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Intended for UK patients and members of the public

Topiramate Tablets

Active Ingredients

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

Topiramate Accord 100mg Film-coated Tablets

PL Number:
20075/0147
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • To update sections 1, 4.3, 4.4, 4.5 and 4.6 of the SmPC, PIL, Carton and Patient Card in line with CHM advice regarding EMEA/H/A-31/1520 Article 31 referral: risk of neurodevelopmental disorders associated with in utero exposure to AEDs.

     

    Additional updates:

    - Editorial and formatting updates to SmPC sections 4.3, 4.4, 4.5, 4.6 and the PIL.

    - QRD updates have been made to the PIL.

    - Editorial updates to the Foil and Carton including removal of NN.

  • To update sections 1, 4.3, 4.4, 4.5 and 4.6 of the SmPC, PIL, Carton and Patient Card in line with CHM advice regarding EMEA/H/A-31/1520 Article 31 referral: risk of neurodevelopmental disorders associated with in utero exposure to AEDs.

     

    Additional updates:

    - Editorial and formatting updates to SmPC sections 4.3, 4.4, 4.5, 4.6 and the PIL.

    - QRD updates have been made to the PIL.

    - Editorial updates to the Foil and Carton including removal of NN.

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

Topiramate Accord 200mg Film-coated Tablets

PL Number:
20075/0148
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

Topiramate Accord 25mg Film-coated Tablets

PL Number:
20075/0145
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • To update sections 1, 4.3, 4.4, 4.5 and 4.6 of the SmPC, PIL, Carton and Patient Card in line with CHM advice regarding EMEA/H/A-31/1520 Article 31 referral: risk of neurodevelopmental disorders associated with in utero exposure to AEDs.

     

    Additional updates:

    - Editorial and formatting updates to SmPC sections 4.3, 4.4, 4.5, 4.6 and the PIL.

    - QRD updates have been made to the PIL.

    - Editorial updates to the Foil and Carton including removal of NN.

  • To update sections 1, 4.3, 4.4, 4.5 and 4.6 of the SmPC, PIL, Carton and Patient Card in line with CHM advice regarding EMEA/H/A-31/1520 Article 31 referral: risk of neurodevelopmental disorders associated with in utero exposure to AEDs.

     

    Additional updates:

    - Editorial and formatting updates to SmPC sections 4.3, 4.4, 4.5, 4.6 and the PIL.

    - QRD updates have been made to the PIL.

    - Editorial updates to the Foil and Carton including removal of NN.

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

Topiramate Accord 50mg Film-coated Tablets

PL Number:
20075/0146
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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Topiramate Accord healthcare 100mg Film-coated Tablets

PL Number:
20075/0716
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Topiramate Accord healthcare 200mg Film-coated Tablets

PL Number:
20075/0717
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • Variation Description:

    • To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.

    • Additional updates have been made to the SPC and Label:

    • To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.

    • To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.

    • To update the ATC level name in section 5.1 of the SPC.

    • To update the braille on the cartons for hyphen in line with United English Braille (UEB).

     SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3 and 10.

  • Variation Description:

    • To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.

    • Additional updates have been made to the SPC and Label:

    • To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.

    • To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.

    • To update the ATC level name in section 5.1 of the SPC.

    • To update the braille on the cartons for hyphen in line with United English Braille (UEB).

    PIL sections updated – Index, 1, 2, 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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Topiramate Accord healthcare 25mg Film-coated Tablets

PL Number:
20075/0718
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Topiramate Accord healthcare 50mg Film-coated Tablets

PL Number:
20075/0719
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • Variation Description:

    • To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.

    • Additional updates have been made to the SPC and Label:

    • To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.

    • To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.

    • To update the ATC level name in section 5.1 of the SPC.

    • To update the braille on the cartons for hyphen in line with United English Braille (UEB).

     SmPC sections updated – 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3 and 10.

  • Variation Description:

    • To update sections 4.2, 4.4 and 5.1 of the SPC in line with reference product, Topamax 25, 50, 100, 200mg film-coated tablets (PL 00242/0301-4; MAH: Janssen-Cilag Ltd; dated 16/09/2022). Consequently, the PIL has been updated.

    • Additional updates have been made to the SPC and Label:

    • To update typographical and text formatting in sections 4.1, 4.5, 4.6, 4.7, 4.8, 5.2 and 5.3 of the SPC.

    • To make amendment to the ‘Excipients’ information in section 4.4 of the SPC to be specific for each strength.

    • To update the ATC level name in section 5.1 of the SPC.

    • To update the braille on the cartons for hyphen in line with United English Braille (UEB).

    PIL sections updated – Index, 1, 2, 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

For any further assistance, please get in touch.

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