dolori ai testicoli, di una diminuzione della libido. È possibile che questi effetti persistano dopo l’interruzione del trattamento, e per una durata indeterminata.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों ने यौन समस्याएँ बताई हैं। ये इरेक्शन की समस्याएँ, स्खलन की समस्याएँ, अंडकोष में दर्द, या कामेच्छा में कमी हो सकती हैं। संभव है कि ये असर इलाज बंद करने के बाद भी, अनिश्चित अवधि तक बने रहें।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm202305",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm202305",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finastéride 1 mg (Propecia et génériques) : ajout de mentions d’alerte sur les boîtes pour renforcer l’information sur les effets indésirables",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/finasteride-1-mg-propecia-et-generiques-ajout-de-mentions-dalerte-sur-les-boites-pour-renforcer-linformation-sur-les-effets-indesirables",
            "fetchedUrl": null,
            "textDate": "2023-05-24",
            "textDateKind": "publication",
            "textDateAsPrinted": "Actualisation du 24/05/2023"
          },
          "passages": [
            {
              "key": "boxes",
              "kind": "regulator-statement",
              "section": [
                "Actualisation du 24/05/2023"
              ],
              "since": null,
              "lang": "fr",
              "text": "Depuis le 28 avril 2023, sont progressivement mises sur le marché des boîtes de finastéride 1 mg comportant sur leur face principale (face avant) un encadré rouge indiquant que des effets indésirables de type sexuel et/ou psychiatrique peuvent survenir pendant et après le traitement, accompagné d’un QR code qui renvoie à notre dossier thématique « Finastéride 1 mg et chute de cheveux ».",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Since 28 April 2023, packs of finasteride 1 mg have gradually been coming onto the market with a red box on their main (front) face stating that sexual and/or psychiatric adverse effects may occur during and after treatment, together with a QR code linking to our topic file “Finasteride 1 mg and hair loss”.",
                  "by": "ours"
                },
                "de": {
                  "text": "Seit dem 28. April 2023 kommen nach und nach Packungen mit Finasterid 1 mg in den Handel, die auf der Vorderseite einen roten Kasten tragen. Er weist darauf hin, dass während und nach der Behandlung Nebenwirkungen sexueller und/oder psychiatrischer Art auftreten können, und ist mit einem QR-Code versehen, der auf unser Themendossier „Finastéride 1 mg et chute de cheveux“ verweist.",
                  "by": "ours"
                },
                "es": {
                  "text": "Desde el 28 de abril de 2023 se comercializan progresivamente cajas de finasterida 1 mg que llevan en su cara principal (cara frontal) un recuadro rojo que indica que pueden aparecer efectos adversos de tipo sexual y/o psiquiátrico durante y después del tratamiento, acompañado de un código QR que remite a nuestro dossier temático «Finasterida 1 mg y caída del cabello».",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Desde 28 de abril de 2023, estão sendo colocadas progressivamente no mercado caixas de finasterida 1 mg com um quadro vermelho na face principal (frente), indicando que podem ocorrer efeitos indesejáveis de tipo sexual e/ou psiquiátrico durante e depois do tratamento, acompanhado de um QR code que remete ao nosso dossiê temático “Finasterida 1 mg e queda de cabelo”.",
                  "by": "ours"
                },
                "it": {
                  "text": "Dal 28 aprile 2023 vengono progressivamente immesse sul mercato confezioni di finasteride 1 mg che riportano sulla faccia principale (fronte) un riquadro rosso che indica che effetti indesiderati di tipo sessuale e/o psichiatrico possono comparire durante e dopo il trattamento, accompagnato da un codice QR che rimanda al nostro dossier tematico «Finasteride 1 mg e caduta dei capelli».",
                  "by": "ours"
                },
                "hi": {
                  "text": "28 अप्रैल 2023 से फ़िनास्टेराइड 1 mg के ऐसे डिब्बे धीरे-धीरे बाज़ार में आ रहे हैं, जिनके मुख्य हिस्से (सामने की तरफ़) पर एक लाल बॉक्स है। यह बताता है कि इलाज के दौरान और बाद में यौन और/या मानसिक साइड इफ़ेक्ट हो सकते हैं, और उसके साथ एक QR कोड है जो हमारी विषयगत फ़ाइल « Finastéride 1 mg et chute de cheveux » (फ़िनास्टेराइड 1 mg और बालों का झड़ना) तक ले जाता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the update box at the top of the page was read; it describes the red frame printed on the packs and is not itself a sentence about sexual side effects continuing after the medicine is stopped",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm202410",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm202410",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Réévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastéride",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/reevaluation-europeenne-de-la-balance-benefice-risque-des-medicaments-contenant-du-finasteride-ou-du-dutasteride",
            "fetchedUrl": null,
            "textDate": "2024-10-17",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 17/10/2024"
          },
          "passages": [
            {
              "key": "reported",
              "kind": "sexual-persistence",
              "section": [
                "Réévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastéride"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Malgré ces actions, des cas graves de troubles psychiatriques et de troubles sexuels (pouvant parfois perdurer longtemps après l’arrêt du traitement) continuent de nous être rapportés.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Despite these actions, serious cases of psychiatric disorders and sexual disorders (which can sometimes last long after treatment is stopped) continue to be reported to us.",
                  "by": "ours"
                },
                "de": {
                  "text": "Trotz dieser Maßnahmen werden uns weiterhin schwere Fälle von psychiatrischen Störungen und sexuellen Störungen (die manchmal noch lange nach dem Absetzen der Behandlung anhalten können) gemeldet.",
                  "by": "ours"
                },
                "es": {
                  "text": "A pesar de estas acciones, se nos siguen notificando casos graves de trastornos psiquiátricos y de trastornos sexuales (que a veces pueden perdurar mucho tiempo después de interrumpir el tratamiento).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Apesar dessas ações, continuam a nos ser relatados casos graves de distúrbios psiquiátricos e de distúrbios sexuais (que às vezes podem durar muito tempo depois de parar o tratamento).",
                  "by": "ours"
                },
                "it": {
                  "text": "Nonostante queste azioni, continuano a esserci segnalati casi gravi di disturbi psichiatrici e di disturbi sessuali (che possono talvolta durare a lungo dopo l’interruzione del trattamento).",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन कदमों के बावजूद, मानसिक और यौन समस्याओं के गंभीर मामले (जो कभी-कभी इलाज बंद करने के बाद लंबे समय तक बने रह सकते हैं) हमें रिपोर्ट होते रहते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm202505",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm202505",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Retour d’information sur le PRAC de mai 2025 (5 – 8 mai)",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-mai-2025-5-8-mai",
            "fetchedUrl": null,
            "textDate": "2025-05-21",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 21/05/2025"
          },
          "passages": [
            {
              "key": "position",
              "kind": "sexual-persistence",
              "section": [
                "Position ANSM"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Par ailleurs, les troubles de la fonction sexuelle peuvent persister à l’arrêt du traitement et potentiellement conduire à des altérations de l’humeur, dont des idées suicidaires.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, sexual function disorders may persist when treatment is stopped and may lead to changes in mood, including suicidal thoughts.",
                  "by": "ours"
                },
                "de": {
                  "text": "Außerdem können die Störungen der Sexualfunktion nach dem Absetzen der Behandlung anhalten und möglicherweise zu Stimmungsveränderungen bis hin zu Suizidgedanken führen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Por otra parte, los trastornos de la función sexual pueden persistir al interrumpir el tratamiento y llevar potencialmente a alteraciones del estado de ánimo, entre ellas ideas suicidas.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, os distúrbios da função sexual podem persistir ao parar o tratamento e potencialmente levar a alterações do humor, entre elas ideias suicidas.",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, i disturbi della funzione sessuale possono persistere dopo l’interruzione del trattamento e potenzialmente portare ad alterazioni dell’umore, tra cui idee suicide.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, यौन क्रिया की समस्याएँ इलाज बंद करने के बाद भी बनी रह सकती हैं और संभावित रूप से मूड में बदलाव ला सकती हैं, जिनमें आत्महत्या के विचार भी शामिल हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm202509",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm202509",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finastéride et risque d’idées suicidaires : nouvelles mesures",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/finasteride-et-risque-didees-suicidaires-nouvelles-mesures",
            "fetchedUrl": null,
            "textDate": "2025-09-25",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 25/09/2025"
          },
          "passages": [
            {
              "key": "risks",
              "kind": "sexual-persistence",
              "section": [
                "Finastéride et risque d’idées suicidaires : nouvelles mesures"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Ces médicaments exposent à des risques de troubles psychiatriques, ainsi qu’à des troubles de la fonction sexuelle qui peuvent persister après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "These medicines carry risks of psychiatric disorders, and of sexual function disorders that may persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Diese Arzneimittel bergen Risiken für psychiatrische Störungen sowie für Störungen der Sexualfunktion, die nach dem Absetzen der Behandlung anhalten können.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos medicamentos exponen a riesgos de trastornos psiquiátricos, así como a trastornos de la función sexual que pueden persistir después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses medicamentos expõem a riscos de distúrbios psiquiátricos, bem como a distúrbios da função sexual que podem persistir depois de parar o tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi medicinali espongono a rischi di disturbi psichiatrici, nonché di disturbi della funzione sessuale che possono persistere dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये दवाएँ मानसिक समस्याओं के जोखिम के साथ-साथ यौन क्रिया की ऐसी समस्याओं का भी जोखिम पैदा करती हैं, जो इलाज बंद करने के बाद भी बनी रह सकती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-ansm202602",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-ansm202602",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finastéride 1 mg : une attestation d’information partagée bientôt nécessaire pour toute dispensation",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/actualites/finasteride-1-mg-une-attestation-dinformation-partagee-bientot-necessaire-pour-toute-dispensation",
            "fetchedUrl": null,
            "textDate": "2026-02-05",
            "textDateKind": "publication",
            "textDateAsPrinted": "PUBLIÉ LE 05/02/2026"
          },
          "passages": [
            {
              "key": "discussed",
              "kind": "general-persistence",
              "section": [
                "Finastéride 1 mg : une attestation d’information partagée bientôt nécessaire pour toute dispensation"
              ],
              "since": null,
              "lang": "fr",
              "text": "La persistance possible de certains effets après l’arrêt du traitement ;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The possible persistence of certain effects after treatment is stopped;",
                  "by": "ours"
                },
                "de": {
                  "text": "Die mögliche Persistenz bestimmter Wirkungen nach dem Absetzen der Behandlung;",
                  "by": "ours"
                },
                "es": {
                  "text": "La posible persistencia de algunos efectos después de interrumpir el tratamiento;",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A possível persistência de certos efeitos depois de parar o tratamento;",
                  "by": "ours"
                },
                "it": {
                  "text": "La possibile persistenza di alcuni effetti dopo l’interruzione del trattamento;",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद कुछ असर के बने रहने की संभावना;",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the list on this page of what doctor and patient must have discussed was read; the sentence shown is its item about effects after stopping, and that item names no sexual side effect",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-attestation202602",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-attestation202602",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Attestation d’information partagée : attestation destinée aux patients traités par les spécialités à base de finastéride 1 mg",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2026/02/05/attestation-d-information-partagee-finasteride-1-mg.pdf",
            "fetchedUrl": null,
            "textDate": "2026-02",
            "textDateKind": "publication",
            "textDateAsPrinted": "Version 1 – FEV 2026"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "general-persistence",
              "section": [
                "Attestation d’information partagée : attestation destinée aux patients traités par les spécialités à base de finastéride 1 mg"
              ],
              "since": null,
              "lang": "fr",
              "text": "Certains effets peuvent persister de quelques années à une durée indéterminée après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Certain effects may persist from a few years to an undetermined length of time after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Manche Wirkungen können nach dem Absetzen der Behandlung einige Jahre bis zu einer unbestimmten Dauer anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Algunos efectos pueden persistir desde unos años hasta una duración indeterminada después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Certos efeitos podem persistir de alguns anos a um período indeterminado depois de parar o tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Alcuni effetti possono persistere da qualche anno a una durata indeterminata dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ असर इलाज बंद करने के बाद कुछ सालों से लेकर अनिश्चित अवधि तक बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the statements the patient ticks on this form were read; the sentence shown is the one about effects after stopping, and it names no sexual side effect",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-regulator-dossier202602",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-regulator-dossier202602",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Dossier thématique « Finastéride 1 mg et chute de cheveux », page « Risques liés à la prise de finastéride 1 mg »",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/dossiers-thematiques/finasteride-1-mg-et-chute-de-cheveux/risques-lies-a-la-prise-de-finasteride-1-mg",
            "fetchedUrl": null,
            "textDate": "2026-02-05",
            "textDateKind": "publication",
            "textDateAsPrinted": "MIS À JOUR LE 05/02/2026"
          },
          "passages": [
            {
              "key": "risks",
              "kind": "sexual-persistence",
              "section": [
                "Troubles sexuels"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "fr",
              "text": "Des patients ont rapporté des troubles sexuels lors de l’utilisation de finastéride 1 mg. Dans certains cas, ceux-ci peuvent persister après l’arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Patients have reported sexual problems while using finasteride 1 mg. In some cases, these may persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Patienten haben bei der Anwendung von Finasterid 1 mg über sexuelle Störungen berichtet. In einigen Fällen können diese nach dem Absetzen der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Algunos pacientes han notificado trastornos sexuales durante el uso de finasterida 1 mg. En algunos casos, estos pueden persistir después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Pacientes relataram distúrbios sexuais durante o uso de finasterida 1 mg. Em alguns casos, eles podem persistir depois de parar o tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "Alcuni pazienti hanno riportato disturbi sessuali durante l’uso di finasteride 1 mg. In alcuni casi, questi possono persistere dopo l’interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों ने फ़िनास्टेराइड 1 mg के उपयोग के दौरान यौन समस्याएँ बताई हैं। कुछ मामलों में ये इलाज बंद करने के बाद भी बनी रह सकती हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-fr-leaflet-card",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-fr-leaflet-card",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "CARTE PATIENT, FINASTERIDE 1 mg, Comprimé pelliculé",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/uploads/2026/02/05/finasteride-1mg-carte-patient.pdf",
            "fetchedUrl": null,
            "textDate": "2026-01-29",
            "textDateKind": "publication",
            "textDateAsPrinted": "29.01.2026 V2"
          },
          "passages": [],
          "searched": "\"persist\", \"après l'arrêt\", \"à l'arrêt\", \"poursui\", \"durable\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Propecia",
              "form": "1 mg compresse rivestite con film",
              "holder": "Organon Italia S.r.l."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7001/farmaci/34237/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2026-02-25",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 25/02/2026"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Disturbi psichiatrici:",
                "Non comune*"
              ],
              "since": null,
              "lang": "it",
              "text": "Diminuzione della libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decreased libido",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "Diminution de la libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella:",
                "Non comune*"
              ],
              "since": null,
              "lang": "it",
              "text": "Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Erectile dysfunction, ejaculation disorders (including decreased volume of ejaculate)",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion, Ejakulationsstörungen (einschließlich vermindertes Ejakulatvolumen)",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção erétil, distúrbios da ejaculação (incluindo diminuição do volume do ejaculado)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de l’érection, troubles de l’éjaculation (y compris diminution du volume de l’éjaculat)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, स्खलन विकार (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी सहित)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "incidence-note",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-reproductive-1",
              "lang": "it",
              "text": "Incidenze presentate quali differenze dal placebo negli studi clinici al 12° mese.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Incidences given as differences from placebo in clinical studies at month 12.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeiten sind als Unterschied zu Placebo in klinischen Studien nach 12 Monaten angegeben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las incidencias se presentan en forma de diferencia respecto al placebo en estudios clínicos a los 12 meses.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Incidências apresentadas como diferenças em relação ao placebo nos estudos clínicos no 12º mês.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Incidences présentées sous forme de différences par rapport au placebo dans les essais cliniques au 12e mois.",
                  "by": "ours"
                },
                "hi": {
                  "text": "घटना दरें 12वें महीने पर क्लिनिकल अध्ययनों में प्लेसीबो से अंतर के रूप में दी गई हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "Inoltre, durante l’uso post-marketing sono stati riportati: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasteride",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, during post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "Außerdem wurde bei der Anwendung nach Markteinführung berichtet: persistierende sexuelle Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen der Behandlung mit Finasterid",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasterida",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, durante o uso pós-comercialização foram relatados: disfunção sexual persistente (diminuição da libido, disfunção erétil e distúrbios da ejaculação) depois de interromper o tratamento com finasterida",
                  "by": "ours"
                },
                "fr": {
                  "text": "En outre, pendant l’utilisation après la mise sur le marché, ont été rapportés : dysfonction sexuelle persistante (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) après l’arrêt du traitement par finastéride",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, बाज़ार में आने के बाद के उपयोग में ये रिपोर्ट हुए हैं: फ़िनास्टेराइड से इलाज बंद करने के बाद भी बना रहने वाला सेक्शुअल डिस्फ़ंक्शन (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-drug-related",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "lang": "it",
              "text": "Effetti indesiderati correlati al medicinale inerenti la sfera sessuale sono stati più comuni fra gli uomini trattati con finasteride che fra quelli trattati con placebo con frequenze durante i primi 12 mesi di 3,8 % vs 2,1 %, rispettivamente. L’incidenza di tali effetti è diminuita allo 0,6 % negli uomini trattati con finasteride nel corso dei successivi quattro anni. Circa l’1 % degli uomini in ciascun gruppo di trattamento ha interrotto la terapia a seguito di esperienze avverse della sfera sessuale correlate con il medicinale verificatesi nei primi 12 mesi e l’incidenza è in seguito diminuita.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Drug-related adverse effects affecting the sexual sphere were more common among men treated with finasteride than among those treated with placebo, with frequencies during the first 12 months of 3.8% vs 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men in each treatment group stopped therapy because of drug-related sexual adverse experiences in the first 12 months, and the incidence decreased thereafter.",
                  "by": "ours"
                },
                "de": {
                  "text": "Mit dem Arzneimittel zusammenhängende sexuelle Nebenwirkungen waren bei den mit Finasterid behandelten Männern häufiger als bei den mit Placebo behandelten Männern, mit Häufigkeiten von 3,8 % bzw. 2,1 % während der ersten 12 Monate. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern im Laufe der folgenden vier Jahre auf 0,6 %. Etwa 1 % der Männer in jeder Behandlungsgruppe brach die Therapie aufgrund arzneimittelbedingter unerwünschter sexueller Ereignisse ab, die in den ersten 12 Monaten auftraten; danach nahm die Häufigkeit ab.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis sexuais relacionados ao medicamento foram mais comuns nos homens tratados com finasterida do que nos tratados com placebo, com frequências durante os primeiros 12 meses de 3,8% vs 2,1%, respectivamente. A incidência desses efeitos diminuiu para 0,6% nos homens tratados com finasterida ao longo dos quatro anos seguintes. Cerca de 1% dos homens de cada grupo de tratamento interrompeu a terapia por experiências adversas sexuais relacionadas ao medicamento ocorridas nos primeiros 12 meses, e a incidência diminuiu depois disso.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sexuels liés au médicament ont été plus fréquents chez les hommes traités par finastéride que chez ceux traités par placebo, avec des fréquences respectives de 3,8 % contre 2,1 % au cours des 12 premiers mois. L’incidence de ces effets a diminué à 0,6 % chez les hommes traités par finastéride au cours des quatre années suivantes. Environ 1 % des hommes de chaque groupe de traitement ont arrêté le traitement en raison d’événements indésirables sexuels liés au médicament survenus au cours des 12 premiers mois, et l’incidence a ensuite diminué.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पहले 12 महीनों में क्रमशः 3.8% बनाम 2.1% की आवृत्ति के साथ, दवा से जुड़े यौन क्षेत्र के अवांछित प्रभाव फ़िनास्टेराइड से इलाज किए गए पुरुषों में प्लेसीबो वाले पुरुषों से ज़्यादा आम थे। अगले चार सालों में इन प्रभावों की दर घटकर 0.6% रह गई। हर इलाज समूह के लगभग 1% पुरुषों ने पहले 12 महीनों में दवा से जुड़े यौन क्षेत्र के प्रतिकूल अनुभवों के कारण इलाज बंद किया, और उसके बाद यह दर घटती गई।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
            "lang": "it",
            "product": {
              "name": "Propecia",
              "form": "1 mg compresse rivestite con film",
              "holder": "Organon Italia S.r.l."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7001/farmaci/34237/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2026-02-25",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 25/02/2026"
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non comune: (può interessare fino a 1 persona su 100):"
              ],
              "since": null,
              "lang": "it",
              "text": "diminuzione del desiderio sessuale",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non comune: (può interessare fino a 1 persona su 100):"
              ],
              "since": null,
              "lang": "it",
              "text": "difficoltà nel raggiungimento dell’erezione",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty in achieving an erection",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten bei der Erektion",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades para lograr la erección",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade de atingir a ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à obtenir une érection",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन हासिल करने में दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non comune: (può interessare fino a 1 persona su 100):"
              ],
              "since": null,
              "lang": "it",
              "text": "problemi con l’eiaculazione quali riduzione della quantità di sperma emesso",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with ejaculation, such as a reduced amount of semen released",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, etwa eine verminderte Samenergussmenge",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación, como una disminución de la cantidad de semen expulsado",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação, como diminuição da quantidade de sêmen emitido",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation tels qu’une diminution de la quantité de sperme émise",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जैसे निकलने वाले वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "it",
              "text": "Gli effetti indesiderati sono stati generalmente temporanei con un trattamento continuativo o sono regrediti con la interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects were generally temporary with continued treatment or went away when treatment was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen waren im Allgemeinen bei fortgesetzter Behandlung vorübergehend oder bildeten sich nach dem Absetzen der Behandlung zurück.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos han sido, normalmente, pasajeros con el tratamiento continuado o han desaparecido cuando el tratamiento se interrumpe.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos indesejáveis geralmente foram temporários com a continuação do tratamento ou regrediram com a interrupção do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables ont été généralement temporaires pendant la poursuite du traitement ou ont disparu à l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "अवांछित प्रभाव आम तौर पर लगातार इलाज के साथ अस्थायी रहे, या इलाज बंद करने पर खत्म हो गए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non nota: la frequenza non può essere definita sulla base dei dati disponibili"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "difficoltà persistente ad avere una erezione dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent difficulty in having an erection after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Schwierigkeiten bei der Erektion nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad persistente para tener erección después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade persistente de ter uma ereção depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté persistante à avoir une érection après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी इरेक्शन होने में बनी रहने वाली दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non nota: la frequenza non può essere definita sulla base dei dati disponibili"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent reduction in sexual drive after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Abnahme des sexuellen Verlangens nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución persistente en el deseo sexual después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição persistente do impulso sexual depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution persistante du désir sexuel après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी यौन इच्छा में बनी रहने वाली कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Non nota: la frequenza non può essere definita sulla base dei dati disponibili"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent problems with ejaculation after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Ejakulationsschwierigkeiten nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas persistentes de eyaculación después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas persistentes de ejaculação depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation persistants après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी स्खलन की बनी रहने वाली समस्याएँ",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-pro-proscar",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle caratteristiche del prodotto",
            "lang": "it",
            "product": {
              "name": "Proscar",
              "form": "5 mg compresse rivestite con film",
              "holder": "Organon Italia S.r.l."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7001/farmaci/28308/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2024-10-30",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 30/10/2024"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "lang": "it",
              "text": "Impotenza e diminuzione della libido sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence and decreased libido are the most frequent adverse reactions. These adverse reactions appear in the early phase of therapy and, in most patients, resolve during therapy.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência e diminuição da libido são as reações adversas mais frequentes. Essas reações adversas aparecem na fase inicial da terapia e, na maioria dos pacientes, desaparecem no decorrer da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’impuissance et la diminution de la libido sont les effets indésirables les plus fréquents. Ces effets indésirables apparaissent au début du traitement et, chez la plupart des patients, disparaissent au cours du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष और कामेच्छा में कमी सबसे आम प्रतिकूल प्रतिक्रियाएँ हैं। ये प्रतिकूल प्रतिक्रियाएँ थेरेपी की शुरुआती अवस्था में होती हैं और ज़्यादातर मरीज़ों में थेरेपी के दौरान ठीक हो जाती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Disturbi psichiatrici",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "diminuzione della libido.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido.",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido.",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la libido.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Disturbi psichiatrici",
                "Non nota"
              ],
              "since": null,
              "lang": "it",
              "text": "depressione, disfunzione sessuale persistente*, ansia, ideazione suicidaria.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "depression, persistent sexual dysfunction*, anxiety, suicidal ideation.",
                  "by": "ours"
                },
                "de": {
                  "text": "Depression, persistierende sexuelle Dysfunktion*, Angst, Suizidgedanken.",
                  "by": "ours"
                },
                "es": {
                  "text": "depresión, disfunción sexual persistente*, ansiedad, ideación suicida.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "depressão, disfunção sexual persistente*, ansiedade, ideação suicida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "dépression, dysfonction sexuelle persistante*, anxiété, idées suicidaires.",
                  "by": "ours"
                },
                "hi": {
                  "text": "डिप्रेशन, बना रहने वाला सेक्शुअल डिस्फ़ंक्शन*, चिंता, आत्महत्या के विचार।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-footnote",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Effetti indesiderati",
                "nota (*)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "(*) Durante l’uso post-marketing è stata riportata: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con PROSCAR.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "(*) During post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with PROSCAR was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "(*) Während der Anwendung nach Markteinführung wurde berichtet: persistierende sexuelle Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen der Behandlung mit PROSCAR.",
                  "by": "ours"
                },
                "es": {
                  "text": "(*) Durante el uso poscomercialización se ha notificado: disfunción sexual persistente (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con PROSCAR.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "(*) Durante o uso pós-comercialização foi relatada: disfunção sexual persistente (diminuição da libido, disfunção erétil e distúrbios da ejaculação) depois de interromper o tratamento com PROSCAR.",
                  "by": "ours"
                },
                "fr": {
                  "text": "(*) Pendant l’utilisation après la mise sur le marché, a été rapportée : dysfonction sexuelle persistante (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) après l’arrêt du traitement par PROSCAR.",
                  "by": "ours"
                },
                "hi": {
                  "text": "(*) बाज़ार में आने के बाद के उपयोग में रिपोर्ट हुआ: PROSCAR से इलाज बंद करने के बाद भी बना रहने वाला सेक्शुअल डिस्फ़ंक्शन (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "impotenza.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "impotence.",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz.",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência.",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Non comune"
              ],
              "since": null,
              "lang": "it",
              "text": "disturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders, breast tenderness, breast enlargement.",
                  "by": "ours"
                },
                "de": {
                  "text": "Ejakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der Brust.",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación, hipersensibilidad mamaria, crecimiento mamario.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação, tensão mamária, aumento de volume da mama.",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation, tension mammaire, augmentation du volume des seins.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार, स्तनों में तनाव या कोमलता, स्तनों का बढ़ना।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8 Effetti indesiderati",
                "Patologie dell’apparato riproduttivo e della mammella",
                "Non nota"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "dolore testicolare, disfunzione erettile che è proseguita dopo l’interruzione del trattamento, ematospermia, infertilità maschile e/o scarsa qualità del liquido seminale. Normalizzazione o miglioramento della qualità del liquido seminale è stata riportata dopo l’interruzione della finasteride. Cancro della mammella nell’uomo (vedere 4.4 Avvertenze speciali e precauzioni d’impiego).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "testicular pain, erectile dysfunction that continued after treatment was stopped, haematospermia, male infertility and/or poor seminal quality. Normalisation or improvement of seminal quality has been reported after finasteride was stopped. Breast cancer in men (see 4.4 Special warnings and precautions for use).",
                  "by": "ours"
                },
                "de": {
                  "text": "Hodenschmerzen, erektile Dysfunktion, die nach dem Absetzen der Behandlung anhielt, Hämatospermie, Infertilität bei Männern und/oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet. Brustkrebs beim Mann (siehe 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).",
                  "by": "ours"
                },
                "es": {
                  "text": "dolor testicular, disfunción eréctil que continuó después de la interrupción del tratamiento, hematospermia, infertilidad masculina y/o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida. Cáncer de mama en el varón (ver 4.4 Advertencias y precauciones especiales de empleo).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dor testicular, disfunção erétil que prosseguiu depois de interromper o tratamento, hematospermia, infertilidade masculina e/ou má qualidade do líquido seminal. Foi relatada normalização ou melhora da qualidade do líquido seminal depois de interromper a finasterida. Câncer de mama no homem (ver 4.4 Advertências especiais e precauções de uso).",
                  "by": "ours"
                },
                "fr": {
                  "text": "douleur testiculaire, troubles de l’érection qui ont continué après l’arrêt du traitement, hématospermie, infertilité masculine et/ou mauvaise qualité du liquide séminal. Une normalisation ou une amélioration de la qualité du liquide séminal a été rapportée après l’arrêt du finastéride. Cancer du sein chez l’homme (voir 4.4 Mises en garde spéciales et précautions d’emploi).",
                  "by": "ours"
                },
                "hi": {
                  "text": "अंडकोष में दर्द, स्तंभन दोष जो इलाज बंद करने के बाद भी जारी रहा, वीर्य में खून (हीमैटोस्पर्मिया), पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता। फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है। पुरुषों में स्तन कैंसर (देखें 4.4 विशेष चेतावनियाँ और उपयोग की सावधानियाँ)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8 Effetti indesiderati"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "it",
              "text": "La frequenza o la relazione causale delle reazioni avverse, riportate durante l’uso post-marketing con finasteride a dosi più basse, non può essere determinata poiché derivano da segnalazioni spontanee.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The frequency or causal relationship of the adverse reactions reported during post-marketing use with finasteride at lower doses cannot be determined, as they come from spontaneous reports.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit oder der ursächliche Zusammenhang der Nebenwirkungen, die während der Anwendung nach Markteinführung bei Finasterid in niedrigeren Dosierungen berichtet wurden, kann nicht bestimmt werden, da sie auf Spontanberichten beruhen.",
                  "by": "ours"
                },
                "es": {
                  "text": "No puede determinarse la frecuencia ni la relación causal de las reacciones adversas notificadas durante el uso poscomercialización con finasterida a dosis más bajas, ya que proceden de notificaciones espontáneas.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A frequência ou a relação causal das reações adversas relatadas durante o uso pós-comercialização com finasterida em doses menores não pode ser determinada, pois derivam de relatos espontâneos.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence ou le lien de causalité des effets indésirables rapportés pendant l’utilisation après la mise sur le marché du finastéride à des doses plus faibles ne peuvent pas être déterminés, car ils proviennent de signalements spontanés.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद के उपयोग में कम डोज़ की फ़िनास्टेराइड के साथ रिपोर्ट हुई प्रतिकूल प्रतिक्रियाओं की आवृत्ति या कारण-संबंध तय नहीं किया जा सकता, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-investigations-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Esami diagnostici",
                "Comune"
              ],
              "since": null,
              "lang": "it",
              "text": "diminuzione del volume dell’eiaculato.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased volume of ejaculate.",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes Ejakulatvolumen.",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del volumen de eyaculación.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado.",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de l’éjaculat.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-mtops",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Medical Therapy Of Prostatic Symptoms (MTOPS)"
              ],
              "since": null,
              "lang": "it",
              "text": "L’incidenza di disturbi dell’eiaculazione nei pazienti trattati con l’associazione è risultata paragonabile alla somma delle incidenze di tale esperienza avversa per le due monoterapie.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The incidence of ejaculation disorders in patients treated with the combination was comparable to the sum of the incidences of this adverse experience for the two monotherapies.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit von Ejakulationsstörungen bei Patienten unter Kombinationstherapie entsprach der Summe der Häufigkeiten dieses unerwünschten Ereignisses unter den beiden Monotherapien.",
                  "by": "ours"
                },
                "es": {
                  "text": "La incidencia del trastorno de eyaculación en pacientes recibiendo tratamiento combinado fue comparable a la suma de las incidencias de esta experiencia adversa para las dos monoterapias.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A incidência de distúrbios da ejaculação nos pacientes tratados com a associação foi comparável à soma das incidências dessa experiência adversa nas duas monoterapias.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’incidence des troubles de l’éjaculation chez les patients traités par l’association était comparable à la somme des incidences de cet événement indésirable pour les deux monothérapies.",
                  "by": "ours"
                },
                "hi": {
                  "text": "संयुक्त इलाज लेने वाले मरीज़ों में स्खलन विकारों की दर इस प्रतिकूल अनुभव की दोनों अलग-अलग इलाजों की दरों के जोड़ के बराबर रही।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-leaflet-proscar",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per il paziente",
            "lang": "it",
            "product": {
              "name": "Proscar",
              "form": "5 mg compresse rivestite con film",
              "holder": "Organon Italia S.r.l."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/7001/farmaci/28308/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2024-10-30",
            "textDateKind": "regulator-stamp",
            "textDateAsPrinted": "Documento reso disponibile da AIFA il 30/10/2024"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "lang": "it",
              "text": "Impotenza e diminuzione del desiderio sessuale sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Impotence and decreased sexual desire are the most frequent adverse reactions. These adverse reactions appear in the early phase of therapy and, in most patients, resolve during therapy.",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz und verminderter Sexualtrieb sind die häufigsten Nebenwirkungen. Diese Nebenwirkungen treten zu Beginn der Therapie auf und bilden sich bei den meisten Patienten im Verlauf der Therapie zurück.",
                  "by": "ours"
                },
                "es": {
                  "text": "La impotencia y la disminución del deseo sexual son las reacciones adversas más frecuentes. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Impotência e diminuição do desejo sexual são as reações adversas mais frequentes. Essas reações adversas aparecem na fase inicial da terapia e, na maioria dos pacientes, desaparecem no decorrer da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’impuissance et la diminution du désir sexuel sont les effets indésirables les plus fréquents. Ces effets indésirables apparaissent au début du traitement et, chez la plupart des patients, disparaissent au cours du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष और यौन इच्छा में कमी सबसे आम प्रतिकूल प्रतिक्रियाएँ हैं। ये प्रतिकूल प्रतिक्रियाएँ थेरेपी की शुरुआती अवस्था में होती हैं और ज़्यादातर मरीज़ों में थेरेपी के दौरान ठीक हो जाती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)"
              ],
              "since": null,
              "lang": "it",
              "text": "diminuzione del volume di sperma",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased volume of semen",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Samenflüssigkeitsmenge",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución de la cantidad de semen",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume de sêmen",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de sperme",
                  "by": "ours"
                },
                "hi": {
                  "text": "वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)"
              ],
              "since": null,
              "lang": "it",
              "text": "impotenza",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz",
                  "by": "ours"
                },
                "es": {
                  "text": "impotencia",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)"
              ],
              "since": null,
              "lang": "it",
              "text": "diminuzione del desiderio sessuale",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes sexuelles Verlangen",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100)"
              ],
              "since": null,
              "lang": "it",
              "text": "disturbi dell’eiaculazione",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses",
                  "by": "ours"
                },
                "es": {
                  "text": "trastornos de la eyaculación",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "disfunzione erettile, che può proseguire dopo l’interruzione della finasteride",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "erectile dysfunction, which may continue after finasteride is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion, die nach dem Absetzen von Finasterid andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción eréctil, que puede continuar después de la interrupción de finasterida",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção erétil, que pode prosseguir depois de interromper a finasterida",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’érection, qui peuvent se poursuivre après l’arrêt du finastéride",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, जो फ़िनास्टेराइड बंद करने के बाद भी जारी रह सकता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent reduction in sexual drive after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Abnahme des sexuellen Verlangens nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución persistente en el deseo sexual después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição persistente do impulso sexual depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution persistante du désir sexuel après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी यौन इच्छा में बनी रहने वाली कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Possibili effetti indesiderati",
                "Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent problems with ejaculation after treatment is stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Ejakulationsschwierigkeiten nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas persistentes de eyaculación después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas persistentes de ejaculação depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation persistants après l’arrêt du traitement",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी स्खलन की बनी रहने वाली समस्याएँ",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it-regulator-nii201807",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-regulator-nii201807",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Nota Informativa Importante concordata con l’Agenzia Italiana del Farmaco (AIFA)",
            "lang": "it",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AIFA"
            },
            "url": "https://www.aifa.gov.it/documents/20142/0/Nota_Informativa_Importante_Finasteride_30.07.2018.pdf",
            "fetchedUrl": null,
            "textDate": "2018-07-30",
            "textDateKind": "publication",
            "textDateAsPrinted": "30 Luglio 2018"
          },
          "passages": [
            {
              "key": "inform",
              "kind": "sexual-persistence",
              "section": [
                "Riassunto"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "Inoltre, i pazienti devono essere informati del fatto che sono stati segnalati eventi avversi di disfunzione sessuale che persistevano anche dopo l’interruzione della terapia",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, patients must be informed that adverse events of sexual dysfunction have been reported that persisted even after therapy was stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "Außerdem sollten die Patienten darüber informiert werden, dass unerwünschte Ereignisse in Form sexueller Dysfunktion berichtet wurden, die auch nach dem Absetzen der Therapie anhielten",
                  "by": "ours"
                },
                "es": {
                  "text": "Además, debe informarse a los pacientes de que se han notificado acontecimientos adversos de disfunción sexual que persistían incluso después de interrumpir el tratamiento",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, os pacientes devem ser informados de que foram relatados eventos adversos de disfunção sexual que persistiam mesmo depois de interromper a terapia",
                  "by": "ours"
                },
                "fr": {
                  "text": "En outre, les patients doivent être informés que des événements indésirables de dysfonction sexuelle persistant même après l’arrêt du traitement ont été signalés",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, मरीज़ों को बताया जाना चाहिए कि सेक्शुअल डिस्फ़ंक्शन की प्रतिकूल घटनाएँ रिपोर्ट हुई हैं, जो थेरेपी बंद करने के बाद भी बनी रहीं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-it-regulator-aifa202211",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-regulator-aifa202211",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Comunicazione di sicurezza: FINASTERIDE 1 mg e possibili disturbi sessuali e psichiatrici",
            "lang": "it",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AIFA"
            },
            "url": "https://www.aifa.gov.it/documents/20142/1135360/2022.11.30_Comunicazione_finasteride.pdf",
            "fetchedUrl": null,
            "textDate": "2022-11-30",
            "textDateKind": "publication",
            "textDateAsPrinted": "30-11-2022"
          },
          "passages": [
            {
              "key": "reported",
              "kind": "sexual-persistence",
              "section": [
                "Sintesi"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "Sono stati segnalati casi in cui i pazienti hanno riportato: - disturbi sessuali tra cui disfunzione erettile, disfunzione eiaculatoria, dolore ai testicoli e diminuzione della libido; - disturbi psichiatrici, come ansia, depressione o persino pensieri suicidi. Tutti questi disturbi possono avere un importante impatto sulla vita sociale e personale. Il tempo di comparsa dei sintomi sopra riportati può variare, da pochi giorni ad alcuni anni dopo l’inizio del trattamento. Anche la durata degli effetti avversi può variare ampiamente da paziente a paziente. Gli effetti avversi possono persistere dopo l’interruzione del trattamento e, in alcuni casi, per un periodo indefinito.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Cases have been reported in which patients reported: - sexual disorders, including erectile dysfunction, ejaculatory dysfunction, pain in the testicles and decreased libido; - psychiatric disorders, such as anxiety, depression or even suicidal thoughts. All these disorders can have a major impact on social and personal life. The time at which the above symptoms appear can vary, from a few days to several years after the start of treatment. The duration of the adverse effects can also vary widely from patient to patient. The adverse effects can persist after treatment is stopped and, in some cases, for an indefinite period.",
                  "by": "ours"
                },
                "de": {
                  "text": "Es wurden Fälle gemeldet, in denen Patienten Folgendes berichteten: - sexuelle Störungen, darunter erektile Dysfunktion, Ejakulationsstörung, Hodenschmerzen und verminderte Libido; - psychiatrische Störungen, etwa Angst, Depression oder sogar Suizidgedanken. All diese Störungen können erhebliche Auswirkungen auf das soziale und das persönliche Leben haben. Der Zeitpunkt, zu dem die genannten Symptome auftreten, kann variieren, von wenigen Tagen bis zu einigen Jahren nach Beginn der Behandlung. Auch die Dauer der Nebenwirkungen kann von Patient zu Patient stark variieren. Die Nebenwirkungen können nach dem Absetzen der Behandlung anhalten, in einigen Fällen für einen unbestimmten Zeitraum.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos en los que los pacientes refirieron: - trastornos sexuales, entre ellos disfunción eréctil, disfunción eyaculatoria, dolor testicular y disminución de la libido; - trastornos psiquiátricos, como ansiedad, depresión o incluso pensamientos suicidas. Todos estos trastornos pueden tener un impacto importante en la vida social y personal. El momento de aparición de los síntomas indicados puede variar, desde unos pocos días hasta algunos años después del inicio del tratamiento. La duración de los efectos adversos también puede variar mucho de un paciente a otro. Los efectos adversos pueden persistir después de interrumpir el tratamiento y, en algunos casos, durante un periodo indefinido.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos em que os pacientes informaram: - distúrbios sexuais, entre eles disfunção erétil, disfunção ejaculatória, dor nos testículos e diminuição da libido; - distúrbios psiquiátricos, como ansiedade, depressão ou até pensamentos suicidas. Todos esses distúrbios podem ter um impacto importante na vida social e pessoal. O tempo de aparecimento dos sintomas acima pode variar, de poucos dias a alguns anos depois do início do tratamento. A duração dos efeitos adversos também pode variar muito de paciente para paciente. Os efeitos adversos podem persistir depois de interromper o tratamento e, em alguns casos, por um período indefinido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas ont été signalés dans lesquels des patients ont rapporté : - des troubles sexuels, notamment troubles de l’érection, troubles de l’éjaculation, douleur aux testicules et diminution de la libido ; - des troubles psychiatriques, tels qu’anxiété, dépression ou même pensées suicidaires. Tous ces troubles peuvent avoir un impact important sur la vie sociale et personnelle. Le délai d’apparition des symptômes ci-dessus peut varier, de quelques jours à plusieurs années après le début du traitement. La durée des effets indésirables peut aussi varier largement d’un patient à l’autre. Les effets indésirables peuvent persister après l’arrêt du traitement et, dans certains cas, pendant une durée indéterminée.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऐसे मामले रिपोर्ट हुए हैं जिनमें मरीज़ों ने बताया: - यौन विकार, जिनमें स्तंभन दोष, स्खलन की गड़बड़ी, अंडकोष में दर्द और कामेच्छा में कमी शामिल हैं; - मानसिक विकार, जैसे चिंता, डिप्रेशन या आत्महत्या के विचार तक। ये सभी विकार सामाजिक और निजी जीवन पर गहरा असर डाल सकते हैं। ऊपर बताए लक्षण इलाज शुरू करने के कुछ दिनों से लेकर कुछ सालों बाद तक किसी भी समय शुरू हो सकते हैं। प्रतिकूल प्रभावों की अवधि भी हर मरीज़ में काफ़ी अलग हो सकती है। प्रतिकूल प्रभाव इलाज बंद करने के बाद भी, और कुछ मामलों में अनिश्चित अवधि तक, बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "recommendation",
              "kind": "sexual-persistence",
              "section": [
                "Sintesi"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "it",
              "text": "discutere con i pazienti dei benefici che ci si potrebbe aspettare dal trattamento con finasteride 1 mg e dei potenziali rischi, con particolare riferimento alla possibilità che si verifichino disturbi sessuali e/o disordini psichiatrici e che tali eventi, in alcuni casi, possano persistere anche dopo l’interruzione della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "discuss with patients the benefits that could be expected from treatment with finasteride 1 mg and the potential risks, with particular reference to the possibility that sexual disorders and/or psychiatric disorders may occur and that such events may, in some cases, persist even after therapy is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "mit den Patienten über den Nutzen zu sprechen, der von der Behandlung mit Finasterid 1 mg erwartet werden kann, und über die möglichen Risiken, insbesondere über die Möglichkeit des Auftretens sexueller Störungen und/oder psychiatrischer Störungen und darüber, dass diese Ereignisse in einigen Fällen auch nach dem Absetzen der Therapie anhalten können.",
                  "by": "ours"
                },
                "es": {
                  "text": "comentar con los pacientes los beneficios que cabe esperar del tratamiento con finasterida 1 mg y los posibles riesgos, con especial referencia a la posibilidad de que se produzcan trastornos sexuales y/o trastornos psiquiátricos y de que estos acontecimientos, en algunos casos, puedan persistir incluso después de interrumpir el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "discutir com os pacientes os benefícios que se pode esperar do tratamento com finasterida 1 mg e os riscos potenciais, em particular a possibilidade de ocorrerem distúrbios sexuais e/ou distúrbios psiquiátricos e de esses eventos, em alguns casos, poderem persistir mesmo depois de interromper a terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "discuter avec les patients des bénéfices que l’on peut attendre du traitement par finastéride 1 mg et des risques potentiels, en particulier de la possibilité que surviennent des troubles sexuels et/ou des troubles psychiatriques, et que ces événements, dans certains cas, puissent persister même après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "मरीज़ों से इस पर चर्चा करें कि फ़िनास्टेराइड 1 mg के इलाज से क्या फ़ायदे अपेक्षित हो सकते हैं और क्या संभावित जोखिम हैं, खास तौर पर यौन विकारों और/या मानसिक विकारों के होने की संभावना, और इस बात की कि ये घटनाएँ कुछ मामलों में थेरेपी बंद करने के बाद भी बनी रह सकती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "applies-to",
              "kind": "qualification",
              "section": [
                "Sintesi"
              ],
              "since": null,
              "qualifies": "recommendation",
              "lang": "it",
              "text": "Queste raccomandazioni si applicano al dosaggio da 1 mg e all'indicazione per il trattamento dell'alopecia androgenetica",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "These recommendations apply to the 1 mg dose and to the indication for the treatment of androgenetic alopecia",
                  "by": "ours"
                },
                "de": {
                  "text": "Diese Empfehlungen gelten für die Dosierung von 1 mg und für die Indikation zur Behandlung der androgenetischen Alopezie",
                  "by": "ours"
                },
                "es": {
                  "text": "Estas recomendaciones se aplican a la dosis de 1 mg y a la indicación de tratamiento de la alopecia androgenética",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Estas recomendações se aplicam à dose de 1 mg e à indicação para o tratamento da alopecia androgenética",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces recommandations s’appliquent au dosage de 1 mg et à l’indication de traitement de l’alopécie androgénétique",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये सिफ़ारिशें 1 mg की डोज़ पर और एंड्रोजेनिक एलोपेसिया (गंजेपन) के इलाज के संकेत पर लागू होती हैं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-it-regulator-ema202505",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-regulator-ema202505",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Misure per minimizzare il rischio di pensieri suicidari con i medicinali contenenti finasteride e dutasteride",
            "lang": "it",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AIFA"
            },
            "url": "https://www.aifa.gov.it/documents/20142/2695701/2025.05.08_com-EMA_finasteride-dutasteride_IT.pdf",
            "fetchedUrl": null,
            "textDate": "2025-05-08",
            "textDateKind": "publication",
            "textDateAsPrinted": "8 Maggio 2025"
          },
          "passages": [
            {
              "key": "statement",
              "kind": "regulator-statement",
              "section": [
                "Misure per minimizzare il rischio di pensieri suicidari con i medicinali contenenti finasteride e dutasteride"
              ],
              "since": null,
              "lang": "it",
              "text": "Le informazioni sul prodotto per finasteride 1 mg compresse avviseranno adesso i pazienti anche sulla necessità di consultare il medico in caso di problemi di disfunzione sessuale (come diminuzione del desiderio sessuale o disfunzione erettile), che sono effetti indesiderati noti del medicinale e possono contribuire ai cambiamenti di umore.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The product information for finasteride 1 mg tablets will now also advise patients of the need to consult their doctor in case of problems of sexual dysfunction (such as decreased sexual desire or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Produktinformation für Finasterid-1-mg-Tabletten wird die Patienten künftig auch darauf hinweisen, dass sie bei Problemen mit der Sexualfunktion (wie vermindertem sexuellem Verlangen oder erektiler Dysfunktion), die bekannte Nebenwirkungen des Arzneimittels sind und zu Stimmungsveränderungen beitragen können, ärztlichen Rat einholen sollen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto de finasterida 1 mg comprimidos advertirá ahora también a los pacientes de la necesidad de consultar al médico si tienen problemas de función sexual (como disminución del deseo sexual o disfunción eréctil), que son efectos secundarios conocidos del medicamento y pueden contribuir a los cambios en el estado de ánimo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto da finasterida 1 mg comprimidos agora também avisarão os pacientes sobre a necessidade de consultar o médico em caso de problemas de disfunção sexual (como diminuição do desejo sexual ou disfunção erétil), que são efeitos indesejáveis conhecidos do medicamento e podem contribuir para mudanças de humor.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit du finastéride 1 mg comprimés avertiront désormais aussi les patients qu’ils doivent consulter un médecin en cas de problèmes de dysfonction sexuelle (comme une diminution du désir sexuel ou des troubles de l’érection), qui sont des effets indésirables connus du médicament et peuvent contribuer à des changements d’humeur.",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड 1 mg की गोलियों की आधिकारिक जानकारी अब मरीज़ों को यह भी सचेत करेगी कि अगर उन्हें यौन क्रिया की समस्याएँ (जैसे यौन इच्छा में कमी या स्तंभन दोष) हों, जो दवा के जाने-माने अवांछित प्रभाव हैं और मूड में बदलाव में योगदान दे सकते हैं, तो वे डॉक्टर से सलाह लें।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, prosegu, dopo l’interruzione, dopo la sospensione, periodo indefinito, a lungo termine, irreversib, permanent",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-it-regulator-nii202509",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-it-regulator-nii202509",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Nota Informativa Importante di Sicurezza concordata con le Autorita’ Regolatorie Europee e l’Agenzia Italiana del Farmaco (AIFA)",
            "lang": "it",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AIFA"
            },
            "url": "https://www.aifa.gov.it/documents/20142/2690608/NIIS_Finasteride_dutasteride_IT_16.09.2025.pdf",
            "fetchedUrl": null,
            "textDate": "2025-09-16",
            "textDateKind": "publication",
            "textDateAsPrinted": "16 Settembre 2025"
          },
          "passages": [
            {
              "key": "update",
              "kind": "regulator-statement",
              "section": [
                "Informazioni generali sul problema di sicurezza",
                "Finasteride 1 mg (alopecia androgenetica)"
              ],
              "since": null,
              "lang": "it",
              "text": "Le avvertenze e le precauzioni d’impiego saranno aggiornate per raccomandare ai pazienti di contattare il proprio medico qualora insorgano disfunzione sessuale e di prendere in considerazione l’interruzione del trattamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The warnings and precautions for use will be updated to recommend that patients contact their doctor if sexual dysfunction occurs, and consider stopping treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Warnhinweise und Vorsichtsmaßnahmen für die Anwendung werden dahingehend aktualisiert, dass den Patienten empfohlen wird, sich an ihren Arzt zu wenden, wenn sexuelle Dysfunktion auftritt, und in Erwägung zu ziehen, die Behandlung abzubrechen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las advertencias y precauciones de empleo se actualizarán para recomendar a los pacientes que se pongan en contacto con su médico si aparece disfunción sexual y que consideren la interrupción del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As advertências e precauções de uso serão atualizadas para recomendar que os pacientes procurem o médico caso surja disfunção sexual e considerem interromper o tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les mises en garde et précautions d’emploi seront mises à jour pour recommander aux patients de contacter leur médecin en cas de dysfonction sexuelle et d’envisager l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "चेतावनियाँ और उपयोग की सावधानियाँ अपडेट की जाएँगी, ताकि मरीज़ों को सलाह दी जा सके कि सेक्शुअल डिस्फ़ंक्शन होने पर वे अपने डॉक्टर से संपर्क करें और इलाज बंद करने पर विचार करें।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, prosegu, continu, dopo l’interruzione, dopo la sospensione, periodo indefinito, a lungo termine, irreversib, permanent",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "Propecia",
              "form": "1 mg comprimidos recubiertos con película",
              "holder": "Organon Salud, S.L."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/62441/FT_62441.html",
            "fetchedUrl": null,
            "textDate": "2025-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO 11/2025"
          },
          "passages": [
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos psiquiátricos:",
                "Poco frecuentes*"
              ],
              "since": null,
              "lang": "es",
              "text": "Disminución de la libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decreased libido",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "Diminution de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama:",
                "Poco frecuentes*"
              ],
              "since": null,
              "lang": "es",
              "text": "Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)",
                  "by": "ours"
                },
                "de": {
                  "text": "erektile Dysfunktion, Ejakulationsstörung (einschließlich vermindertes Ejakulatvolumen)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção erétil, distúrbio da ejaculação (incluindo diminuição do volume de ejaculação)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Troubles de l’érection, troubles de l’éjaculation (y compris diminution du volume de l’éjaculat)",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, स्खलन विकार (स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी सहित)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "incidence-note",
              "kind": "qualification",
              "section": [
                "4.8 Reacciones adversas"
              ],
              "since": null,
              "qualifies": "listed-reproductive-1",
              "lang": "es",
              "text": "Las incidencias se presentan en forma de diferencia respecto al placebo en estudios clínicos a los 12 meses.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Incidences are given as the difference from placebo in clinical studies at 12 months.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeiten sind als Unterschied zum Placebo in klinischen Studien nach 12 Monaten angegeben.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As incidências são apresentadas como diferença em relação ao placebo em estudos clínicos aos 12 meses.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les incidences sont présentées sous forme de différence par rapport au placebo dans les études cliniques à 12 mois.",
                  "by": "ours"
                },
                "it": {
                  "text": "Incidenze presentate quali differenze dal placebo negli studi clinici al 12° mese.",
                  "by": "ours"
                },
                "hi": {
                  "text": "घटना दरें 12 महीने पर क्लिनिकल अध्ययनों में प्लेसीबो से अंतर के रूप में दी गई हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "Además, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasterida",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In addition, during use after marketing the following has been reported: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped",
                  "by": "ours"
                },
                "de": {
                  "text": "Außerdem wurde bei der Anwendung nach der Markteinführung berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen der Behandlung mit Finasterid",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Além disso, durante o uso após a comercialização foi notificada: persistência da disfunção sexual (diminuição da libido, disfunção erétil e distúrbios da ejaculação) depois da interrupção do tratamento com finasterida",
                  "by": "ours"
                },
                "fr": {
                  "text": "En outre, pendant l’utilisation après la commercialisation, ont été rapportés : persistance de la dysfonction sexuelle (diminution de la libido, troubles de l’érection et troubles de l’éjaculation) après l’arrêt du traitement par finastéride",
                  "by": "ours"
                },
                "it": {
                  "text": "Inoltre, durante l’uso post-marketing è stata riportata: persistenza della disfunzione sessuale (diminuzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasteride",
                  "by": "ours"
                },
                "hi": {
                  "text": "इसके अलावा, बाज़ार में आने के बाद के उपयोग में ये रिपोर्ट हुए हैं: फ़िनास्टेराइड से इलाज बंद करने के बाद भी सेक्शुअल डिस्फ़ंक्शन का बने रहना (कामेच्छा में कमी, स्तंभन दोष और स्खलन विकार)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-drug-related",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "lang": "es",
              "text": "Las reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Drug-related sexual adverse reactions were more frequent in men treated with finasteride than in those receiving placebo, with frequencies during the first 12 months of 3.8% and 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of the men in each treatment group stopped treatment because of drug-related sexual adverse reactions in the first 12 months, and the incidence decreased afterwards.",
                  "by": "ours"
                },
                "de": {
                  "text": "Arzneimittelbedingte sexuelle Nebenwirkungen waren bei den mit Finasterid behandelten Männern häufiger als bei den Männern, die Placebo erhielten, mit Häufigkeiten von 3,8 % bzw. 2,1 % während der ersten 12 Monate. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern im Laufe der folgenden vier Jahre auf 0,6 %. Etwa 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung in den ersten 12 Monaten aufgrund arzneimittelbedingter sexueller Nebenwirkungen, danach nahm die Häufigkeit ab.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas sexuais relacionadas ao medicamento foram mais frequentes nos homens tratados com finasterida do que nos que receberam placebo, com frequências durante os 12 primeiros meses de 3,8% e 2,1%, respectivamente. A incidência desses efeitos diminuiu para 0,6% nos homens tratados com finasterida ao longo dos quatro anos seguintes. Aproximadamente 1% dos homens de cada grupo de tratamento interrompeu o tratamento por reações adversas sexuais relacionadas ao medicamento nos primeiros 12 meses, e depois disso a incidência diminuiu.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sexuels liés au médicament ont été plus fréquents chez les hommes traités par finastéride que chez ceux recevant un placebo, avec des fréquences respectives de 3,8 % et 2,1 % au cours des 12 premiers mois. L’incidence de ces effets a diminué à 0,6 % chez les hommes traités par finastéride au cours des quatre années suivantes. Environ 1 % des hommes de chaque groupe de traitement ont arrêté le traitement en raison d’effets indésirables sexuels liés au médicament au cours des 12 premiers mois, puis l’incidence a diminué.",
                  "by": "ours"
                },
                "it": {
                  "text": "Effetti indesiderati correlati al medicinale inerenti la sfera sessuale sono stati più comuni fra gli uomini trattati con finasteride che fra quelli trattati con placebo con frequenze durante i primi 12 mesi di 3,8 % vs 2,1 %, rispettivamente. L’incidenza di tali effetti è diminuita allo 0,6 % negli uomini trattati con finasteride nel corso dei successivi quattro anni. Circa l’1 % degli uomini in ciascun gruppo di trattamento ha interrotto la terapia a seguito di esperienze avverse della sfera sessuale correlate con il medicinale verificatesi nei primi 12 mesi e l’incidenza è in seguito diminuita.",
                  "by": "ours"
                },
                "hi": {
                  "text": "पहले 12 महीनों में क्रमशः 3.8% और 2.1% की आवृत्ति के साथ, दवा से जुड़ी यौन प्रतिकूल प्रतिक्रियाएँ फ़िनास्टेराइड से इलाज किए गए पुरुषों में प्लेसीबो लेने वालों से ज़्यादा आम थीं। अगले चार सालों में फ़िनास्टेराइड से इलाज किए गए पुरुषों में इन प्रभावों की दर घटकर 0.6% रह गई। हर इलाज समूह के लगभग 1% पुरुषों ने पहले 12 महीनों में दवा से जुड़ी यौन प्रतिकूल प्रतिक्रियाओं के कारण इलाज बंद किया, और उसके बाद यह दर घटती गई।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es-leaflet",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: información para el usuario",
            "lang": "es",
            "product": {
              "name": "Propecia",
              "form": "1 mg comprimidos recubiertos con película",
              "holder": "Organon Salud, S.L."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/62441/P_62441.html",
            "fetchedUrl": null,
            "textDate": "2025-11",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: 11/2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Poco frecuentes: pueden afectar hasta 1 de 100 personas"
              ],
              "since": null,
              "lang": "es",
              "text": "menos deseo sexual",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "less sexual desire",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes Verlangen nach Sex",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "menos desejo sexual",
                  "by": "ours"
                },
                "fr": {
                  "text": "moins de désir sexuel",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Poco frecuentes: pueden afectar hasta 1 de 100 personas"
              ],
              "since": null,
              "lang": "es",
              "text": "dificultades para lograr la erección",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty achieving an erection",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten bei der Erektion",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldades para ter ereção",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficultés à obtenir une érection",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà nel raggiungimento dell’erezione",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन हासिल करने में दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Poco frecuentes: pueden afectar hasta 1 de 100 personas"
              ],
              "since": null,
              "lang": "es",
              "text": "problemas con la eyaculación, incluyendo una disminución de la cantidad de semen eyaculado",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with ejaculation, including a decrease in the amount of semen ejaculated",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, einschließlich einer verminderten Samenergussmenge",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas com a ejaculação, incluindo uma diminuição da quantidade de sêmen ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation, notamment une diminution de la quantité de sperme éjaculé",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi con l’eiaculazione quali riduzione della quantità di sperma emesso",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जिनमें स्खलित वीर्य की मात्रा में कमी शामिल है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Posibles efectos adversos"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "es",
              "text": "Los efectos adversos han sido, normalmente, pasajeros con el tratamiento continuado o han desaparecido cuando el tratamiento se interrumpe.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects have usually been temporary with continued treatment, or have disappeared when treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen waren in der Regel bei fortgesetzter Behandlung vorübergehend oder verschwanden nach Abbruch der Behandlung.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos geralmente foram passageiros com a continuação do tratamento ou desapareceram quando o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables ont normalement été passagers avec la poursuite du traitement ou ont disparu à l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono stati generalmente temporanei con un trattamento continuativo o sono regrediti con la interruzione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर लगातार इलाज के दौरान अस्थायी रहे हैं, या इलाज रोकने पर खत्म हो गए हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "dificultad persistente para tener erección después de interrumpir el tratamiento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent difficulty in having an erection after stopping treatment",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Schwierigkeiten bei der Erektion nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dificuldade persistente de ter ereção depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté persistante à avoir une érection après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà persistente ad avere una erezione dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज रोकने के बाद भी इरेक्शन होने में बनी रहने वाली दिक्कत",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "disminución persistente en el deseo sexual después de interrumpir el tratamiento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent decrease in sexual desire after stopping treatment",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Abnahme des sexuellen Verlangens nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição persistente do desejo sexual depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution persistante du désir sexuel après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज रोकने के बाद भी सेक्स की इच्छा में बनी रहने वाली कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "problemas persistentes de eyaculación después de interrumpir el tratamiento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "persistent problems with ejaculation after stopping treatment",
                  "by": "ours"
                },
                "de": {
                  "text": "anhaltende Ejakulationsschwierigkeiten nach dem Absetzen der Behandlung",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "problemas persistentes de ejaculação depois de interromper o tratamento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation persistants après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "persistenti problemi di eiaculazione dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज रोकने के बाद भी स्खलन की बनी रहने वाली समस्याएँ",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es-pro-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es-pro-proscar",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "Proscar",
              "form": "5 mg comprimidos recubiertos con película",
              "holder": "Organon Salud, S.L."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/59830/FT_59830.html",
            "fetchedUrl": null,
            "textDate": "2024-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO 07/2024"
          },
          "passages": [
            {
              "key": "listed-most-frequent",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "lang": "es",
              "text": "Las reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur in the early phases of treatment and, in most patients, resolve with continued treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas mais frequentes são impotência e diminuição da libido. Essas reações adversas ocorrem nas primeiras fases do tratamento e, na maioria dos pacientes, desaparecem com a continuação do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables les plus fréquents sont l’impuissance et la diminution de la libido. Ces effets indésirables apparaissent au début du traitement et, chez la plupart des patients, disparaissent avec la poursuite du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Impotenza e diminuzione della libido sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सबसे आम प्रतिकूल प्रतिक्रियाएँ स्तंभन दोष और कामेच्छा में कमी हैं। ये प्रतिकूल प्रतिक्रियाएँ इलाज के शुरुआती चरणों में होती हैं और ज़्यादातर मरीज़ों में इलाज जारी रखने पर ठीक हो जाती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-psychiatric-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos psiquiátricos",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "disminución de la libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased libido",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderte Libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos psiquiátricos",
                "Frecuencia no conocida"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "depresión, disminución de la libido que continuó después de la discontinuación del tratamiento, ansiedad, ideación suicida",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "depression, decreased libido that continued after treatment was discontinued, anxiety, suicidal ideation",
                  "by": "ours"
                },
                "de": {
                  "text": "Depression, verminderte Libido, die nach dem Absetzen der Behandlung andauerte, Angst, Suizidgedanken",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "depressão, diminuição da libido que continuou depois da descontinuação do tratamento, ansiedade, ideação suicida",
                  "by": "ours"
                },
                "fr": {
                  "text": "dépression, diminution de la libido qui a continué après l’arrêt du traitement, anxiété, idées suicidaires",
                  "by": "ours"
                },
                "it": {
                  "text": "depressione, diminuzione della libido che è proseguita dopo l’interruzione del trattamento, ansia, ideazione suicidaria",
                  "by": "ours"
                },
                "hi": {
                  "text": "डिप्रेशन, कामेच्छा में कमी जो इलाज बंद करने के बाद भी जारी रही, चिंता, आत्महत्या के विचार",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "impotencia",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "impotence",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance",
                  "by": "ours"
                },
                "it": {
                  "text": "impotenza",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-reproductive-2",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Poco frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "trastornos de la eyaculación, hipersensibilidad mamaria, crecimiento mamario",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "ejaculation disorders, breast tenderness, breast enlargement",
                  "by": "ours"
                },
                "de": {
                  "text": "Ejakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der Brust",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "distúrbios da ejaculação, hipersensibilidade mamária, aumento das mamas",
                  "by": "ours"
                },
                "fr": {
                  "text": "troubles de l’éjaculation, hypersensibilité des seins, augmentation du volume des seins",
                  "by": "ours"
                },
                "it": {
                  "text": "disturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन विकार, स्तनों में अतिसंवेदनशीलता, स्तनों का बढ़ना",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.8. Reacciones adversas",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuencia no conocida"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "disfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó después de la discontinuación del tratamiento, dolor testicular, hematospermia, infertilidad masculina o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la discontinuación de finasterida.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after treatment was discontinued, testicular pain, haematospermia, male infertility or poor seminal quality. Normalisation or improvement of seminal quality has been reported after finasteride was discontinued.",
                  "by": "ours"
                },
                "de": {
                  "text": "sexuelle Funktionsstörungen (erektile Dysfunktion und Ejakulationsstörungen), die nach dem Absetzen der Behandlung andauerten, Hodenschmerzen, Hämatospermie, Infertilität bei Männern oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual (disfunção erétil e distúrbios da ejaculação) que continuou depois da descontinuação do tratamento, dor testicular, hematospermia, infertilidade masculina ou má qualidade do sêmen. Foi relatada normalização ou melhora da qualidade do sêmen depois da descontinuação da finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle (troubles de l’érection et troubles de l’éjaculation) qui a continué après l’arrêt du traitement, douleur testiculaire, hématospermie, infertilité masculine ou mauvaise qualité du sperme. Une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale (disfunzione erettile e disturbi dell’eiaculazione) che è proseguita dopo l’interruzione del trattamento, dolore testicolare, ematospermia, infertilità maschile o scarsa qualità del liquido seminale. Normalizzazione o miglioramento della qualità del liquido seminale è stata riportata dopo l’interruzione della finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन (स्तंभन दोष और स्खलन विकार) जो इलाज बंद करने के बाद भी जारी रहा, अंडकोष में दर्द, वीर्य में खून (हीमैटोस्पर्मिया), पुरुष बाँझपन या वीर्य की खराब गुणवत्ता। फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "frequency-unknown",
              "kind": "qualification",
              "section": [
                "4.8. Reacciones adversas"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "es",
              "text": "No se puede determinar la frecuencia de reacciones adversas notificadas durante el uso posterior a la comercialización, ya que proceden de notificaciones espontáneas.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The frequency of adverse reactions reported during use after marketing cannot be determined, as they come from spontaneous reports.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit der während der Anwendung nach Markteinführung berichteten Nebenwirkungen kann nicht bestimmt werden, da sie aus Spontanberichten stammen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Não é possível determinar a frequência das reações adversas notificadas durante o uso posterior à comercialização, pois elas vêm de notificações espontâneas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La fréquence des effets indésirables rapportés pendant l’utilisation après la commercialisation ne peut pas être déterminée, car ils proviennent de signalements spontanés.",
                  "by": "ours"
                },
                "it": {
                  "text": "La frequenza delle reazioni avverse riportate durante l’uso post-marketing non può essere determinata, perché derivano da segnalazioni spontanee.",
                  "by": "ours"
                },
                "hi": {
                  "text": "बाज़ार में आने के बाद के उपयोग में रिपोर्ट हुई प्रतिकूल प्रतिक्रियाओं की आवृत्ति तय नहीं की जा सकती, क्योंकि वे स्वतःस्फूर्त रिपोर्टों से आती हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-investigations-1",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Exploraciones complementarias",
                "Frecuente"
              ],
              "since": null,
              "lang": "es",
              "text": "disminución del volumen de eyaculación",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased volume of ejaculate",
                  "by": "ours"
                },
                "de": {
                  "text": "vermindertes Ejakulatvolumen",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do volume do ejaculado",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du volume de l’éjaculat",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del volume dell’eiaculato",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन के समय निकलने वाले वीर्य की मात्रा में कमी",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-mtops",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Tratamiento médico de los síntomas prostáticos (MTOPS)"
              ],
              "since": null,
              "lang": "es",
              "text": "La incidencia del trastorno de eyaculación en pacientes recibiendo tratamiento combinado fue comparable a la suma de las incidencias de esta experiencia adversa para las dos monoterapias.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The incidence of ejaculation disorder in patients receiving combined treatment was comparable to the sum of the incidences of this adverse experience for the two monotherapies.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Häufigkeit von Ejakulationsstörungen bei Patienten unter Kombinationstherapie entsprach der Summe der Häufigkeiten dieses unerwünschten Ereignisses unter den beiden Monotherapien.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A incidência do distúrbio da ejaculação em pacientes que receberam tratamento combinado foi comparável à soma das incidências dessa experiência adversa nas duas monoterapias.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’incidence des troubles de l’éjaculation chez les patients recevant le traitement combiné était comparable à la somme des incidences de cet événement indésirable pour les deux monothérapies.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’incidenza di disturbi dell’eiaculazione nei pazienti trattati con l’associazione è risultata paragonabile alla somma delle incidenze di tale esperienza avversa per le due monoterapie.",
                  "by": "ours"
                },
                "hi": {
                  "text": "संयुक्त इलाज लेने वाले मरीज़ों में स्खलन विकार की दर इस प्रतिकूल अनुभव की दोनों अलग-अलग इलाजों की दरों के जोड़ के बराबर रही।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es-leaflet-proscar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es-leaflet-proscar",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: información para el usuario",
            "lang": "es",
            "product": {
              "name": "Proscar",
              "form": "5 mg comprimidos recubiertos con película",
              "holder": "Organon Salud, S.L."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/59830/P_59830.html",
            "fetchedUrl": null,
            "textDate": "2024-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de la última revisión de este prospecto: julio 2024."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)"
              ],
              "since": null,
              "lang": "es",
              "text": "reducción del deseo sexual.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "reduced sexual desire.",
                  "by": "ours"
                },
                "de": {
                  "text": "verminderter Sexualtrieb.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição do desejo sexual.",
                  "by": "ours"
                },
                "fr": {
                  "text": "réduction du désir sexuel.",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "depresión, disminución del deseo sexual que continuó después de suspender la medicación, ansiedad, pensamientos suicidas.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "depression, decreased sexual desire that continued after the medicine was stopped, anxiety, suicidal thoughts.",
                  "by": "ours"
                },
                "de": {
                  "text": "Depression, verminderter Sexualtrieb, der nach dem Absetzen des Arzneimittels andauerte, Angst, Selbstmordgedanken.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "depressão, diminuição do desejo sexual que continuou depois de suspender a medicação, ansiedade, pensamentos suicidas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "dépression, diminution du désir sexuel qui a continué après l’arrêt du médicament, anxiété, pensées suicidaires.",
                  "by": "ours"
                },
                "it": {
                  "text": "depressione, diminuzione del desiderio sessuale che è proseguita dopo l’interruzione del medicinale, ansia, pensieri suicidi.",
                  "by": "ours"
                },
                "hi": {
                  "text": "डिप्रेशन, सेक्स की इच्छा में कमी जो दवा रोकने के बाद भी जारी रही, चिंता, आत्महत्या के विचार।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)"
              ],
              "since": null,
              "lang": "es",
              "text": "impotencia (imposibilidad de tener una erección).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "impotence (inability to have an erection).",
                  "by": "ours"
                },
                "de": {
                  "text": "Impotenz (Unfähigkeit, eine Erektion zu bekommen).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "impotência (impossibilidade de ter uma ereção).",
                  "by": "ours"
                },
                "fr": {
                  "text": "impuissance (impossibilité d’avoir une érection).",
                  "by": "ours"
                },
                "it": {
                  "text": "impotenza (incapacità di avere un’erezione).",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष (इरेक्शन न कर पाना)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-4",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes)"
              ],
              "since": null,
              "lang": "es",
              "text": "hinchazón y aumento de la sensibilidad en el pecho y problemas con la eyaculación.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "swelling and increased tenderness in the breast, and problems with ejaculation.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwellung und erhöhte Berührungsempfindlichkeit der Brust sowie Störungen des Samenergusses.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "inchaço e aumento da sensibilidade nos seios e problemas com a ejaculação.",
                  "by": "ours"
                },
                "fr": {
                  "text": "gonflement et sensibilité accrue des seins, et problèmes d’éjaculation.",
                  "by": "ours"
                },
                "it": {
                  "text": "gonfiore e maggiore sensibilità al seno e problemi di eiaculazione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तनों में सूजन और उनमें संवेदनशीलता का बढ़ना, और स्खलन की समस्याएँ।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "es",
              "text": "dolor en los testículos, sangre en el semen, imposibilidad de tener una erección que continuó después de suspender la medicación; problemas con la eyaculación que continuaron después de suspender la medicación, infertilidad masculina o calidad seminal pobre. Se ha notificado la mejora de la calidad seminal después de suspender la medicación.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "pain in the testicles, blood in the semen, inability to have an erection that continued after the medicine was stopped; problems with ejaculation that continued after the medicine was stopped, male infertility or poor seminal quality. Improvement in seminal quality has been reported after the medicine was stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Hodenschmerzen, Blut im Sperma, Unfähigkeit, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauerte; Störungen des Samenergusses, die nach dem Absetzen des Arzneimittels andauerten, Unfruchtbarkeit bei Männern oder schlechte Samenqualität. Eine Verbesserung der Samenqualität wurde nach dem Absetzen des Arzneimittels berichtet.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "dor nos testículos, sangue no sêmen, impossibilidade de ter uma ereção que continuou depois de suspender a medicação; problemas com a ejaculação que continuaram depois de suspender a medicação, infertilidade masculina ou má qualidade do sêmen. Foi relatada melhora da qualidade do sêmen depois de suspender a medicação.",
                  "by": "ours"
                },
                "fr": {
                  "text": "douleur dans les testicules, sang dans le sperme, impossibilité d’avoir une érection qui a continué après l’arrêt du médicament ; problèmes d’éjaculation qui ont continué après l’arrêt du médicament, infertilité masculine ou mauvaise qualité du sperme. Une amélioration de la qualité du sperme a été rapportée après l’arrêt du médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "dolore ai testicoli, sangue nello sperma, incapacità di avere un’erezione che è proseguita dopo l’interruzione del medicinale; problemi di eiaculazione che sono proseguiti dopo l’interruzione del medicinale, infertilità maschile o scarsa qualità del liquido seminale. Un miglioramento della qualità del liquido seminale è stato riportato dopo l’interruzione del medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "अंडकोष में दर्द, वीर्य में खून, इरेक्शन न कर पाना जो दवा रोकने के बाद भी जारी रहा; स्खलन की समस्याएँ जो दवा रोकने के बाद भी जारी रहीं, पुरुष बाँझपन या वीर्य की खराब गुणवत्ता। दवा रोकने के बाद वीर्य की गुणवत्ता में सुधार की रिपोर्ट हुई है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-6",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)"
              ],
              "since": null,
              "lang": "es",
              "text": "disminución de la cantidad de semen expulsado en el acto sexual. Esta disminución en la cantidad de semen no parece alterar el funcionamiento sexual normal.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme der beim Geschlechtsverkehr abgegebenen Samenmenge. Diese Abnahme der Samenmenge scheint die normale Sexualfunktion nicht zu beeinträchtigen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "diminuição da quantidade de sêmen expelido no ato sexual. Essa diminuição na quantidade de sêmen não parece alterar o funcionamento sexual normal.",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution de la quantité de sperme émise lors du rapport sexuel. Cette diminution de la quantité de sperme ne semble pas altérer le fonctionnement sexuel normal.",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione della quantità di sperma emesso durante il rapporto sessuale. Questa diminuzione della quantità di sperma non sembra influire sulla normale funzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यौन क्रिया के दौरान निकलने वाले वीर्य की मात्रा में कमी। वीर्य की मात्रा में यह कमी सामान्य यौन क्रिया को प्रभावित करती नहीं लगती।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "qualification",
              "section": [
                "4. Posibles efectos adversos"
              ],
              "since": null,
              "qualifies": "listed-6",
              "lang": "es",
              "text": "En algunos casos, estos efectos secundarios desaparecieron a pesar de que el paciente continuó tomando Proscar. Cuando los síntomas persistieron, estos generalmente desaparecieron al dejar de tomar Proscar.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In some cases, these side effects disappeared even though the patient continued taking Proscar. When the symptoms persisted, they generally disappeared on stopping Proscar.",
                  "by": "ours"
                },
                "de": {
                  "text": "In einigen Fällen verschwanden diese Nebenwirkungen, obwohl der Patient Proscar weiter einnahm. Wenn die Symptome anhielten, verschwanden sie in der Regel nach dem Absetzen von Proscar.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em alguns casos, esses efeitos colaterais desapareceram mesmo com o paciente continuando a tomar Proscar. Quando os sintomas persistiram, geralmente desapareceram ao parar de tomar Proscar.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans certains cas, ces effets secondaires ont disparu alors que le patient continuait à prendre Proscar. Lorsque les symptômes ont persisté, ils ont généralement disparu à l’arrêt de Proscar.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi questi effetti indesiderati sono scomparsi anche se il paziente ha continuato a prendere Proscar. Quando i sintomi sono persistiti, di solito sono scomparsi dopo l’interruzione di Proscar.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में, मरीज़ के Proscar लेते रहने पर भी ये साइड इफ़ेक्ट खत्म हो गए। जब लक्षण बने रहे, तो वे आम तौर पर Proscar लेना बंद करने पर खत्म हो गए।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es-regulator-aemps202505",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es-regulator-aemps202505",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Nota de seguridad MUH (FV), 02/2025: «La AEMPS informa de las nuevas recomendaciones para minimizar el riesgo de ideación suicida en pacientes tratados con finasterida»",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/la-aemps-informa-de-las-nuevas-recomendaciones-para-minimizar-el-riesgo-de-ideacion-suicida-en-pacientes-tratados-con-finasterida/",
            "fetchedUrl": null,
            "textDate": "2025-05-09",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 09 de mayo de 2025"
          },
          "passages": [
            {
              "key": "card",
              "kind": "regulator-statement",
              "section": [
                "La AEMPS informa de las nuevas recomendaciones para minimizar el riesgo de ideación suicida en pacientes tratados con finasterida"
              ],
              "since": null,
              "lang": "es",
              "text": "Como medida adicional, se incluirá una tarjeta de información para el paciente en todos los envases de finasterida 1 mg para informar sobre los riesgos de alteraciones del estado de ánimo y la disfunción sexual, indicando cómo actuar en cada caso.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "As an additional measure, a patient information card will be included in all packs of finasteride 1 mg to inform about the risks of mood changes and sexual dysfunction, saying how to act in each case.",
                  "by": "ours"
                },
                "de": {
                  "text": "Als zusätzliche Maßnahme wird allen Packungen von Finasterid 1 mg eine Patientenkarte beigelegt, die über die Risiken von Stimmungsveränderungen und sexueller Dysfunktion informiert und angibt, wie in jedem Fall zu handeln ist.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Como medida adicional, será incluído um cartão de informação para o paciente em todas as embalagens de finasterida 1 mg, para informar sobre os riscos de alterações do estado de ânimo e de disfunção sexual, indicando como agir em cada caso.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Comme mesure supplémentaire, une carte d’information pour le patient sera incluse dans tous les emballages de finastéride 1 mg afin d’informer sur les risques d’altérations de l’humeur et de dysfonction sexuelle, en indiquant comment agir dans chaque cas.",
                  "by": "ours"
                },
                "it": {
                  "text": "Come misura aggiuntiva, in tutte le confezioni di finasteride 1 mg sarà inclusa una scheda informativa per il paziente per informarlo sui rischi di alterazioni dell’umore e di disfunzione sessuale, indicando come agire in ciascun caso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "एक अतिरिक्त उपाय के रूप में, फ़िनास्टेराइड 1 mg के सभी पैकों में मरीज़ के लिए एक सूचना कार्ड रखा जाएगा, जो मूड में बदलाव और सेक्शुअल डिस्फ़ंक्शन के जोखिमों के बारे में बताएगा और यह भी कि हर स्थिति में क्या करना चाहिए।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, continu, después de / tras la interrupción or suspensión, dejar, irreversib, permanent, duradero, larga duración",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-es-leaflet-card",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-es-leaflet-card",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Tarjeta de información para el paciente · Finasterida 1mg",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/DocsPub/16/3727",
            "fetchedUrl": null,
            "textDate": "2026-06",
            "textDateKind": "publication",
            "textDateAsPrinted": "Información sobre prevención de riesgos acordada con la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Fecha de revisión: Junio 2026"
          },
          "passages": [],
          "searched": "persist, continu, después de / tras la interrupción or suspensión, dejar, irreversib, permanent, duradero, larga duración",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "finasterida, EMS S/A, comprimido revestido 1 mg: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Finasterida",
              "form": "1 mg comprimido revestido",
              "holder": "EMS S/A"
            },
            "source": {
              "type": "holder",
              "name": "Sara – Plataforma Oficial de Bulas Digitais de Medicamentos do Grupo EMS"
            },
            "url": "https://www.sara.com.br/bula-do-paciente-finasterida-1mg-com-30-comprimidos-revestidos-ems/7896004706405",
            "fetchedUrl": "https://cdn.sara.com.br/leafletDocuments/cd2f05f0-c108-434b-bc6c-efe0673e7f7a.pdf",
            "textDate": "2025-02-13",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi atualizada conforme Bula Padrão aprovada pela Anvisa em 13/02/2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "pode sentir menos desejo de manter relações sexuais e/ou dificuldade na obtenção de uma ereção.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "you may feel less desire to have sexual relations and/or have difficulty getting an erection.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sie haben möglicherweise weniger Lust auf Sex und/oder Schwierigkeiten bei der Erektion.",
                  "by": "ours"
                },
                "es": {
                  "text": "puede sentir menos deseo sexual y/o dificultad para conseguir una erección.",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez ressentir moins de désir sexuel et/ou avoir des difficultés à obtenir une érection.",
                  "by": "ours"
                },
                "it": {
                  "text": "può avere meno desiderio sessuale e/o difficoltà nel raggiungimento dell’erezione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपमें सेक्स की इच्छा कम हो सकती है और/या इरेक्शन होने में दिक्कत हो सकती है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "pode ter uma redução na quantidade de sêmen liberada durante a relação sexual (isto não parece interferir na função sexual normal).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "you may have a reduction in the amount of semen released during sexual intercourse (this does not appear to interfere with normal sexual function).",
                  "by": "ours"
                },
                "de": {
                  "text": "Die beim Geschlechtsverkehr abgegebene Samenmenge kann abnehmen (dies scheint die normale Sexualfunktion nicht zu beeinträchtigen).",
                  "by": "ours"
                },
                "es": {
                  "text": "puede tener una disminución de la cantidad de semen expulsado durante el acto sexual (esto no parece interferir en el funcionamiento sexual normal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez avoir une diminution de la quantité de sperme émise pendant le rapport sexuel (cela ne semble pas interférer avec la fonction sexuelle normale).",
                  "by": "ours"
                },
                "it": {
                  "text": "può avere una riduzione della quantità di sperma emesso durante il rapporto sessuale (questo non sembra interferire con la normale funzione sessuale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी हो सकती है (यह सामान्य यौन क्रिया में बाधा डालती नहीं लगती)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "in-trials",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "pt-BR",
              "text": "Nos estudos clínicos, estes efeitos adversos desapareceram em homens que pararam de tomar finasterida e em muitos homens que continuaram o tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In clinical studies, these adverse effects disappeared in men who stopped taking finasteride and in many men who continued treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "In klinischen Studien verschwanden diese Nebenwirkungen bei Männern, die die Einnahme von Finasterid beendeten, und bei vielen Männern, die die Behandlung fortsetzten.",
                  "by": "ours"
                },
                "es": {
                  "text": "En los ensayos clínicos, estos efectos adversos desaparecieron en los hombres que dejaron de tomar finasterida y en muchos hombres que continuaron el tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans les études cliniques, ces effets indésirables ont disparu chez des hommes qui ont arrêté de prendre du finastéride et chez beaucoup d’hommes qui ont poursuivi le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Negli studi clinici questi effetti indesiderati sono scomparsi negli uomini che hanno smesso di prendere la finasteride e in molti uomini che hanno proseguito il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्लिनिकल अध्ययनों में ये प्रतिकूल प्रभाव उन पुरुषों में खत्म हो गए जिन्होंने फ़िनास्टेराइड लेना बंद किया, और इलाज जारी रखने वाले कई पुरुषों में भी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "problemas de ejaculação que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with ejaculation that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, die nach dem Absetzen der Behandlung andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continuaron después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui ont continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che sono proseguiti dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जो इलाज बंद करने के बाद भी जारी रहीं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "diminuição do desejo sexual que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen der Behandlung andauerte",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual que continuó después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel qui a continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale che è proseguita dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो इलाज बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "dificuldade de ter ereção que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty having an erection that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten bei der Erektion, die nach dem Absetzen der Behandlung andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para tener una erección que continuó después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à avoir une érection qui a continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà ad avere un’erezione che è proseguita dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत, जो इलाज बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "originatorWithdrawn",
              "text": {
                "en": "An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.",
                "de": "In einer offiziellen Arzneimittelliste, die wir gelesen haben, ist das Originalpräparat als gestrichen, widerrufen oder archiviert verzeichnet. Dies ist der Text eines anderen Produkts, nämlich des in dieser Zeile genannten.",
                "es": "En una lista oficial de medicamentos que hemos leído, el producto original figura como anulado, revocado o archivado. Este es el texto de otro producto, el que se nombra en esta fila.",
                "pt-br": "Uma lista oficial de medicamentos que lemos mostra o produto original como cancelado, revogado ou arquivado. Este é o texto de outro produto, o que está indicado nesta linha.",
                "fr": "Une liste officielle de médicaments que nous avons lue présente le produit d’origine comme annulé, révoqué ou archivé. Il s’agit ici du texte d’un autre produit, celui qui est nommé dans cette ligne.",
                "it": "Un elenco ufficiale di medicinali che abbiamo letto indica il medicinale originatore come annullato, revocato o archiviato. Questo è il testo di un altro prodotto, quello indicato in questa riga.",
                "hi": "हमने दवाओं की जो एक आधिकारिक सूची पढ़ी, उसमें दवा के मूल (originator) उत्पाद को रद्द, निरस्त या आर्काइव किया हुआ दिखाया गया है। यह एक दूसरे उत्पाद का दस्तावेज़ है, जिसका नाम इस पंक्ति में दिया गया है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-br-leaflet-teuto",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br-leaflet-teuto",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "finasterida, Laboratório Teuto Brasileiro S/A, comprimido revestido 1 mg: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Finasterida",
              "form": "1 mg comprimido revestido",
              "holder": "Laboratório Teuto Brasileiro S/A"
            },
            "source": {
              "type": "holder",
              "name": "Laboratório Teuto Brasileiro S/A"
            },
            "url": "https://teutodigital.com.br/wp-content/uploads/2023/11/Finasterida-1mg-VP-407323-05.pdf",
            "fetchedUrl": null,
            "textDate": "2025-07-24",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi atualizada conforme Bula Padrão aprovada pela Anvisa em 24/07/2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "pode sentir menos desejo de manter relações sexuais e/ou dificuldade na obtenção de uma ereção.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "you may feel less desire to have sexual relations and/or have difficulty getting an erection.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sie haben möglicherweise weniger Lust auf Sex und/oder Schwierigkeiten bei der Erektion.",
                  "by": "ours"
                },
                "es": {
                  "text": "puede sentir menos deseo sexual y/o dificultad para conseguir una erección.",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez ressentir moins de désir sexuel et/ou avoir des difficultés à obtenir une érection.",
                  "by": "ours"
                },
                "it": {
                  "text": "può avere meno desiderio sessuale e/o difficoltà nel raggiungimento dell’erezione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आपमें सेक्स की इच्छा कम हो सकती है और/या इरेक्शन होने में दिक्कत हो सकती है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "pode ter uma redução na quantidade de sêmen liberada durante a relação sexual (isto não parece interferir na função sexual normal).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "you may have a reduction in the amount of semen released during sexual intercourse (this does not appear to interfere with normal sexual function).",
                  "by": "ours"
                },
                "de": {
                  "text": "Die beim Geschlechtsverkehr abgegebene Samenmenge kann abnehmen (dies scheint die normale Sexualfunktion nicht zu beeinträchtigen).",
                  "by": "ours"
                },
                "es": {
                  "text": "puede tener una disminución de la cantidad de semen expulsado durante el acto sexual (esto no parece interferir en el funcionamiento sexual normal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "vous pouvez avoir une diminution de la quantité de sperme émise pendant le rapport sexuel (cela ne semble pas interférer avec la fonction sexuelle normale).",
                  "by": "ours"
                },
                "it": {
                  "text": "può avere una riduzione della quantità di sperma emesso durante il rapporto sessuale (questo non sembra interferire con la normale funzione sessuale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी हो सकती है (यह सामान्य यौन क्रिया में बाधा डालती नहीं लगती)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "in-trials",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-2",
              "lang": "pt-BR",
              "text": "Nos estudos clínicos, estes efeitos adversos desapareceram em homens que pararam de tomar finasterida e em muitos homens que continuaram o tratamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In clinical studies, these adverse effects disappeared in men who stopped taking finasteride and in many men who continued treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "In klinischen Studien verschwanden diese Nebenwirkungen bei Männern, die die Einnahme von Finasterid beendeten, und bei vielen Männern, die die Behandlung fortsetzten.",
                  "by": "ours"
                },
                "es": {
                  "text": "En los ensayos clínicos, estos efectos adversos desaparecieron en los hombres que dejaron de tomar finasterida y en muchos hombres que continuaron el tratamiento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans les études cliniques, ces effets indésirables ont disparu chez des hommes qui ont arrêté de prendre du finastéride et chez beaucoup d’hommes qui ont poursuivi le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Negli studi clinici questi effetti indesiderati sono scomparsi negli uomini che hanno smesso di prendere la finasteride e in molti uomini che hanno proseguito il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "क्लिनिकल अध्ययनों में ये प्रतिकूल प्रभाव उन पुरुषों में खत्म हो गए जिन्होंने फ़िनास्टेराइड लेना बंद किया, और इलाज जारी रखने वाले कई पुरुषों में भी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "problemas de ejaculação que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with ejaculation that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Störungen des Samenergusses, die nach dem Absetzen der Behandlung andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que continuaron después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation qui ont continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che sono proseguiti dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जो इलाज बंद करने के बाद भी जारी रहीं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "diminuição do desejo sexual que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen der Behandlung andauerte",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual que continuó después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel qui a continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale che è proseguita dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो इलाज बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "dificuldade de ter ereção que continuou após a descontinuação do tratamento",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "difficulty having an erection that continued after treatment was discontinued",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten bei der Erektion, die nach dem Absetzen der Behandlung andauerten",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultad para tener una erección que continuó después de la interrupción del tratamiento",
                  "by": "ours"
                },
                "fr": {
                  "text": "difficulté à avoir une érection qui a continué après l’arrêt du traitement",
                  "by": "ours"
                },
                "it": {
                  "text": "difficoltà ad avere un’erezione che è proseguita dopo l’interruzione del trattamento",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने में दिक्कत, जो इलाज बंद करने के बाद भी जारी रही",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-br-leaflet-finastil",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br-leaflet-finastil",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FINASTIL® finasterida, EMS Sigma Pharma Ltda, comprimido revestido 5 mg: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Finastil",
              "form": "5 mg comprimido revestido",
              "holder": "EMS Sigma Pharma Ltda."
            },
            "source": {
              "type": "holder",
              "name": "Sara – Plataforma Oficial de Bulas Digitais de Medicamentos do Grupo EMS"
            },
            "url": "https://www.sara.com.br/bula-do-paciente-finastil-5mg-com-30-comprimidos-revestidos-ems/7894916500715",
            "fetchedUrl": "https://www.sara.com.br/bula-do-paciente-finastil-5mg-com-30-comprimidos-revestidos-ems/7894916500715/pdf",
            "textDate": "2025-07-21",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi atualizada conforme Bula Padrão aprovada pela Anvisa em 21/07/2025."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "não conseguir ter uma ereção (impotência);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "not being able to have an erection (impotence);",
                  "by": "ours"
                },
                "de": {
                  "text": "keine Erektion bekommen zu können (Impotenz);",
                  "by": "ours"
                },
                "es": {
                  "text": "no conseguir tener una erección (impotencia);",
                  "by": "ours"
                },
                "fr": {
                  "text": "ne pas arriver à avoir une érection (impuissance) ;",
                  "by": "ours"
                },
                "it": {
                  "text": "non riuscire ad avere un’erezione (impotenza);",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना (स्तंभन दोष);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "ter menos vontade de fazer sexo;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "having less desire to have sex;",
                  "by": "ours"
                },
                "de": {
                  "text": "weniger Lust auf Sex zu haben;",
                  "by": "ours"
                },
                "es": {
                  "text": "tener menos ganas de tener relaciones sexuales;",
                  "by": "ours"
                },
                "fr": {
                  "text": "avoir moins envie de faire l’amour ;",
                  "by": "ours"
                },
                "it": {
                  "text": "avere meno desiderio sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा कम होना;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de esperma liberada durante o ato sexual. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "having problems with ejaculation, for example a decrease in the amount of sperm released during the sexual act. This decrease in the amount of semen does not appear to affect normal sexual function.",
                  "by": "ours"
                },
                "de": {
                  "text": "Probleme mit dem Samenerguss zu haben, zum Beispiel eine Abnahme der beim Geschlechtsverkehr abgegebenen Samenmenge. Diese Abnahme der Samenmenge scheint die normale Sexualfunktion nicht zu beeinträchtigen.",
                  "by": "ours"
                },
                "es": {
                  "text": "tener problemas con la eyaculación, por ejemplo, una disminución de la cantidad de semen expulsado durante el acto sexual. Esta disminución de la cantidad de semen no parece afectar al funcionamiento sexual normal.",
                  "by": "ours"
                },
                "fr": {
                  "text": "avoir des problèmes d’éjaculation, par exemple une diminution de la quantité de sperme émise pendant l’acte sexuel. Cette diminution de la quantité de sperme ne semble pas affecter la fonction sexuelle normale.",
                  "by": "ours"
                },
                "it": {
                  "text": "avere problemi con l’eiaculazione, per esempio una diminuzione della quantità di sperma emesso durante l’atto sessuale. Questa diminuzione della quantità di sperma non sembra influire sulla normale funzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कत होना, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी। वीर्य की मात्रा में यह कमी सामान्य यौन क्रिया पर असर डालती नहीं लगती।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "usually-go-away",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "pt-BR",
              "text": "Estes efeitos secundários acima podem desaparecer depois de algum tempo se continuar a tomar finasterida 5 mg. Se não, eles geralmente regridem depois de parar de usar este medicamento.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "These side effects above may disappear after a while if you continue taking finasteride 5 mg. If not, they usually go away after you stop using this medicine.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die oben genannten Nebenwirkungen können nach einiger Zeit verschwinden, wenn Sie weiter Finasterid 5 mg einnehmen. Wenn nicht, klingen sie in der Regel ab, nachdem Sie dieses Arzneimittel abgesetzt haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos secundarios pueden desaparecer pasado un tiempo si sigue tomando finasterida 5 mg. Si no, por lo general desaparecen después de dejar de usar este medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces effets secondaires peuvent disparaître au bout d’un moment si vous continuez à prendre du finastéride 5 mg. Sinon, ils disparaissent généralement après l’arrêt de ce médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi effetti indesiderati possono scomparire dopo un po’ di tempo se continua a prendere finasteride 5 mg. In caso contrario, di solito regrediscono dopo l’interruzione del medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऊपर के ये साइड इफ़ेक्ट फ़िनास्टेराइड 5 mg लेते रहने पर कुछ समय बाद खत्म हो सकते हैं। अगर नहीं, तो इस दवा को बंद करने के बाद वे आम तौर पर ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "incapacidade de ter uma ereção que pode continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "inability to have an erection, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Unfähigkeit, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "incapacidad de tener una erección que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "incapacité à avoir une érection, qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "incapacità di avere un’erezione che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना, जो दवा बंद करने के बाद भी बना रह सकता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "diminuição do desejo sexual que pode continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "decreased sexual desire, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "disminución del deseo sexual que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "diminution du désir sexuel, qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "diminuzione del desiderio sessuale che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी बनी रह सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "problemas com a ejaculação que podem continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "problems with ejaculation, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauern können",
                  "by": "ours"
                },
                "es": {
                  "text": "problemas con la eyaculación que pueden continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "problèmes d’éjaculation, qui peuvent se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "problemi di eiaculazione che possono proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जो दवा बंद करने के बाद भी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            },
            {
              "key": "moodWarningNotShown",
              "text": {
                "en": "This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.",
                "de": "Dieser Text enthält auch einen Warnhinweis zu Stimmungsveränderungen, der sexuelle Funktionsstörungen als etwas nennt, das dazu beitragen kann. Dieser Warnhinweis sagt nichts dazu, dass sexuelle Nebenwirkungen nach dem Absetzen anhalten. Er wird hier nicht wiedergegeben, weil diese Dokumentation zeigt, welche sexuellen Nebenwirkungen ein Text aufführt und ob er sagt, dass sie nach dem Absetzen anhalten. Der Link zum Dokument in dieser Zeile öffnet den Text.",
                "es": "Este texto tiene también una advertencia sobre cambios en el estado de ánimo que cita la disfunción sexual como algo que puede contribuir a ellos. Esa advertencia no dice nada sobre efectos secundarios sexuales que continúen después de dejar el medicamento. No se reproduce aquí porque este registro muestra los efectos secundarios sexuales que recoge un texto y si dice que continúan después de dejar el medicamento. El enlace al documento de esta fila abre el texto.",
                "pt-br": "Este texto também traz um alerta sobre alterações de humor que cita a disfunção sexual como algo que pode contribuir para elas. Esse alerta não diz nada sobre efeitos colaterais sexuais que continuam depois de parar. Ele não é reproduzido aqui, porque este levantamento mostra os efeitos colaterais sexuais que um texto lista e se ele diz que eles continuam depois de parar. O link do documento nesta linha abre o texto.",
                "fr": "Ce texte contient aussi une mise en garde sur les changements d’humeur, qui cite la dysfonction sexuelle parmi ce qui peut y contribuer. Cette mise en garde ne dit rien des effets secondaires sexuels qui continuent après l’arrêt. Elle n’est pas reproduite ici, car cette fiche montre les effets secondaires sexuels qu’un texte cite et s’il dit qu’ils continuent après l’arrêt. Le lien vers le document, dans cette ligne, ouvre le texte.",
                "it": "Questo testo ha anche un’avvertenza sui cambiamenti dell’umore che indica la disfunzione sessuale come qualcosa che può contribuirvi. Quell’avvertenza non dice nulla sugli effetti collaterali sessuali che continuano dopo l’interruzione. Non è riprodotta qui, perché questa raccolta mostra gli effetti collaterali sessuali che un testo elenca e se dice che continuano dopo l’interruzione. Il link al documento presente in questa riga apre il testo.",
                "hi": "इस दस्तावेज़ में मूड में बदलाव के बारे में भी एक चेतावनी है, जो सेक्शुअल डिस्फ़ंक्शन को उन्हें बढ़ाने वाली चीज़ों में से एक के रूप में नाम देती है। वह चेतावनी दवा बंद करने के बाद यौन साइड इफ़ेक्ट के जारी रहने के बारे में कुछ नहीं कहती। उसे यहाँ नहीं दिखाया गया है, क्योंकि यह रिकॉर्ड वे यौन साइड इफ़ेक्ट दिखाता है जो कोई दस्तावेज़ गिनाता है, और यह कि क्या वह कहता है कि वे दवा बंद करने के बाद भी जारी रहते हैं। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है।"
              }
            }
          ]
        },
        {
          "id": "finasteride-br-leaflet-finarid",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br-leaflet-finarid",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Finarid® finasterida, Laboratório Teuto Brasileiro S/A, comprimido revestido 5 mg: bula para o paciente",
            "lang": "pt-BR",
            "product": {
              "name": "Finarid",
              "form": "5 mg comprimido revestido",
              "holder": "Laboratório Teuto Brasileiro S/A"
            },
            "source": {
              "type": "holder",
              "name": "Laboratório Teuto Brasileiro S/A"
            },
            "url": "https://teutodigital.com.br/wp-content/uploads/2023/10/Finarid-VP-406398-03-clone.pdf",
            "fetchedUrl": null,
            "textDate": "2020-10-16",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi atualizada conforme Bula Padrão aprovada pela Anvisa em 16/10/2020."
          },
          "passages": [
            {
              "key": "listed-1",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Não conseguir ter uma ereção (impotência);",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Not being able to have an erection (impotence);",
                  "by": "ours"
                },
                "de": {
                  "text": "Keine Erektion bekommen zu können (Impotenz);",
                  "by": "ours"
                },
                "es": {
                  "text": "No conseguir tener una erección (impotencia);",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ne pas arriver à avoir une érection (impuissance) ;",
                  "by": "ours"
                },
                "it": {
                  "text": "Non riuscire ad avere un’erezione (impotenza);",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना (स्तंभन दोष);",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-2",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Ter menos vontade de fazer sexo;",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Having less desire to have sex;",
                  "by": "ours"
                },
                "de": {
                  "text": "Weniger Lust auf Sex zu haben;",
                  "by": "ours"
                },
                "es": {
                  "text": "Tener menos ganas de tener relaciones sexuales;",
                  "by": "ours"
                },
                "fr": {
                  "text": "Avoir moins envie de faire l’amour ;",
                  "by": "ours"
                },
                "it": {
                  "text": "Avere meno desiderio sessuale;",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा कम होना;",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-3",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais podem incluir:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de esperma liberada durante o ato sexual. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Having problems with ejaculation, for example a decrease in the amount of sperm released during the sexual act. This decrease in the amount of semen does not appear to affect normal sexual function.",
                  "by": "ours"
                },
                "de": {
                  "text": "Probleme mit dem Samenerguss zu haben, zum Beispiel eine Abnahme der beim Geschlechtsverkehr abgegebenen Samenmenge. Diese Abnahme der Samenmenge scheint die normale Sexualfunktion nicht zu beeinträchtigen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Tener problemas con la eyaculación, por ejemplo, una disminución de la cantidad de semen expulsado durante el acto sexual. Esta disminución de la cantidad de semen no parece afectar al funcionamiento sexual normal.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Avoir des problèmes d’éjaculation, par exemple une diminution de la quantité de sperme émise pendant l’acte sexuel. Cette diminution de la quantité de sperme ne semble pas affecter la fonction sexuelle normale.",
                  "by": "ours"
                },
                "it": {
                  "text": "Avere problemi con l’eiaculazione, per esempio una diminuzione della quantità di sperma emesso durante l’atto sessuale. Questa diminuzione della quantità di sperma non sembra influire sulla normale funzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन में दिक्कत होना, जैसे सेक्स के दौरान निकलने वाले वीर्य की मात्रा में कमी। वीर्य की मात्रा में यह कमी सामान्य यौन क्रिया पर असर डालती नहीं लगती।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "usually-go-away",
              "kind": "qualification",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed-3",
              "lang": "pt-BR",
              "text": "Estes efeitos secundários acima podem desaparecer depois de algum tempo se continuar a tomar finasterida. Se não, eles geralmente regridem depois de parar de usar finasterida.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "These side effects above may disappear after a while if you continue taking finasteride. If not, they usually go away after you stop using finasteride.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die oben genannten Nebenwirkungen können nach einiger Zeit verschwinden, wenn Sie weiter Finasterid einnehmen. Wenn nicht, klingen sie in der Regel ab, nachdem Sie Finasterid abgesetzt haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos secundarios pueden desaparecer pasado un tiempo si sigue tomando finasterida. Si no, por lo general desaparecen después de dejar de usar finasterida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces effets secondaires peuvent disparaître au bout d’un moment si vous continuez à prendre du finastéride. Sinon, ils disparaissent généralement après l’arrêt du finastéride.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi effetti indesiderati possono scomparire dopo un po’ di tempo se continua a prendere finasteride. In caso contrario, di solito regrediscono dopo l’interruzione della finasteride.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ऊपर के ये साइड इफ़ेक्ट फ़िनास्टेराइड लेते रहने पर कुछ समय बाद खत्म हो सकते हैं। अगर नहीं, तो फ़िनास्टेराइड बंद करने के बाद वे आम तौर पर ठीक हो जाते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-erection",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "Incapacidade de ter uma ereção que pode continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Inability to have an erection, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Unfähigkeit, eine Erektion zu bekommen, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "Incapacidad de tener una erección que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "Incapacité à avoir une érection, qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Incapacità di avere un’erezione che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन न कर पाना, जो दवा बंद करने के बाद भी बना रह सकता है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-sex-drive",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "Diminuição do desejo sexual que pode continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Decreased sexual desire, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Abnahme des sexuellen Verlangens, die nach dem Absetzen des Arzneimittels andauern kann",
                  "by": "ours"
                },
                "es": {
                  "text": "Disminución del deseo sexual que puede continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "Diminution du désir sexuel, qui peut se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Diminuzione del desiderio sessuale che può proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्स की इच्छा में कमी, जो दवा बंद करने के बाद भी बनी रह सकती है",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-ejaculation",
              "kind": "sexual-persistence",
              "section": [
                "8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Outros efeitos colaterais relatados em alguns homens são:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "pt-BR",
              "text": "Problemas com a ejaculação que podem continuar depois de parar a medicação",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Problems with ejaculation, which may continue after stopping the medication",
                  "by": "ours"
                },
                "de": {
                  "text": "Probleme mit dem Samenerguss, die nach dem Absetzen des Arzneimittels andauern können",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas con la eyaculación que pueden continuar después de dejar la medicación",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’éjaculation, qui peuvent se poursuivre après l’arrêt du médicament",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi di eiaculazione che possono proseguire dopo l’interruzione del medicinale",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्खलन की समस्याएँ, जो दवा बंद करने के बाद भी बनी रह सकती हैं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "finasteride-br-pro-finalop",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br-pro-finalop",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
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          "access": "could-not-open",
          "accessReason": [
            "country-block",
            "bot-check"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Finalop",
              "form": "1 mg",
              "holder": "Libbs Farmacêutica Ltda."
            },
            "source": null,
            "url": null,
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            "textDateKind": "none",
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          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://www.libbs.com.br/produtos/finalop/",
            "https://www.libbs.com.br/bulas/"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "confirmed-unopenable"
          },
          "history": [
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          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "finasteride-br-leaflet-finalop",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-br-leaflet-finalop",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
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          "document": {
            "name": null,
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              "name": "Finalop",
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              "holder": "Libbs Farmacêutica Ltda."
            },
            "source": null,
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        {
          "id": "finasteride-br-pro-eurofarma",
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          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
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              "holder": "Eurofarma Laboratórios S.A."
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        {
          "id": "finasteride-br-leaflet-eurofarma",
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          },
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          ],
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        },
        {
          "id": "finasteride-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FINPECIA Tablets",
            "lang": "en-IN",
            "product": {
              "name": "Finpecia",
              "form": "tablets (finasteride IP 1 mg, film-coated)",
              "holder": "Cipla Ltd."
            },
            "source": {
              "type": "holder",
              "name": "Cipla (ciplamed.com)"
            },
            "url": "https://www.ciplamed.com/product-index/finpecia-tablets",
            "fetchedUrl": null,
            "textDate": "2018-10",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last updated: Oct 2018 Last reviewed: Oct 2018"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Undesirable Effects",
                "Postmarketing Experience",
                "Reproductive System:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-IN",
              "text": "Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Dysfunktion, die nach dem Absetzen der Behandlung andauerte, darunter erektile Dysfunktion, Libidostörungen, Ejakulationsstörungen und Orgasmusstörungen; Infertilität bei Männern und/oder schlechte Spermienqualität (eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet); Hodenschmerzen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual que continuó después de la interrupción del tratamiento, incluidas disfunción eréctil, trastornos de la libido, trastornos de la eyaculación y trastornos del orgasmo; infertilidad masculina y/o calidad seminal pobre (se ha notificado normalización o mejora de la calidad seminal después de la interrupción de finasterida); dolor testicular.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual que continuou depois da descontinuação do tratamento, incluindo disfunção erétil, distúrbios da libido, distúrbios da ejaculação e distúrbios do orgasmo; infertilidade masculina e/ou má qualidade do sêmen (foi relatada normalização ou melhora da qualidade do sêmen depois da descontinuação da finasterida); dor testicular.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction sexuelle qui a continué après l’arrêt du traitement, notamment troubles de l’érection, troubles de la libido, troubles de l’éjaculation et troubles de l’orgasme ; infertilité masculine et/ou mauvaise qualité du sperme (une normalisation ou une amélioration de la qualité du sperme a été rapportée après l’arrêt du finastéride) ; douleur testiculaire.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale che è proseguita dopo l’interruzione del trattamento, comprese disfunzione erettile, disturbi della libido, disturbi dell’eiaculazione e disturbi dell’orgasmo; infertilità maschile e/o scarsa qualità del liquido seminale (normalizzazione o miglioramento della qualità del liquido seminale sono stati riportati dopo l’interruzione della finasteride); dolore testicolare.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष, कामेच्छा के विकार, स्खलन विकार और ऑर्गेज़्म विकार शामिल हैं; पुरुष बाँझपन और/या वीर्य की खराब गुणवत्ता (फ़िनास्टेराइड बंद करने के बाद वीर्य की गुणवत्ता के सामान्य होने या सुधरने की रिपोर्ट हुई है); अंडकोष में दर्द।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "uncertain",
              "kind": "qualification",
              "section": [
                "Undesirable Effects",
                "Postmarketing Experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-IN",
              "text": "The following adverse reactions have been identified during post-approval use of finasteride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Nach der Zulassung wurden bei der Anwendung von Finasterid die folgenden Nebenwirkungen festgestellt. Da diese Reaktionen freiwillig aus einer Population unbekannter Größe gemeldet werden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han identificado las siguientes reacciones adversas durante el uso de finasterida después de su aprobación. Como estas reacciones se notifican voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento:",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir foram identificadas durante o uso após a aprovação da finasterida. Como essas reações são relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência delas nem estabelecer uma relação causal com a exposição ao medicamento:",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants ont été identifiés lors de l’utilisation du finastéride après son approbation. Comme ces réactions sont rapportées volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable leur fréquence ni d’établir un lien de causalité avec l’exposition au médicament :",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse sono state identificate durante l’uso successivo all’approvazione della finasteride. Poiché queste reazioni sono riportate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale:",
                  "by": "ours"
                },
                "hi": {
                  "text": "फ़िनास्टेराइड के मंज़ूरी के बाद के उपयोग में ये प्रतिकूल प्रतिक्रियाएँ पहचानी गई हैं। क्योंकि ये प्रतिक्रियाएँ अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती हैं, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि ये कितनी बार होती हैं:",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyNoDatabase",
              "text": {
                "en": "This is the holder's own copy. This regulator publishes no database of such texts.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Diese Arzneimittelbehörde veröffentlicht keine Datenbank mit solchen Texten.",
                "es": "Es la copia del propio laboratorio titular. Esta agencia del medicamento no publica ninguna base de datos de estos textos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. Esta agência reguladora não publica um banco de dados com esses textos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. Cette agence ne publie aucune base de données de ces textes.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. Questa agenzia del farmaco non pubblica una banca dati di questi testi.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। इस देश का दवा नियामक ऐसे दस्तावेज़ों का कोई डेटाबेस प्रकाशित नहीं करता।"
              }
            },
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            },
            {
              "key": "cellsShownWhole",
              "text": {
                "en": "A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.",
                "de": "Tabellenzellen oder Listenzeilen werden vollständig gezeigt, so wie sie im Text stehen. Manche nennen auch Nebenwirkungen, die nicht sexueller Art sind.",
                "es": "Cada celda de tabla o línea de lista se muestra entera, tal como figura en el texto. Algunas nombran también efectos secundarios que no son sexuales.",
                "pt-br": "Cada célula de tabela ou item de lista aparece por inteiro, como está no texto. Alguns deles também citam efeitos colaterais que não são sexuais.",
                "fr": "Les cellules de tableau et les éléments de liste sont montrés en entier, tels qu’ils figurent dans le texte. Certains citent aussi des effets secondaires qui ne sont pas sexuels.",
                "it": "Una cella di tabella o una voce di elenco è mostrata per intero, così come il testo la riporta. Alcune di queste nominano anche effetti collaterali che non sono sessuali.",
                "hi": "दस्तावेज़ की तालिका का खाना या सूची की लाइन यहाँ पूरी दिखाई गई है, ठीक वैसी जैसी वह छपी है। इनमें से कुछ में ऐसे साइड इफ़ेक्ट के नाम भी हैं, जो यौन साइड इफ़ेक्ट नहीं हैं।"
              }
            }
          ]
        },
        {
          "id": "finasteride-in-pro-fincar",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#finasteride-in-pro-fincar",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FINCAR Tablets",
            "lang": "en-IN",
            "product": {
              "name": "Fincar",
              "form": "tablets (finasteride 5 mg, film-coated)",
              "holder": "Cipla Ltd."
            },
            "source": {
              "type": "holder",
              "name": "Cipla (ciplamed.com)"
            },
            "url": "https://www.ciplamed.com/product-index/fincar-tablets",
            "fetchedUrl": null,
            "textDate": "2018-12",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last updated: December 2018 Last reviewed: January 2019"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Undesirable Effects",
                "Postmarketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-IN",
              "text": "sexual dysfunction that continued after discontinuation of treatment including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "sexuelle Dysfunktion, die nach dem Absetzen der Behandlung andauerte, darunter erektile Dysfunktion, verminderte Libido und Ejakulationsstörungen (z. B. vermindertes Ejakulatvolumen).",
                  "by": "ours"
                },
                "es": {
                  "text": "disfunción sexual que continuó después de la interrupción del tratamiento, incluidas disfunción eréctil, disminución de la libido y trastornos de la eyaculación (p. ej., volumen de eyaculación reducido).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "disfunção sexual que continuou depois da descontinuação do tratamento, incluindo disfunção erétil, diminuição da libido e distúrbios da ejaculação (por exemplo, volume de ejaculado reduzido).",
                  "by": "ours"
                },
                "fr": {
                  "text": "dysfonction sexuelle qui a continué après l’arrêt du traitement, notamment troubles de l’érection, diminution de la libido et troubles de l’éjaculation (par ex. réduction du volume de l’éjaculat).",
                  "by": "ours"
                },
                "it": {
                  "text": "disfunzione sessuale che è proseguita dopo l’interruzione del trattamento, comprese disfunzione erettile, diminuzione della libido e disturbi dell’eiaculazione (ad es. volume ridotto dell’eiaculato).",
                  "by": "ours"
                },
                "hi": {
                  "text": "इलाज बंद करने के बाद भी जारी रहने वाला सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष, कामेच्छा में कमी और स्खलन विकार (जैसे वीर्य की मात्रा में कमी) शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "reported-rarely",
              "kind": "qualification",
              "section": [
                "Undesirable Effects",
                "Postmarketing Experience"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-IN",
              "text": "These events were reported rarely in men taking finasteride for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of finasteride in these events is unknown.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Ereignisse wurden bei Männern, die Finasterid zur Behandlung der BPH einnahmen, selten berichtet. Die meisten Männer waren älter und nahmen Begleitmedikation ein und/oder hatten Begleiterkrankungen. Die eigenständige Rolle von Finasterid bei diesen Ereignissen ist unbekannt.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos acontecimientos se notificaron raramente en varones que tomaban finasterida para el tratamiento de la HBP. La mayoría de los varones eran de edad avanzada y tomaban medicamentos concomitantes o tenían enfermedades concomitantes. Se desconoce el papel independiente de la finasterida en estos acontecimientos.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses eventos foram relatados raramente em homens que tomavam finasterida para o tratamento da HPB. A maioria dos homens era mais velha e tomava medicamentos concomitantes e/ou tinha outras condições de saúde. O papel independente da finasterida nesses eventos é desconhecido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces événements ont été rapportés rarement chez des hommes prenant du finastéride pour traiter une HBP. La plupart étaient plus âgés et prenaient d’autres médicaments et/ou avaient d’autres maladies. Le rôle propre du finastéride dans ces événements est inconnu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi eventi sono stati riportati raramente negli uomini che assumevano finasteride per il trattamento dell’IPB. La maggior parte degli uomini era di età più avanzata e assumeva medicinali concomitanti e/o aveva patologie concomitanti. Il ruolo indipendente della finasteride in questi eventi non è noto.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रोस्टेट के बढ़ने (BPH) के इलाज के लिए फ़िनास्टेराइड लेने वाले पुरुषों में ये घटनाएँ कभी-कभार ही रिपोर्ट हुईं। ज़्यादातर पुरुष उम्रदराज़ थे और साथ में दूसरी दवाएँ ले रहे थे और/या उन्हें साथ की दूसरी बीमारियाँ थीं। इन घटनाओं में फ़िनास्टेराइड की अपनी अलग भूमिका अज्ञात है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-lower-doses",
              "kind": "sexual-persistence",
              "section": [
                "Undesirable Effects",
                "Postmarketing Experience"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-IN",
              "text": "The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:\n- orgasm disorders",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Das folgende zusätzliche unerwünschte Ereignis im Zusammenhang mit sexueller Dysfunktion, die nach dem Absetzen der Behandlung andauerte, wurde nach Markteinführung bei Finasterid in den niedrigeren Dosierungen berichtet, die zur Behandlung des erblich bedingten Haarausfalls bei Männern angewendet werden. Da das Ereignis freiwillig aus einer Population unbekannter Größe gemeldet wird, ist es nicht immer möglich, seine Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen:\n- Orgasmusstörungen",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado el siguiente acontecimiento adverso adicional relacionado con la disfunción sexual que continuó después de la interrupción del tratamiento en la experiencia poscomercialización con finasterida en las dosis más bajas utilizadas para tratar la alopecia masculina androgénica. Como el acontecimiento se notifica voluntariamente a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento:\n- trastornos del orgasmo",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O seguinte evento adverso adicional relacionado à disfunção sexual que continuou depois da descontinuação do tratamento foi relatado na experiência pós-comercialização com a finasterida em doses menores, usadas para tratar a calvície masculina. Como o evento é relatado voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar de forma confiável a frequência dele nem estabelecer uma relação causal com a exposição ao medicamento:\n- distúrbios do orgasmo",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’événement indésirable supplémentaire suivant, lié à une dysfonction sexuelle qui a continué après l’arrêt du traitement, a été rapporté depuis la commercialisation du finastéride aux doses plus faibles utilisées pour traiter la calvitie masculine. Comme cet événement est rapporté volontairement par une population de taille incertaine, il n’est pas toujours possible d’estimer de façon fiable sa fréquence ni d’établir un lien de causalité avec l’exposition au médicament :\n- troubles de l’orgasme",
                  "by": "ours"
                },
                "it": {
                  "text": "Il seguente ulteriore evento avverso relativo alla disfunzione sessuale che è proseguita dopo l’interruzione del trattamento è stato riportato nell’esperienza post-marketing con la finasteride a dosi più basse, usate per trattare la calvizie maschile. Poiché l’evento è riportato volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza né stabilire un nesso causale con l’esposizione al medicinale:\n- disturbi dell’orgasmo",
                  "by": "ours"
                },
                "hi": {
                  "text": "गंजेपन के इलाज में इस्तेमाल होने वाली कम डोज़ की फ़िनास्टेराइड के मंज़ूरी के बाद के अनुभव में, इलाज बंद करने के बाद भी जारी रहने वाले सेक्शुअल डिस्फ़ंक्शन से जुड़ी यह अतिरिक्त प्रतिकूल घटना रिपोर्ट हुई है। क्योंकि यह घटना अनिश्चित आकार की आबादी से स्वेच्छा से रिपोर्ट की जाती है, इसलिए हमेशा यह भरोसेमंद ढंग से आँकना या दवा के संपर्क से कारण-संबंध स्थापित करना संभव नहीं होता कि यह कितनी बार होती है:\n- ऑर्गेज़्म विकार",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-14",
          "changed": "2026-10-14",
          "verified": {
            "date": "2026-10-14",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-14",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyNoDatabase",
              "text": {
                "en": "This is the holder's own copy. This regulator publishes no database of such texts.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Diese Arzneimittelbehörde veröffentlicht keine Datenbank mit solchen Texten.",
                "es": "Es la copia del propio laboratorio titular. Esta agencia del medicamento no publica ninguna base de datos de estos textos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. Esta agência reguladora não publica um banco de dados com esses textos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. Cette agence ne publie aucune base de données de ces textes.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. Questa agenzia del farmaco non pubblica una banca dati di questi testi.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। इस देश का दवा नियामक ऐसे दस्तावेज़ों का कोई डेटाबेस प्रकाशित नहीं करता।"
              }
            },
            {
              "key": "listingNotShown",
              "text": {
                "en": "This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.",
                "de": "Dieser Text nennt sexuelle Nebenwirkungen an mehreren Stellen, die diese Zeile nicht zeigt. Zusammengenommen sind diese Stellen zu lang, um sie hier wiederzugeben. Der Link zum Dokument in dieser Zeile öffnet den Text. Dass sie nicht gezeigt werden, sagt nichts darüber, wie häufig diese Nebenwirkungen sind.",
                "es": "Este texto nombra efectos secundarios sexuales en varios lugares que esta fila no muestra. En conjunto, esos pasajes son demasiado largos para reproducirlos aquí. El enlace al documento de esta fila abre el texto. Que no se muestren no dice nada sobre lo frecuentes que son estos efectos secundarios.",
                "pt-br": "Este texto cita efeitos colaterais sexuais em vários trechos que esta linha não mostra. Juntos, esses trechos são longos demais para reproduzir aqui. O link do documento nesta linha abre o texto. O fato de esses trechos não aparecerem aqui não diz nada sobre a frequência desses efeitos colaterais.",
                "fr": "Ce texte cite des effets secondaires sexuels dans plusieurs passages que cette ligne ne montre pas. Réunis, ces passages sont trop longs pour être reproduits ici. Le lien vers le document, dans cette ligne, ouvre le texte. Le fait qu’ils ne soient pas montrés ne dit rien de la fréquence de ces effets secondaires.",
                "it": "Questo testo nomina effetti collaterali sessuali in diversi punti che questa riga non mostra. Nel complesso quei passaggi sono troppo lunghi per essere riprodotti qui. Il link al documento presente in questa riga apre il testo. Il fatto che non siano mostrati non dice nulla su quanto siano comuni questi effetti collaterali.",
                "hi": "इस दस्तावेज़ में कई ऐसी जगहों पर यौन साइड इफ़ेक्ट के नाम हैं, जो इस पंक्ति में नहीं दिखाई गई हैं। वे हिस्से मिलकर इतने लंबे हैं कि यहाँ नहीं दिए जा सकते। इस पंक्ति में दिए गए दस्तावेज़ के लिंक से वह दस्तावेज़ खुलता है। उनके यहाँ न दिखाए जाने से यह पता नहीं चलता कि ये साइड इफ़ेक्ट कितने आम हैं।"
              }
            }
          ]
        }
      ]
    },
    {
      "id": "isotretinoin",
      "inn": "isotretinoin",
      "names": {
        "en": "isotretinoin",
        "de": "Isotretinoin",
        "es": "isotretinoína",
        "pt-br": "isotretinoína",
        "fr": "isotrétinoïne",
        "it": "isotretinoina",
        "hi": "आइसोट्रेटिनॉइन"
      },
      "class": "retinoid",
      "classLabel": {
        "en": "retinoid",
        "de": "Retinoid",
        "es": "retinoide",
        "pt-br": "retinoide",
        "fr": "rétinoïde",
        "it": "retinoide",
        "hi": "रेटिनॉइड"
      },
      "condition": "pas",
      "lead": {
        "en": "For the acne medicine isotretinoin (Roaccutane, Accutane), the texts for professionals we read in the United Kingdom, in the United States (some products), in Canada, in Australia and in New Zealand say that sexual side effects have been reported to continue, or may continue, after the medicine is stopped; several of those texts add that a causal link has not been established, and one that an effect cannot be ruled out. Some other texts we read, among them the wording EU regulators agreed in 2017, list sexual side effects and have no sentence about them continuing after the medicine is stopped. Patients call lasting effects after isotretinoin post-Accutane syndrome (PAS).",
        "de": "Zum Aknemittel Isotretinoin (Roaccutane, Accutane) steht im Vereinigten Königreich, in den USA (einige Produkte), in Kanada, in Australien und in Neuseeland in den Fachinformationen, die wir gelesen haben, dass sexuelle Nebenwirkungen nach dem Absetzen des Medikaments Berichten zufolge angehalten haben oder anhalten können. Mehrere dieser Texte ergänzen, ein ursächlicher Zusammenhang sei nicht nachgewiesen, und einer ergänzt, eine Wirkung lasse sich nicht ausschließen. Einige andere Texte, die wir gelesen haben, darunter der Wortlaut, auf den sich die Arzneimittelbehörden der EU 2017 einigten, führen sexuelle Nebenwirkungen auf und enthalten keinen Satz dazu, dass sie nach dem Absetzen des Medikaments anhalten. Anhaltende Folgen nach Isotretinoin nennen Betroffene Post-Accutane-Syndrom (PAS).",
        "es": "En el caso de la isotretinoína (Roaccutane, Accutane), un medicamento para el acné, los textos para profesionales que hemos leído en el Reino Unido, en Estados Unidos (algunos productos), en Canadá, en Australia y en Nueva Zelanda dicen que se ha notificado que los efectos secundarios sexuales continúan, o que pueden continuar, después de dejar el medicamento; varios de esos textos añaden que no se ha establecido una relación causal, y uno, que no puede descartarse un efecto. Algunos otros textos que hemos leído, entre ellos el que acordaron en 2017 las agencias del medicamento de la UE, recogen efectos secundarios sexuales y no tienen ninguna frase que diga que continúan después de dejar el medicamento. Los pacientes llaman síndrome post-Accutane (PAS) a los efectos duraderos tras la isotretinoína.",
        "pt-br": "No caso do medicamento para acne isotretinoína (Roaccutane, Accutane), as bulas para profissionais de saúde que lemos no Reino Unido, nos Estados Unidos (alguns produtos), no Canadá, na Austrália e na Nova Zelândia dizem que há relatos de efeitos colaterais sexuais que continuaram, ou que esses efeitos podem continuar, depois de parar o medicamento. Vários desses textos acrescentam que uma ligação causal não foi estabelecida, e um deles, que um efeito não pode ser descartado. Alguns outros textos que lemos, entre eles o que as agências reguladoras da UE definiram em conjunto em 2017, listam efeitos colaterais sexuais e não têm nenhuma frase sobre eles continuarem depois de parar o medicamento. Os pacientes chamam de síndrome pós-Accutane (PAS) os efeitos duradouros depois da isotretinoína.",
        "fr": "Pour l’isotrétinoïne (Roaccutane, Accutane), un médicament contre l’acné, les textes destinés aux professionnels que nous avons lus au Royaume-Uni, aux États-Unis (certains produits), au Canada, en Australie et en Nouvelle-Zélande indiquent que des effets secondaires sexuels ont été signalés comme persistant après l’arrêt du médicament, ou qu’ils peuvent persister après l’arrêt. Plusieurs de ces textes ajoutent qu’un lien de causalité n’a pas été établi, et l’un d’eux qu’un effet ne peut pas être exclu. Certains autres textes que nous avons lus, dont la formulation adoptée en 2017 par les agences du médicament de l’UE, citent des effets secondaires sexuels et ne contiennent aucune phrase disant qu’ils persistent après l’arrêt du médicament. Les patients appellent syndrome post-Accutane (PAS) les effets qui durent après l’isotrétinoïne.",
        "it": "Per il medicinale contro l’acne isotretinoina (Roaccutane, Accutane), i testi per i professionisti sanitari che abbiamo letto nel Regno Unito, negli Stati Uniti (alcuni prodotti), in Canada, in Australia e in Nuova Zelanda dicono che sono stati segnalati effetti collaterali sessuali che continuano, o che questi effetti possono continuare, dopo l’interruzione del medicinale. Diversi di questi testi aggiungono che un nesso causale non è stato stabilito, e uno che un effetto non può essere escluso. Alcuni altri testi che abbiamo letto, tra cui quello concordato nel 2017 dalle agenzie del farmaco dell’UE, elencano gli effetti collaterali sessuali e non hanno nessuna frase che dica che continuano dopo l’interruzione del medicinale. Gli effetti che durano dopo il trattamento con isotretinoina, i pazienti li chiamano sindrome post-Accutane (PAS).",
        "hi": "मुँहासों की दवा आइसोट्रेटिनॉइन (Roaccutane, Accutane) के मामले में, डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए बने जो दस्तावेज़ हमने ब्रिटेन में, अमेरिका में (कुछ उत्पादों के), कनाडा में, ऑस्ट्रेलिया में और न्यूज़ीलैंड में पढ़े, वे कहते हैं कि दवा बंद करने के बाद यौन साइड इफ़ेक्ट के बने रहने की रिपोर्टें आई हैं, या वे बने रह सकते हैं। इनमें से कई दस्तावेज़ यह भी कहते हैं कि कारण और असर का संबंध स्थापित नहीं हुआ है, और एक कहता है कि असर की संभावना को खारिज नहीं किया जा सकता। हमारे पढ़े कुछ दूसरे दस्तावेज़ यौन साइड इफ़ेक्ट गिनाते हैं, और उनमें दवा बंद करने के बाद उनके बने रहने के बारे में कोई वाक्य नहीं है। इनमें वे शब्द भी हैं, जिन पर यूरोपीय संघ (EU) के नियामकों ने 2017 में सहमति बनाई। आइसोट्रेटिनॉइन के बाद बने रहने वाले असर को मरीज़ पोस्ट-Accutane सिंड्रोम (PAS) कहते हैं।"
      },
      "brands": [
        {
          "name": "Roaccutane",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "emc",
              "sourceUrl": "https://www.medicines.org.uk/emc/ingredient/613",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=isotretinoin",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "ie",
              "status": "brand",
              "sourceName": "HPRA",
              "sourceUrl": "https://assets.hpra.ie/products/xml/latestHumanlist.xml",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "sa",
              "status": "brand",
              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "my",
              "status": "brand",
              "sourceName": "QUEST 3+ Product Search",
              "sourceUrl": "https://quest3plus.bpfk.gov.my/pmo2/index.php",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Accutane",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b524a51-a16b-496e-b764-11c98c479c36",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=5129",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Reticutan",
          "listings": [
            {
              "jurisdiction": "uk",
              "status": "brand",
              "sourceName": "GOV.UK",
              "sourceUrl": "https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Absorica",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ef0cff8-19c1-4441-b780-fca6c7ee1615",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Absorica LD",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
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              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102772",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Claravis",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a31fd109-d0fd-4ab9-ba98-a3d64333c18d",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Amnesteem",
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              "status": "brand",
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            }
          ]
        },
        {
          "name": "Zenatane",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27b3cf26-f22e-5b70-1c24-009933b7c6ee",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Myorisan",
          "listings": [
            {
              "jurisdiction": "us",
              "status": "brand",
              "sourceName": "DailyMed",
              "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51ff6346-9256-4c01-9f52-417d13f2df05",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Clarus",
          "listings": [
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=74320",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Epuris",
          "listings": [
            {
              "jurisdiction": "ca",
              "status": "brand",
              "sourceName": "Drug Product Database",
              "sourceUrl": "https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88199",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Oratane",
          "listings": [
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=isotretinoin",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "nz",
              "status": "brand",
              "sourceName": "Medsafe",
              "sourceUrl": "https://www.medsafe.govt.nz/profs/Datasheet/datasheet.htm",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "sa",
              "status": "brand",
              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "my",
              "status": "brand",
              "sourceName": "QUEST 3+ Product Search",
              "sourceUrl": "https://quest3plus.bpfk.gov.my/pmo2/index.php",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Dermatane",
          "listings": [
            {
              "jurisdiction": "au",
              "status": "brand",
              "sourceName": "TGA eBS",
              "sourceUrl": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=isotretinoin",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Aknenormin",
          "listings": [
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "EMA's list of nationally authorised medicinal products",
              "sourceUrl": "https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-list-nationally-authorised-medicinal-products-psusa-00010488-202505_en.pdf",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "IsoGalen",
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            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "EMA's list of nationally authorised medicinal products",
              "sourceUrl": "https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-list-nationally-authorised-medicinal-products-psusa-00010488-202505_en.pdf",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isotiorga",
          "listings": [
            {
              "jurisdiction": "de",
              "status": "brand",
              "sourceName": "EMA's list of nationally authorised medicinal products",
              "sourceUrl": "https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-list-nationally-authorised-medicinal-products-psusa-00010488-202505_en.pdf",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000062730?lang=it",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=86648",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Contracne",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Curacne",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/62318935/extrait",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "sa",
              "status": "brand",
              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Procuta",
          "listings": [
            {
              "jurisdiction": "fr",
              "status": "brand",
              "sourceName": "Base de données publique des médicaments",
              "sourceUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/65250375/extrait",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Aisoskin",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000034820?lang=it",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isoriac",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000039463?lang=it",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isdiben",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000047722?lang=it",
              "checked": "2026-10-13"
            },
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=66121",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Noidak",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000053768?lang=it",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isodifa",
          "listings": [
            {
              "jurisdiction": "it",
              "status": "brand",
              "sourceName": "Banca Dati Farmaci",
              "sourceUrl": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/formadosaggio/0000054640?lang=it",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Acnemin",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=65413",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Acnisdin",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=85584",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Dercutane",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=65333",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Flexresan",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=66160",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isoacne",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=67570",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Mayesta",
          "listings": [
            {
              "jurisdiction": "es",
              "status": "brand",
              "sourceName": "CIMA",
              "sourceUrl": "https://cima.aemps.es/cima/publico/detalle.html?nregistro=69571",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Roacutan",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Acnova",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Amalfi",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Isoac",
          "listings": [
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              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Ison",
          "listings": [
            {
              "jurisdiction": "br",
              "status": "brand",
              "sourceName": "ANVISA open-data register of medicines",
              "sourceUrl": "https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv",
              "checked": "2026-10-13"
            }
          ]
        },
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          "name": "Xeractan",
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              "jurisdiction": "sa",
              "status": "brand",
              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            }
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        },
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          "name": "Ruatine",
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              "jurisdiction": "sa",
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              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            }
          ]
        },
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          "name": "Capitan",
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              "jurisdiction": "sa",
              "status": "brand",
              "sourceName": "SFDA drugs list",
              "sourceUrl": "https://www.sfda.gov.sa/en/drugs-list?ScientificName=isotretinoin",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Acnotin",
          "listings": [
            {
              "jurisdiction": "my",
              "status": "brand",
              "sourceName": "QUEST 3+ Product Search",
              "sourceUrl": "https://quest3plus.bpfk.gov.my/pmo2/index.php",
              "checked": "2026-10-13"
            }
          ]
        },
        {
          "name": "Nimegen",
          "listings": [
            {
              "jurisdiction": "my",
              "status": "brand",
              "sourceName": "QUEST 3+ Product Search",
              "sourceUrl": "https://quest3plus.bpfk.gov.my/pmo2/index.php",
              "checked": "2026-10-13"
            }
          ]
        }
      ],
      "leadBrands": [
        "Roaccutane",
        "Accutane"
      ],
      "cardSince": null,
      "unknowns": [
        {
          "id": "frequency-isotretinoin",
          "sourceUrl": "https://www.medicines.org.uk/emc/product/100633/smpc",
          "text": {
            "en": "The UK text for professionals gives the frequency of the sexual side effects it lists as “not known”: it cannot be estimated from the available data. None of the product texts we read gives a figure for how often they continue after stopping.",
            "de": "Die britische Fachinformation gibt die Häufigkeit der sexuellen Nebenwirkungen, die sie aufführt, mit „nicht bekannt“ an: Sie lässt sich auf Grundlage der verfügbaren Daten nicht abschätzen. Keiner der Produkttexte, die wir gelesen haben, nennt eine Zahl dazu, wie oft diese Nebenwirkungen nach dem Absetzen anhalten.",
            "es": "El texto británico para profesionales da como «no conocida» la frecuencia de los efectos secundarios sexuales que recoge: no puede estimarse a partir de los datos disponibles. Ninguno de los textos de producto que hemos leído da una cifra de la frecuencia con la que continúan después de dejar el medicamento.",
            "pt-br": "A bula britânica para o profissional de saúde informa como “not known” (desconhecida) a frequência dos efeitos colaterais sexuais que lista: ela não pode ser estimada a partir dos dados disponíveis. Nenhuma das bulas que lemos traz um número sobre a frequência com que esses efeitos continuam depois de parar o medicamento.",
            "fr": "Le texte britannique destiné aux professionnels donne pour les effets secondaires sexuels qu’il cite une fréquence « indéterminée » : elle ne peut pas être estimée à partir des données disponibles. Aucun des textes de produits que nous avons lus ne donne de chiffre sur la fréquence à laquelle ils persistent après l’arrêt.",
            "it": "Il testo britannico per i professionisti sanitari indica come «non nota» la frequenza degli effetti collaterali sessuali che elenca: non può essere definita sulla base dei dati disponibili. Nessuno dei testi dei prodotti che abbiamo letto dà una cifra su quanto spesso continuino dopo l’interruzione.",
            "hi": "ब्रिटेन में डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए बना दस्तावेज़ जिन यौन साइड इफ़ेक्ट को गिनाता है, उनकी दर “ज्ञात नहीं” बताता है: उपलब्ध आँकड़ों से इसका अनुमान नहीं लगाया जा सकता। हमने दवा के जो दस्तावेज़ पढ़े, उनमें से कोई यह आँकड़ा नहीं देता कि दवा बंद करने के बाद ये कितनी बार बने रहते हैं।"
          }
        },
        {
          "id": "cause-isotretinoin",
          "sourceUrl": "https://sidefxhub.com/label-wording-by-country/#isotretinoin",
          "moreSourceUrls": [
            "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-regulator-dsu202304"
          ],
          "text": {
            "en": "The texts for professionals we read in Australia and New Zealand say it has not been established that isotretinoin causes the sexual side effects reported. The Canadian text says this could not be definitively established, and that an effect cannot be ruled out. The UK expert group whose review led to the UK warning said it was not possible to say that isotretinoin definitively caused these side effects.",
            "de": "In den Fachinformationen aus Australien und Neuseeland, die wir gelesen haben, steht, es sei nicht nachgewiesen, dass Isotretinoin die gemeldeten sexuellen Nebenwirkungen verursacht. Im kanadischen Text steht, dies habe sich nicht eindeutig nachweisen lassen und eine Wirkung lasse sich nicht ausschließen. Die britische Expertengruppe, deren Überprüfung zum britischen Warnhinweis führte, erklärte, es sei nicht möglich zu sagen, dass Isotretinoin eindeutig die Ursache dieser Nebenwirkungen war.",
            "es": "Los textos para profesionales que hemos leído en Australia y Nueva Zelanda dicen que no se ha establecido que la isotretinoína cause los efectos secundarios sexuales notificados. El texto canadiense dice que eso no pudo establecerse de forma definitiva, y que no puede descartarse un efecto. El grupo de expertos británico cuya revisión dio lugar a la advertencia británica dijo que no era posible decir que la isotretinoína causara de forma definitiva estos efectos secundarios.",
            "pt-br": "As bulas para profissionais de saúde que lemos na Austrália e na Nova Zelândia dizem que não foi estabelecido que a isotretinoína causa os efeitos colaterais sexuais relatados. O texto canadense diz que isso não pôde ser estabelecido de forma definitiva e que um efeito não pode ser descartado. O grupo britânico de especialistas cuja revisão levou ao alerta britânico disse que não era possível dizer que a isotretinoína causou de forma definitiva esses efeitos colaterais.",
            "fr": "Les textes destinés aux professionnels que nous avons lus en Australie et en Nouvelle-Zélande indiquent qu’il n’a pas été établi que l’isotrétinoïne cause les effets secondaires sexuels signalés. Le texte canadien indique que cela n’a pas pu être établi de façon certaine, et qu’un effet ne peut pas être exclu. Le groupe d’experts britannique dont l’examen a conduit à la mise en garde au Royaume-Uni a indiqué qu’il n’était pas possible de dire que l’isotrétinoïne avait causé de façon certaine ces effets secondaires.",
            "it": "I testi per i professionisti sanitari che abbiamo letto in Australia e in Nuova Zelanda dicono che non è stato stabilito che l’isotretinoina causi gli effetti collaterali sessuali segnalati. Il testo canadese dice che non è stato possibile stabilirlo con certezza, e che un effetto non può essere escluso. Il gruppo di esperti britannico la cui revisione ha portato all’avvertenza britannica ha detto che non era possibile dire che l’isotretinoina avesse causato con certezza questi effetti collaterali.",
            "hi": "ऑस्ट्रेलिया और न्यूज़ीलैंड में डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए बने जो दस्तावेज़ हमने पढ़े, वे कहते हैं कि यह स्थापित नहीं हुआ है कि रिपोर्ट किए गए यौन साइड इफ़ेक्ट आइसोट्रेटिनॉइन की वजह से होते हैं। कनाडा का दस्तावेज़ कहता है कि यह निश्चित रूप से स्थापित नहीं किया जा सका, और असर की संभावना को खारिज नहीं किया जा सकता। ब्रिटेन के जिस विशेषज्ञ समूह की समीक्षा के नतीजे में ब्रिटेन की चेतावनी आई, उसने कहा कि यह कहना संभव नहीं था कि ये साइड इफ़ेक्ट निश्चित रूप से आइसोट्रेटिनॉइन की वजह से हुए।"
          }
        }
      ],
      "changed": "2026-10-13",
      "records": [
        {
          "id": "isotretinoin-uk",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics (SmPC): Roaccutane 10 mg soft capsules",
            "lang": "en-GB",
            "product": {
              "name": "Roaccutane",
              "form": "10 mg soft capsules",
              "holder": "Neon Healthcare Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/100633/smpc",
            "fetchedUrl": null,
            "textDate": "2026-04-27",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. Date of revision of the text 27/04/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4 Special warnings and precautions for use",
                "Sexual disorders"
              ],
              "since": {
                "date": "2023",
                "scope": "jurisdiction",
                "basis": [
                  "isotretinoin-uk-regulator-dsu202310",
                  "isotretinoin-uk-regulator-dsu202304"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte über lang anhaltende sexuelle Funktionsstörungen, bei denen die Symptome trotz Absetzen von Isotretinoin angehalten haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado pese a la interrupción de la isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da interrupção da isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui se sont poursuivis malgré l’arrêt de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione dell’isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें आइसोट्रेटिनॉइन बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Summary of safety profile"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento, pero algunos pueden persistir una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis após a alteração da dose ou a interrupção do tratamento, mas alguns podem persistir depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni, comunque, possono persistere dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin",
                "Reproductive system and breast disorders",
                "Not known*"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, Vulvovaginal dryness, orgasm abnormal, genital hypoaesthesia",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, vulvovaginale Trockenheit, anomaler Orgasmus, genitale Hypästhesie",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginal, orgasmo anormal, hipoestesia genital",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e diminuição da libido, ginecomastia, ressecamento vulvovaginal, orgasmo anormal, hipoestesia genital",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido, gynécomastie, sécheresse vulvo-vaginale, orgasme anormal, hypoesthésie génitale",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginale, orgasmo anormale, ipoestesia genitale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, वल्वा और योनि में सूखापन, ऑर्गेज़्म में गड़बड़ी, जननांगों में संवेदना कम होना",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "sinceTwoDocuments",
              "text": {
                "en": "One of these documents announced the sentence and the other reports the update as done. Neither prints the day the text changed.",
                "de": "Eines dieser Dokumente kündigte den Satz an, das andere meldet die Aktualisierung als erfolgt. Keines nennt den Tag, an dem der Text geändert wurde.",
                "es": "Uno de estos documentos anunció la frase y el otro da la actualización por hecha. Ninguno indica el día en que cambió el texto.",
                "pt-br": "Um destes documentos anunciou a frase e o outro informa que a atualização foi feita. Nenhum dos dois traz o dia em que o texto mudou.",
                "fr": "L’un de ces documents a annoncé la phrase, l’autre indique que la mise à jour est faite. Aucun des deux ne donne le jour où le texte a changé.",
                "it": "Uno di questi documenti ha annunciato la frase e l’altro riferisce che l’aggiornamento è stato fatto. Nessuno dei due riporta il giorno in cui il testo è cambiato.",
                "hi": "इनमें से एक दस्तावेज़ ने इस वाक्य की घोषणा की, और दूसरा बताता है कि अपडेट हो चुका है। दोनों में से किसी पर वह दिन नहीं छपा, जब दस्तावेज़ बदला।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-uk-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-leaflet",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package leaflet: Information for the user. Roaccutane 10 mg and 20 mg soft capsules. isotretinoin",
            "lang": "en-GB",
            "product": {
              "name": "Roaccutane",
              "form": "10 mg and 20 mg soft capsules",
              "holder": "Neon Healthcare Limited"
            },
            "source": {
              "type": "compendium",
              "name": "emc"
            },
            "url": "https://www.medicines.org.uk/emc/product/100633/pil",
            "fetchedUrl": "https://www.medicines.org.uk/emc/files/pil.100633.pdf",
            "textDate": "2026-04",
            "textDateKind": "revision",
            "textDateAsPrinted": "This leaflet was last revised in April 2026"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "2. What you need to know before you take Roaccutane",
                "Warnings and precautions",
                "Advice for all patients"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "Isotretinoin has been associated with sexual problems. These include problems getting or maintaining an erection, lower libido, vaginal dryness, orgasm difficulties and reduced sensation in the genitals.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Isotretinoin wurde mit sexuellen Problemen in Verbindung gebracht. Dazu gehören Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten, schwächere Libido, Scheidentrockenheit, Orgasmusstörungen und vermindertes Empfinden im Genitalbereich.",
                  "by": "ours"
                },
                "es": {
                  "text": "La isotretinoína se ha asociado con problemas sexuales. Entre ellos figuran problemas para conseguir o mantener una erección, disminución de la libido, sequedad vaginal, dificultades con el orgasmo y reducción de la sensibilidad en los genitales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A isotretinoína foi associada a problemas sexuais. Eles incluem problemas para ter ou manter uma ereção, queda da libido, ressecamento vaginal, dificuldades com o orgasmo e redução da sensibilidade nos genitais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’isotrétinoïne a été associée à des troubles sexuels. Il s’agit notamment de problèmes d’obtention ou de maintien d’une érection, d’une baisse de la libido, d’une sécheresse vaginale, de difficultés à atteindre l’orgasme et d’une diminution de la sensibilité des organes génitaux.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’isotretinoina è stata associata a problemi sessuali. Questi comprendono problemi a raggiungere o mantenere l’erezione, calo della libido, secchezza vaginale, difficoltà legate all’orgasmo e ridotta sensibilità ai genitali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन यौन समस्याओं से जुड़ी पाई गई है। इनमें इरेक्शन होने या बनाए रखने में समस्या, कामेच्छा में कमी, योनि में सूखापन, ऑर्गेज़्म में दिक्कत और जननांगों में संवेदना कम होना शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "2. What you need to know before you take Roaccutane",
                "Warnings and precautions",
                "Advice for all patients"
              ],
              "since": {
                "date": "2023",
                "scope": "jurisdiction",
                "basis": [
                  "isotretinoin-uk-regulator-dsu202310",
                  "isotretinoin-uk-regulator-dsu202304"
                ]
              },
              "inWarnings": true,
              "lang": "en-GB",
              "text": "There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte über lang anhaltende sexuelle Probleme, bei denen die Symptome trotz Beendigung der Behandlung mit Isotretinoin angehalten haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado problemas sexuales de larga duración en los que los síntomas han continuado a pesar de dejar el tratamiento con isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de problemas sexuais de longa duração em que os sintomas continuaram apesar da interrupção do tratamento com isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des troubles sexuels durables ont été signalés, avec des symptômes qui se sont poursuivis malgré l’arrêt du traitement par isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati problemi sessuali a lungo termine in cui i sintomi sono continuati nonostante l’interruzione del trattamento con isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "लंबे समय तक रहने वाली यौन समस्याओं की रिपोर्टें आई हैं, जिनमें आइसोट्रेटिनॉइन से इलाज बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder nach Beendigung der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios son generalmente reversibles tras cambiar la dosis o interrumpir el tratamiento; sin embargo, algunos pueden continuar una vez interrumpido el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis depois de mudar a dose ou interromper o tratamento, mas alguns podem continuar depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent continuer après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o l’interruzione del trattamento, alcuni, comunque, possono continuare dopo la sospensione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी जारी रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "sinceTwoDocuments",
              "text": {
                "en": "One of these documents announced the sentence and the other reports the update as done. Neither prints the day the text changed.",
                "de": "Eines dieser Dokumente kündigte den Satz an, das andere meldet die Aktualisierung als erfolgt. Keines nennt den Tag, an dem der Text geändert wurde.",
                "es": "Uno de estos documentos anunció la frase y el otro da la actualización por hecha. Ninguno indica el día en que cambió el texto.",
                "pt-br": "Um destes documentos anunciou a frase e o outro informa que a atualização foi feita. Nenhum dos dois traz o dia em que o texto mudou.",
                "fr": "L’un de ces documents a annoncé la phrase, l’autre indique que la mise à jour est faite. Aucun des deux ne donne le jour où le texte a changé.",
                "it": "Uno di questi documenti ha annunciato la frase e l’altro riferisce che l’aggiornamento è stato fatto. Nessuno dei due riporta il giorno in cui il testo è cambiato.",
                "hi": "इनमें से एक दस्तावेज़ ने इस वाक्य की घोषणा की, और दूसरा बताता है कि अपडेट हो चुका है। दोनों में से किसी पर वह दिन नहीं छपा, जब दस्तावेज़ बदला।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-uk-regulator-dsu202304",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-regulator-dsu202304",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/isotretinoin-roaccutanev-new-safety-measures-to-be-introduced-in-the-coming-months-including-additional-oversight-on-initiation-of-treatment-for-patients-under-18-years",
            "fetchedUrl": null,
            "textDate": "2023-04-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 26 April 2023"
          },
          "passages": [
            {
              "key": "announcement",
              "kind": "sexual-persistence",
              "section": [
                "Recommendations from the review"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "The product information for isotretinoin medicines is being updated with these new requirements and to add new information and warnings regarding psychiatric and sexual disorders. This will include a warning that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Produktinformationen zu Isotretinoin-Medikamenten werden derzeit um diese neuen Anforderungen sowie um neue Informationen und Warnhinweise zu psychiatrischen und sexuellen Störungen ergänzt. Dazu gehört ein Warnhinweis, dass es Berichte über lang anhaltende sexuelle Funktionsstörungen gibt, bei denen die Symptome trotz Absetzen von Isotretinoin angehalten haben.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto de los medicamentos con isotretinoína se está actualizando con estos nuevos requisitos y para añadir nueva información y advertencias sobre trastornos psiquiátricos y sexuales. Esto incluirá una advertencia de que se han notificado casos de disfunción sexual de larga duración en los que los síntomas han continuado pese a la interrupción de la isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto dos medicamentos com isotretinoína estão sendo atualizadas com essas novas exigências e para acrescentar novas informações e alertas sobre distúrbios psiquiátricos e sexuais. Isso vai incluir um alerta de que houve relatos de disfunção sexual de longa duração em que os sintomas continuaram apesar da interrupção da isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit des médicaments à base d’isotrétinoïne sont en cours de mise à jour pour intégrer ces nouvelles exigences et pour ajouter de nouvelles informations et mises en garde concernant les troubles psychiatriques et sexuels. Elles comporteront une mise en garde indiquant que des cas de dysfonction sexuelle durable ont été signalés, avec des symptômes qui se sont poursuivis malgré l’arrêt de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto dei medicinali a base di isotretinoina sono in corso di aggiornamento con questi nuovi requisiti e per aggiungere nuove informazioni e avvertenze sui disturbi psichiatrici e sessuali. Sarà inclusa un’avvertenza secondo cui sono stati segnalati casi di disfunzione sessuale a lungo termine in cui i sintomi sono continuati nonostante l’interruzione dell’isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन दवाओं की आधिकारिक जानकारी (product information) अपडेट की जा रही है, ताकि उसमें ये नई शर्तें आएँ, और मानसिक और यौन समस्याओं के बारे में नई जानकारी और चेतावनियाँ जुड़ें। इसमें यह चेतावनी शामिल होगी कि लंबे समय तक रहने वाले सेक्शुअल डिस्फ़ंक्शन की रिपोर्टें आई हैं, जिनमें आइसोट्रेटिनॉइन बंद करने के बावजूद लक्षण जारी रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Recommendations from the review"
              ],
              "since": null,
              "qualifies": "announcement",
              "lang": "en-GB",
              "text": "The IEWG considered all the available evidence, including information from patients and their families and concluded that gaps in the available evidence meant that it was not possible to say that isotretinoin definitively caused many of the short-term or longer-term psychiatric and sexual side effects.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die IEWG prüfte alle verfügbaren Belege, darunter Informationen von Patientinnen und Patienten und ihren Familien, und kam zu dem Schluss, dass es wegen Lücken in den verfügbaren Belegen nicht möglich war zu sagen, dass Isotretinoin eindeutig die Ursache vieler der kurzfristigen oder längerfristigen psychiatrischen und sexuellen Nebenwirkungen war.",
                  "by": "ours"
                },
                "es": {
                  "text": "El IEWG examinó toda la evidencia disponible, incluida la información de pacientes y familiares, y concluyó que, por las lagunas en la evidencia disponible, no era posible decir que la isotretinoína causara de forma definitiva muchos de los efectos secundarios psiquiátricos y sexuales a corto o a más largo plazo.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "O IEWG considerou todas as evidências disponíveis, incluindo informações de pacientes e de suas famílias, e concluiu que, por causa das lacunas nas evidências disponíveis, não era possível dizer que a isotretinoína causou de forma definitiva muitos dos efeitos colaterais psiquiátricos e sexuais de curto ou de mais longo prazo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’IEWG a examiné toutes les données disponibles, y compris les informations fournies par les patients et leurs familles, et a conclu qu’en raison des lacunes dans les données disponibles, il n’était pas possible de dire que l’isotrétinoïne avait causé de façon certaine un grand nombre des effets indésirables psychiatriques et sexuels à court ou à plus long terme.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’IEWG ha esaminato tutti i dati disponibili, comprese le informazioni fornite dai pazienti e dalle loro famiglie, e ha concluso che, per le lacune nei dati disponibili, non era possibile dire che l’isotretinoina avesse causato con certezza molti degli effetti indesiderati psichiatrici e sessuali a breve o a più lungo termine.",
                  "by": "ours"
                },
                "hi": {
                  "text": "IEWG ने सभी उपलब्ध प्रमाणों पर विचार किया, जिनमें मरीज़ों और उनके परिवारों से मिली जानकारी भी थी। उसका निष्कर्ष था कि उपलब्ध प्रमाणों में कमियों की वजह से यह कहना संभव नहीं था कि आइसोट्रेटिनॉइन निश्चित रूप से कम समय या ज़्यादा समय तक रहने वाले कई मानसिक और यौन साइड इफ़ेक्ट का कारण थी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "markedSuperseded",
              "text": {
                "en": "The regulator has marked this document as superseded.",
                "de": "Die Arzneimittelbehörde hat dieses Dokument als ersetzt gekennzeichnet.",
                "es": "La agencia del medicamento ha marcado este documento como sustituido.",
                "pt-br": "A agência reguladora marcou este documento como substituído.",
                "fr": "L’agence du médicament indique que ce document a été remplacé.",
                "it": "L’agenzia del farmaco ha contrassegnato questo documento come superato.",
                "hi": "नियामक ने इस दस्तावेज़ पर दर्ज किया है कि इसकी जगह नया दस्तावेज़ आ चुका है (superseded)।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-uk-regulator-dsu202310",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-regulator-dsu202310",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/isotretinoin-roaccutanev-introduction-of-new-safety-measures-including-additional-oversight-of-the-initiation-of-treatment-for-patients-under-18-years-of-age",
            "fetchedUrl": null,
            "textDate": "2023-10-31",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 31 October 2023"
          },
          "passages": [
            {
              "key": "updated",
              "kind": "regulator-statement",
              "section": [
                "Isotretinoin treatment and new safety measures"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The product information for isotretinoin medicines has been updated following the review’s recommendations.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Produktinformationen zu Isotretinoin-Medikamenten wurden entsprechend den Empfehlungen der Überprüfung aktualisiert.",
                  "by": "ours"
                },
                "es": {
                  "text": "La información del producto de los medicamentos con isotretinoína se ha actualizado siguiendo las recomendaciones de la revisión.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As informações do produto dos medicamentos com isotretinoína foram atualizadas de acordo com as recomendações da revisão.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les informations sur le produit des médicaments à base d’isotrétinoïne ont été mises à jour à la suite des recommandations de l’examen.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le informazioni sul prodotto dei medicinali a base di isotretinoina sono state aggiornate in seguito alle raccomandazioni della revisione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समीक्षा की सिफ़ारिशों के बाद आइसोट्रेटिनॉइन दवाओं की आधिकारिक जानकारी (product information) अपडेट कर दी गई है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the page was read in full; it says the product information has been updated and does not repeat the sentence itself",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-uk-regulator-chm2023",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-regulator-chm2023",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "REPORT OF THE COMMISSION ON HUMAN MEDICINES ISOTRETINOIN EXPERT WORKING GROUP",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://assets.publishing.service.gov.uk/media/6448cd0a529eda00123b047d/Isotretinoin-final-CHM-report-26April2023.pdf",
            "fetchedUrl": null,
            "textDate": "2023-04-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "26 April 2023"
          },
          "passages": [
            {
              "key": "recommendation",
              "kind": "sexual-persistence",
              "section": [
                "8.2.1. Changes to product information"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-GB",
              "text": "Warnings about the potential for the sexual side effects (erectile dysfunction, vulvovaginal dryness, reduced libido, orgasm difficulties and genital hypoaesthesia) to continue long-term after treatment with isotretinoin has been stopped should be added to the SmPC and PIL.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Warnhinweise darauf, dass die sexuellen Nebenwirkungen (erektile Dysfunktion, vulvovaginale Trockenheit, verminderte Libido, Orgasmusstörungen und genitale Hypästhesie) nach Beendigung der Behandlung mit Isotretinoin langfristig anhalten können, sollten in die Fachinformation und die Packungsbeilage aufgenommen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Deberían añadirse a la ficha técnica y al prospecto advertencias sobre la posibilidad de que los efectos secundarios sexuales (disfunción eréctil, sequedad vulvovaginal, disminución de la libido, dificultades con el orgasmo e hipoestesia genital) continúen a largo plazo después de interrumpir el tratamiento con isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Devem ser acrescentados à bula para o profissional de saúde e à bula para pacientes alertas sobre a possibilidade de os efeitos colaterais sexuais (disfunção erétil, ressecamento vulvovaginal, redução da libido, dificuldades com o orgasmo e hipoestesia genital) continuarem a longo prazo depois que o tratamento com isotretinoína é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des mises en garde sur la possibilité que les effets indésirables sexuels (dysfonction érectile, sécheresse vulvo-vaginale, baisse de la libido, difficultés à atteindre l’orgasme et hypoesthésie génitale) continuent à long terme après l’arrêt du traitement par isotrétinoïne devraient être ajoutées au RCP et à la notice.",
                  "by": "ours"
                },
                "it": {
                  "text": "All’RCP e al foglio illustrativo dovrebbero essere aggiunte avvertenze sulla possibilità che gli effetti indesiderati sessuali (disfunzione erettile, secchezza vulvovaginale, riduzione della libido, difficoltà legate all’orgasmo e ipoestesia genitale) continuino a lungo termine dopo l’interruzione del trattamento con isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "SmPC और PIL में यह चेतावनी जोड़ी जानी चाहिए कि यौन साइड इफ़ेक्ट (स्तंभन दोष, वल्वा और योनि में सूखापन, कामेच्छा में कमी, ऑर्गेज़्म में दिक्कत और जननांगों में संवेदना कम होना) आइसोट्रेटिनॉइन से इलाज बंद होने के बाद भी लंबे समय तक जारी रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-uk-regulator-dsu2017",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-uk-regulator-dsu2017",
          "reportUrl": "https://yellowcard.mhra.gov.uk/",
          "jurisdiction": "uk",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido",
            "lang": "en-GB",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "GOV.UK"
            },
            "url": "https://www.gov.uk/drug-safety-update/isotretinoin-roaccutane-rare-reports-of-erectile-dysfunction-and-decreased-libido",
            "fetchedUrl": null,
            "textDate": "2017-10-26",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 26 October 2017"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Sexual dysfunction"
              ],
              "since": null,
              "lang": "en-GB",
              "text": "The review recommended that sexual dysfunction including erectile dysfunction and decreased libido should be added to the list of side effects in the product information. The package leaflet for patients will include “Problems getting or maintaining an erection and lower libido” as possible side effects.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung empfahl, sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido in die Liste der Nebenwirkungen in der Produktinformation aufzunehmen. Die Packungsbeilage für Patientinnen und Patienten wird „Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten, und schwächere Libido“ als mögliche Nebenwirkungen enthalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión recomendó añadir la disfunción sexual, incluyendo disfunción eréctil y disminución de la libido, a la lista de efectos secundarios de la información del producto. El prospecto para pacientes incluirá «Problemas para conseguir o mantener una erección y disminución de la libido» como posibles efectos secundarios.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão recomendou que a disfunção sexual, incluindo disfunção erétil e diminuição da libido, fosse acrescentada à lista de efeitos colaterais nas informações do produto. A bula para pacientes vai incluir “Problemas para ter ou manter uma ereção e queda da libido” como possíveis efeitos colaterais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen a recommandé d’ajouter le dysfonctionnement sexuel, y compris le dysfonctionnement érectile et la baisse de la libido, à la liste des effets indésirables figurant dans les informations sur le produit. La notice destinée aux patients mentionnera « Problèmes d’obtention ou de maintien d’une érection et baisse de la libido » parmi les effets indésirables possibles.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione ha raccomandato di aggiungere la disfunzione sessuale, tra cui disfunzione erettile e calo della libido, all’elenco degli effetti indesiderati nelle informazioni sul prodotto. Il foglio illustrativo per i pazienti includerà «Problemi a raggiungere o mantenere l’erezione e calo della libido» tra i possibili effetti indesiderati.",
                  "by": "ours"
                },
                "hi": {
                  "text": "समीक्षा ने सिफ़ारिश की कि दवा की आधिकारिक जानकारी (product information) में साइड इफ़ेक्ट की सूची में सेक्शुअल डिस्फ़ंक्शन जोड़ा जाए, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं। मरीज़ों के लिए लीफ़लेट में “इरेक्शन होने या बनाए रखने में समस्या और कामेच्छा में कमी” संभावित साइड इफ़ेक्ट के तौर पर शामिल होंगे।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the page was read in full; it has no wording about the effects continuing after stopping",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "markedSuperseded",
              "text": {
                "en": "The regulator has marked this document as superseded.",
                "de": "Die Arzneimittelbehörde hat dieses Dokument als ersetzt gekennzeichnet.",
                "es": "La agencia del medicamento ha marcado este documento como sustituido.",
                "pt-br": "A agência reguladora marcou este documento como substituído.",
                "fr": "L’agence du médicament indique que ce document a été remplacé.",
                "it": "L’agenzia del farmaco ha contrassegnato questo documento come superato.",
                "hi": "नियामक ने इस दस्तावेज़ पर दर्ज किया है कि इसकी जगह नया दस्तावेज़ आ चुका है (superseded)।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-eu",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-eu",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_en.pdf",
            "fetchedUrl": null,
            "textDate": "2017-07",
            "textDateKind": "adoption",
            "textDateAsPrinted": "Adoption of CMDh position: July 2017 CMDh meeting"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-side-effects",
              "section": [
                "Annex II",
                "Amendments to the product information of the nationally authorised medicinal product(s)",
                "Summary of Product Characteristics",
                "Section 4.8"
              ],
              "since": null,
              "lang": "en",
              "text": "Sexual dysfunction including erectile dysfunction and decreased libido",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "ANHANG II",
                    "Änderungen der Produktinformation des/der national zugelassenenArzneimittel(s)",
                    "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS",
                    "Abschnitt 4.8"
                  ],
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido"
                },
                {
                  "lang": "fr",
                  "section": [
                    "Annexe II",
                    "Modifications apportées aux informations sur le produit du ou des médicament(s) autorisé(s) au niveau national",
                    "Résumé des caractéristiques du produit",
                    "Section 4.8"
                  ],
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido"
                },
                {
                  "lang": "it",
                  "section": [
                    "Allegato II",
                    "Modifiche alle informazioni sul medicinale del/i medicinale/i autorizzato/i a livello nazionale",
                    "Riassunto delle caratteristiche del prodotto",
                    "Paragrafo 4.8"
                  ],
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido"
                },
                {
                  "lang": "es",
                  "section": [
                    "Anexo II",
                    "Modificaciones de la información del producto para el los medicamento(s) autorizado(s) por procedimiento nacional",
                    "Ficha Técnica o Resumen de las Características del Producto",
                    "Sección 4.8"
                  ],
                  "text": "Disfunción sexual incluyendo disfunción erectil y disminución de la líbido"
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "Anexo II",
                    "Alterações à Informação do Medicamento do(s) medicamento(s) autorizado(s) por meio de procedimentos nacionais",
                    "Resumo das Características do Medicamento",
                    "Secção 4.8"
                  ],
                  "text": "Disfunção sexual incluindo disfunção eréctil e diminuição da líbido"
                }
              ],
              "translations": {
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido",
                  "by": "official"
                },
                "es": {
                  "text": "Disfunción sexual incluyendo disfunción erectil y disminución de la líbido",
                  "by": "official"
                },
                "pt-br": {
                  "text": "Disfunção sexual incluindo disfunção eréctil e diminuição da líbido",
                  "by": "official"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido",
                  "by": "official"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido",
                  "by": "official"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं",
                  "by": "ours"
                }
              }
            },
            {
              "key": "leaflet",
              "kind": "sexual-side-effects",
              "section": [
                "Annex II",
                "Amendments to the product information of the nationally authorised medicinal product(s)",
                "Package Leaflet",
                "4. Possible side effects",
                "Unknown frequency: (frequency cannot be estimated from the available data)"
              ],
              "since": null,
              "lang": "en",
              "text": "• Problems getting or maintaining an erection\n• Lower libido",
              "officialVersions": [
                {
                  "lang": "de",
                  "section": [
                    "ANHANG II",
                    "Änderungen der Produktinformation des/der national zugelassenenArzneimittel(s)",
                    "Packungsbeilage",
                    "4. Welche Nebenwirkungen sind möglich?",
                    "Unbekannte Häufigkeit: (Häufigkeit kann auf Basis der verfügbaren Daten nicht bestimmt werden)"
                  ],
                  "text": "• Schwierigkeiten eine Erektion zu bekommen oder aufrechtzuerhalten\n• Schwächere Libido"
                },
                {
                  "lang": "fr",
                  "section": [
                    "Annexe II",
                    "Modifications apportées aux informations sur le produit du ou des médicament(s) autorisé(s) au niveau national",
                    "Notice",
                    "4. Quels sont les effets indésirables éventuels",
                    "Fréquence indéterminée : (la fréquence ne peut être estimée à partir des données disponibles)"
                  ],
                  "text": "• Problèmes d’obtention ou de maintien d’une érection\n• Baisse de la libido"
                },
                {
                  "lang": "it",
                  "section": [
                    "Allegato II",
                    "Modifiche alle informazioni sul medicinale del/i medicinale/i autorizzato/i a livello nazionale",
                    "Foglio illustrativo",
                    "4. Possibili effetti indesiderati",
                    "Frequenza non nota: (la frequenza non può essere definita sulla base dei dati disponibili)"
                  ],
                  "text": "• Problemi a raggiungere o mantenere l’erezione\n• Calo della libido"
                },
                {
                  "lang": "es",
                  "section": [
                    "Anexo II",
                    "Modificaciones de la información del producto para el los medicamento(s) autorizado(s) por procedimiento nacional",
                    "Prospecto",
                    "4. Posibles efectos adversos",
                    "Frecuencia no conocida: (no puede estimarse a partir de los datos disponibles)"
                  ],
                  "text": "• Problemas para conseguir o mantener una erección\n• Disminución de la líbido"
                },
                {
                  "lang": "pt-PT",
                  "section": [
                    "Anexo II",
                    "Alterações à Informação do Medicamento do(s) medicamento(s) autorizado(s) por meio de procedimentos nacionais",
                    "Folheto Informativo",
                    "4. Efeitos secundários possíveis",
                    "Frequência desconhecida: (não pode ser estimada a partir dos dados disponíveis)"
                  ],
                  "text": "• Dificuldades em ter ou manter uma erecção\n• Líbido diminuída"
                }
              ],
              "translations": {
                "de": {
                  "text": "• Schwierigkeiten eine Erektion zu bekommen oder aufrechtzuerhalten\n• Schwächere Libido",
                  "by": "official"
                },
                "es": {
                  "text": "• Problemas para conseguir o mantener una erección\n• Disminución de la líbido",
                  "by": "official"
                },
                "pt-br": {
                  "text": "• Dificuldades em ter ou manter uma erecção\n• Líbido diminuída",
                  "by": "official"
                },
                "fr": {
                  "text": "• Problèmes d’obtention ou de maintien d’une érection\n• Baisse de la libido",
                  "by": "official"
                },
                "it": {
                  "text": "• Problemi a raggiungere o mantenere l’erezione\n• Calo della libido",
                  "by": "official"
                },
                "hi": {
                  "text": "• इरेक्शन होने या बनाए रखने में समस्या\n• कामेच्छा में कमी",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, continu, after discontinu, after stopping, long-lasting, long lasting, irreversib, permanent, resolv, withdraw, dechallenge",
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "de",
              "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
              "url": "https://www.ema.europa.eu/de/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_de.pdf",
              "textDateAsPrinted": "Annahme der Stellungnahme der CMDh Sitzung der CMDh im Juli 2017",
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "fr",
              "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
              "url": "https://www.ema.europa.eu/fr/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_fr.pdf",
              "textDateAsPrinted": "Adoption de l’avis du CMDh : Réunion du CMDh de juillet 2017",
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "it",
              "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
              "url": "https://www.ema.europa.eu/it/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_it.pdf",
              "textDateAsPrinted": "Adozione del parere del CMDh: riunione del CMDh di novembre 2017",
              "dateDiffers": true,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "corrected"
              }
            },
            {
              "lang": "es",
              "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
              "url": "https://www.ema.europa.eu/es/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_es.pdf",
              "textDateAsPrinted": "Reunión del CMDh de Julio 2017",
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            },
            {
              "lang": "pt-PT",
              "name": "Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611",
              "url": "https://www.ema.europa.eu/pt/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010488201611_pt.pdf",
              "textDateAsPrinted": "Adoção da posição do CMDh: Reunião do CMDh de Julho/2017",
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "corrected"
              }
            }
          ],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "nationalTexts",
              "text": {
                "en": "This is wording for national product texts. There is no single EU product text for this medicine.",
                "de": "Dies ist ein Wortlaut für nationale Produkttexte. Einen einheitlichen EU-Produkttext gibt es für dieses Medikament nicht.",
                "es": "Esta redacción es para los textos nacionales de cada producto. No existe un único texto de producto de la UE para este medicamento.",
                "pt-br": "Este é um texto para as bulas nacionais. Não existe uma bula única da UE para este medicamento.",
                "fr": "Il s’agit d’une formulation destinée aux textes nationaux des produits. Pour ce médicament, il n’existe pas de texte de produit unique pour toute l’UE.",
                "it": "Questa è la formulazione destinata ai testi nazionali dei prodotti. Per questo medicinale non esiste un unico testo valido per tutta l’UE.",
                "hi": "ये शब्द अलग-अलग देशों में दवा के दस्तावेज़ों के लिए हैं। इस दवा के लिए पूरे EU का कोई एक दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-eu-regulator-referral2018",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-eu-regulator-referral2018",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Updated measures for pregnancy prevention during retinoid use. Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_en.pdf",
            "fetchedUrl": null,
            "textDate": "2018-06-21",
            "textDateKind": "publication",
            "textDateAsPrinted": "21 June 2018"
          },
          "passages": [],
          "searched": "sexual, erectile, libido, impoten, ejaculat, persist, long-lasting, irreversib, not resolving, after stopping, discontinuation",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-eu-regulator-psusa2025",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-eu-regulator-psusa2025",
          "reportUrl": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human",
          "jurisdiction": "eu",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin (oral formulations) : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) - PSUSA/00010488/202505",
            "lang": "en",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "European Medicines Agency"
            },
            "url": "https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-scientific-conclusions-grounds-variation-terms-marketing-authorisations-psusa-00010488-202505_en.pdf",
            "fetchedUrl": null,
            "textDate": "2025-12",
            "textDateKind": "adoption",
            "textDateAsPrinted": "Adoption of CMDh position: December 2025 CMDh meeting"
          },
          "passages": [],
          "searched": "the whole document was read; it has no word on sexual function and none on an effect continuing after stopping",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-us",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ABSORICA (isotretinoin) capsules, for oral use; ABSORICA LD (isotretinoin) capsules, for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Absorica and Absorica LD",
              "form": "capsules",
              "holder": "Sun Pharmaceutical Industries, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ef0cff8-19c1-4441-b780-fca6c7ee1615",
            "fetchedUrl": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/3ef0cff8-19c1-4441-b780-fca6c7ee1615.xml",
            "textDate": "2026-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 08/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "Reproductive System"
              ],
              "since": {
                "date": "2026-08-11",
                "scope": "product",
                "basis": [
                  "isotretinoin-us-regulator-srlc"
                ]
              },
              "inWarnings": false,
              "lang": "en-US",
              "text": "Abnormal menses and sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Menstruationsstörungen und sexuelle Funktionsstörung, die nach Beendigung der Behandlung anhalten kann (einschließlich erektiler Dysfunktion, verminderter Libido, verminderter vaginaler Lubrikation und Scheidentrockenheit).",
                  "by": "ours"
                },
                "es": {
                  "text": "Menstruación anormal y disfunción sexual que puede continuar tras la interrupción del tratamiento (incluidas la disfunción eréctil, la disminución de la libido, la disminución de la lubricación vaginal y la sequedad vaginal).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Menstruação anormal e disfunção sexual que pode continuar após a descontinuação do tratamento (incluindo disfunção erétil, diminuição da libido, diminuição da lubrificação vaginal e ressecamento vaginal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Règles anormales et dysfonction sexuelle qui peut continuer après l’arrêt du traitement (notamment dysfonction érectile, baisse de la libido, diminution de la lubrification vaginale et sécheresse vaginale).",
                  "by": "ours"
                },
                "it": {
                  "text": "Mestruazioni anomale e disfunzione sessuale che può continuare dopo l’interruzione del trattamento (tra cui disfunzione erettile, calo della libido, ridotta lubrificazione vaginale e secchezza vaginale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "असामान्य माहवारी और सेक्शुअल डिस्फ़ंक्शन, जो इलाज बंद करने के बाद भी जारी रह सकता है (जिसमें स्तंभन दोष, कामेच्छा में कमी, योनि में चिकनाई कम होना और योनि में सूखापन शामिल हैं)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "list-introduction",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die folgenden Nebenwirkungen im Zusammenhang mit der Anwendung von Isotretinoin-Kapseln wurden in klinischen Studien oder in Berichten nach der Markteinführung festgestellt. Da einige dieser Nebenwirkungen freiwillig aus einer Population ungewisser Größe gemeldet wurden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas asociadas al uso de cápsulas de isotretinoína se identificaron en ensayos clínicos o en notificaciones poscomercialización. Dado que algunas de estas reacciones se notificaron de forma voluntaria a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir, associadas ao uso de cápsulas de isotretinoína, foram identificadas em ensaios clínicos ou em relatos pós-comercialização. Como algumas dessas reações foram relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar sua frequência de forma confiável ou estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants, associés à l’utilisation des capsules d’isotrétinoïne, ont été identifiés dans des essais cliniques ou dans des signalements après commercialisation. Comme certains de ces effets ont été signalés de façon volontaire dans une population de taille incertaine, il n’est pas toujours possible d’estimer leur fréquence de manière fiable ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse associate all’uso di isotretinoina in capsule sono state individuate negli studi clinici o nelle segnalazioni post-marketing. Poiché alcune di queste reazioni sono state segnalate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza o stabilire una relazione causale con l’esposizione al farmaco.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन कैप्सूल के इस्तेमाल से जुड़े नीचे दिए गए साइड इफ़ेक्ट (adverse reactions) क्लिनिकल ट्रायल में या दवा के बाज़ार में आने के बाद की रिपोर्टों में पहचाने गए। इनमें से कुछ की रिपोर्ट ऐसी आबादी से अपनी मर्ज़ी से की गई, जिसका आकार पक्का नहीं है, इसलिए भरोसे के साथ यह अंदाज़ा लगाना कि ये कितनी बार होते हैं, या दवा लेने के साथ कारण और असर का संबंध स्थापित करना हमेशा संभव नहीं होता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            },
            {
              "key": "sinceThisProduct",
              "text": {
                "en": "The date given is for this product. Texts for other products carry other dates.",
                "de": "Das angegebene Datum gilt für dieses Produkt. Texte zu anderen Produkten tragen andere Daten.",
                "es": "La fecha indicada es la de este producto. Los textos de otros productos llevan otras fechas.",
                "pt-br": "A data indicada vale para este produto. As bulas de outros produtos trazem outras datas.",
                "fr": "La date indiquée vaut pour ce produit. Les textes d’autres produits portent d’autres dates.",
                "it": "La data indicata vale per questo prodotto. I testi di altri prodotti riportano altre date.",
                "hi": "दी गई तारीख इस उत्पाद की है। दूसरे उत्पादों के दस्तावेज़ों पर दूसरी तारीखें हैं।"
              }
            },
            {
              "key": "productsDiffer",
              "text": {
                "en": "Texts for other products in this country do not all say the same. The ones we read are on the full record.",
                "de": "Die Texte zu anderen Produkten in diesem Land sagen nicht alle dasselbe. Die Texte, die wir gelesen haben, stehen in der vollständigen Dokumentation.",
                "es": "Los textos de otros productos de este país no dicen todos lo mismo. Los que hemos leído están en la recopilación completa.",
                "pt-br": "As bulas de outros produtos neste país não dizem todas a mesma coisa. As que lemos estão no levantamento completo.",
                "fr": "Dans ce pays, les textes des autres produits ne disent pas tous la même chose. Ceux que nous avons lus figurent dans le relevé complet.",
                "it": "In questo Paese i testi di altri prodotti non dicono tutti la stessa cosa. Quelli che abbiamo letto sono nella raccolta completa.",
                "hi": "इस देश में दूसरे उत्पादों के दस्तावेज़ सब एक ही बात नहीं कहते। जो हमने पढ़े, वे पूरे रिकॉर्ड में हैं।"
              }
            },
            {
              "key": "usListings",
              "text": {
                "en": "On 13 October 2026 this sentence was in 10 of the 31 isotretinoin listings on DailyMed. No Medication Guide, the text for patients, had it.",
                "de": "Am 13. Oktober 2026 stand dieser Satz in 10 der 31 Isotretinoin-Einträge auf DailyMed. In keinem Medication Guide, dem Text für Patientinnen und Patienten, stand er.",
                "es": "El 13 de octubre de 2026, esta frase estaba en 10 de las 31 entradas de isotretinoína de DailyMed. Ninguna Medication Guide, el texto para pacientes, la tenía.",
                "pt-br": "Em 13 de outubro de 2026, esta frase estava em 10 das 31 entradas de isotretinoína no DailyMed. Nenhum Medication Guide, a bula para pacientes, trazia a frase.",
                "fr": "Le 13 octobre 2026, cette phrase figurait dans 10 des 31 fiches d’isotrétinoïne de DailyMed. Aucun Medication Guide, le texte destiné aux patients, ne la contenait.",
                "it": "Il 13 ottobre 2026 questa frase compariva in 10 delle 31 voci dedicate all’isotretinoina su DailyMed. Nessuna Medication Guide, il testo per i pazienti, la riportava.",
                "hi": "13 अक्टूबर 2026 को यह वाक्य DailyMed पर आइसोट्रेटिनॉइन की 31 में से 10 प्रविष्टियों में था। किसी भी Medication Guide में, यानी मरीज़ों के लिए बने दस्तावेज़ में, यह नहीं था।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-us-pro-claravis",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-pro-claravis",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "CLARAVIS (isotretinoin capsules), for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Claravis",
              "form": "capsules 10 mg, 20 mg, 30 mg, and 40 mg",
              "holder": "Teva Pharmaceuticals USA, Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a31fd109-d0fd-4ab9-ba98-a3d64333c18d",
            "fetchedUrl": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/a31fd109-d0fd-4ab9-ba98-a3d64333c18d.xml",
            "textDate": "2026-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "Rev. P 7/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "Reproductive System"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "Abnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Menstruationsstörungen, sexuelle Funktionsstörung, die nach Beendigung der Behandlung anhalten kann (einschließlich erektiler Dysfunktion, verminderter Libido, verminderter vaginaler Lubrikation und Scheidentrockenheit).",
                  "by": "ours"
                },
                "es": {
                  "text": "Menstruación anormal, disfunción sexual que puede continuar tras la interrupción del tratamiento (incluidas la disfunción eréctil, la disminución de la libido, la disminución de la lubricación vaginal y la sequedad vaginal).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Menstruação anormal, disfunção sexual que pode continuar após a descontinuação do tratamento (incluindo disfunção erétil, diminuição da libido, diminuição da lubrificação vaginal e ressecamento vaginal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Règles anormales, dysfonction sexuelle qui peut continuer après l’arrêt du traitement (notamment dysfonction érectile, baisse de la libido, diminution de la lubrification vaginale et sécheresse vaginale).",
                  "by": "ours"
                },
                "it": {
                  "text": "Mestruazioni anomale, disfunzione sessuale che può continuare dopo l’interruzione del trattamento (tra cui disfunzione erettile, calo della libido, ridotta lubrificazione vaginale e secchezza vaginale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "असामान्य माहवारी, सेक्शुअल डिस्फ़ंक्शन, जो इलाज बंद करने के बाद भी जारी रह सकता है (जिसमें स्तंभन दोष, कामेच्छा में कमी, योनि में चिकनाई कम होना और योनि में सूखापन शामिल हैं)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "list-introduction",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "The following adverse reactions, presented alphabetically by body system, associated with the use of Claravis were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die folgenden Nebenwirkungen im Zusammenhang mit der Anwendung von Claravis, alphabetisch nach Organsystem geordnet, wurden in klinischen Studien oder in Berichten nach der Markteinführung festgestellt. Da einige dieser Nebenwirkungen freiwillig aus einer Population ungewisser Größe gemeldet wurden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas, presentadas en orden alfabético por sistema corporal, asociadas al uso de Claravis se identificaron en estudios clínicos o en notificaciones poscomercialización. Dado que algunas de estas reacciones se notificaron de forma voluntaria a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir, apresentadas em ordem alfabética por sistema do corpo e associadas ao uso de Claravis, foram identificadas em estudos clínicos ou em relatos pós-comercialização. Como algumas dessas reações foram relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar sua frequência de forma confiável ou estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants, présentés par ordre alphabétique des systèmes de l’organisme et associés à l’utilisation de Claravis, ont été identifiés dans des études cliniques ou dans des signalements après commercialisation. Comme certains de ces effets ont été signalés de façon volontaire dans une population de taille incertaine, il n’est pas toujours possible d’estimer leur fréquence de manière fiable ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse, presentate in ordine alfabetico per apparato, associate all’uso di Claravis sono state individuate negli studi clinici o nelle segnalazioni post-marketing. Poiché alcune di queste reazioni sono state segnalate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza o stabilire una relazione causale con l’esposizione al farmaco.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Claravis के इस्तेमाल से जुड़े नीचे दिए गए साइड इफ़ेक्ट (adverse reactions), जो शरीर के तंत्रों के हिसाब से अक्षरों के क्रम में दिए गए हैं, क्लिनिकल अध्ययनों में या दवा के बाज़ार में आने के बाद की रिपोर्टों में पहचाने गए। इनमें से कुछ की रिपोर्ट ऐसी आबादी से अपनी मर्ज़ी से की गई, जिसका आकार पक्का नहीं है, इसलिए भरोसे के साथ यह अंदाज़ा लगाना कि ये कितनी बार होते हैं, या दवा लेने के साथ कारण और असर का संबंध स्थापित करना हमेशा संभव नहीं होता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-us-pro-amnesteem",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-pro-amnesteem",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AMNESTEEM (isotretinoin capsules), for oral use: Full Prescribing Information",
            "lang": "en-US",
            "product": {
              "name": "Amnesteem",
              "form": "capsules 10 mg, 20 mg, 30 mg and 40 mg",
              "holder": "Mylan Pharmaceuticals Inc."
            },
            "source": {
              "type": "government-database",
              "name": "DailyMed"
            },
            "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2cb63c9-f825-4991-9a2c-6260f1bbcc2c",
            "fetchedUrl": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/b2cb63c9-f825-4991-9a2c-6260f1bbcc2c.xml",
            "textDate": "2026-08",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revised: 8/2026"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "6 ADVERSE REACTIONS",
                "Reproductive System"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-US",
              "text": "Abnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Menstruationsstörungen, sexuelle Funktionsstörung, die nach Beendigung der Behandlung anhalten kann (einschließlich erektiler Dysfunktion, verminderter Libido, verminderter vaginaler Lubrikation und Scheidentrockenheit).",
                  "by": "ours"
                },
                "es": {
                  "text": "Menstruación anormal, disfunción sexual que puede continuar tras la interrupción del tratamiento (incluidas la disfunción eréctil, la disminución de la libido, la disminución de la lubricación vaginal y la sequedad vaginal).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Menstruação anormal, disfunção sexual que pode continuar após a descontinuação do tratamento (incluindo disfunção erétil, diminuição da libido, diminuição da lubrificação vaginal e ressecamento vaginal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Règles anormales, dysfonction sexuelle qui peut continuer après l’arrêt du traitement (notamment dysfonction érectile, baisse de la libido, diminution de la lubrification vaginale et sécheresse vaginale).",
                  "by": "ours"
                },
                "it": {
                  "text": "Mestruazioni anomale, disfunzione sessuale che può continuare dopo l’interruzione del trattamento (tra cui disfunzione erettile, calo della libido, ridotta lubrificazione vaginale e secchezza vaginale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "असामान्य माहवारी, सेक्शुअल डिस्फ़ंक्शन, जो इलाज बंद करने के बाद भी जारी रह सकता है (जिसमें स्तंभन दोष, कामेच्छा में कमी, योनि में चिकनाई कम होना और योनि में सूखापन शामिल हैं)।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "list-introduction",
              "kind": "qualification",
              "section": [
                "6 ADVERSE REACTIONS"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-US",
              "text": "The following adverse reactions, presented alphabetically by body system, associated with the use of Amnesteem were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die folgenden Nebenwirkungen im Zusammenhang mit der Anwendung von Amnesteem, alphabetisch nach Organsystem geordnet, wurden in klinischen Studien oder in Berichten nach der Markteinführung festgestellt. Da einige dieser Nebenwirkungen freiwillig aus einer Population ungewisser Größe gemeldet wurden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas, presentadas en orden alfabético por sistema corporal, asociadas al uso de Amnesteem se identificaron en estudios clínicos o en notificaciones poscomercialización. Dado que algunas de estas reacciones se notificaron de forma voluntaria a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir, apresentadas em ordem alfabética por sistema do corpo e associadas ao uso de Amnesteem, foram identificadas em estudos clínicos ou em relatos pós-comercialização. Como algumas dessas reações foram relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar sua frequência de forma confiável ou estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants, présentés par ordre alphabétique des systèmes de l’organisme et associés à l’utilisation d’Amnesteem, ont été identifiés dans des études cliniques ou dans des signalements après commercialisation. Comme certains de ces effets ont été signalés de façon volontaire dans une population de taille incertaine, il n’est pas toujours possible d’estimer leur fréquence de manière fiable ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse, presentate in ordine alfabetico per apparato, associate all’uso di Amnesteem sono state individuate negli studi clinici o nelle segnalazioni post-marketing. Poiché alcune di queste reazioni sono state segnalate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza o stabilire una relazione causale con l’esposizione al farmaco.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Amnesteem के इस्तेमाल से जुड़े नीचे दिए गए साइड इफ़ेक्ट (adverse reactions), जो शरीर के तंत्रों के हिसाब से अक्षरों के क्रम में दिए गए हैं, क्लिनिकल अध्ययनों में या दवा के बाज़ार में आने के बाद की रिपोर्टों में पहचाने गए। इनमें से कुछ की रिपोर्ट ऐसी आबादी से अपनी मर्ज़ी से की गई, जिसका आकार पक्का नहीं है, इसलिए भरोसे के साथ यह अंदाज़ा लगाना कि ये कितनी बार होते हैं, या दवा लेने के साथ कारण और असर का संबंध स्थापित करना हमेशा संभव नहीं होता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-us-pro-zenatane",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-pro-zenatane",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ZENATANE (isotretinoin capsules), for oral use: Full Prescribing Information",
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              "name": "Zenatane",
              "form": "capsules 10 mg, 20 mg, 30 mg and 40 mg",
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              "section": [
                "6 ADVERSE REACTIONS",
                "Reproductive System"
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              "text": "Abnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Menstruationsstörungen, sexuelle Funktionsstörung, die nach Beendigung der Behandlung anhalten kann (einschließlich erektiler Dysfunktion, verminderter Libido, verminderter vaginaler Lubrikation und Scheidentrockenheit).",
                  "by": "ours"
                },
                "es": {
                  "text": "Menstruación anormal, disfunción sexual que puede continuar tras la interrupción del tratamiento (incluidas la disfunción eréctil, la disminución de la libido, la disminución de la lubricación vaginal y la sequedad vaginal).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Menstruação anormal, disfunção sexual que pode continuar após a descontinuação do tratamento (incluindo disfunção erétil, diminuição da libido, diminuição da lubrificação vaginal e ressecamento vaginal).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Règles anormales, dysfonction sexuelle qui peut continuer après l’arrêt du traitement (notamment dysfonction érectile, baisse de la libido, diminution de la lubrification vaginale et sécheresse vaginale).",
                  "by": "ours"
                },
                "it": {
                  "text": "Mestruazioni anomale, disfunzione sessuale che può continuare dopo l’interruzione del trattamento (tra cui disfunzione erettile, calo della libido, ridotta lubrificazione vaginale e secchezza vaginale).",
                  "by": "ours"
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                "hi": {
                  "text": "असामान्य माहवारी, सेक्शुअल डिस्फ़ंक्शन, जो इलाज बंद करने के बाद भी जारी रह सकता है (जिसमें स्तंभन दोष, कामेच्छा में कमी, योनि में चिकनाई कम होना और योनि में सूखापन शामिल हैं)।",
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                "6 ADVERSE REACTIONS"
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              "lang": "en-US",
              "text": "The following adverse reactions, presented alphabetically by body system, associated with the use of Zenatane were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.",
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                "de": {
                  "text": "Die folgenden Nebenwirkungen im Zusammenhang mit der Anwendung von Zenatane, alphabetisch nach Organsystem geordnet, wurden in klinischen Studien oder in Berichten nach der Markteinführung festgestellt. Da einige dieser Nebenwirkungen freiwillig aus einer Population ungewisser Größe gemeldet wurden, ist es nicht immer möglich, ihre Häufigkeit zuverlässig abzuschätzen oder einen ursächlichen Zusammenhang mit der Arzneimittelexposition nachzuweisen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las siguientes reacciones adversas, presentadas en orden alfabético por sistema corporal, asociadas al uso de Zenatane se identificaron en estudios clínicos o en notificaciones poscomercialización. Dado que algunas de estas reacciones se notificaron de forma voluntaria a partir de una población de tamaño incierto, no siempre es posible estimar de forma fiable su frecuencia ni establecer una relación causal con la exposición al medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas a seguir, apresentadas em ordem alfabética por sistema do corpo e associadas ao uso de Zenatane, foram identificadas em estudos clínicos ou em relatos pós-comercialização. Como algumas dessas reações foram relatadas voluntariamente por uma população de tamanho incerto, nem sempre é possível estimar sua frequência de forma confiável ou estabelecer uma relação causal com a exposição ao medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables suivants, présentés par ordre alphabétique des systèmes de l’organisme et associés à l’utilisation de Zenatane, ont été identifiés dans des études cliniques ou dans des signalements après commercialisation. Comme certains de ces effets ont été signalés de façon volontaire dans une population de taille incertaine, il n’est pas toujours possible d’estimer leur fréquence de manière fiable ni d’établir un lien de causalité avec l’exposition au médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le seguenti reazioni avverse, presentate in ordine alfabetico per apparato, associate all’uso di Zenatane sono state individuate negli studi clinici o nelle segnalazioni post-marketing. Poiché alcune di queste reazioni sono state segnalate volontariamente da una popolazione di dimensioni incerte, non è sempre possibile stimarne in modo affidabile la frequenza o stabilire una relazione causale con l’esposizione al farmaco.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Zenatane के इस्तेमाल से जुड़े नीचे दिए गए साइड इफ़ेक्ट (adverse reactions), जो शरीर के तंत्रों के हिसाब से अक्षरों के क्रम में दिए गए हैं, क्लिनिकल अध्ययनों में या दवा के बाज़ार में आने के बाद की रिपोर्टों में पहचाने गए। इनमें से कुछ की रिपोर्ट ऐसी आबादी से अपनी मर्ज़ी से की गई, जिसका आकार पक्का नहीं है, इसलिए भरोसे के साथ यह अंदाज़ा लगाना कि ये कितनी बार होते हैं, या दवा लेने के साथ कारण और असर का संबंध स्थापित करना हमेशा संभव नहीं होता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
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          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
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            "result": "exact"
          },
          "history": [
            {
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              "fields": [
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          "notes": [
            {
              "key": "listedNotWarning",
              "text": {
                "en": "This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.",
                "de": "Dieser Satz steht in der Liste der Nebenwirkungen. Der Abschnitt mit den Warnhinweisen enthält in diesem Text keinen Eintrag zur sexuellen Funktion.",
                "es": "Esta frase está en la lista de reacciones adversas. El apartado de advertencias de este texto no tiene ninguna entrada sobre la función sexual.",
                "pt-br": "Esta frase está na lista de reações adversas. A seção de alertas deste texto não tem nenhum item sobre a função sexual.",
                "fr": "Cette phrase figure dans la liste des effets indésirables. La rubrique des mises en garde de ce texte ne contient aucune entrée sur la fonction sexuelle.",
                "it": "Questa frase si trova nell’elenco delle reazioni avverse. La sezione delle avvertenze di questo testo non ha nessuna voce sulla funzione sessuale.",
                "hi": "यह वाक्य साइड इफ़ेक्ट (adverse reactions) की सूची में है। इस दस्तावेज़ के चेतावनियों वाले सेक्शन में यौन क्रिया पर कोई प्रविष्टि नहीं है।"
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                  "text": "Menstruationsstörungen und sexuelle Funktionsstörung, die nach Beendigung der Behandlung anhalten kann (einschließlich erektiler Dysfunktion, verminderter Libido, verminderter vaginaler Lubrikation und Scheidentrockenheit).",
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                  "by": "ours"
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                  "by": "ours"
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                  "by": "ours"
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                },
                "hi": {
                  "text": "असामान्य माहवारी और सेक्शुअल डिस्फ़ंक्शन, जो इलाज बंद करने के बाद भी जारी रह सकता है (जिसमें स्तंभन दोष, कामेच्छा में कमी, योनि में चिकनाई कम होना और योनि में सूखापन शामिल हैं)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-us-regulator-approval",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-regulator-approval",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "SUPPLEMENT APPROVAL, NDA 021951/S-031 and NDA 211913/S-023",
            "lang": "en-US",
            "product": {
              "name": "Absorica",
              "form": "capsules",
              "holder": "Sun Pharmaceutical Industries, Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drugs@FDA"
            },
            "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021951Orig1s031;211913Orig1s023ltr.pdf",
            "fetchedUrl": null,
            "textDate": "2026-08-11",
            "textDateKind": "approval",
            "textDateAsPrinted": "08/11/2026 10:32:31 AM"
          },
          "passages": [
            {
              "key": "letter",
              "kind": "regulator-statement",
              "section": [
                "SUPPLEMENT APPROVAL"
              ],
              "since": null,
              "lang": "en-US",
              "text": "We also refer to our letter dated June 16, 2026, notifying you, under Section 505(o)(4) of the FD&C Act, of new safety information that we have determined should be included in the labeling for Absorica and Absorica LD. This information pertains to the risk of reproductive system adverse events.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Wir beziehen uns außerdem auf unser Schreiben vom 16. Juni 2026, mit dem wir Sie gemäß Abschnitt 505(o)(4) des FD&C Act über neue Sicherheitsinformationen unterrichtet haben, die nach unserer Feststellung in die Fachinformation zu Absorica und Absorica LD aufgenommen werden sollten. Diese Informationen betreffen das Risiko unerwünschter Ereignisse am Fortpflanzungssystem.",
                  "by": "ours"
                },
                "es": {
                  "text": "Nos remitimos también a nuestra carta de 16 de junio de 2026, en la que le notificábamos, en virtud de la sección 505(o)(4) de la FD&C Act, nueva información de seguridad que hemos determinado que debe incluirse en la ficha técnica de Absorica y Absorica LD. Esta información se refiere al riesgo de acontecimientos adversos del aparato reproductor.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Também nos referimos à nossa carta de 16 de junho de 2026, em que notificamos os senhores, nos termos da Seção 505(o)(4) da FD&C Act, sobre novas informações de segurança que, conforme determinamos, devem ser incluídas na bula do Absorica e do Absorica LD. Essas informações dizem respeito ao risco de eventos adversos do sistema reprodutivo.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Nous nous référons également à notre lettre du 16 juin 2026, qui vous informait, en vertu de l’article 505(o)(4) du FD&C Act, de nouvelles informations de sécurité dont nous avons établi qu’elles devaient figurer dans la notice d’Absorica et d’Absorica LD. Ces informations concernent le risque d’événements indésirables touchant l’appareil reproducteur.",
                  "by": "ours"
                },
                "it": {
                  "text": "Facciamo inoltre riferimento alla nostra lettera del 16 giugno 2026, con cui vi abbiamo notificato, ai sensi della Sezione 505(o)(4) dell’FD&C Act, nuove informazioni di sicurezza che abbiamo stabilito debbano essere incluse nella scheda tecnica di Absorica e Absorica LD. Queste informazioni riguardano il rischio di eventi avversi a carico dell’apparato riproduttivo.",
                  "by": "ours"
                },
                "hi": {
                  "text": "हम 16 जून 2026 के अपने उस पत्र का भी हवाला देते हैं, जिसमें हमने FD&C Act की धारा 505(o)(4) के तहत आपको उस नई सुरक्षा जानकारी के बारे में बताया था, जिसे हमने Absorica और Absorica LD के लेबल में शामिल करना ज़रूरी माना है। यह जानकारी प्रजनन तंत्र से जुड़ी प्रतिकूल घटनाओं (adverse events) के जोखिम के बारे में है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the letter was read in full; it does not print the wording and does not mention sexual function by name",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-us-regulator-petition",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-regulator-petition",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "could-not-open",
          "accessReason": [
            "request-refused"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": null,
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.regulations.gov/document/FDA-2018-P-4088-0040",
            "https://downloads.regulations.gov/FDA-2018-P-4088-0040/attachment_1.pdf",
            "https://downloads.regulations.gov/FDA-2018-P-4088-0040/content.pdf"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-us-regulator-bulletin",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-us-regulator-bulletin",
          "reportUrl": "https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home",
          "jurisdiction": "us",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "FDA Requests Labeling Updates for Generic Isotretinoin Products",
            "lang": "en-US",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "FDA email bulletins"
            },
            "url": "https://content.govdelivery.com/accounts/USFDA/bulletins/41c7192",
            "fetchedUrl": null,
            "textDate": "2026-06-17",
            "textDateKind": "publication",
            "textDateAsPrinted": "U.S. Food and Drug Administration sent this bulletin at 06/17/2026 12:00 PM EDT"
          },
          "passages": [
            {
              "key": "request",
              "kind": "regulator-statement",
              "section": [
                "FDA Requests Labeling Updates for Generic Isotretinoin Products"
              ],
              "since": null,
              "lang": "en-US",
              "text": "Yesterday, the U.S. Food and Drug Administration requested labeling updates for all generic drugs referencing Accutane (isotretinoin) capsules as their reference listed drug (RLD).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Gestern hat die U.S. Food and Drug Administration Aktualisierungen der Fachinformation für alle Generika angefordert, die sich auf Accutane-Kapseln (Isotretinoin) als Referenzarzneimittel (reference listed drug, RLD) beziehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Ayer, la Food and Drug Administration de EE. UU. solicitó actualizar la ficha técnica de todos los medicamentos genéricos que tienen como medicamento de referencia (RLD) las cápsulas de Accutane (isotretinoína).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Ontem, a Food and Drug Administration dos EUA solicitou atualizações de bula para todos os medicamentos genéricos que têm as cápsulas de Accutane (isotretinoína) como medicamento de referência listado (RLD).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Hier, la Food and Drug Administration des États-Unis a demandé des mises à jour des notices de tous les médicaments génériques dont le médicament de référence (RLD) est Accutane (isotrétinoïne) en capsules.",
                  "by": "ours"
                },
                "it": {
                  "text": "Ieri la Food and Drug Administration statunitense ha richiesto aggiornamenti della scheda tecnica per tutti i farmaci generici che hanno come farmaco di riferimento (reference listed drug, RLD) le capsule di Accutane (isotretinoina).",
                  "by": "ours"
                },
                "hi": {
                  "text": "कल U.S. Food and Drug Administration ने उन सभी जेनेरिक दवाओं के लेबल अपडेट करने को कहा, जिनकी संदर्भ दवा (reference listed drug, RLD) Accutane (आइसोट्रेटिनॉइन) कैप्सूल है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "sexual, persist, continue, discontinuation",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ACCUTANE, Isotretinoin Capsules",
            "lang": "en-CA",
            "product": {
              "name": "Accutane",
              "form": "capsules USP 10 mg and 40 mg",
              "holder": "CHEPLAPHARM Schweiz GmbH"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00081681.PDF",
            "fetchedUrl": null,
            "textDate": "2025-09-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: SEP 05, 2025"
          },
          "passages": [
            {
              "key": "listed-7",
              "kind": "sexual-side-effects",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function",
                "Risk of Sexual Side Effects"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Cases of sexual dysfunction including erectile dysfunction, decreased/loss of libido, vulvovaginal dryness, orgasm difficulties, and genital hypoaesthesia have been reported in patients with the use of isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Patientinnen und Patienten wurden unter der Anwendung von Isotretinoin Fälle von sexueller Funktionsstörung gemeldet, darunter erektile Dysfunktion, verminderte oder fehlende Libido, vulvovaginale Trockenheit, Orgasmusstörungen und genitale Hypästhesie.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado casos de disfunción sexual, que incluyen disfunción eréctil, disminución o pérdida de la libido, sequedad vulvovaginal, dificultades con el orgasmo e hipoestesia genital, en pacientes con el uso de isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Foram relatados casos de disfunção sexual, incluindo disfunção erétil, diminuição/perda da libido, ressecamento vulvovaginal, dificuldades com o orgasmo e hipoestesia genital, em pacientes que usaram isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de dysfonction sexuelle, notamment dysfonction érectile, baisse ou perte de la libido, sécheresse vulvo-vaginale, difficultés à atteindre l’orgasme et hypoesthésie génitale, ont été signalés chez des patients utilisant l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti che usano isotretinoina sono stati segnalati casi di disfunzione sessuale, tra cui disfunzione erettile, calo/perdita della libido, secchezza vulvovaginale, difficoltà legate all’orgasmo e ipoestesia genitale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन लेने वाले मरीज़ों में सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं, जिनमें स्तंभन दोष, कामेच्छा में कमी या उसका खत्म होना, वल्वा और योनि में सूखापन, ऑर्गेज़्म में दिक्कत और जननांगों में संवेदना कम होना शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function",
                "Risk of Sexual Side Effects"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "There have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte, dass diese Ereignisse nach dem Absetzen des Medikaments fortbestanden. Ein ursächlicher Zusammenhang mit Isotretinoin konnte zwar nicht eindeutig nachgewiesen werden, doch eine Wirkung kann nicht ausgeschlossen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado la persistencia de estos acontecimientos tras la interrupción del medicamento. Aunque la causalidad con la isotretinoína no pudo establecerse de forma definitiva, no puede descartarse un efecto.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de persistência desses eventos após a descontinuação do medicamento. A causalidade em relação à isotretinoína não pôde ser estabelecida de forma definitiva, mas um efeito não pode ser descartado.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de persistance de ces événements après l’arrêt du médicament ont été signalés. Bien que la causalité avec l’isotrétinoïne n’ait pas pu être établie de façon certaine, un effet ne peut pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di persistenza di questi eventi dopo l’interruzione del farmaco. Il nesso causale con l’isotretinoina non ha potuto essere stabilito con certezza, ma un effetto non può essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा बंद करने के बाद इन घटनाओं के बने रहने की रिपोर्टें आई हैं। आइसोट्रेटिनॉइन के साथ कारण और असर का संबंध निश्चित रूप से स्थापित नहीं किया जा सका, लेकिन असर की संभावना को खारिज नहीं किया जा सकता।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-8-2",
              "kind": "sexual-side-effects",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.2 Clinical Trial Adverse Reactions"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Reproductive system: abnormal menses, erectile dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Fortpflanzungssystem: Menstruationsstörungen, erektile Dysfunktion.",
                  "by": "ours"
                },
                "es": {
                  "text": "Aparato reproductor: menstruación anormal, disfunción eréctil.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sistema reprodutivo: menstruação anormal, disfunção erétil.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Appareil reproducteur : règles anormales, dysfonction érectile.",
                  "by": "ours"
                },
                "it": {
                  "text": "Apparato riproduttivo: mestruazioni anomale, disfunzione erettile.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र: असामान्य माहवारी, स्तंभन दोष।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed-8-5",
              "kind": "sexual-side-effects",
              "section": [
                "8 ADVERSE REACTIONS",
                "8.5 Post-Market Adverse Reactions"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Reproductive system: Sexual dysfunction.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Fortpflanzungssystem: Sexuelle Funktionsstörung.",
                  "by": "ours"
                },
                "es": {
                  "text": "Aparato reproductor: disfunción sexual.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sistema reprodutivo: disfunção sexual.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Appareil reproducteur : dysfonction sexuelle.",
                  "by": "ours"
                },
                "it": {
                  "text": "Apparato riproduttivo: disfunzione sessuale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र: सेक्शुअल डिस्फ़ंक्शन।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-leaflet-accutane",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-leaflet-accutane",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: ACCUTANE, Isotretinoin Capsules",
            "lang": "en-CA",
            "product": {
              "name": "Accutane",
              "form": "capsules USP 10 mg and 40 mg",
              "holder": "CHEPLAPHARM Schweiz GmbH"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00081681.PDF",
            "fetchedUrl": null,
            "textDate": "2025-09-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: SEP 05, 2025"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Other warnings you should know about",
                "Sexual Dysfunction"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "While taking ACCUTANE, you may have the inability to get or maintain an erection, dryness in the vagina or vulva, reduced interest in sex, orgasm difficulties and loss of sensation or tingling in the genital area.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Während Sie ACCUTANE einnehmen, kann es bei Ihnen zu Folgendem kommen: Unfähigkeit, eine Erektion zu bekommen oder aufrechtzuerhalten, Trockenheit der Scheide oder der Vulva, weniger Interesse an Sex, Orgasmusstörungen sowie Gefühlsverlust oder Kribbeln im Genitalbereich.",
                  "by": "ours"
                },
                "es": {
                  "text": "Mientras toma ACCUTANE, puede tener incapacidad para conseguir o mantener una erección, sequedad en la vagina o la vulva, menor interés por el sexo, dificultades con el orgasmo y pérdida de sensibilidad u hormigueo en la zona genital.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Enquanto toma ACCUTANE, você pode ter incapacidade de ter ou manter uma ereção, ressecamento da vagina ou da vulva, menos interesse por sexo, dificuldades com o orgasmo e perda de sensibilidade ou formigamento na região genital.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Pendant que vous prenez ACCUTANE, vous pouvez présenter une incapacité à obtenir ou à maintenir une érection, une sécheresse du vagin ou de la vulve, une baisse de l’intérêt pour le sexe, des difficultés à atteindre l’orgasme et une perte de sensibilité ou des picotements dans la région génitale.",
                  "by": "ours"
                },
                "it": {
                  "text": "Mentre prende ACCUTANE, può manifestare incapacità di raggiungere o mantenere l’erezione, secchezza della vagina o della vulva, ridotto interesse per il sesso, difficoltà legate all’orgasmo e perdita di sensibilità o formicolio nella zona genitale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ACCUTANE लेते समय आपको ये समस्याएँ हो सकती हैं: इरेक्शन न हो पाना या न बना रह पाना, योनि या वल्वा में सूखापन, सेक्स में रुचि कम होना, ऑर्गेज़्म में दिक्कत और जननांगों के हिस्से में संवेदना खत्म होना या झुनझुनी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about",
                "Sexual Dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "This may continue after treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dies kann nach der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esto puede continuar después del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Isso pode continuar depois do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cela peut continuer après le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questo può continuare dopo il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह इलाज के बाद भी जारी रह सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-pro-epuris",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-pro-epuris",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: EPURIS, Isotretinoin Capsules",
            "lang": "en-CA",
            "product": {
              "name": "Epuris",
              "form": "capsules 10, 20, 30, 40 mg",
              "holder": "Cipher Pharmaceuticals Inc."
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00080498.PDF",
            "fetchedUrl": null,
            "textDate": "2025-05-13",
            "textDateKind": "approval",
            "textDateAsPrinted": "Date of Authorization: 2025-05-13"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7. Warnings and Precautions",
                "Reproductive Health: Female and Male Potential",
                "Function",
                "Risk of Sexual Side Effects"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "There have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte, dass diese Ereignisse nach dem Absetzen des Medikaments fortbestanden. Ein ursächlicher Zusammenhang mit Isotretinoin konnte zwar nicht eindeutig nachgewiesen werden, doch eine Wirkung kann nicht ausgeschlossen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado la persistencia de estos acontecimientos tras la interrupción del medicamento. Aunque la causalidad con la isotretinoína no pudo establecerse de forma definitiva, no puede descartarse un efecto.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de persistência desses eventos após a descontinuação do medicamento. A causalidade em relação à isotretinoína não pôde ser estabelecida de forma definitiva, mas um efeito não pode ser descartado.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de persistance de ces événements après l’arrêt du médicament ont été signalés. Bien que la causalité avec l’isotrétinoïne n’ait pas pu être établie de façon certaine, un effet ne peut pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di persistenza di questi eventi dopo l’interruzione del farmaco. Il nesso causale con l’isotretinoina non ha potuto essere stabilito con certezza, ma un effetto non può essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा बंद करने के बाद इन घटनाओं के बने रहने की रिपोर्टें आई हैं। आइसोट्रेटिनॉइन के साथ कारण और असर का संबंध निश्चित रूप से स्थापित नहीं किया जा सका, लेकिन असर की संभावना को खारिज नहीं किया जा सकता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
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          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
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            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
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        },
        {
          "id": "isotretinoin-ca-leaflet-epuris",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-leaflet-epuris",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
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          "access": "opened",
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          "document": {
            "name": "PATIENT MEDICATION INFORMATION: EPURIS, Isotretinoin Capsules",
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              "name": "Epuris",
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            },
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              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00080498.PDF",
            "fetchedUrl": null,
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          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about",
                "Sexual Dysfunction:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "This may continue after treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dies kann nach der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esto puede continuar después del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Isso pode continuar depois do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cela peut continuer après le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questo può continuare dopo il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह इलाज के बाद भी जारी रह सकता है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-side-effects",
              "kind": "sexual-persistence",
              "section": [
                "Possible side effects from using EPURIS®:"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "You may experience following side effects while EPURIS® and even after you stop taking it: inability to have or maintain an erection during sex, dryness in the vagina or vulva, reduced sexual drive interest, orgasm difficulties and loss of sensation or tingling in the genital area.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Während der Einnahme von EPURIS® und auch nach dem Absetzen können bei Ihnen folgende Nebenwirkungen auftreten: Unfähigkeit, beim Sex eine Erektion zu bekommen oder aufrechtzuerhalten, Trockenheit der Scheide oder der Vulva, weniger sexuelles Verlangen, Orgasmusstörungen sowie Gefühlsverlust oder Kribbeln im Genitalbereich.",
                  "by": "ours"
                },
                "es": {
                  "text": "Puede presentar los siguientes efectos secundarios mientras toma EPURIS® e incluso después de dejar de tomarlo: incapacidad para tener o mantener una erección durante las relaciones sexuales, sequedad en la vagina o la vulva, disminución del deseo o del interés sexual, dificultades con el orgasmo y pérdida de sensibilidad u hormigueo en la zona genital.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Você pode ter os seguintes efeitos colaterais enquanto toma EPURIS® e mesmo depois de parar de tomá-lo: incapacidade de ter ou manter uma ereção durante o sexo, ressecamento da vagina ou da vulva, redução do desejo/interesse sexual, dificuldades com o orgasmo e perda de sensibilidade ou formigamento na região genital.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Vous pouvez présenter les effets indésirables suivants pendant que vous prenez EPURIS® et même après avoir arrêté de le prendre : incapacité à avoir ou à maintenir une érection pendant un rapport sexuel, sécheresse du vagin ou de la vulve, baisse du désir sexuel, difficultés à atteindre l’orgasme et perte de sensibilité ou picotements dans la région génitale.",
                  "by": "ours"
                },
                "it": {
                  "text": "Può manifestare i seguenti effetti indesiderati mentre prende EPURIS® e anche dopo averne interrotto l’assunzione: incapacità di avere o mantenere l’erezione durante il rapporto sessuale, secchezza della vagina o della vulva, riduzione del desiderio o dell’interesse sessuale, difficoltà legate all’orgasmo e perdita di sensibilità o formicolio nella zona genitale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "EPURIS® लेते समय, और उसे बंद करने के बाद भी, आपको ये साइड इफ़ेक्ट हो सकते हैं: सेक्स के दौरान इरेक्शन न हो पाना या न बना रह पाना, योनि या वल्वा में सूखापन, यौन इच्छा और रुचि में कमी, ऑर्गेज़्म में दिक्कत और जननांगों के हिस्से में संवेदना खत्म होना या झुनझुनी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-pro-clarus",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-pro-clarus",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: CLARUS, Isotretinoin Capsules, USP",
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            "product": {
              "name": "Clarus",
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              "holder": "Mylan Pharmaceuticals ULC"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00083106.PDF",
            "fetchedUrl": null,
            "textDate": "2026-01-06",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: 2026-01-06"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function",
                "Risk of Sexual Side Effects"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "There have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte, dass diese Ereignisse nach dem Absetzen des Medikaments fortbestanden. Ein ursächlicher Zusammenhang mit Isotretinoin konnte zwar nicht eindeutig nachgewiesen werden, doch eine Wirkung kann nicht ausgeschlossen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado la persistencia de estos acontecimientos tras la interrupción del medicamento. Aunque la causalidad con la isotretinoína no pudo establecerse de forma definitiva, no puede descartarse un efecto.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de persistência desses eventos após a descontinuação do medicamento. A causalidade em relação à isotretinoína não pôde ser estabelecida de forma definitiva, mas um efeito não pode ser descartado.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de persistance de ces événements après l’arrêt du médicament ont été signalés. Bien que la causalité avec l’isotrétinoïne n’ait pas pu être établie de façon certaine, un effet ne peut pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di persistenza di questi eventi dopo l’interruzione del farmaco. Il nesso causale con l’isotretinoina non ha potuto essere stabilito con certezza, ma un effetto non può essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा बंद करने के बाद इन घटनाओं के बने रहने की रिपोर्टें आई हैं। आइसोट्रेटिनॉइन के साथ कारण और असर का संबंध निश्चित रूप से स्थापित नहीं किया जा सका, लेकिन असर की संभावना को खारिज नहीं किया जा सकता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-leaflet-clarus",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-leaflet-clarus",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: CLARUS, Isotretinoin Capsules, USP",
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              "name": "Clarus",
              "form": "capsules USP 10 mg and 40 mg",
              "holder": "Mylan Pharmaceuticals ULC"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00083106.PDF",
            "fetchedUrl": null,
            "textDate": "2026-01-06",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised: 2026-01-06"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about",
                "Sexual Dysfunction"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "This may continue after treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dies kann nach der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esto puede continuar después del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Isso pode continuar depois do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cela peut continuer après le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questo può continuare dopo il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह इलाज के बाद भी जारी रह सकता है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
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          "checked": "2026-10-13",
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            "result": "exact"
          },
          "history": [
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          ],
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        {
          "id": "isotretinoin-ca-pro-absoricald",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-pro-absoricald",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
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          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: Absorica LD, Isotretinoin Capsules, Micronized formulation",
            "lang": "en-CA",
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              "name": "Absorica LD",
              "form": "capsules, micronized formulation, 8 mg, 16 mg, 24 mg, and 32 mg",
              "holder": "Sun Pharmaceutical Industries Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
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            "url": "https://pdf.hres.ca/dpd_pm/00080569.PDF",
            "fetchedUrl": null,
            "textDate": "2025-05-15",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of Revision: MAY 15, 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "7 WARNINGS AND PRECAUTIONS",
                "Reproductive Health: Female and Male Potential",
                "Function"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "There have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Es gibt Berichte, dass diese Ereignisse nach dem Absetzen des Medikaments fortbestanden. Ein ursächlicher Zusammenhang mit Isotretinoin konnte zwar nicht eindeutig nachgewiesen werden, doch eine Wirkung kann nicht ausgeschlossen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se ha notificado la persistencia de estos acontecimientos tras la interrupción del medicamento. Aunque la causalidad con la isotretinoína no pudo establecerse de forma definitiva, no puede descartarse un efecto.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Houve relatos de persistência desses eventos após a descontinuação do medicamento. A causalidade em relação à isotretinoína não pôde ser estabelecida de forma definitiva, mas um efeito não pode ser descartado.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des cas de persistance de ces événements après l’arrêt du médicament ont été signalés. Bien que la causalité avec l’isotrétinoïne n’ait pas pu être établie de façon certaine, un effet ne peut pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Sono stati segnalati casi di persistenza di questi eventi dopo l’interruzione del farmaco. Il nesso causale con l’isotretinoina non ha potuto essere stabilito con certezza, ma un effetto non può essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा बंद करने के बाद इन घटनाओं के बने रहने की रिपोर्टें आई हैं। आइसोट्रेटिनॉइन के साथ कारण और असर का संबंध निश्चित रूप से स्थापित नहीं किया जा सका, लेकिन असर की संभावना को खारिज नहीं किया जा सकता।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
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          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-leaflet-absoricald",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-leaflet-absoricald",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT MEDICATION INFORMATION: Absorica LD, Isotretinoin Capsules, Micronized formulation",
            "lang": "en-CA",
            "product": {
              "name": "Absorica LD",
              "form": "capsules, micronized formulation, 8 mg, 16 mg, 24 mg, and 32 mg",
              "holder": "Sun Pharmaceutical Industries Limited"
            },
            "source": {
              "type": "regulator-database",
              "name": "Drug Product Database"
            },
            "url": "https://pdf.hres.ca/dpd_pm/00080569.PDF",
            "fetchedUrl": null,
            "textDate": "2025-05-15",
            "textDateKind": "revision",
            "textDateAsPrinted": "Last Revised MAY 15, 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Other warnings you should know about",
                "Sexual Dysfunction:"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-CA",
              "text": "This may continue after treatment.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Dies kann nach der Behandlung anhalten.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esto puede continuar después del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Isso pode continuar depois do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cela peut continuer après le traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questo può continuare dopo il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "यह इलाज के बाद भी जारी रह सकता है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-side-effects",
              "kind": "sexual-persistence",
              "section": [
                "What are possible side effects from using Absorica LD?"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "You may experience following side effects while you are taking Absorica LD and even after you stop taking it: inability to have or maintain an erection during sex, dryness in the vagina or vulva, reduced sexual drive interest, orgasm difficulties and loss of sensation or tingling in the genital area.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Während der Einnahme von Absorica LD und auch nach dem Absetzen können bei Ihnen folgende Nebenwirkungen auftreten: Unfähigkeit, beim Sex eine Erektion zu bekommen oder aufrechtzuerhalten, Trockenheit der Scheide oder der Vulva, weniger sexuelles Verlangen, Orgasmusstörungen sowie Gefühlsverlust oder Kribbeln im Genitalbereich.",
                  "by": "ours"
                },
                "es": {
                  "text": "Puede presentar los siguientes efectos secundarios mientras toma Absorica LD e incluso después de dejar de tomarlo: incapacidad para tener o mantener una erección durante las relaciones sexuales, sequedad en la vagina o la vulva, disminución del deseo o del interés sexual, dificultades con el orgasmo y pérdida de sensibilidad u hormigueo en la zona genital.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Você pode ter os seguintes efeitos colaterais enquanto estiver tomando Absorica LD e mesmo depois de parar de tomá-lo: incapacidade de ter ou manter uma ereção durante o sexo, ressecamento da vagina ou da vulva, redução do desejo/interesse sexual, dificuldades com o orgasmo e perda de sensibilidade ou formigamento na região genital.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Vous pouvez présenter les effets indésirables suivants pendant que vous prenez Absorica LD et même après avoir arrêté de le prendre : incapacité à avoir ou à maintenir une érection pendant un rapport sexuel, sécheresse du vagin ou de la vulve, baisse du désir sexuel, difficultés à atteindre l’orgasme et perte de sensibilité ou picotements dans la région génitale.",
                  "by": "ours"
                },
                "it": {
                  "text": "Può manifestare i seguenti effetti indesiderati mentre prende Absorica LD e anche dopo averne interrotto l’assunzione: incapacità di avere o mantenere l’erezione durante il rapporto sessuale, secchezza della vagina o della vulva, riduzione del desiderio o dell’interesse sessuale, difficoltà legate all’orgasmo e perdita di sensibilità o formicolio nella zona genitale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "Absorica LD लेते समय, और उसे बंद करने के बाद भी, आपको ये साइड इफ़ेक्ट हो सकते हैं: सेक्स के दौरान इरेक्शन न हो पाना या न बना रह पाना, योनि या वल्वा में सूखापन, यौन इच्छा और रुचि में कमी, ऑर्गेज़्म में दिक्कत और जननांगों के हिस्से में संवेदना खत्म होना या झुनझुनी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-regulator-review2024",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-regulator-review2024",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Isotretinoin - Assessing the Potential Risk of Sexual Dysfunction, Including Persistent Sexual Dysfunction After Drug Discontinuation",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1717527382406",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "findings",
              "kind": "sexual-persistence",
              "section": [
                "Safety Review Findings"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "In just over half of the events, the sexual dysfunction was reported as persisting for months to years following drug discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei etwas mehr als der Hälfte der Ereignisse wurde gemeldet, dass die sexuelle Funktionsstörung nach dem Absetzen des Medikaments Monate bis Jahre anhielt.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algo más de la mitad de los acontecimientos, se notificó que la disfunción sexual persistía de meses a años tras la interrupción del medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em pouco mais da metade dos eventos, a disfunção sexual foi relatada como persistindo por meses a anos após a descontinuação do medicamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans un peu plus de la moitié des événements, la dysfonction sexuelle a été signalée comme persistant de plusieurs mois à plusieurs années après l’arrêt du médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "In poco più della metà degli eventi, la disfunzione sessuale è stata segnalata come persistente per mesi o anni dopo l’interruzione del farmaco.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आधी से कुछ ज़्यादा घटनाओं में रिपोर्ट किया गया कि सेक्शुअल डिस्फ़ंक्शन दवा बंद करने के बाद महीनों से लेकर सालों तक बना रहा।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "findings-causality",
              "kind": "qualification",
              "section": [
                "Safety Review Findings"
              ],
              "since": null,
              "qualifies": "findings",
              "lang": "en-CA",
              "text": "These cases overall did not include sufficient clinical information, including details on mental health at the time of sexual dysfunction, to definitively determine a link between isotretinoin use and sexual dysfunction. However, given the timing of the events, a link could not be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Fälle enthielten insgesamt nicht genügend klinische Angaben, etwa zur psychischen Gesundheit zum Zeitpunkt der sexuellen Funktionsstörung, um einen Zusammenhang zwischen der Anwendung von Isotretinoin und sexuellen Funktionsstörungen eindeutig festzustellen. Angesichts des zeitlichen Ablaufs der Ereignisse konnte ein Zusammenhang jedoch nicht ausgeschlossen werden.",
                  "by": "ours"
                },
                "es": {
                  "text": "En conjunto, estos casos no incluían información clínica suficiente, como detalles sobre la salud mental en el momento de la disfunción sexual, para determinar de forma definitiva una relación entre el uso de isotretinoína y la disfunción sexual. Sin embargo, dada la cronología de los acontecimientos, no podía descartarse una relación.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "No conjunto, esses casos não incluíam informações clínicas suficientes, entre elas detalhes sobre a saúde mental no momento da disfunção sexual, para determinar de forma definitiva uma ligação entre o uso de isotretinoína e a disfunção sexual. No entanto, dado o momento em que os eventos ocorreram, uma ligação não podia ser descartada.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dans l’ensemble, ces cas ne contenaient pas assez d’informations cliniques, notamment de précisions sur la santé mentale au moment de la dysfonction sexuelle, pour établir un lien de façon certaine entre l’utilisation de l’isotrétinoïne et la dysfonction sexuelle. Toutefois, compte tenu de la chronologie des événements, un lien ne pouvait pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nel complesso questi casi non comprendevano informazioni cliniche sufficienti, compresi i dettagli sulla salute mentale al momento della disfunzione sessuale, per stabilire con certezza un collegamento tra l’uso di isotretinoina e la disfunzione sessuale. Tuttavia, data la tempistica degli eventi, un collegamento non poteva essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुल मिलाकर इन मामलों में इतनी क्लिनिकल जानकारी नहीं थी, जिसमें सेक्शुअल डिस्फ़ंक्शन के समय के मानसिक स्वास्थ्य का ब्योरा भी शामिल है, कि आइसोट्रेटिनॉइन के इस्तेमाल और सेक्शुअल डिस्फ़ंक्शन के बीच संबंध निश्चित रूप से तय किया जा सके। लेकिन घटनाओं के समय को देखते हुए, संबंध को खारिज नहीं किया जा सका।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "conclusion",
              "kind": "regulator-statement",
              "section": [
                "Conclusions and Actions"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Health Canada’s review of the available information concluded that a link between isotretinoin and the risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, could not be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung der verfügbaren Informationen durch Health Canada kam zu dem Schluss, dass ein Zusammenhang zwischen Isotretinoin und dem Risiko sexueller Funktionsstörungen, einschließlich anhaltender sexueller Funktionsstörungen nach dem Absetzen des Medikaments, nicht ausgeschlossen werden konnte.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de la información disponible realizada por Health Canada concluyó que no podía descartarse una relación entre la isotretinoína y el riesgo de disfunción sexual, incluida la disfunción sexual persistente tras la interrupción del medicamento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão das informações disponíveis feita pela Health Canada concluiu que uma ligação entre a isotretinoína e o risco de disfunção sexual, incluindo disfunção sexual persistente após a descontinuação do medicamento, não podia ser descartada.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen des informations disponibles mené par Santé Canada a conclu qu’un lien entre l’isotrétinoïne et le risque de dysfonction sexuelle, y compris de dysfonction sexuelle persistante après l’arrêt du médicament, ne pouvait pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione delle informazioni disponibili condotta da Health Canada ha concluso che un collegamento tra l’isotretinoina e il rischio di disfunzione sessuale, compresa la disfunzione sessuale persistente dopo l’interruzione del farmaco, non poteva essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "उपलब्ध जानकारी की Health Canada की समीक्षा का निष्कर्ष था कि आइसोट्रेटिनॉइन और सेक्शुअल डिस्फ़ंक्शन के जोखिम के बीच संबंध को खारिज नहीं किया जा सका। इसमें दवा बंद करने के बाद भी बना रहने वाला सेक्शुअल डिस्फ़ंक्शन शामिल है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-regulator-review2017",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-regulator-review2017",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Drug and Health Product Portal"
            },
            "url": "https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00143",
            "fetchedUrl": null,
            "textDate": "2017-01-10",
            "textDateKind": "publication",
            "textDateAsPrinted": "Issued: 2017-01-10"
          },
          "passages": [
            {
              "key": "conclusion",
              "kind": "regulator-statement",
              "section": [
                "Conclusions and actions"
              ],
              "since": null,
              "lang": "en-CA",
              "text": "Health Canada's review of the available information concluded that there may be a link between the use of oral isotretinoin products and the risk of impotence, but could not draw the same conclusion for the other drugs in the class.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Überprüfung der verfügbaren Informationen durch Health Canada kam zu dem Schluss, dass es möglicherweise einen Zusammenhang zwischen der Anwendung von Isotretinoin-Produkten zum Einnehmen und dem Risiko einer Impotenz gibt, konnte für die anderen Medikamente dieser Klasse aber nicht denselben Schluss ziehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de la información disponible realizada por Health Canada concluyó que puede haber una relación entre el uso de productos de isotretinoína oral y el riesgo de impotencia, pero no pudo llegar a la misma conclusión para los demás medicamentos de la clase.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão das informações disponíveis feita pela Health Canada concluiu que pode haver uma ligação entre o uso de produtos orais com isotretinoína e o risco de impotência, mas não pôde chegar à mesma conclusão para os outros medicamentos da classe.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen des informations disponibles mené par Santé Canada a conclu qu’il peut exister un lien entre l’utilisation des produits à base d’isotrétinoïne par voie orale et le risque d’impuissance, mais n’a pas pu tirer la même conclusion pour les autres médicaments de la classe.",
                  "by": "ours"
                },
                "it": {
                  "text": "La revisione delle informazioni disponibili condotta da Health Canada ha concluso che può esserci un collegamento tra l’uso di prodotti a base di isotretinoina per via orale e il rischio di impotenza, ma non ha potuto trarre la stessa conclusione per gli altri farmaci della classe.",
                  "by": "ours"
                },
                "hi": {
                  "text": "उपलब्ध जानकारी की Health Canada की समीक्षा का निष्कर्ष था कि मुँह से ली जाने वाली आइसोट्रेटिनॉइन दवाओं के इस्तेमाल और स्तंभन दोष (impotence) के जोखिम के बीच संबंध हो सकता है, लेकिन वह इस समूह की दूसरी दवाओं के लिए यही निष्कर्ष नहीं निकाल सकी।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, continu, after stopping, discontinu",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ca-regulator-infowatch202407",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ca-regulator-infowatch202407",
          "reportUrl": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html",
          "jurisdiction": "ca",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Health Product InfoWatch, July 2024",
            "lang": "en-CA",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Government of Canada Publications"
            },
            "url": "https://publications.gc.ca/collections/collection_2024/sc-hc/H167-1-2024-7-eng.pdf",
            "fetchedUrl": null,
            "textDate": "2024-07",
            "textDateKind": "publication",
            "textDateAsPrinted": "July 2024"
          },
          "passages": [
            {
              "key": "recap",
              "kind": "sexual-persistence",
              "section": [
                "MONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION",
                "Isotretinoin"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-CA",
              "text": "This safety review evaluated the risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, with the use of isotretinoin-containing products. Health Canada’s review of the available information concluded that a link could not be ruled out.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Sicherheitsüberprüfung bewertete das Risiko sexueller Funktionsstörungen, einschließlich anhaltender sexueller Funktionsstörungen nach dem Absetzen des Medikaments, bei der Anwendung von Produkten, die Isotretinoin enthalten. Die Überprüfung der verfügbaren Informationen durch Health Canada kam zu dem Schluss, dass ein Zusammenhang nicht ausgeschlossen werden konnte.",
                  "by": "ours"
                },
                "es": {
                  "text": "Esta revisión de seguridad evaluó el riesgo de disfunción sexual, incluida la disfunción sexual persistente tras la interrupción del medicamento, con el uso de productos que contienen isotretinoína. La revisión de la información disponible realizada por Health Canada concluyó que no podía descartarse una relación.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esta revisão de segurança avaliou o risco de disfunção sexual, incluindo disfunção sexual persistente após a descontinuação do medicamento, com o uso de produtos que contêm isotretinoína. A revisão das informações disponíveis feita pela Health Canada concluiu que uma ligação não podia ser descartada.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Cet examen de sécurité a évalué le risque de dysfonction sexuelle, y compris de dysfonction sexuelle persistante après l’arrêt du médicament, lors de l’utilisation de produits contenant de l’isotrétinoïne. L’examen des informations disponibles mené par Santé Canada a conclu qu’un lien ne pouvait pas être exclu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questa revisione di sicurezza ha valutato il rischio di disfunzione sessuale, compresa la disfunzione sessuale persistente dopo l’interruzione del farmaco, con l’uso di prodotti contenenti isotretinoina. La revisione delle informazioni disponibili condotta da Health Canada ha concluso che un collegamento non poteva essere escluso.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इस सुरक्षा समीक्षा ने आइसोट्रेटिनॉइन वाली दवाओं के इस्तेमाल के साथ सेक्शुअल डिस्फ़ंक्शन के जोखिम को परखा, जिसमें दवा बंद करने के बाद भी बना रहने वाला सेक्शुअल डिस्फ़ंक्शन शामिल है। उपलब्ध जानकारी की Health Canada की समीक्षा का निष्कर्ष था कि संबंध को खारिज नहीं किया जा सका।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-au",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-au",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "AUSTRALIAN PRODUCT INFORMATION Roaccutane (isotretinoin)",
            "lang": "en-AU",
            "product": {
              "name": "Roaccutane",
              "form": null,
              "holder": "Pharmaco"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2025-PI-01849-1",
            "textDate": "2025-07-15",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Section 4.4",
                "Sexual Disorders"
              ],
              "since": null,
              "inWarnings": true,
              "summary": {
                "en": "Section 4.4 of Australia's product information for Roaccutane has a warning headed sexual disorders. It says erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men have been reported, and tells prescribers to ask about sexual problems before treatment and to check for new ones during it. It says no mechanism for these effects has been established, and that stopping the medicine may not relieve the symptoms, so a specialist may need to assess them.",
                "de": "Abschnitt 4.4 der australischen Fachinformation zu Roaccutane enthält einen Warnhinweis mit der Überschrift sexuelle Störungen. Dort heißt es, gemeldet worden seien Erektionsstörungen, weniger sexuelles Verlangen, Trockenheit von Vulva und Scheide, der Verlust der Fähigkeit, Freude zu empfinden, und Brustwachstum bei Männern. Wer das Medikament verschreibt, solle vor der Behandlung nach sexuellen Problemen fragen und währenddessen auf neue achten. Ein Mechanismus für diese Wirkungen sei nicht nachgewiesen, und das Absetzen des Medikaments lindere die Symptome möglicherweise nicht, sodass eine fachärztliche Beurteilung nötig sein könne.",
                "es": "La sección 4.4 de la información del producto australiana de Roaccutane tiene una advertencia titulada trastornos sexuales. Dice que se han notificado problemas de erección, menor deseo sexual, sequedad de la vulva y la vagina, pérdida de placer y crecimiento de las mamas en hombres. Indica a quien receta el medicamento que pregunte por problemas sexuales antes del tratamiento y que compruebe si aparecen otros nuevos durante este. Dice que no se ha establecido ningún mecanismo para estos efectos y que dejar el medicamento puede no aliviar los síntomas, por lo que puede hacer falta que un especialista los valore.",
                "pt-br": "A seção 4.4 da bula australiana do Roaccutane para o profissional de saúde tem um alerta com o título distúrbios sexuais. Ela diz que foram relatados problemas de ereção, queda do desejo sexual, ressecamento da vulva e da vagina, perda de prazer e crescimento das mamas em homens, e orienta quem receita a perguntar sobre problemas sexuais antes do tratamento e a verificar se surgem novos durante ele. Diz que nenhum mecanismo para esses efeitos foi estabelecido e que parar o medicamento pode não aliviar os sintomas, de modo que pode ser preciso que um especialista os avalie.",
                "fr": "En Australie, la rubrique 4.4 des informations sur le produit de Roaccutane contient une mise en garde qui a pour titre les troubles sexuels. Elle indique que des troubles de l’érection, une baisse du désir sexuel, une sécheresse de la vulve et du vagin, une perte du plaisir et un développement des seins chez les hommes ont été signalés. Elle demande aux prescripteurs de poser des questions sur d’éventuels troubles sexuels avant le traitement et de rechercher l’apparition de nouveaux troubles pendant celui-ci. Elle indique qu’aucun mécanisme n’a été établi pour ces effets et que l’arrêt du médicament peut ne pas soulager les symptômes, si bien qu’une évaluation par un spécialiste peut être nécessaire.",
                "it": "La sezione 4.4 delle informazioni sul prodotto australiane di Roaccutane ha un’avvertenza intitolata disturbi sessuali. Dice che sono stati segnalati problemi di erezione, calo del desiderio sessuale, secchezza della vulva e della vagina, perdita del piacere e crescita del seno negli uomini, e chiede a chi prescrive di informarsi sui problemi sessuali prima del trattamento e di verificare se ne compaiono di nuovi nel suo corso. Dice che per questi effetti non è stato stabilito nessun meccanismo e che l’interruzione del medicinale potrebbe non alleviare i sintomi, per cui può essere necessaria la valutazione di uno specialista.",
                "hi": "ऑस्ट्रेलिया में Roaccutane की आधिकारिक जानकारी (product information) के सेक्शन 4.4 में यौन समस्याओं के शीर्षक से एक चेतावनी है। वह कहती है कि इरेक्शन की समस्या, कामेच्छा में कमी, वल्वा और योनि में सूखापन, आनंद महसूस न होना और पुरुषों में स्तन बढ़ना रिपोर्ट हुए हैं। वह दवा लिखने वाले डॉक्टरों से कहती है कि वे इलाज से पहले यौन समस्याओं के बारे में पूछें और इलाज के दौरान नई समस्याओं पर नज़र रखें। वह कहती है कि ये असर कैसे होते हैं, यह स्थापित नहीं हुआ है, और दवा बंद करने से शायद लक्षणों में राहत न मिले, इसलिए किसी विशेषज्ञ को उनकी जाँच करनी पड़ सकती है।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Section 4.8",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "summary": {
                "en": "Section 4.8 lists sexual dysfunction, including erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men.",
                "de": "Abschnitt 4.8 führt sexuelle Funktionsstörungen auf, darunter Erektionsstörungen, weniger sexuelles Verlangen, Trockenheit von Vulva und Scheide, den Verlust der Fähigkeit, Freude zu empfinden, und Brustwachstum bei Männern.",
                "es": "La sección 4.8 recoge la disfunción sexual, que incluye problemas de erección, menor deseo sexual, sequedad de la vulva y la vagina, pérdida de placer y crecimiento de las mamas en hombres.",
                "pt-br": "A seção 4.8 lista disfunção sexual, incluindo problemas de ereção, queda do desejo sexual, ressecamento da vulva e da vagina, perda de prazer e crescimento das mamas em homens.",
                "fr": "La rubrique 4.8 cite la dysfonction sexuelle, notamment des troubles de l’érection, une baisse du désir sexuel, une sécheresse de la vulve et du vagin, une perte du plaisir et un développement des seins chez les hommes.",
                "it": "La sezione 4.8 elenca la disfunzione sessuale, compresi problemi di erezione, calo del desiderio sessuale, secchezza della vulva e della vagina, perdita del piacere e crescita del seno negli uomini.",
                "hi": "सेक्शन 4.8 सेक्शुअल डिस्फ़ंक्शन को गिनाता है, जिसमें इरेक्शन की समस्या, कामेच्छा में कमी, वल्वा और योनि में सूखापन, आनंद महसूस न होना और पुरुषों में स्तन बढ़ना शामिल हैं।"
              },
              "summaryReason": "access-terms"
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Section 4.8",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "qualifies": "listed",
              "summary": {
                "en": "Directly after that list, section 4.8 says it has not been established that the medicine causes these effects.",
                "de": "Direkt nach dieser Liste steht in Abschnitt 4.8, es sei nicht nachgewiesen, dass das Medikament diese Wirkungen verursacht.",
                "es": "Justo después de esa lista, la sección 4.8 dice que no se ha establecido que el medicamento cause estos efectos.",
                "pt-br": "Logo depois dessa lista, a seção 4.8 diz que não foi estabelecido que o medicamento causa esses efeitos.",
                "fr": "Juste après cette liste, la rubrique 4.8 indique qu’il n’a pas été établi que le médicament cause ces effets.",
                "it": "Subito dopo questo elenco, la sezione 4.8 dice che non è stato stabilito che il medicinale causi questi effetti.",
                "hi": "उस सूची के ठीक बाद सेक्शन 4.8 कहता है कि यह स्थापित नहीं हुआ है कि ये असर दवा की वजह से होते हैं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-au-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-au-leaflet",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information",
            "lang": "en-AU",
            "product": {
              "name": "Roaccutane",
              "form": null,
              "holder": "Pharmaco"
            },
            "source": {
              "type": "regulator-database",
              "name": "TGA eBS"
            },
            "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2025-CMI-01850-1",
            "textDate": "2025-07",
            "textDateKind": "revision",
            "fetchedUrl": null,
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Side effects: sexual and reproductive health"
              ],
              "since": null,
              "summary": {
                "en": "Australia's consumer medicine information for Roaccutane has a list of symptoms to do with sexual and reproductive health. It names trouble getting or keeping an erection, a lower sex drive or feeling less pleasure, dryness of the vagina and breast swelling in men.",
                "de": "Die australische Packungsbeilage zu Roaccutane enthält eine Liste von Symptomen rund um die sexuelle und reproduktive Gesundheit. Sie nennt Schwierigkeiten, eine Erektion zu bekommen oder zu halten, weniger sexuelles Verlangen oder weniger Freude, Scheidentrockenheit und eine Schwellung der Brust bei Männern.",
                "es": "El prospecto australiano de Roaccutane (Consumer Medicine Information) tiene una lista de síntomas relacionados con la salud sexual y reproductiva. Nombra la dificultad para conseguir o mantener una erección, un menor deseo sexual o sentir menos placer, la sequedad vaginal y la hinchazón de las mamas en hombres.",
                "pt-br": "A bula australiana do Roaccutane para pacientes tem uma lista de sintomas ligados à saúde sexual e reprodutiva. Ela cita dificuldade para ter ou manter uma ereção, queda do desejo sexual ou menos prazer, ressecamento da vagina e inchaço das mamas em homens.",
                "fr": "En Australie, la notice de Roaccutane destinée aux patients contient une liste de symptômes liés à la santé sexuelle et reproductive. Elle cite des difficultés à obtenir ou à maintenir une érection, une baisse du désir sexuel ou du plaisir ressenti, une sécheresse du vagin et un gonflement des seins chez les hommes.",
                "it": "Il foglio illustrativo australiano di Roaccutane (Consumer Medicine Information) ha un elenco di sintomi che riguardano la salute sessuale e riproduttiva. Nomina la difficoltà ad avere o mantenere un’erezione, il calo del desiderio sessuale o del piacere, la secchezza della vagina e il gonfiore del seno negli uomini.",
                "hi": "ऑस्ट्रेलिया में Roaccutane के मरीज़ों वाले लीफ़लेट (consumer medicine information) में यौन और प्रजनन स्वास्थ्य से जुड़े लक्षणों की एक सूची है। उसमें इरेक्शन होने या बने रहने में दिक्कत, कामेच्छा में कमी या आनंद कम महसूस होना, योनि में सूखापन और पुरुषों में स्तनों में सूजन के नाम हैं।"
              },
              "summaryReason": "access-terms"
            }
          ],
          "searched": "the leaflet was read in full for a sentence saying the sexual symptoms can continue after stopping",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "summary-checked"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "termsPage",
              "text": {
                "en": "The regulator's site asks readers to accept its terms before it shows this text.",
                "de": "Die Website der Arzneimittelbehörde verlangt, dass man ihre Bedingungen akzeptiert, bevor sie diesen Text anzeigt.",
                "es": "La web de la agencia del medicamento pide a quien la lee que acepte sus condiciones antes de mostrar este texto.",
                "pt-br": "O site da agência reguladora pede que o leitor aceite os seus termos antes de mostrar este texto.",
                "fr": "Le site de l’agence du médicament demande aux lecteurs d’accepter ses conditions avant d’afficher ce texte.",
                "it": "Il sito dell’agenzia del farmaco chiede ai lettori di accettare le sue condizioni prima di mostrare questo testo.",
                "hi": "नियामक की साइट यह दस्तावेज़ दिखाने से पहले पढ़ने वालों से अपनी शर्तें मानने को कहती है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-au-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-au-regulator",
          "reportUrl": "https://www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem",
          "jurisdiction": "au",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "could-not-open",
          "accessReason": [
            "no-answer"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": null,
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://www.tga.gov.au/news/safety-updates/new-safety-warnings-isotretinoin-roaccutane"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-nz",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-nz",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "New Zealand Data Sheet, ORATANE",
            "lang": "en-NZ",
            "product": {
              "name": "Oratane",
              "form": "5 mg, 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules",
              "holder": "Douglas Pharmaceuticals Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/Datasheet/o/oratanecap.pdf",
            "fetchedUrl": null,
            "textDate": "2025-11-17",
            "textDateKind": "revision",
            "textDateAsPrinted": "10.DATE OF REVISION OF THE TEXT 17 November 2025"
          },
          "passages": [
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "4.4. Special warnings and precautions for use",
                "Sexual disorders"
              ],
              "since": null,
              "inWarnings": true,
              "lang": "en-NZ",
              "text": "Erectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia have been reported in patients treated with isotretinoin (refer to section 4.8, Reproductive system and breast disorders). In some cases, symptoms have persisted after discontinuation of isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Isotretinoin behandelt wurden, sind erektile Dysfunktion, verminderte Libido, vulvovaginale Trockenheit, Anhedonie und Gynäkomastie gemeldet worden (siehe Abschnitt 4.8, Erkrankungen der Geschlechtsorgane und der Brustdrüse). In einigen Fällen blieben die Symptome nach dem Absetzen von Isotretinoin bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado disfunción eréctil, disminución de la libido, sequedad vulvovaginal, anhedonia y ginecomastia en pacientes tratados con isotretinoína (ver sección 4.8, Trastornos del aparato reproductor y de la mama). En algunos casos, los síntomas han persistido tras la interrupción de la isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção erétil, diminuição da libido, ressecamento vulvovaginal, anedonia e ginecomastia foram relatados em pacientes tratados com isotretinoína (ver seção 4.8, Distúrbios do sistema reprodutivo e da mama). Em alguns casos, os sintomas persistiram após a descontinuação da isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une dysfonction érectile, une baisse de la libido, une sécheresse vulvo-vaginale, une anhédonie et une gynécomastie ont été signalées chez des patients traités par isotrétinoïne (voir rubrique 4.8, Affections des organes de reproduction et du sein). Dans certains cas, les symptômes ont persisté après l’arrêt de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, calo della libido, secchezza vulvovaginale, anedonia e ginecomastia sono stati segnalati in pazienti trattati con isotretinoina (vedere paragrafo 4.8, Patologie dell’apparato riproduttivo e della mammella). In alcuni casi, i sintomi sono persistiti dopo l’interruzione dell’isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन से जिन मरीज़ों का इलाज हुआ, उनमें स्तंभन दोष, कामेच्छा में कमी, वल्वा और योनि में सूखापन, एनहेडोनिया और गाइनेकोमास्टिया रिपोर्ट हुए हैं (सेक्शन 4.8, Reproductive system and breast disorders देखें)। कुछ मामलों में आइसोट्रेटिनॉइन बंद करने के बाद भी लक्षण बने रहे हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "4.4. Special warnings and precautions for use",
                "Sexual disorders"
              ],
              "since": null,
              "qualifies": "persistence",
              "lang": "en-NZ",
              "text": "A causal relationship or mechanism of action for these events has not been established. However, vulvovaginal dryness may be related to the known mucocutaneous effects of isotretinoin (refer to section 4.8, Hypervitaminosis A)",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Ein ursächlicher Zusammenhang oder ein Wirkmechanismus für diese Ereignisse ist nicht nachgewiesen. Die vulvovaginale Trockenheit hängt jedoch möglicherweise mit den bekannten mukokutanen Wirkungen von Isotretinoin zusammen (siehe Abschnitt 4.8, Hypervitaminose A)",
                  "by": "ours"
                },
                "es": {
                  "text": "No se ha establecido una relación causal ni un mecanismo de acción para estos acontecimientos. Sin embargo, la sequedad vulvovaginal puede estar relacionada con los efectos mucocutáneos conocidos de la isotretinoína (ver sección 4.8, Hipervitaminosis A)",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Não foi estabelecida uma relação causal ou um mecanismo de ação para esses eventos. No entanto, o ressecamento vulvovaginal pode estar relacionado aos conhecidos efeitos mucocutâneos da isotretinoína (ver seção 4.8, Hipervitaminose A)",
                  "by": "ours"
                },
                "fr": {
                  "text": "Un lien de causalité ou un mécanisme d’action n’a pas été établi pour ces événements. Toutefois, la sécheresse vulvo-vaginale peut être liée aux effets cutanéo-muqueux connus de l’isotrétinoïne (voir rubrique 4.8, Hypervitaminose A)",
                  "by": "ours"
                },
                "it": {
                  "text": "Per questi eventi non è stato stabilito un nesso causale né un meccanismo d’azione. Tuttavia, la secchezza vulvovaginale può essere correlata ai noti effetti mucocutanei dell’isotretinoina (vedere paragrafo 4.8, Ipervitaminosi A)",
                  "by": "ours"
                },
                "hi": {
                  "text": "इन घटनाओं के लिए कारण और असर का संबंध या तंत्र (mechanism of action) स्थापित नहीं हुआ है। हालाँकि, वल्वा और योनि में सूखापन आइसोट्रेटिनॉइन के उन ज्ञात असरों से जुड़ा हो सकता है, जो त्वचा और श्लेष्मा झिल्लियों पर होते हैं (सेक्शन 4.8, Hypervitaminosis A देखें)",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Undesirable effects",
                "Reproductive system and breast disorders"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "Erectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia (unknown frequency) (refer to section 4.4, Sexual disorders).",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Erektile Dysfunktion, verminderte Libido, vulvovaginale Trockenheit, Anhedonie und Gynäkomastie (Häufigkeit nicht bekannt) (siehe Abschnitt 4.4, Sexuelle Störungen).",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción eréctil, disminución de la libido, sequedad vulvovaginal, anhedonia y ginecomastia (frecuencia no conocida) (ver sección 4.4, Trastornos sexuales).",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção erétil, diminuição da libido, ressecamento vulvovaginal, anedonia e ginecomastia (frequência desconhecida) (ver seção 4.4, Distúrbios sexuais).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonction érectile, baisse de la libido, sécheresse vulvo-vaginale, anhédonie et gynécomastie (fréquence indéterminée) (voir rubrique 4.4, Troubles sexuels).",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione erettile, calo della libido, secchezza vulvovaginale, anedonia e ginecomastia (frequenza non nota) (vedere paragrafo 4.4, Disturbi sessuali).",
                  "by": "ours"
                },
                "hi": {
                  "text": "स्तंभन दोष, कामेच्छा में कमी, वल्वा और योनि में सूखापन, एनहेडोनिया और गाइनेकोमास्टिया (कितनी बार होते हैं, यह ज्ञात नहीं) (सेक्शन 4.4, Sexual disorders देखें)।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-nz-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-nz-leaflet",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medicine Information, ORATANE",
            "lang": "en-NZ",
            "product": {
              "name": "Oratane",
              "form": "5 mg, 10 mg, 20 mg, 30 mg and 40 mg capsules",
              "holder": "Douglas Pharmaceuticals Ltd"
            },
            "source": {
              "type": "regulator-database",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/consumers/cmi/o/oratane.pdf",
            "fetchedUrl": null,
            "textDate": "2025-11-17",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of preparation 17 November 2025"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Side effects",
                "Tell your doctor if you notice any of the following and they worry you:"
              ],
              "since": null,
              "lang": "en-NZ",
              "text": "• Problems getting or maintaining an erection\n• Lower libido or ability to feel pleasure.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "• Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten\n• Schwächere Libido oder verminderte Fähigkeit, Freude zu empfinden.",
                  "by": "ours"
                },
                "es": {
                  "text": "• Problemas para conseguir o mantener una erección\n• Disminución de la libido o de la capacidad de sentir placer.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "• Problemas para ter ou manter uma ereção\n• Queda da libido ou da capacidade de sentir prazer.",
                  "by": "ours"
                },
                "fr": {
                  "text": "• Problèmes d’obtention ou de maintien d’une érection\n• Baisse de la libido ou de la capacité à ressentir du plaisir.",
                  "by": "ours"
                },
                "it": {
                  "text": "• Problemi a raggiungere o mantenere l’erezione\n• Calo della libido o della capacità di provare piacere.",
                  "by": "ours"
                },
                "hi": {
                  "text": "• इरेक्शन होने या बनाए रखने में समस्या\n• कामेच्छा या आनंद महसूस करने की क्षमता में कमी।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "after-stopping",
              "kind": "qualification",
              "section": [
                "Side effects"
              ],
              "since": null,
              "qualifies": "listed",
              "lang": "en-NZ",
              "text": "These side effects are usually mild and dose related. After the dose of ORATANE capsules is reduced or stopped most of these side effects should disappear within a few days or weeks.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Nebenwirkungen sind in der Regel leicht und dosisabhängig. Nach einer Verringerung der Dosis oder dem Absetzen von ORATANE-Kapseln sollten die meisten dieser Nebenwirkungen innerhalb weniger Tage oder Wochen verschwinden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos efectos secundarios suelen ser leves y están relacionados con la dosis. Después de reducir la dosis de las cápsulas de ORATANE o de interrumpirlas, la mayoría de estos efectos secundarios debería desaparecer en unos días o semanas.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses efeitos colaterais costumam ser leves e relacionados à dose. Depois que a dose das cápsulas de ORATANE é reduzida ou interrompida, a maioria desses efeitos colaterais deve desaparecer em alguns dias ou semanas.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces effets indésirables sont généralement légers et liés à la dose. Une fois la dose des capsules ORATANE réduite ou arrêtée, la plupart de ces effets indésirables devraient disparaître en quelques jours ou quelques semaines.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi effetti indesiderati sono di solito lievi e correlati alla dose. Una volta ridotta o sospesa la dose di ORATANE capsule, la maggior parte di questi effetti indesiderati dovrebbe scomparire entro pochi giorni o settimane.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये साइड इफ़ेक्ट आम तौर पर हल्के होते हैं और डोज़ पर निर्भर करते हैं। ORATANE कैप्सूल की डोज़ घटाने या दवा बंद करने के बाद इनमें से ज़्यादातर साइड इफ़ेक्ट कुछ दिनों या हफ़्तों में चले जाने चाहिए।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "sexual, sex, persist, continu, after stopping, stopp, long-lasting, libido, erect, orgasm, vagin, breast, pleasure, last, long, remain, permanent, go away, after treatment, despite, resolve, months, years",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-nz-regulator-pu202603",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-nz-regulator-pu202603",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Recent data sheet updates: Important new safety information",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/PUArticles/March2026/Recent-data-sheet-updates-important-new-safety-information.html",
            "fetchedUrl": null,
            "textDate": "2026-03-05",
            "textDateKind": "publication",
            "textDateAsPrinted": "Published: 5 March 2026"
          },
          "passages": [
            {
              "key": "update",
              "kind": "sexual-persistence",
              "section": [
                "Table 1: Recently updated data sheets (by active ingredient): important new safety information",
                "Isotretinoin, Oratane, 4.4"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-NZ",
              "text": "Sexual disorders have been reported in patients treated with isotretinoin. In some cases, symptoms have persisted after discontinuation.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Bei Patientinnen und Patienten, die mit Isotretinoin behandelt wurden, sind sexuelle Störungen gemeldet worden. In einigen Fällen blieben die Symptome nach dem Absetzen bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Se han notificado trastornos sexuales en pacientes tratados con isotretinoína. En algunos casos, los síntomas han persistido tras la interrupción.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Distúrbios sexuais foram relatados em pacientes tratados com isotretinoína. Em alguns casos, os sintomas persistiram após a descontinuação.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des troubles sexuels ont été signalés chez des patients traités par isotrétinoïne. Dans certains cas, les symptômes ont persisté après l’arrêt.",
                  "by": "ours"
                },
                "it": {
                  "text": "Nei pazienti trattati con isotretinoina sono stati segnalati disturbi sessuali. In alcuni casi, i sintomi sono persistiti dopo l’interruzione.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन से जिन मरीज़ों का इलाज हुआ, उनमें यौन समस्याएँ रिपोर्ट हुई हैं। कुछ मामलों में दवा बंद करने के बाद भी लक्षण बने रहे हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-nz-regulator-marc202309",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-nz-regulator-marc202309",
          "reportUrl": "https://www.medsafe.govt.nz/safety/report-a-problem.asp",
          "jurisdiction": "nz",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Minutes of the 195th Medicines Adverse Reactions Committee Meeting, 14 September 2023",
            "lang": "en-NZ",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "Medsafe"
            },
            "url": "https://www.medsafe.govt.nz/profs/adverse/Minutes195.htm",
            "fetchedUrl": null,
            "textDate": "2023-09-14",
            "textDateKind": "adoption",
            "textDateAsPrinted": "The one hundred and ninety-fifth meeting of the Medicines Adverse Reactions Committee (MARC) was held on 14 September 2023"
          },
          "passages": [],
          "searched": "persist, continu, after stopping, stopp, discontinu, cessation, long-lasting, long lasting, irreversib, permanent, after treatment",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-de",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-de",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Fachinformation",
            "lang": "de",
            "product": {
              "name": "Isotretinoin-ratiopharm",
              "form": "10 mg Weichkapseln",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/label/Isotretinoin-ratiopharm%20Weichkapseln%20-%209.pdf?pzn=4478655",
            "fetchedUrl": null,
            "textDate": "2026-02",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. STAND DER INFORMATION Februar 2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8 Nebenwirkungen",
                "Zusammenfassung des Sicherheitsprofils"
              ],
              "since": null,
              "lang": "de",
              "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects generally subside after a change of dose or after treatment is stopped, but some may remain even after the end of treatment.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios remiten después de modificar la dosis o interrumpir el tratamiento, pero algunos pueden persistir incluso una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais em geral regridem após a mudança da dose ou a interrupção do tratamento, mas alguns podem permanecer mesmo depois do fim do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables s’atténuent en général après une modification de la dose ou l’interruption du traitement, mais certains peuvent persister même après la fin du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati in genere regrediscono dopo una modifica della dose o l’interruzione del trattamento, ma alcuni possono persistere anche dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद धीरे-धीरे खत्म हो जाते हैं, लेकिन कुछ इलाज खत्म होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Nebenwirkungen",
                "Tabelle 1 „Tabellarische Liste der Nebenwirkungen bei mit Isotretinoin behandelten Patienten“",
                "Erkrankungen der Geschlechtsorgane und der Brustdrüse",
                "Nicht bekannt"
              ],
              "since": null,
              "lang": "de",
              "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, ulvovaginale Trockenheit",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e diminuição da libido, ginecomastia, ressecamento vulvovaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido, gynécomastie, sécheresse vulvo-vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, वल्वा और योनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "\"sexuell\", \"Libido\", \"erektil\", \"Erektion\", \"Gynäkomast\", \"vulvovagin\", \"Scheide\", \"anhalt\", \"fortbesteh\", \"bestehen bleiben\", \"bestehen blieben\", \"nach Absetzen\", \"nach Beendigung\", \"nach dem Ende\", \"langanhaltend\", \"persist\", \"dauerhaft\", \"andauer\", \"weiterbesteh\", \"irreversib\", \"bleibend\", \"abgeklungen\", \"reversib\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-de-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-de-leaflet",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Gebrauchsinformation: Information für Anwender",
            "lang": "de",
            "product": {
              "name": "Isotretinoin-ratiopharm",
              "form": "10 mg Weichkapseln",
              "holder": "ratiopharm GmbH"
            },
            "source": {
              "type": "holder",
              "name": "ratiopharm GmbH"
            },
            "url": "https://www.ratiopharm.de/assets/products/de/pkg_insert/Isotretinoin-ratiopharm%2010%20mg%20Weichkapseln%20-%206.pdf?pzn=4478655",
            "fetchedUrl": null,
            "textDate": "2026-02",
            "textDateKind": "revision",
            "textDateAsPrinted": "Diese Packungsbeilage wurde zuletzt überarbeitet im Februar 2026."
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?"
              ],
              "since": null,
              "lang": "de",
              "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder nach Beendigung der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects generally subside after a change of dose or after treatment has ended, but some may remain even after the end of treatment.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios remiten después de modificar la dosis o de finalizar el tratamiento, pero algunos pueden persistir incluso una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais em geral regridem após a mudança da dose ou após o término do tratamento, mas alguns podem permanecer mesmo depois do fim do tratamento.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables s’atténuent en général après une modification de la dose ou après l’arrêt du traitement, mais certains peuvent persister même après la fin du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati in genere regrediscono dopo una modifica della dose o dopo la conclusione del trattamento, ma alcuni possono persistere anche dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने के बाद या इलाज खत्म करने के बाद धीरे-धीरे खत्म हो जाते हैं, लेकिन कुछ इलाज खत्म होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4. Welche Nebenwirkungen sind möglich?",
                "Andere Nebenwirkungen",
                "Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)"
              ],
              "since": null,
              "lang": "de",
              "text": "Schwierigkeiten eine Erektion zu bekommen oder aufrechtzuerhalten\nschwächere Libido\nBrustschwellung bei Männern mit oder ohne Druckempfindlichkeit\nScheidentrockenheit",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Difficulty getting or keeping an erection\nlower libido\nbreast swelling in men, with or without tenderness\nvaginal dryness",
                  "by": "ours"
                },
                "es": {
                  "text": "dificultades para conseguir o mantener una erección\ndisminución de la libido\ninflamación de los senos en los hombres, con o sin sensibilidad a la presión\nsequedad vaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Dificuldade para ter ou manter uma ereção\nlibido mais fraca\ninchaço das mamas em homens, com ou sem sensibilidade ao toque\nressecamento vaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’obtention ou de maintien d’une érection\nbaisse de la libido\ngonflement des seins chez les hommes, avec ou sans sensibilité\nsécheresse vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Difficoltà a raggiungere o mantenere l’erezione\ncalo della libido\ningrossamento delle mammelle negli uomini, con o senza dolorabilità\nsecchezza vaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में दिक्कत\nकामेच्छा में कमी\nपुरुषों में स्तनों में सूजन, दबाने पर दर्द के साथ या उसके बिना\nयोनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "\"sexuell\", \"Libido\", \"erektil\", \"Erektion\", \"Gynäkomast\", \"vulvovagin\", \"Scheide\", \"anhalt\", \"fortbesteh\", \"bestehen bleiben\", \"bestehen blieben\", \"nach Absetzen\", \"nach Beendigung\", \"nach dem Ende\", \"langanhaltend\", \"persist\", \"dauerhaft\", \"andauer\", \"weiterbesteh\", \"irreversib\", \"bleibend\", \"abgeklungen\", \"reversib\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorTerms",
              "text": {
                "en": "This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde verlangt, dass man zuerst ihre Bedingungen akzeptiert, was wir nicht getan haben.",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento pide a quien la visita que acepte primero sus condiciones, y no lo hicimos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora pede que o visitante aceite antes os seus termos, o que não fizemos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament demande d’abord aux visiteurs d’accepter ses conditions, ce que nous n’avons pas fait.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco chiede prima ai visitatori di accettare le sue condizioni, cosa che non abbiamo fatto.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक का डेटाबेस पहले अपनी शर्तें मानने को कहता है, और हमने ऐसा नहीं किया।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-de-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-de-regulator",
          "reportUrl": "https://nebenwirkungen.bund.de/nw/EN/home/home_node.html",
          "jurisdiction": "de",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Bescheid vom 19.02.2019: Umsetzung der zwei einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh/439088/2017 vom 19.07.2017 und EMA/CMDh/848760/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff „Isotretinoin (orale Darreichungsformen)“",
            "lang": "de",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "BfArM"
            },
            "url": "https://www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Periodic-Safety-Update-Reports_PSURs/PSUR-Single-Assessment/Anlagen/g-l/Isotretinoin_oral-CMDh-Beschluss.html",
            "fetchedUrl": null,
            "textDate": "2019-02-19",
            "textDateKind": "publication",
            "textDateAsPrinted": "Bonn, 19. Februar 2019"
          },
          "passages": [
            {
              "key": "smpc",
              "kind": "sexual-side-effects",
              "section": [
                "Anlage 3",
                "ANHANG II",
                "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS • Abschnitt 4.8"
              ],
              "since": null,
              "lang": "de",
              "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction including erectile dysfunction and decreased libido",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual incluyendo disfunción eréctil y disminución de la libido",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e diminuição da libido",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the order and its annex 3 were read for a sentence about sexual side effects continuing after stopping; it orders the listing only",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-fr",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-fr",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Résumé des Caractéristiques du Produit",
            "lang": "fr",
            "product": {
              "name": "CONTRACNE",
              "form": "10 mg, capsule molle",
              "holder": "LABORATOIRES BAILLEUL S.A."
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait#tab-rcp",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait",
            "textDate": "2026-09-08",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 08/09/2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8. Effets indésirables",
                "Résumé du profil de tolérance"
              ],
              "since": null,
              "lang": "fr",
              "text": "D'une manière générale, la plupart des effets indésirables sont réversibles après diminution de la posologie ou interruption du traitement ; certains cependant persistent après l'arrêt du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In general, most side effects are reversible after the dose is reduced or treatment is interrupted; some, however, persist after treatment is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Im Allgemeinen klingen die meisten Nebenwirkungen nach einer Verringerung der Dosis oder einer Unterbrechung der Behandlung ab; manche bleiben jedoch nach dem Absetzen der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, la mayoría de los efectos adversos son reversibles tras la disminución de la dosis o la interrupción del tratamiento; algunos, sin embargo, persisten después de la suspensión del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "De modo geral, a maioria dos efeitos adversos é reversível após a redução da dose ou a interrupção do tratamento; alguns, porém, persistem após a suspensão do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "In generale, la maggior parte degli effetti indesiderati è reversibile dopo la riduzione della posologia o l’interruzione del trattamento; alcuni tuttavia persistono dopo la sospensione del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम तौर पर ज़्यादातर साइड इफ़ेक्ट डोज़ घटाने या इलाज रोकने के बाद ठीक हो जाने वाले होते हैं; हालाँकि, कुछ इलाज बंद करने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Effets indésirables",
                "Liste tabulée des effets indésirables",
                "Affections des organes de reproduction et du sein",
                "Indéterminée"
              ],
              "since": null,
              "lang": "fr",
              "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido.\nGynécomastie.\nSécheresse vulvo-vaginale.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction, including erectile dysfunction and decreased libido.\nGynaecomastia.\nVulvovaginal dryness.",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido.\nGynäkomastie.\nVulvovaginale Trockenheit.",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual, incluidas disfunción eréctil y disminución de la libido.\nGinecomastia.\nSequedad vulvovaginal.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e diminuição da libido.\nGinecomastia.\nRessecamento vulvovaginal.",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido.\nGinecomastia.\nSecchezza vulvovaginale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं।\nगाइनेकोमास्टिया।\nवल्वा और योनि में सूखापन।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "\"persist\", \"après l'arrêt\", \"à l'arrêt\", \"malgré l'arrêt\", \"durable\", \"prolong\", \"dysfonction\", \"troubles sexuels\", \"sexuel\", \"libido\", \"érectile\", \"érection\", \"vulvo\", \"vaginale\", \"gynécomastie\", \"réversible\", \"irréversible\", \"définitif\", \"subsist\", \"ne s'améliore\", \"permanent\", \"à long terme\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-fr-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-fr-leaflet",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Notice patient",
            "lang": "fr",
            "product": {
              "name": "CONTRACNE",
              "form": "10 mg, capsule molle",
              "holder": "LABORATOIRES BAILLEUL S.A."
            },
            "source": {
              "type": "government-database",
              "name": "Base de données publique des médicaments"
            },
            "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait#tab-notice",
            "fetchedUrl": "https://base-donnees-publique.medicaments.gouv.fr/medicament/63918395/extrait",
            "textDate": "2026-09-08",
            "textDateKind": "regulator-update",
            "textDateAsPrinted": "ANSM - Mis à jour le : 08/09/2026"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?",
                "Effets au niveau des organes de reproduction et du sein : fréquence indéterminée"
              ],
              "since": null,
              "lang": "fr",
              "text": "Problèmes d’obtention ou de maintien d’une érection,\nBaisse de la libido,\nGonflement des seins chez les hommes, avec ou sans sensibilité,\nSécheresse vaginale.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Problems getting or keeping an erection,\nLower libido,\nBreast swelling in men, with or without tenderness,\nVaginal dryness.",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten,\nSchwächere Libido,\nBrustschwellung bei Männern mit oder ohne Druckempfindlichkeit,\nScheidentrockenheit.",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas para obtener o mantener una erección,\nDisminución de la libido,\nInflamación de los senos en los hombres, con o sin sensibilidad,\nSequedad vaginal.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas para obter ou manter uma ereção,\nDiminuição da libido,\nInchaço das mamas em homens, com ou sem sensibilidade,\nRessecamento vaginal.",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi a raggiungere o mantenere l’erezione,\nCalo della libido,\nIngrossamento delle mammelle negli uomini, con o senza dolorabilità,\nSecchezza vaginale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या,\nकामेच्छा में कमी,\nपुरुषों में स्तनों में सूजन, छूने पर दर्द के साथ या उसके बिना,\nयोनि में सूखापन।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "\"persist\", \"après l'arrêt\", \"à l'arrêt\", \"malgré l'arrêt\", \"durable\", \"prolong\", \"dysfonction\", \"troubles sexuels\", \"sexuel\", \"libido\", \"érectile\", \"érection\", \"vulvo\", \"vaginale\", \"gynécomastie\", \"réversible\", \"irréversible\", \"définitif\", \"subsist\", \"ne s'améliore\", \"permanent\", \"à long terme\"",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "textPrintsNoDate",
              "text": {
                "en": "The text itself prints no date of revision.",
                "de": "Der Text selbst trägt kein Überarbeitungsdatum.",
                "es": "El propio texto no lleva fecha de revisión.",
                "pt-br": "O próprio texto não traz data de revisão.",
                "fr": "Le texte lui-même ne porte aucune date de révision.",
                "it": "Il testo in sé non riporta nessuna data di revisione.",
                "hi": "खुद दस्तावेज़ पर संशोधन की कोई तारीख नहीं छपी है।"
              }
            },
            {
              "key": "productsDifferNamed",
              "text": {
                "en": "Another product's leaflet reads differently. This row shows the product named, and no other.",
                "de": "Die Packungsbeilage eines anderen Produkts lautet anders. Diese Zeile zeigt das genannte Produkt und kein anderes.",
                "es": "El prospecto de otro producto dice otra cosa. Esta fila muestra el producto que se nombra, y ningún otro.",
                "pt-br": "A bula de outro produto diz outra coisa. Esta linha mostra o produto indicado, e nenhum outro.",
                "fr": "La notice d’un autre produit est rédigée différemment. Cette ligne montre le produit nommé, et aucun autre.",
                "it": "Il foglio illustrativo di un altro prodotto dice una cosa diversa. Questa riga mostra il prodotto indicato, e nessun altro.",
                "hi": "एक दूसरे उत्पाद का लीफ़लेट कुछ और कहता है। यह पंक्ति उसी उत्पाद की है, जिसका नाम दिया गया है, किसी और की नहीं।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-fr-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-fr-regulator",
          "reportUrl": "https://signalement.social-sante.gouv.fr/",
          "jurisdiction": "fr",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Risques liés à la prise d’isotrétinoïne par voie orale",
            "lang": "fr",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "ANSM"
            },
            "url": "https://ansm.sante.fr/dossiers-thematiques/risques-lies-a-la-prise-disotretinoine-par-voie-orale",
            "fetchedUrl": null,
            "textDate": "2025-07-17",
            "textDateKind": "revision",
            "textDateAsPrinted": "MIS À JOUR LE 17/07/2025"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "Risques liés à la prise d’isotrétinoïne par voie orale"
              ],
              "since": null,
              "lang": "fr",
              "text": "La plupart de ces effets sont réversibles après une diminution de la posologie ou l’arrêt du traitement, cependant certains effets peuvent persister après la fin du traitement.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Most of these effects are reversible after the dose is reduced or treatment is stopped; however, some effects may persist after the end of treatment.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die meisten dieser Wirkungen klingen nach einer Verringerung der Dosis oder nach dem Absetzen der Behandlung ab, manche können jedoch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de estos efectos son reversibles tras una disminución de la dosis o la suspensión del tratamiento; sin embargo, algunos efectos pueden persistir una vez finalizado el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria desses efeitos é reversível após uma redução da dose ou a suspensão do tratamento; no entanto, alguns efeitos podem persistir após o fim do tratamento.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte di questi effetti è reversibile dopo una riduzione della posologia o la sospensione del trattamento, tuttavia alcuni effetti possono persistere dopo la fine del trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "इनमें से ज़्यादातर असर डोज़ घटाने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ असर इलाज खत्म होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the whole page was read for a sentence on sexual side effects continuing after stopping",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-it",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-it",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Riassunto delle Caratteristiche del Prodotto",
            "lang": "it",
            "product": {
              "name": "Isotretinoina Difa Cooper",
              "form": "10 mg capsule molli",
              "holder": "Difa Cooper S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1180/farmaci/36083/stampati?ts=RCP",
            "fetchedUrl": null,
            "textDate": "2026-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. DATA DI REVISIONE DEL TESTO Settembre 2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8 Effetti indesiderati",
                "Riassunto del profilo di sicurezza"
              ],
              "since": null,
              "lang": "it",
              "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni comunque, possono persistere dopo l’interruzione della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects are generally reversible after the dose is changed or treatment is stopped; some, however, may persist after therapy is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos son en general reversibles tras la modificación de la dosis o la suspensión del tratamiento; algunos, sin embargo, pueden persistir después de la interrupción de la terapia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos são em geral reversíveis após a modificação da dose ou a suspensão do tratamento; alguns, porém, podem persistir após a interrupção da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont en général réversibles après une modification de la dose ou l’arrêt du traitement ; certains, toutefois, peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज रोकने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद करने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Effetti indesiderati",
                "Tabella 1 Elenco delle reazioni avverse in pazienti trattati con isotretinoina",
                "Patologie dell'apparato riproduttivo e della mammella",
                "Non nota"
              ],
              "since": null,
              "lang": "it",
              "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginale",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction, including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, vulvovaginale Trockenheit",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual, que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e queda da libido, ginecomastia, ressecamento vulvovaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido, gynécomastie, sécheresse vulvo-vaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, वल्वा और योनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, dopo l’interruzione, dopo la sospensione, dopo la fine, al termine del trattamento, a lungo termine, continu, protrarsi, permanent, irreversibil, non si sono risolti, disfunzione sessuale, erettile, erezione, libido, secchezza vaginale/vulvovaginale, orgasm, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            },
            {
              "key": "asPrinted",
              "text": {
                "en": "Spelling and punctuation are the document's own.",
                "de": "Schreibweise und Zeichensetzung sind die des Dokuments.",
                "es": "La ortografía y la puntuación son las del propio documento.",
                "pt-br": "A grafia e a pontuação são as do próprio documento.",
                "fr": "L’orthographe et la ponctuation sont celles du document.",
                "it": "Ortografia e punteggiatura sono quelle del documento.",
                "hi": "स्पेलिंग और विराम चिह्न दस्तावेज़ के अपने हैं।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-it-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-it-leaflet",
          "reportUrl": "https://servizionline.aifa.gov.it/schedasegnalazioni/",
          "jurisdiction": "it",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Foglio illustrativo: informazioni per l’utilizzatore",
            "lang": "it",
            "product": {
              "name": "Isotretinoina Difa Cooper",
              "form": "10 mg capsule molli",
              "holder": "Difa Cooper S.p.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "Banca Dati Farmaci"
            },
            "url": "https://api.aifa.gov.it/aifa-bdf-eif-be/1.0.0/organizzazione/1180/farmaci/36083/stampati?ts=FI",
            "fetchedUrl": null,
            "textDate": "2026-09",
            "textDateKind": "revision",
            "textDateAsPrinted": "Questo foglio illustrativo è stato aggiornato il settembre 2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4. Possibili effetti indesiderati"
              ],
              "since": null,
              "lang": "it",
              "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o l’interruzione del trattamento, alcuni comunque, possono continuare dopo la sospensione della terapia.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The side effects are generally reversible after the dose is changed or treatment is stopped; some, however, may continue after therapy is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder nach Beendigung der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos son en general reversibles tras la modificación de la dosis o la interrupción del tratamiento; algunos, sin embargo, pueden continuar después de la suspensión de la terapia.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos adversos são em geral reversíveis após a modificação da dose ou a interrupção do tratamento; alguns, porém, podem continuar após a suspensão da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont en général réversibles après une modification de la dose ou l’arrêt du traitement ; certains, toutefois, peuvent continuer après l’arrêt du traitement.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज रोकने के बाद भी जारी रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possibili effetti indesiderati",
                "Altri effetti indesiderati:",
                "Non noti (non possono essere definiti sulla base dei dati disponibili)."
              ],
              "since": null,
              "lang": "it",
              "text": "- Problemi a raggiungere o mantenere l’erezione\n- Calo della libido\n- Ingrossamento delle mammelle con o senza dolorabilità negli uomini\n- Secchezza vaginale",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "- Problems getting or keeping an erection\n- Decreased libido\n- Breast enlargement with or without tenderness in men\n- Vaginal dryness",
                  "by": "ours"
                },
                "de": {
                  "text": "- Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten\n- Schwächere Libido\n- Brustschwellung bei Männern mit oder ohne Druckempfindlichkeit\n- Scheidentrockenheit",
                  "by": "ours"
                },
                "es": {
                  "text": "- Problemas para conseguir o mantener la erección\n- Disminución de la libido\n- Aumento de tamaño de las mamas con o sin sensibilidad dolorosa en los hombres\n- Sequedad vaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "- Problemas para alcançar ou manter a ereção\n- Queda da libido\n- Aumento das mamas, com ou sem dor ao toque, em homens\n- Ressecamento vaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "- Problèmes d’obtention ou de maintien d’une érection\n- Baisse de la libido\n- Gonflement des seins chez les hommes, avec ou sans sensibilité\n- Sécheresse vaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "- इरेक्शन होने या बनाए रखने में समस्या\n- कामेच्छा में कमी\n- पुरुषों में स्तनों का बढ़ना, छूने पर दर्द के साथ या उसके बिना\n- योनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, dopo l’interruzione, dopo la sospensione, dopo la fine, al termine del trattamento, a lungo termine, continu, protrarsi, permanent, irreversibil, non si sono risolti, disfunzione sessuale, erettile, erezione, libido, secchezza vaginale/vulvovaginale, orgasm, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "notOriginator",
              "text": {
                "en": "The originator product is not in the list we read. This is another product from that list.",
                "de": "Das Originalpräparat steht nicht in der Liste, die wir gelesen haben. Dies ist ein anderes Produkt aus dieser Liste.",
                "es": "El producto original no está en la lista que hemos leído. Este es otro producto de esa lista.",
                "pt-br": "O produto original não está na lista que lemos. Este é outro produto dessa lista.",
                "fr": "Le produit d’origine ne figure pas dans la liste que nous avons lue. Il s’agit ici d’un autre produit de cette liste.",
                "it": "Il medicinale originatore non è nell’elenco che abbiamo letto. Questo è un altro prodotto di quell’elenco.",
                "hi": "दवा का मूल (originator) उत्पाद उस सूची में नहीं है, जो हमने पढ़ी। यह उसी सूची का एक दूसरा उत्पाद है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-es",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-es",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Ficha técnica",
            "lang": "es",
            "product": {
              "name": "Isdiben",
              "form": "20 mg cápsulas blandas EFG",
              "holder": "Isdin, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/ft/66122/FT_66122.html",
            "fetchedUrl": null,
            "textDate": "2026-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "10. FECHA DE LA REVISIÓN DEL TEXTO Mayo 2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8. Reacciones adversas",
                "Resumen del perfil de seguridad"
              ],
              "since": null,
              "lang": "es",
              "text": "En general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento pero algunos persisten una vez finalizado éste.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "In general, the side effects reverse after the dose is changed or treatment is stopped, but some persist once it has ended.",
                  "by": "ours"
                },
                "de": {
                  "text": "Im Allgemeinen klingen die Nebenwirkungen nach Dosisänderung oder Abbruch der Behandlung ab, manche bleiben jedoch nach dem Ende der Behandlung bestehen.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Em geral, os efeitos colaterais regridem depois de modificar a dose ou interromper o tratamento, mas alguns persistem depois que ele termina.",
                  "by": "ours"
                },
                "fr": {
                  "text": "En général, les effets secondaires régressent après une modification de la dose ou l’interruption du traitement, mais certains persistent une fois celui-ci terminé.",
                  "by": "ours"
                },
                "it": {
                  "text": "In generale, gli effetti indesiderati regrediscono dopo la modifica della dose o l’interruzione del trattamento, ma alcuni persistono una volta terminato il trattamento.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आम तौर पर साइड इफ़ेक्ट डोज़ बदलने या इलाज रोकने के बाद ठीक हो जाते हैं, लेकिन कुछ इलाज खत्म होने के बाद भी बने रहते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8. Reacciones adversas",
                "Tabla 1 – Listado tabulado de reacciones adversas en pacientes tratados con isotretinoína.",
                "Trastornos del aparato reproductor y de la mama",
                "Frecuencia no conocida"
              ],
              "since": null,
              "lang": "es",
              "text": "Disfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginal",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness",
                  "by": "ours"
                },
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, vulvovaginale Trockenheit",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual que inclui disfunção erétil e diminuição da libido, ginecomastia, ressecamento vulvovaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido, gynécomastie, sécheresse vulvo-vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, वल्वा और योनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, tras la interrupción, tras interrumpir, después de suspender/interrumpir/finalizar/dejar, tras suspender/finalizar/dejar, una vez finalizado, larga duración, a largo plazo, han continuado, no se resuelven, disfunción sexual, eréctil, erección, libido, sequedad vaginal/vulvovaginal, orgasm, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-es-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-es-leaflet",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Prospecto: INFORMACIÓN PARA EL PACIENTE",
            "lang": "es",
            "product": {
              "name": "Isdiben",
              "form": "20 mg Cápsulas blandas EFG",
              "holder": "Isdin, S.A."
            },
            "source": {
              "type": "regulator-database",
              "name": "CIMA"
            },
            "url": "https://cima.aemps.es/cima/dochtml/p/66122/P_66122.html",
            "fetchedUrl": null,
            "textDate": "2026-05",
            "textDateKind": "revision",
            "textDateAsPrinted": "Fecha de última revision de este prospecto: mayo 2026"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4. Posibles efectos adversos",
                "Frecuencia no conocida: (la frecuencia no puede estimarse a partir de los datos disponibles)"
              ],
              "since": null,
              "lang": "es",
              "text": "Problemas para obtener o mantener una erección.\nDisminución de la libido.\nInflamación de los senos con o sin sensibilidad en los hombres.\nSequedad vaginal",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Problems getting or keeping an erection.\nDecreased libido.\nSwelling of the breasts with or without tenderness in men.\nVaginal dryness",
                  "by": "ours"
                },
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten.\nSchwächere Libido.\nBrustschwellung bei Männern mit oder ohne Druckempfindlichkeit.\nScheidentrockenheit",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas para obter ou manter uma ereção.\nDiminuição da libido.\nInchaço das mamas, com ou sem sensibilidade, em homens.\nRessecamento vaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’obtention ou de maintien d’une érection.\nBaisse de la libido.\nGonflement des seins chez les hommes, avec ou sans sensibilité.\nSécheresse vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi a raggiungere o mantenere l’erezione.\nCalo della libido.\nIngrossamento delle mammelle con o senza dolorabilità negli uomini.\nSecchezza vaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या।\nकामेच्छा में कमी।\nपुरुषों में स्तनों में सूजन, छूने पर दर्द के साथ या उसके बिना।\nयोनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "persist, tras la interrupción, tras interrumpir, después de suspender/interrumpir/finalizar/dejar, tras suspender/finalizar/dejar, una vez finalizado, larga duración, a largo plazo, han continuado, no se resuelven, disfunción sexual, eréctil, erección, libido, sequedad vaginal/vulvovaginal, orgasm, genital",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-es-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-es-regulator",
          "reportUrl": "https://www.notificaram.es/",
          "jurisdiction": "es",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Boletín mensual de la AEMPS sobre medicamentos de uso humano. Septiembre de 2017",
            "lang": "es",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "AEMPS"
            },
            "url": "https://www.aemps.gob.es/informa/boletines-aemps/boletinMensual/2017/septiembre/boletin-septiembre-2/",
            "fetchedUrl": null,
            "textDate": "2017-10-13",
            "textDateKind": "publication",
            "textDateAsPrinted": "Fecha de publicación: 13 de octubre de 2017"
          },
          "passages": [
            {
              "key": "bulletin",
              "kind": "sexual-side-effects",
              "section": [
                "Información sobre seguridad",
                "Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia",
                "Isotretinoína"
              ],
              "since": null,
              "lang": "es",
              "text": "Los datos presentados en la última revisión sugieren que hay evidencia de que la isotretinoína pueda estar asociada con disfunción sexual incluyendo disfunción eréctil y disminución de la libido; el mecanismo responsable puede estar mediado por una reducción de la testosterona en plasma. Por este motivo se incluirán, en la información del producto de medicamentos con isotretinoína, como reacciones adversas los trastornos del aparato reproductor y de la mama de frecuencia desconocida: disfunción sexual incluyendo disfunción eréctil y disminución de la libido.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The data presented in the latest review suggest there is evidence that isotretinoin may be associated with sexual dysfunction, including erectile dysfunction and decreased libido; the mechanism responsible may be mediated by a reduction in plasma testosterone. For this reason, the product information of medicines with isotretinoin will include, as adverse reactions, reproductive system and breast disorders of unknown frequency: sexual dysfunction including erectile dysfunction and decreased libido.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die in der letzten Überprüfung vorgelegten Daten deuten darauf hin, dass es Belege dafür gibt, dass Isotretinoin mit sexueller Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido in Verbindung stehen könnte; der verantwortliche Mechanismus könnte über eine Senkung des Testosterons im Plasma vermittelt sein. Aus diesem Grund werden in die Produktinformation von Medikamenten mit Isotretinoin als Nebenwirkungen Erkrankungen der Geschlechtsorgane und der Brustdrüse mit nicht bekannter Häufigkeit aufgenommen: sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os dados apresentados na última revisão sugerem que há evidências de que a isotretinoína possa estar associada a disfunção sexual, incluindo disfunção erétil e diminuição da libido; o mecanismo responsável pode ser mediado por uma redução da testosterona no plasma. Por esse motivo, serão incluídos nas informações do produto dos medicamentos com isotretinoína, como reações adversas, os distúrbios do sistema reprodutor e da mama de frequência desconhecida: disfunção sexual, incluindo disfunção erétil e diminuição da libido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les données présentées lors de la dernière évaluation suggèrent qu’il existe des éléments indiquant que l’isotrétinoïne peut être associée à un dysfonctionnement sexuel, y compris un dysfonctionnement érectile et une baisse de la libido ; le mécanisme en cause peut passer par une diminution de la testostérone plasmatique. Pour cette raison, les informations sur le produit des médicaments contenant de l’isotrétinoïne mentionneront, parmi les effets indésirables, les affections des organes de reproduction et du sein de fréquence indéterminée : dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido.",
                  "by": "ours"
                },
                "it": {
                  "text": "I dati presentati nell’ultima revisione suggeriscono che ci siano prove che l’isotretinoina possa essere associata a disfunzione sessuale, tra cui disfunzione erettile e calo della libido; il meccanismo responsabile può essere mediato da una riduzione del testosterone nel plasma. Per questo motivo, nelle informazioni sul prodotto dei medicinali con isotretinoina saranno incluse come reazioni avverse le patologie dell’apparato riproduttivo e della mammella di frequenza non nota: disfunzione sessuale, tra cui disfunzione erettile e calo della libido.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ताज़ा समीक्षा में पेश किए गए आँकड़े ऐसे प्रमाण होने की ओर इशारा करते हैं कि आइसोट्रेटिनॉइन सेक्शुअल डिस्फ़ंक्शन से जुड़ी हो सकती है, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं; इसके लिए ज़िम्मेदार तंत्र (mechanism) खून के प्लाज़्मा में टेस्टोस्टेरोन घटने के ज़रिए काम कर सकता है। इसी वजह से आइसोट्रेटिनॉइन वाली दवाओं की आधिकारिक जानकारी में साइड इफ़ेक्ट के तौर पर प्रजनन तंत्र और स्तन की ऐसी समस्याएँ जोड़ी जाएँगी, जिनकी दर ज्ञात नहीं है: सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the item on isotretinoin was read in full; it says nothing about the effects continuing after stopping",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-br",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-br",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Roacutan® Isotretinoína: BULA PACIENTE",
            "lang": "pt-BR",
            "product": {
              "name": "Roacutan",
              "form": "cápsulas gelatinosas 20 mg",
              "holder": "Farmoquímica S/A"
            },
            "source": {
              "type": "holder",
              "name": "Farmoquímica S/A"
            },
            "url": "https://www.fqmgrupo.com.br/fqmmelora/userfiles/produtosPdf/17894918916aa97ab3e4239.pdf",
            "fetchedUrl": null,
            "textDate": "2025-12-10",
            "textDateKind": "approval",
            "textDateAsPrinted": "Esta bula foi aprovada pela ANVISA em 10/12/2025."
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Os efeitos adversos são geralmente reversíveis, com a alteração da dose ou interrupção do tratamento, e alguns podem persistir após a suspensão da medicação.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse effects are generally reversible with a change of dose or discontinuation of treatment, and some may persist after the medicine is stopped.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen bei Dosisänderung oder Abbruch der Behandlung ab, und manche können nach dem Absetzen des Medikaments bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos adversos son generalmente reversibles con la modificación de la dosis o la interrupción del tratamiento, y algunos pueden persistir después de la suspensión de la medicación.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles avec une modification de la dose ou l’interruption du traitement, et certains peuvent persister après l’arrêt du médicament.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti avversi sono generalmente reversibili con la modifica della dose o l’interruzione del trattamento, e alcuni possono persistere dopo la sospensione del medicinale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने पर ठीक हो जाने वाले होते हैं, और कुछ दवा बंद करने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR?",
                "Reações sem frequência estabelecida:"
              ],
              "since": null,
              "lang": "pt-BR",
              "text": "Sistema reprodutivo: disfunção sexual, inclusive disfunção erétil (incapacidade de alcançar ou manter ereção satisfatória para a relação sexual) e diminuição da libido (redução no impulso sexual).",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "Reproductive system: sexual dysfunction, including erectile dysfunction (inability to reach or keep an erection satisfactory for sexual intercourse) and decreased libido (reduced sex drive).",
                  "by": "ours"
                },
                "de": {
                  "text": "Fortpflanzungssystem: sexuelle Dysfunktion einschließlich erektiler Dysfunktion (Unfähigkeit, eine für den Geschlechtsverkehr ausreichende Erektion zu erreichen oder aufrechtzuerhalten) und verminderter Libido (vermindertes sexuelles Verlangen).",
                  "by": "ours"
                },
                "es": {
                  "text": "Aparato reproductor: disfunción sexual, incluida la disfunción eréctil (incapacidad para alcanzar o mantener una erección satisfactoria para la relación sexual) y la disminución de la libido (reducción del impulso sexual).",
                  "by": "ours"
                },
                "fr": {
                  "text": "Appareil reproducteur : dysfonction sexuelle, y compris dysfonction érectile (incapacité à obtenir ou à maintenir une érection suffisante pour un rapport sexuel) et baisse de la libido (diminution du désir sexuel).",
                  "by": "ours"
                },
                "it": {
                  "text": "Apparato riproduttivo: disfunzione sessuale, tra cui disfunzione erettile (incapacità di raggiungere o mantenere un’erezione soddisfacente per il rapporto sessuale) e calo della libido (riduzione dell’impulso sessuale).",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र: सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष (यौन संबंध के लिए काफ़ी इरेक्शन न हो पाना या उसे बनाए न रख पाना) और कामेच्छा में कमी (यौन इच्छा कम होना) शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "list-introduction",
              "kind": "qualification",
              "section": [
                "8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR?"
              ],
              "since": null,
              "qualifies": "listed",
              "lang": "pt-BR",
              "text": "Os eventos adversos listados a seguir refletem a experiência de estudos de investigação e de pós-comercialização. A relação de alguns desses eventos com a terapia com Roacutan® é desconhecida.",
              "officialVersions": [],
              "translations": {
                "en": {
                  "text": "The adverse events listed below reflect experience from investigational studies and from post-marketing use. The relationship of some of these events to therapy with Roacutan® is unknown.",
                  "by": "ours"
                },
                "de": {
                  "text": "Die im Folgenden aufgeführten unerwünschten Ereignisse spiegeln die Erfahrungen aus klinischen Prüfungen und aus der Zeit nach der Markteinführung wider. Der Zusammenhang einiger dieser Ereignisse mit der Behandlung mit Roacutan® ist nicht bekannt.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los acontecimientos adversos que se enumeran a continuación reflejan la experiencia de estudios de investigación y de poscomercialización. Se desconoce la relación de algunos de estos acontecimientos con el tratamiento con Roacutan®.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les événements indésirables énumérés ci-dessous reflètent l’expérience issue des études de recherche et de la période après commercialisation. Le lien entre certains de ces événements et le traitement par Roacutan® est inconnu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli eventi avversi elencati di seguito riflettono l’esperienza degli studi sperimentali e della fase successiva alla commercializzazione. La relazione di alcuni di questi eventi con la terapia con Roacutan® non è nota.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे दी गई प्रतिकूल घटनाएँ शोध अध्ययनों के अनुभव और दवा के बाज़ार में आने के बाद के अनुभव को दिखाती हैं। इनमें से कुछ घटनाओं का Roacutan® से इलाज के साथ क्या संबंध है, यह ज्ञात नहीं है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "the leaflet was read in full for a sentence saying sexual side effects can continue after the medicine is stopped; it has the general sentence only",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyRegulatorBlocked",
              "text": {
                "en": "This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Die Datenbank der Arzneimittelbehörde hat unsere Anfragen abgelehnt (sie sperrt Zugriffe je nach Land; wir haben aus Dänemark angefragt).",
                "es": "Es la copia del propio laboratorio titular. La base de datos de la agencia del medicamento rechazó nuestras solicitudes (bloquea por país; las hicimos desde Dinamarca).",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. O banco de dados da agência reguladora recusou os nossos pedidos de acesso (ele bloqueia por país; fizemos os pedidos a partir da Dinamarca).",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. La base de données de l’agence du médicament a refusé nos requêtes (elle bloque l’accès selon le pays ; nous avons essayé depuis le Danemark).",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. La banca dati dell’agenzia del farmaco ha rifiutato le nostre richieste (blocca gli accessi in base al Paese; le abbiamo inviate dalla Danimarca).",
                "hi": "यह प्रति दवा कंपनी की अपनी है। नियामक के डेटाबेस ने हमारे अनुरोध नामंज़ूर कर दिए (वह देश के हिसाब से रोक लगाता है; हमने डेनमार्क से अनुरोध भेजे)।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-br-pro",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-br-pro",
          "reportUrl": "https://www.gov.br/pt-br/servicos/notificar-eventos-adversos-de-medicamentos-e-vacinas-no-vigimed",
          "jurisdiction": "br",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "country-block"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "Roacutan",
              "form": "cápsulas gelatinosas moles 20 mg",
              "holder": "Farmoquímica S/A"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://consultas.anvisa.gov.br/#/bulario/",
            "https://consultas.anvisa.gov.br/",
            "https://www.anvisa.gov.br/datavisa/fila_bula/index.asp"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-in",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-in",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "ISOTROIN Capsules (Isotretinoin Capsules)",
            "lang": "en-IN",
            "product": {
              "name": "Isotroin",
              "form": "capsules",
              "holder": "Cipla Ltd."
            },
            "source": {
              "type": "holder",
              "name": "Cipla (ciplamed.com)"
            },
            "url": "https://www.ciplamed.com/product-index/isotroin-capsules",
            "fetchedUrl": null,
            "textDate": "2021-11-15",
            "textDateKind": "revision",
            "textDateAsPrinted": "DATE OF REVISION 15/11/2021"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "CLINICAL PARTICULARS",
                "Undesirable Effects",
                "Dose Relationship"
              ],
              "since": null,
              "lang": "en-IN",
              "text": "Most adverse reactions reported in clinical trials with isotretinoin were reversible when therapy was discontinued; however, some persisted after cessation of therapy.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die meisten Nebenwirkungen, die in klinischen Studien mit Isotretinoin gemeldet wurden, klangen ab, wenn die Behandlung abgesetzt wurde; manche blieben jedoch nach dem Ende der Behandlung bestehen.",
                  "by": "ours"
                },
                "es": {
                  "text": "La mayoría de las reacciones adversas notificadas en los ensayos clínicos con isotretinoína fueron reversibles al interrumpir el tratamiento; sin embargo, algunas persistieron tras el cese del tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A maioria das reações adversas relatadas em ensaios clínicos com isotretinoína foi reversível quando a terapia foi descontinuada; no entanto, algumas persistiram após a interrupção da terapia.",
                  "by": "ours"
                },
                "fr": {
                  "text": "La plupart des effets indésirables signalés dans les essais cliniques menés avec l’isotrétinoïne ont été réversibles à l’arrêt du traitement ; certains ont toutefois persisté après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "La maggior parte delle reazioni avverse segnalate negli studi clinici con isotretinoina è risultata reversibile con l’interruzione della terapia; alcune, tuttavia, sono persistite dopo la cessazione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन के क्लिनिकल ट्रायल में रिपोर्ट हुए ज़्यादातर साइड इफ़ेक्ट इलाज बंद करने पर ठीक हो गए; हालाँकि, कुछ इलाज बंद होने के बाद भी बने रहे।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "CLINICAL PARTICULARS",
                "Undesirable Effects",
                "Clinical Trials and Postmarketing Surveillance"
              ],
              "since": null,
              "lang": "en-IN",
              "text": "Reproductive System: Abnormal menses, sexual dysfunction including erectile dysfunction and decreased libido.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Fortpflanzungssystem: Menstruationsstörungen, sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido.",
                  "by": "ours"
                },
                "es": {
                  "text": "Aparato reproductor: menstruación anormal, disfunción sexual que incluye disfunción eréctil y disminución de la libido.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Sistema reprodutivo: menstruação anormal, disfunção sexual, incluindo disfunção erétil e diminuição da libido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Appareil reproducteur : règles anormales, dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido.",
                  "by": "ours"
                },
                "it": {
                  "text": "Apparato riproduttivo: mestruazioni anomale, disfunzione sessuale, tra cui disfunzione erettile e calo della libido.",
                  "by": "ours"
                },
                "hi": {
                  "text": "प्रजनन तंत्र: असामान्य माहवारी, सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "list-introduction",
              "kind": "qualification",
              "section": [
                "CLINICAL PARTICULARS",
                "Undesirable Effects",
                "Clinical Trials and Postmarketing Surveillance"
              ],
              "since": null,
              "qualifies": "listed",
              "lang": "en-IN",
              "text": "The adverse reactions listed below reflect experience from investigational studies of isotretinoin, and the postmarketing experience. The relationship of some of these events to isotretinoin therapy is unknown.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die unten aufgeführten Nebenwirkungen spiegeln die Erfahrungen aus klinischen Prüfungen mit Isotretinoin und aus der Zeit nach der Markteinführung wider. Der Zusammenhang einiger dieser Ereignisse mit der Isotretinoin-Behandlung ist nicht bekannt.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las reacciones adversas que se enumeran a continuación reflejan la experiencia de los estudios de investigación con isotretinoína y la experiencia poscomercialización. Se desconoce la relación de algunos de estos acontecimientos con el tratamiento con isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "As reações adversas listadas a seguir refletem a experiência de estudos de investigação com isotretinoína e a experiência pós-comercialização. A relação de alguns desses eventos com a terapia com isotretinoína é desconhecida.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables énumérés ci-dessous reflètent l’expérience issue des études de recherche sur l’isotrétinoïne et l’expérience acquise après commercialisation. Le lien entre certains de ces événements et le traitement par isotrétinoïne est inconnu.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le reazioni avverse elencate di seguito riflettono l’esperienza degli studi sperimentali sull’isotretinoina e l’esperienza post-marketing. La relazione di alcuni di questi eventi con la terapia con isotretinoina non è nota.",
                  "by": "ours"
                },
                "hi": {
                  "text": "नीचे दिए गए साइड इफ़ेक्ट आइसोट्रेटिनॉइन के शोध अध्ययनों के अनुभव को, और दवा के बाज़ार में आने के बाद के अनुभव को दिखाते हैं। इनमें से कुछ घटनाओं का आइसोट्रेटिनॉइन से इलाज के साथ क्या संबंध है, यह ज्ञात नहीं है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "sexual, erectile, libido, persist, discontinu, after stopping, continue, long-lasting, vagin, gynaecom/gynecom, cessation, reversib, resolve",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyNoDatabase",
              "text": {
                "en": "This is the holder's own copy. This regulator publishes no database of such texts.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Diese Arzneimittelbehörde veröffentlicht keine Datenbank mit solchen Texten.",
                "es": "Es la copia del propio laboratorio titular. Esta agencia del medicamento no publica ninguna base de datos de estos textos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. Esta agência reguladora não publica um banco de dados com esses textos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. Cette agence ne publie aucune base de données de ces textes.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. Questa agenzia del farmaco non pubblica una banca dati di questi testi.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। इस देश का दवा नियामक ऐसे दस्तावेज़ों का कोई डेटाबेस प्रकाशित नहीं करता।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-in-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-in-leaflet",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "PATIENT INFORMATION LEAFLET: PATIENT COUNSELLING INFORMATION (ISOTROIN)",
            "lang": "en-IN",
            "product": {
              "name": "Isotroin",
              "form": null,
              "holder": "Cipla Ltd."
            },
            "source": {
              "type": "holder",
              "name": "Cipla (ciplamed.com)"
            },
            "url": "https://www.ciplamed.com/explore/patienteducationmaterial/isotretinoin-patient-information-leaflet",
            "fetchedUrl": "https://www.ciplamed.com/-/media/ciplamed/contentmigration/patient-education/pdf/isotretinoin--patient-information-leaflet.pdf",
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": "the English block of the leaflet was read in full; it has no section on side effects and does not mention sexual function",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "holderCopyNoDatabase",
              "text": {
                "en": "This is the holder's own copy. This regulator publishes no database of such texts.",
                "de": "Das ist der Text, wie ihn der Zulassungsinhaber selbst veröffentlicht. Diese Arzneimittelbehörde veröffentlicht keine Datenbank mit solchen Texten.",
                "es": "Es la copia del propio laboratorio titular. Esta agencia del medicamento no publica ninguna base de datos de estos textos.",
                "pt-br": "Esta é a cópia da própria empresa titular do registro. Esta agência reguladora não publica um banco de dados com esses textos.",
                "fr": "C’est le texte tel que le laboratoire titulaire le publie lui-même. Cette agence ne publie aucune base de données de ces textes.",
                "it": "Questa è la copia pubblicata dal titolare dell’autorizzazione. Questa agenzia del farmaco non pubblica una banca dati di questi testi.",
                "hi": "यह प्रति दवा कंपनी की अपनी है। इस देश का दवा नियामक ऐसे दस्तावेज़ों का कोई डेटाबेस प्रकाशित नहीं करता।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-in-regulator",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-in-regulator",
          "reportUrl": "https://ipc.gov.in/mandates/pvpi/adr-reporting/8-category-en/430-adr-reporting-form-for-consumers-in-hindi-other-vernacular-languages.html",
          "jurisdiction": "in",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Safety guidelines for Isotretinoin - Regarding",
            "lang": "en-IN",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "CDSCO"
            },
            "url": "https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Isotretinoinlates.pdf",
            "fetchedUrl": null,
            "textDate": "2018-12-19",
            "textDateKind": "publication",
            "textDateAsPrinted": "19.12.2018"
          },
          "passages": [],
          "searched": "sexual, erectile, libido, impoten, persist, after stopping, after I stop, continu, long-lasting, go away, permanent, side effect",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ie",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ie",
          "reportUrl": "https://forms.hpra.ie/Human-And-Covid-Report-Form/",
          "jurisdiction": "ie",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Summary of Product Characteristics",
            "lang": "en-IE",
            "product": {
              "name": "Roaccutane",
              "form": "20 mg soft capsules",
              "holder": "Cheplapharm Registration GmbH"
            },
            "source": {
              "type": "regulator-database",
              "name": "Health Products Regulatory Authority (HPRA)"
            },
            "url": "https://assets.hpra.ie/products/Human/30769/Licence_PA25306-001-002_17072026113849.pdf",
            "fetchedUrl": null,
            "textDate": "2026-07",
            "textDateKind": "revision",
            "textDateAsPrinted": "10 DATE OF REVISION OF THE TEXT: July 2026"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4.8 Undesirable effects",
                "Summary of safety profile"
              ],
              "since": null,
              "lang": "en-IE",
              "text": "The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento, pero algunos pueden persistir una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis após a alteração da dose ou a interrupção do tratamento, mas alguns podem persistir depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni, comunque, possono persistere dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4.8 Undesirable effects",
                "Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin",
                "Reproductive system and breast disorders",
                "Not known*"
              ],
              "since": null,
              "lang": "en-IE",
              "text": "Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, vulvovaginale Trockenheit",
                  "by": "ours"
                },
                "es": {
                  "text": "Disfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Disfunção sexual, incluindo disfunção erétil e diminuição da libido, ginecomastia, ressecamento vulvovaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Dysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido, gynécomastie, sécheresse vulvo-vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, वल्वा और योनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "Sexual function: sexual, sex, libido, erect, impoten, orgasm, anorgasm, ejaculat, arous, genital, vagin, vulv, lubricat, gynaecomast/gynecomast, breast, reproductive, fertil, sperm, semen, testosterone, intercourse, desire, sex drive, intima, penis, penile, testic, menstr, pleasure, numb. Persistence: persist, continu, discontinu, cessation, withdraw, stopp, after treatment, after therapy, following treatment, post-treatment, irreversib, revers, permanent, long-term, long term, long-lasting, long lasting, lasting, prolong, endur, remain, resolv, recover, sequela, chronic, alleviat, go away, not improve, specialist.",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-ie-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-ie-leaflet",
          "reportUrl": "https://forms.hpra.ie/Human-And-Covid-Report-Form/",
          "jurisdiction": "ie",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Package leaflet: Information for the user",
            "lang": "en-IE",
            "product": {
              "name": "Roaccutane",
              "form": "10 mg and 20 mg soft capsules",
              "holder": "CHEPLAPHARM Registration GmbH"
            },
            "source": {
              "type": "regulator-database",
              "name": "Health Products Regulatory Authority (HPRA)"
            },
            "url": "https://assets.hpra.ie/products/Human/30769/cf6d47b9-959d-4fb7-8a7b-572daac60b53.pdf",
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "4. Possible side effects"
              ],
              "since": null,
              "lang": "en-IE",
              "text": "The side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder nach Beendigung der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "Los efectos secundarios son generalmente reversibles tras cambiar la dosis o interrumpir el tratamiento; sin embargo, algunos pueden continuar una vez interrumpido el tratamiento.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis depois de mudar a dose ou interromper o tratamento, mas alguns podem continuar depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent continuer après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o l’interruzione del trattamento, alcuni, comunque, possono continuare dopo la sospensione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी जारी रह सकते हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "4. Possible side effects",
                "Unknown frequency: (frequency cannot be estimated from the available data)"
              ],
              "since": null,
              "lang": "en-IE",
              "text": "Problems getting or maintaining an erection\nLower libido\nBreast swelling with or without tenderness in males\nVaginal dryness",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Schwierigkeiten, eine Erektion zu bekommen oder aufrechtzuerhalten\nSchwächere Libido\nBrustschwellung bei Männern mit oder ohne Druckempfindlichkeit\nScheidentrockenheit",
                  "by": "ours"
                },
                "es": {
                  "text": "Problemas para conseguir o mantener una erección\nDisminución de la libido\nInflamación de los senos con o sin sensibilidad en los hombres\nSequedad vaginal",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Problemas para ter ou manter uma ereção\nQueda da libido\nInchaço das mamas, com ou sem sensibilidade, em homens\nRessecamento vaginal",
                  "by": "ours"
                },
                "fr": {
                  "text": "Problèmes d’obtention ou de maintien d’une érection\nBaisse de la libido\nGonflement des seins chez les hommes, avec ou sans sensibilité\nSécheresse vaginale",
                  "by": "ours"
                },
                "it": {
                  "text": "Problemi a raggiungere o mantenere l’erezione\nCalo della libido\nIngrossamento delle mammelle con o senza dolorabilità negli uomini\nSecchezza vaginale",
                  "by": "ours"
                },
                "hi": {
                  "text": "इरेक्शन होने या बनाए रखने में समस्या\nकामेच्छा में कमी\nपुरुषों में स्तनों में सूजन, छूने पर दर्द के साथ या उसके बिना\nयोनि में सूखापन",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "Sexual function: sexual, sex, libido, erect, impoten, orgasm, anorgasm, ejaculat, arous, genital, vagin, vulv, lubricat, gynaecomast/gynecomast, breast, reproductive, fertil, sperm, semen, testosterone, intercourse, desire, sex drive, intima, penis, penile, testic, menstr, pleasure, numb. Persistence: persist, continu, discontinu, cessation, withdraw, stopp, after treatment, after therapy, following treatment, post-treatment, irreversib, revers, permanent, long-term, long term, long-lasting, long lasting, lasting, prolong, endur, remain, resolv, recover, sequela, chronic, alleviat, go away, not improve, specialist.",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "corrected"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-sa",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-sa",
          "reportUrl": "https://ade.sfda.gov.sa/",
          "jurisdiction": "sa",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Direct Healthcare Professional Communication: Isotretinoin (Roaccutane®) – Important Safety Information on Psychiatric and Sexual Disorders",
            "lang": "en",
            "product": {
              "name": "Roaccutane",
              "form": "capsules",
              "holder": "CHEPLAPHARM Schweiz GmbH"
            },
            "source": {
              "type": "regulator-site",
              "name": "Saudi Food and Drug Authority (SFDA)"
            },
            "url": "https://www.sfda.gov.sa/sites/default/files/2026-08/20260202%20DHPC%20Psychiatric%20Disorders%20SA_clean.pdf",
            "fetchedUrl": null,
            "textDate": "2026-02-02",
            "textDateKind": "dated",
            "textDateAsPrinted": "Date: 02/Feb/2026"
          },
          "passages": [
            {
              "key": "summary",
              "kind": "sexual-persistence",
              "section": [
                "Summary"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en",
              "text": "Discontinuation of isotretinoin may not always resolve psychiatric or sexual disorders.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Das Absetzen von Isotretinoin behebt psychiatrische oder sexuelle Störungen möglicherweise nicht immer.",
                  "by": "ours"
                },
                "es": {
                  "text": "La interrupción de la isotretinoína puede no resolver siempre los trastornos psiquiátricos o sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A descontinuação da isotretinoína pode nem sempre resolver os distúrbios psiquiátricos ou sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’arrêt de l’isotrétinoïne peut ne pas toujours faire disparaître les troubles psychiatriques ou sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’interruzione dell’isotretinoina potrebbe non risolvere sempre i disturbi psichiatrici o sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "हो सकता है कि आइसोट्रेटिनॉइन बंद करने से मानसिक या यौन समस्याएँ हमेशा ठीक न हों।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Further information on the safety concerns and recommendations",
                "Sexual disorders"
              ],
              "since": null,
              "lang": "en",
              "text": "Post-marketing reports describe sexual dysfunction including erectile dysfunction and decreased libido, gynecomastia and vulvovaginal dryness in patients treated with isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Berichte nach der Markteinführung beschreiben sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie und vulvovaginale Trockenheit bei Patientinnen und Patienten, die mit Isotretinoin behandelt wurden.",
                  "by": "ours"
                },
                "es": {
                  "text": "Las notificaciones poscomercialización describen disfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia y sequedad vulvovaginal en pacientes tratados con isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Relatos pós-comercialização descrevem disfunção sexual, incluindo disfunção erétil e diminuição da libido, ginecomastia e ressecamento vulvovaginal em pacientes tratados com isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Des signalements après commercialisation décrivent un dysfonctionnement sexuel, y compris un dysfonctionnement érectile et une baisse de la libido, une gynécomastie et une sécheresse vulvo-vaginale chez des patients traités par isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Le segnalazioni post-marketing descrivono disfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia e secchezza vulvovaginale in pazienti trattati con isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "दवा के बाज़ार में आने के बाद की रिपोर्टों में, आइसोट्रेटिनॉइन से जिन मरीज़ों का इलाज हुआ, उनमें इन समस्याओं का ज़िक्र है: सेक्शुअल डिस्फ़ंक्शन, जिसमें स्तंभन दोष और कामेच्छा में कमी शामिल हैं, गाइनेकोमास्टिया, और वल्वा और योनि में सूखापन।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence",
              "kind": "sexual-persistence",
              "section": [
                "Further information on the safety concerns and recommendations",
                "Sexual disorders"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en",
              "text": "These events may persist after discontinuation, and in such cases, further specialist evaluation is recommended.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Diese Ereignisse können nach dem Absetzen fortbestehen, und in solchen Fällen wird eine weitere fachärztliche Untersuchung empfohlen.",
                  "by": "ours"
                },
                "es": {
                  "text": "Estos acontecimientos pueden persistir tras la interrupción y, en esos casos, se recomienda una evaluación adicional por un especialista.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Esses eventos podem persistir após a descontinuação e, nesses casos, recomenda-se uma avaliação adicional com especialista.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Ces événements peuvent persister après l’arrêt et, dans ce cas, une évaluation complémentaire par un spécialiste est recommandée.",
                  "by": "ours"
                },
                "it": {
                  "text": "Questi eventi possono persistere dopo l’interruzione e, in tali casi, si raccomanda un’ulteriore valutazione specialistica.",
                  "by": "ours"
                },
                "hi": {
                  "text": "ये घटनाएँ दवा बंद करने के बाद भी बनी रह सकती हैं, और ऐसे मामलों में किसी विशेषज्ञ से आगे जाँच करवाने की सलाह दी जाती है।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "companyLetter",
              "text": {
                "en": "The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.",
                "de": "Am Anfang des Briefs steht, er sei in Abstimmung mit der Arzneimittelbehörde verfasst worden. Die Worte sind die des Unternehmens, und der Brief ist nicht der Text des Produkts.",
                "es": "La carta empieza diciendo que se escribió de acuerdo con la agencia del medicamento. Las palabras son de la empresa, y no es el texto del propio producto.",
                "pt-br": "A carta começa dizendo que foi escrita em acordo com a agência reguladora. As palavras são da empresa, e a carta não é a bula do produto.",
                "fr": "La lettre commence par indiquer qu’elle a été rédigée en accord avec l’agence du médicament. Les mots sont ceux du laboratoire, et ce n’est pas le texte du produit lui-même.",
                "it": "La lettera si apre dicendo di essere stata scritta in accordo con l’agenzia del farmaco. Le parole sono dell’azienda, e non si tratta del testo del prodotto.",
                "hi": "पत्र की शुरुआत में लिखा है कि यह नियामक की सहमति से लिखा गया। शब्द कंपनी के हैं, और यह दवा का अपना दस्तावेज़ नहीं है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-sa-pro",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-sa-pro",
          "reportUrl": "https://ade.sfda.gov.sa/",
          "jurisdiction": "sa",
          "kind": "professional",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "no-answer"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "ROACCUTANE",
              "form": "20MG CAPS",
              "holder": "CHEPLAPHARM Arzneimittel GmbH"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://sdi.sfda.gov.sa/",
            "https://sdi.sfda.gov.sa/Home/Index",
            "https://sdi.sfda.gov.sa/home/Result?drugId=1"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-sa-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-sa-leaflet",
          "reportUrl": "https://ade.sfda.gov.sa/",
          "jurisdiction": "sa",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "could-not-open",
          "accessReason": [
            "no-answer"
          ],
          "document": {
            "name": null,
            "lang": null,
            "product": {
              "name": "ROACCUTANE",
              "form": "20MG CAPS",
              "holder": "CHEPLAPHARM Arzneimittel GmbH"
            },
            "source": null,
            "url": null,
            "fetchedUrl": null,
            "textDate": null,
            "textDateKind": "none",
            "textDateAsPrinted": null
          },
          "passages": [],
          "searched": null,
          "tried": [
            "https://sdi.sfda.gov.sa/",
            "https://sdi.sfda.gov.sa/Home/Index",
            "https://sdi.sfda.gov.sa/home/Result?drugId=1"
          ],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-unopenable"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-sa-regulator-ruatine",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-sa-regulator-ruatine",
          "reportUrl": "https://ade.sfda.gov.sa/",
          "jurisdiction": "sa",
          "kind": "regulator-communication",
          "issuer": "company",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Direct Healthcare Professional Communication (DHPC)",
            "lang": "en",
            "product": {
              "name": "Ruatine",
              "form": "capsules",
              "holder": "MS Pharma"
            },
            "source": {
              "type": "regulator-site",
              "name": "Saudi Food and Drug Authority (SFDA)"
            },
            "url": "https://www.sfda.gov.sa/sites/default/files/2025-03/DHPC%20for%20Ruatine%C2%AE%20%28Isotretinoin%29.pdf",
            "fetchedUrl": null,
            "textDate": "2025-03",
            "textDateKind": "publication",
            "textDateAsPrinted": "1.0 – Mar 2025"
          },
          "passages": [],
          "searched": "Read in full (2 pages). Sexual function: sexual, sex, libido, erect, impoten, orgasm, anorgasm, ejaculat, arous, genital, vagin, vulv, lubricat, gynaecomast/gynecomast, breast, reproductive, fertil, sperm, semen, testosterone, intercourse, desire, sex drive, intima, penis, penile, testic, menstr, pleasure, numb. Persistence: persist, continu, discontinu, cessation, withdraw, stopp, after treatment, after therapy, following treatment, post-treatment, irreversib, revers, permanent, long-term, long term, long-lasting, long lasting, lasting, prolong, endur, remain, resolv, recover, sequela, chronic, alleviat, go away, not improve, specialist.",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "confirmed-absent"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-my",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-my",
          "reportUrl": "https://www.npra.gov.my/index.php/en/consumers/reporting/reporting-side-effects-to-medicines-conserf-or-vaccines-aefi-2.html",
          "jurisdiction": "my",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction",
            "lang": "en-MY",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "National Pharmaceutical Regulatory Agency (NPRA)"
            },
            "url": "https://www.npra.gov.my/index.php/en/component/content/article/449-english/safety-alerts-main/safety-alerts-2023/1527528-isotretinoin-risk-of-psychiatric-disorders-and-sexual-dysfunction.html",
            "fetchedUrl": null,
            "textDate": "2023-10-13",
            "textDateKind": "publication",
            "textDateAsPrinted": "13 October 2023"
          },
          "passages": [
            {
              "key": "listed",
              "kind": "sexual-side-effects",
              "section": [
                "Background of the Safety Issue",
                "Sexual dysfunction"
              ],
              "since": null,
              "lang": "en-MY",
              "text": "Sexual dysfunction including erectile dysfunction, decreased libido, vulvovaginal dryness, difficulties achieving orgasm, and reduced sensation in the genital area have also been reported following isotretinoin use.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Sexuelle Funktionsstörungen, darunter erektile Dysfunktion, verminderte Libido, vulvovaginale Trockenheit, Schwierigkeiten, einen Orgasmus zu erreichen, und vermindertes Empfinden im Genitalbereich, wurden nach der Anwendung von Isotretinoin ebenfalls gemeldet.",
                  "by": "ours"
                },
                "es": {
                  "text": "También se ha notificado disfunción sexual, que incluye disfunción eréctil, disminución de la libido, sequedad vulvovaginal, dificultades para alcanzar el orgasmo y reducción de la sensibilidad en la zona genital, tras el uso de isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Também foram relatados, após o uso de isotretinoína, disfunção sexual, incluindo disfunção erétil, diminuição da libido, ressecamento vulvovaginal, dificuldade para atingir o orgasmo e redução da sensibilidade na região genital.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Une dysfonction sexuelle, notamment une dysfonction érectile, une baisse de la libido, une sécheresse vulvo-vaginale, des difficultés à atteindre l’orgasme et une diminution de la sensibilité dans la région génitale, a également été signalée après l’utilisation de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Dopo l’uso di isotretinoina sono stati segnalati anche casi di disfunzione sessuale, tra cui disfunzione erettile, calo della libido, secchezza vulvovaginale, difficoltà a raggiungere l’orgasmo e ridotta sensibilità nella zona genitale.",
                  "by": "ours"
                },
                "hi": {
                  "text": "आइसोट्रेटिनॉइन के इस्तेमाल के बाद सेक्शुअल डिस्फ़ंक्शन भी रिपोर्ट हुआ है, जिसमें स्तंभन दोष, कामेच्छा में कमी, वल्वा और योनि में सूखापन, ऑर्गेज़्म तक पहुँचने में दिक्कत और जननांगों के हिस्से में संवेदना कम होना शामिल हैं।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-background",
              "kind": "sexual-persistence",
              "section": [
                "Background of the Safety Issue",
                "Sexual dysfunction"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-MY",
              "text": "Some cases have also reported persistent sexual dysfunction even after discontinuing isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "In einigen Fällen wurden zudem anhaltende sexuelle Funktionsstörungen selbst nach dem Absetzen von Isotretinoin gemeldet.",
                  "by": "ours"
                },
                "es": {
                  "text": "En algunos casos también se ha notificado disfunción sexual persistente incluso después de interrumpir la isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Alguns casos também relataram disfunção sexual persistente mesmo após a descontinuação da isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Certains cas ont également fait état d’une dysfonction sexuelle persistante, même après l’arrêt de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "In alcuni casi è stata inoltre segnalata una disfunzione sessuale persistente anche dopo l’interruzione dell’isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "कुछ मामलों में आइसोट्रेटिनॉइन बंद करने के बाद भी बने रहने वाला सेक्शुअल डिस्फ़ंक्शन भी रिपोर्ट हुआ है।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "causality",
              "kind": "qualification",
              "section": [
                "Background of the Safety Issue"
              ],
              "since": null,
              "qualifies": "persistence-background",
              "lang": "en-MY",
              "text": "The in-depth safety review by the IEWG of the CHM concluded that the currently available data is unable to definitively confirm that isotretinoin caused the psychiatric and sexual side effects.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die eingehende Sicherheitsüberprüfung durch die IEWG der CHM kam zu dem Schluss, dass die derzeit verfügbaren Daten nicht eindeutig bestätigen können, dass Isotretinoin die psychiatrischen und sexuellen Nebenwirkungen verursacht hat.",
                  "by": "ours"
                },
                "es": {
                  "text": "La revisión de seguridad en profundidad del IEWG de la CHM concluyó que los datos actualmente disponibles no permiten confirmar de forma definitiva que la isotretinoína causara los efectos secundarios psiquiátricos y sexuales.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "A revisão de segurança aprofundada feita pelo IEWG da CHM concluiu que os dados disponíveis atualmente não permitem confirmar de forma definitiva que a isotretinoína causou os efeitos colaterais psiquiátricos e sexuais.",
                  "by": "ours"
                },
                "fr": {
                  "text": "L’examen de sécurité approfondi mené par l’IEWG de la CHM a conclu que les données actuellement disponibles ne permettent pas de confirmer de façon certaine que l’isotrétinoïne a causé les effets indésirables psychiatriques et sexuels.",
                  "by": "ours"
                },
                "it": {
                  "text": "L’approfondita revisione di sicurezza dell’IEWG della CHM ha concluso che i dati attualmente disponibili non sono in grado di confermare con certezza che l’isotretinoina abbia causato gli effetti indesiderati psichiatrici e sessuali.",
                  "by": "ours"
                },
                "hi": {
                  "text": "CHM के IEWG की गहराई से की गई सुरक्षा समीक्षा का निष्कर्ष था कि फ़िलहाल उपलब्ध आँकड़े निश्चित रूप से इसकी पुष्टि नहीं कर सकते कि मानसिक और यौन साइड इफ़ेक्ट आइसोट्रेटिनॉइन की वजह से हुए।",
                  "by": "ours"
                }
              }
            },
            {
              "key": "persistence-advice",
              "kind": "sexual-persistence",
              "section": [
                "Advice for Health Care Providers"
              ],
              "since": null,
              "inWarnings": false,
              "lang": "en-MY",
              "text": "Be vigilant as there are reported cases of persistent sexual dysfunction even after the discontinuation of isotretinoin.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Seien Sie wachsam, denn es gibt gemeldete Fälle anhaltender sexueller Funktionsstörungen selbst nach dem Absetzen von Isotretinoin.",
                  "by": "ours"
                },
                "es": {
                  "text": "Manténgase alerta, ya que hay casos notificados de disfunción sexual persistente incluso después de la interrupción de la isotretinoína.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Mantenha-se vigilante, pois há casos relatados de disfunção sexual persistente mesmo após a descontinuação da isotretinoína.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Soyez vigilants, car il existe des cas signalés de dysfonction sexuelle persistante, même après l’arrêt de l’isotrétinoïne.",
                  "by": "ours"
                },
                "it": {
                  "text": "Vigilare, poiché ci sono casi segnalati di disfunzione sessuale persistente anche dopo l’interruzione dell’isotretinoina.",
                  "by": "ours"
                },
                "hi": {
                  "text": "सतर्क रहें, क्योंकि आइसोट्रेटिनॉइन बंद करने के बाद भी बने रहने वाले सेक्शुअल डिस्फ़ंक्शन के मामले रिपोर्ट हुए हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": null,
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": [
            {
              "key": "alertNoOrder",
              "text": {
                "en": "This is a safety alert for health professionals. It does not order a change to product texts about sexual function.",
                "de": "Dies ist eine Sicherheitsmitteilung für medizinische Fachleute. Sie ordnet keine Änderung der Produkttexte zur sexuellen Funktion an.",
                "es": "Es una alerta de seguridad para profesionales sanitarios. No ordena ningún cambio en los textos de los productos sobre la función sexual.",
                "pt-br": "Este é um alerta de segurança para profissionais de saúde. Ele não determina nenhuma mudança nas bulas quanto à função sexual.",
                "fr": "C’est une alerte de sécurité destinée aux professionnels de santé. Elle n’ordonne aucune modification des textes des produits au sujet de la fonction sexuelle.",
                "it": "Questo è un avviso di sicurezza per i professionisti sanitari. Non dispone nessuna modifica dei testi dei prodotti riguardo alla funzione sessuale.",
                "hi": "यह डॉक्टरों और दूसरे स्वास्थ्यकर्मियों के लिए सुरक्षा अलर्ट है। यह यौन क्रिया के बारे में दवा के दस्तावेज़ बदलने का आदेश नहीं देता।"
              }
            },
            {
              "key": "ukReviewReported",
              "text": {
                "en": "The sentence about the UK review (“unable to definitively confirm”) reports the conclusion of a UK expert group (the Isotretinoin Expert Working Group of the Commission on Human Medicines). It is not the Malaysian regulator's own conclusion.",
                "de": "Der Satz über die britische Überprüfung („nicht eindeutig bestätigen können“) gibt wieder, zu welchem Schluss eine britische Expertengruppe kam (die Isotretinoin Expert Working Group der Commission on Human Medicines). Es ist nicht die eigene Schlussfolgerung der malaysischen Arzneimittelbehörde.",
                "es": "La frase sobre la revisión británica («no permiten confirmar de forma definitiva») recoge la conclusión de un grupo de expertos británico (el Isotretinoin Expert Working Group de la Commission on Human Medicines). No es una conclusión propia de la agencia del medicamento de Malasia.",
                "pt-br": "A frase sobre a revisão britânica (“unable to definitively confirm”; na nossa tradução, “não permitem confirmar de forma definitiva”) relata a conclusão de um grupo britânico de especialistas (o Isotretinoin Expert Working Group da Commission on Human Medicines). Não é uma conclusão da própria agência reguladora da Malásia.",
                "fr": "La phrase sur l’examen britannique (« ne permettent pas de confirmer de façon certaine ») reprend la conclusion d’un groupe d’experts britannique (l’Isotretinoin Expert Working Group de la Commission on Human Medicines). Ce n’est pas la conclusion de l’agence malaisienne du médicament elle-même.",
                "it": "La frase sulla revisione britannica («non sono in grado di confermare con certezza») riferisce la conclusione di un gruppo di esperti britannico (l’Isotretinoin Expert Working Group della Commission on Human Medicines). Non è una conclusione dell’agenzia del farmaco malese.",
                "hi": "ब्रिटेन की समीक्षा वाला वाक्य (“निश्चित रूप से इसकी पुष्टि नहीं कर सकते”) ब्रिटेन के एक विशेषज्ञ समूह का निष्कर्ष बताता है (Commission on Human Medicines का Isotretinoin Expert Working Group)। यह मलेशिया के नियामक का अपना निष्कर्ष नहीं है।"
              }
            },
            {
              "key": "productTextsListNone",
              "text": {
                "en": "The package insert and patient leaflet we read for one product in this country list no sexual side effect.",
                "de": "Die Fachinformation und die Packungsbeilage, die wir zu einem Produkt in diesem Land gelesen haben, führen keine sexuelle Nebenwirkung auf.",
                "es": "El texto para profesionales (package insert) y el prospecto que hemos leído de un producto de este país no recogen ningún efecto secundario sexual.",
                "pt-br": "A bula para o profissional de saúde e a bula para pacientes que lemos de um produto neste país não listam nenhum efeito colateral sexual.",
                "fr": "Le texte destiné aux professionnels et la notice destinée aux patients que nous avons lus pour un produit de ce pays ne citent aucun effet secondaire sexuel.",
                "it": "Il testo per i professionisti sanitari (package insert) e il foglio illustrativo che abbiamo letto per un prodotto di questo Paese non elencano nessun effetto collaterale sessuale.",
                "hi": "इस देश में एक उत्पाद का जो package insert और मरीज़ों का लीफ़लेट हमने पढ़ा, उनमें कोई यौन साइड इफ़ेक्ट नहीं गिनाया गया है।"
              }
            }
          ]
        },
        {
          "id": "isotretinoin-my-pro",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-my-pro",
          "reportUrl": "https://www.npra.gov.my/index.php/en/consumers/reporting/reporting-side-effects-to-medicines-conserf-or-vaccines-aefi-2.html",
          "jurisdiction": "my",
          "kind": "professional",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Roaccutane® Isotretinoin",
            "lang": "en-MY",
            "product": {
              "name": "ROACCUTANE",
              "form": "CAPSULE 20MG",
              "holder": "ZUELLIG PHARMA SDN. BHD."
            },
            "source": {
              "type": "regulator-database",
              "name": "QUEST 3+ Product Search"
            },
            "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/791/pharma/210651/V_107683_20250530_164312_D3.pdf",
            "fetchedUrl": null,
            "textDate": "2025-04",
            "textDateKind": "revision",
            "textDateAsPrinted": "Revision date: April 2025"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "2.6 Undesirable Effects",
                "2.6.1 Clinical Trials",
                "Summary of Safety Profile"
              ],
              "since": null,
              "lang": "en-MY",
              "text": "The side effects are generally reversible after altering the dose or discontinuation of treatment, however, some may persist after treatment has stopped.",
              "officialVersions": [],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento, pero algunos pueden persistir una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis após a alteração da dose ou a interrupção do tratamento, mas alguns podem persistir depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni, comunque, possono persistere dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "Sexual function: sexual, sex, libido, erect, impoten, orgasm, anorgasm, ejaculat, arous, genital, vagin, vulv, lubricat, gynaecomast/gynecomast, breast, reproductive, fertil, sperm, semen, testosterone, intercourse, desire, sex drive, intima, penis, penile, testic, menstr, pleasure, numb. Persistence: persist, continu, discontinu, cessation, withdraw, stopp, after treatment, after therapy, following treatment, post-treatment, irreversib, revers, permanent, long-term, long term, long-lasting, long lasting, lasting, prolong, endur, remain, resolv, recover, sequela, chronic, alleviat, go away, not improve, specialist.",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-my-leaflet",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-my-leaflet",
          "reportUrl": "https://www.npra.gov.my/index.php/en/consumers/reporting/reporting-side-effects-to-medicines-conserf-or-vaccines-aefi-2.html",
          "jurisdiction": "my",
          "kind": "patient-leaflet",
          "issuer": null,
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Consumer Medication Information Leaflet (RiMUP): ROACCUTANE CAPSULE® Isotretinoin (10mg, 20mg)",
            "lang": "en-MY",
            "product": {
              "name": "ROACCUTANE",
              "form": "CAPSULE 20MG",
              "holder": "ZUELLIG PHARMA SDN. BHD."
            },
            "source": {
              "type": "regulator-database",
              "name": "QUEST 3+ Product Search"
            },
            "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/791/pharma/210651/V_107683_20250530_164325_D4.pdf",
            "fetchedUrl": null,
            "textDate": "2025-04-17",
            "textDateKind": "revision",
            "textDateAsPrinted": "Date of revision: 17 Apr 2025"
          },
          "passages": [
            {
              "key": "general",
              "kind": "general-persistence",
              "section": [
                "Side effects"
              ],
              "since": null,
              "lang": "en-MY",
              "text": "The side effects are generally reversible after altering the dose or discontinuation of treatment, however, some may persist after treatment has stopped.",
              "officialVersions": [
                {
                  "lang": "ms",
                  "section": [
                    "Kesan-kesan sampingan"
                  ],
                  "text": "Kesan sampingan secara amnya boleh berbalik selepas mengubah dos atau pemberhentian rawatan, namun ada yang mungkin berterusan selepas rawatan telah dihentikan."
                }
              ],
              "translations": {
                "de": {
                  "text": "Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.",
                  "by": "ours"
                },
                "es": {
                  "text": "En general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento, pero algunos pueden persistir una vez finalizado este.",
                  "by": "ours"
                },
                "pt-br": {
                  "text": "Os efeitos colaterais são geralmente reversíveis após a alteração da dose ou a interrupção do tratamento, mas alguns podem persistir depois que o tratamento é interrompido.",
                  "by": "ours"
                },
                "fr": {
                  "text": "Les effets indésirables sont généralement réversibles après une modification de la dose ou l’arrêt du traitement, mais certains peuvent persister après l’arrêt du traitement.",
                  "by": "ours"
                },
                "it": {
                  "text": "Gli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni, comunque, possono persistere dopo l’interruzione della terapia.",
                  "by": "ours"
                },
                "hi": {
                  "text": "साइड इफ़ेक्ट आम तौर पर डोज़ बदलने या इलाज बंद करने के बाद ठीक हो जाने वाले होते हैं, लेकिन कुछ इलाज बंद होने के बाद भी बने रह सकते हैं।",
                  "by": "ours"
                }
              }
            }
          ],
          "searched": "Sexual function: sexual, sex, libido, erect, impoten, orgasm, anorgasm, ejaculat, arous, genital, vagin, vulv, lubricat, gynaecomast/gynecomast, breast, reproductive, fertil, sperm, semen, testosterone, intercourse, desire, sex drive, intima, penis, penile, testic, menstr, pleasure, numb. Persistence: persist, continu, discontinu, cessation, withdraw, stopp, after treatment, after therapy, following treatment, post-treatment, irreversib, revers, permanent, long-term, long term, long-lasting, long lasting, lasting, prolong, endur, remain, resolv, recover, sequela, chronic, alleviat, go away, not improve, specialist.",
          "tried": [],
          "register": null,
          "officialVersions": [
            {
              "lang": "ms",
              "name": "Risalah Maklumat Ubat untuk Pengguna (RiMUP): ROACCUTANE CAPSULE® Isotretinoin (10mg, 20mg)",
              "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/791/pharma/210651/V_107683_20250530_164322_D4.pdf",
              "textDateAsPrinted": "Tarikh kemaskini RiMUP: 17 Apr 2025",
              "dateDiffers": false,
              "checked": "2026-10-13",
              "verified": {
                "date": "2026-10-13",
                "result": "exact"
              }
            }
          ],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
          "verified": {
            "date": "2026-10-13",
            "result": "exact"
          },
          "history": [
            {
              "date": "2026-10-13",
              "fields": [
                "added"
              ]
            }
          ],
          "retired": null,
          "notes": []
        },
        {
          "id": "isotretinoin-my-regulator-directive2019",
          "anchor": "https://sidefxhub.com/label-wording-by-country/#isotretinoin-my-regulator-directive2019",
          "reportUrl": "https://www.npra.gov.my/index.php/en/consumers/reporting/reporting-side-effects-to-medicines-conserf-or-vaccines-aefi-2.html",
          "jurisdiction": "my",
          "kind": "regulator-communication",
          "issuer": "regulator",
          "access": "opened",
          "accessReason": [],
          "document": {
            "name": "Arahan Pengarah Kanan Perkhidmatan Farmasi Bilangan 6 Tahun 2019: Direktif untuk semua produk yang mengandungi retinoid (oral): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan neuropsychiatric disorders",
            "lang": "ms",
            "product": null,
            "source": {
              "type": "regulator-site",
              "name": "National Pharmaceutical Regulatory Agency (NPRA)"
            },
            "url": "https://www.npra.gov.my/easyarticles/images/users/1048/gambar/DirektifBil6_2019.pdf",
            "fetchedUrl": null,
            "textDate": "2019-03-27",
            "textDateKind": "publication",
            "textDateAsPrinted": "Tarikh : 27 MAR 2019"
          },
          "passages": [],
          "searched": "The file is a scan with no text layer. All four pages were read as images, in Malay and English, for: seksual, seks, libido, zakar, ereksi, faraj, mati pucuk, berterusan, kekal, selepas rawatan, dihentikan; sexual, libido, erectile, vaginal, persist, after discontinuation, long-lasting.",
          "tried": [],
          "register": null,
          "officialVersions": [],
          "checked": "2026-10-13",
          "changed": "2026-10-13",
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            "result": "confirmed-absent"
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}