Topiramate Tablets
- 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 complaintTopiramate Accord 100mg Film-coated Tablets
- PL Number:
- 20075/0147
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord 100mg Film-coated Tablets)
Last updated on this site: 05 Sep 2024
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.
View Patient Information Leaflet (PIL- Topiramate Accord 25mg, 50mg, 100mg, 200mg Film-coated Tablets)Last updated on this site: 05 Sep 2024
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 complaintTopiramate Accord 200mg Film-coated Tablets
- PL Number:
- 20075/0148
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord 200mg 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.
View Patient Information Leaflet (PIL- Topiramate Accord 25mg, 50mg, 100mg, 200mg Film-coated Tablets)Last updated on this site: 05 Sep 2024
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 complaintTopiramate Accord 25mg Film-coated Tablets
- PL Number:
- 20075/0145
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord 25mg Film-coated Tablets)
Last updated on this site: 05 Sep 2024
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.
View Patient Information Leaflet (PIL- Topiramate Accord 25mg, 50mg, 100mg, 200mg Film-coated Tablets)Last updated on this site: 05 Sep 2024
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 complaintTopiramate Accord 50mg Film-coated Tablets
- PL Number:
- 20075/0146
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Active
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord 50mg 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.
View Patient Information Leaflet (PIL- Topiramate Accord 25mg, 50mg, 100mg, 200mg Film-coated Tablets)Last updated on this site: 05 Sep 2024
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 complaintDiscontinued 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
-
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.
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.
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 200mg Film-coated Tablets
- PL Number:
- 20075/0717
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Discontinued
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord Healthcare 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).
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.
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.
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 25mg Film-coated Tablets
- PL Number:
- 20075/0718
- MA Holder:
- Accord Healthcare Limited
- Product Classification:
-
POM
- Product Status:
- Discontinued
Product Documentation
-
View Summary of Product Characteristics (SmPC- Topiramate Accord healthcare 25mg 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.
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.
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:
-
POM
- Product Status:
- Discontinued
Product Documentation
-
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.
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.
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
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What is a Summary of Product Characteristics (SmPC)?
A Summary of Product Characteristics (SmPC) is a document describing the properties and the approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively, and are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) in the EU.
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What is a Patient Information Leaflet (PIL)?
A Patient Information Leaflet (PIL) is a document included in the package of a medication that provides specific information about that medication and its use. It includes information about dose and administration of the medicine, warnings and precautions and potential side effects.
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What is a Risk Minimisation Measure (RMM)?
All medicines have both risks and benefits of treatment, it is important to minimise the risks. Some products will have specific activities or materials that companies need to do or provide in order to make the risks of treatment with the medicine as small as possible, these are known as Risk Minimisation Measures or RMMs. Examples of risk minimisation measures could include written guides for patients or healthcare professionals, an alert card for patients or a requirement to ask specific questions if a patient experiences a particular adverse effect of treatment.
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How do I print off documents on the Accord Product Website?
Search for the relevant product and click on it. Here, you will see all available strengths and their associated documents. Click on one of the links under the “Product Documentation” header to open the document in a new window in your browser. Right click on the document in this new window and select “Print” from the drop-down menu that appears by your cursor.
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How do I search for a product?
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What is a generic medicine?
A generic drug is a medicine that is developed to be the same as a medicine that has already been authorised, and which is usually branded. Generic medications contain the same active ingredient as the original branded medication and work the same way but may differ in shape or size. Most Accord medications are generic medications.
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What is a biosimilar medicine?
A biosimilar medication is a biological medication (one whose active substance is made by a living organism) that is highly similar to an already approved biological medicine. These biosimilar medications are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all medicines.
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I am looking for a product that Accord sells, but which is not listed on your product site. Where can I find it?
As well as Accord products, Accord also sells medications that are licenced by other pharmaceutical companies. If you need information about a product, you may need to check who the marketing authorisation holder is, and this will be on the packaging. You may need to contact the other company for an answer to your query.
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How can I tell two similarly-named products apart?
All Accord medicinal products have a Product Licence (PL) number. This is unique to each type of medicine and will differ by the strength of each medicine as well. PL numbers are listed under each product on this website. To find your medicine’s PL number, look on the carton or bottle label, as this will have the PL number on it (usually on the back – check beneath the dispensing label if necessary).
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▼ What does a black triangle mean?
Medicines showing this symbol are subject to additional monitoring. This will allow quick identification of new safety information. The black triangle will appear on the Summary of Product Characteristics and the Patient Information Leaflet. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk for how to report side effects or report to Accord by clicking on the Report a side effect or a product complaint button, or emailing medinfo@accord-healthcare.com.
For any further assistance, please get in touch.