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Topamax 50 mg tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) ▼ Additional monitoring Details

The Summary of Product Characteristics (SmPC) is written for healthcare professionals. Patients will find plain advice in the patient information leaflet: how to take, side effects, other medicines, pregnancy and breast-feeding.

Medicine strength:
50 mg
Contains active substance:
ATC code:

Summary of Product Characteristics (SmPC) - Topamax 50 mg tablets

1. NAME OF THE MEDICINAL PRODUCT

Not applicable

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Not applicable

3. PHARMACEUTICAL FORM

Not applicable

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Not applicable

4.2. Posology and method of administration

Not applicable

4.3. Contraindications

Not applicable

4.4. Special warnings and precautions for use

Not applicable

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable

4.6. Pregnancy and lactation

Not applicable

4.7. Effects on ability to drive and use machines

Not applicable

4.8. Undesirable effects

Not applicable

4.9. Overdose

Not applicable

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Not applicable

5.2. Pharmacokinetic properties

Not applicable

5.3. Preclinical safety data

Not applicable

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Not applicable

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Not applicable .

6.4. Special precautions for storage

Not applicable

6.5. Nature and contents of container

Not applicable

6.6. Instruction for use and handling (, and disposal)

Not applicable

No Data Held

Administrative Data

7. MARKETING AUTHORISATION HOLDER

Not applicable

8. MARKETING AUTHORISATION NUMBER

Not applicable

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Not applicable

10. DATE OF REVISION OF THE TEXT

Not applicable

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PLPI 15814/1395

MHRA data as of 13 October 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Topamax 50 mg tablets

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Topiramate
Strength 50 mg
Pharmaceutical form Oral tablet
How is it taken Oral
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Drug group (ATC)
  1. N Nervous system drugs
    1. N03 Antiepileptics
      1. N03A Antiepileptics
        1. N03AX Other antiepileptics
          1. N03AX11 topiramate
Additional monitoring Yes ▼ – new safety information is collected quickly. Report any side effect to the Yellow Card scheme.
Marketing authorisation PLPI 15814/1395, PLPI 18799/0626
Codes BNF 04080100

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.