- Active Ingredients
Product Documentation
-
View RMM (Topiramate Epilepsy Patient guide)
Last updated on this site: 08 Jul 2024
View RMM (Topiramate Migraine Patient guide)Last updated on this site: 08 Jul 2024
View RMM (Topiramate Patient Card)Last updated on this site: 08 Jul 2024
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 complaintDiscontinued 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:
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POM
- Product Status:
- Discontinued
Product Documentation
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View Patient Information Leaflet (PIL- Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets)
Last updated on this site: 13 Mar 2023
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.
View Summary of Product Characteristics (SmPC- Topiramate Accord healthcare 50mg Film-coated Tablets)Last updated on this site: 13 Mar 2023
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.
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
For any further assistance, please get in touch.