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Intended for UK patients and members of the public

Fesoterodine Tablets

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

Fesoterodine fumarate Accord 8 mg Prolonged-release Tablets

PL Number:
20075/1396
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

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

Fesoterodine fumerate Accord 4 mg Prolonged-release Tablets

PL Number:
20075/1493
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update:

    SmPC sections 4.4 and 4.8 for the above-listed MA have been updated in line with the reference productTOVIAZ 4 mg prolonged-release tablets - PLGB 00057/1646 (MAH: Pfizer Limited) dated 03/2024.Consequential update to the PIL.

    SmPC section 6.1 and PIL section 6 have also been updated to remove the wording ‘anhydrous’ from the excipient ‘Lactose’ in line with the 9th edition EP.

    Additionally, the PIL has been updated in line with QRD.

    Date of approval: 02/10/2025

    SmPC sections updated: 4.4, 4.8, 6.1 and 10.

  • Description of update:

    SmPC sections 4.4 and 4.8 for the above-listed MA have been updated in line with the reference productTOVIAZ 4 mg prolonged-release tablets - PLGB 00057/1646 (MAH: Pfizer Limited) dated 03/2024.Consequential update to the PIL.

    SmPC section 6.1 and PIL section 6 have also been updated to remove the wording ‘anhydrous’ from the excipient ‘Lactose’ in line with the 9th edition EP.

    Additionally, the PIL has been updated in line with QRD.

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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