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Intended for UK patients and members of the public

Fluoxetine Capsules

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Fluoxetine 20mg Capsules

PL Number:
0142/0444
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To update section 5.1 of the SmPC in line with reference product, Prozac 20mg hard capsules (MA number: 34009 331008 9 6; MAH: Lilly France; dated: 22/01/2021). Consequently, the PIL has been updated. Additionally, the pharmacotherapeutic group name in SmPC section 5.1 has been updated in line with the WHO ATC Index and section 1 of the SmPC and the PIL have been updated in line with QRD template. The PIL headline has also been updated in line with MHRA guidelines for SSRIs (‘Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines’ (September 2019)) and editorial updates have been made to the PIL.

    SmPC sections updated: 1, 5.1 and 10.

  • Description of update: To update section 5.1 of the SmPC in line with reference product, Prozac 20mg hard capsules (MA number: 34009 331008 9 6; MAH: Lilly France; dated: 22/01/2021). Consequently, the PIL has been updated. Additionally, the pharmacotherapeutic group name in SmPC section 5.1 has been updated in line with the WHO ATC Index and section 1 of the SmPC and the PIL have been updated in line with QRD template. The PIL headline has also been updated in line with MHRA guidelines for SSRIs (‘Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines’ (September 2019)) and editorial updates have been made to the PIL.

    PIL sections updated: Heading, headline, introduction, 2, 3, 4, 5 and 6.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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