Product Documentation

• View Summary of Product Characteristics (SmPC- Topiramate Accord Healthcare 100mg Film-coated Tablets)

  Last updated on this site: 18 Nov 2024

  To correct the transcription error from embossed to debossed in description of core & coated tablets. Consequently, section 3 of the SmPC and the PIL have been updated.

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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.

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