Topiramate (Epitoz, Topiramate Unicorn, Zydus Topiramate Sprinkles)
Topiramate
Zydus Healthcare (Pty) Ltd
Registration
- Applicant
- Zydus Healthcare (Pty) Ltd
- Certificate holder
- Zydus Healthcare SA (Pty) Ltd
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Epitoz 25 EACH TABLET CONTAINS TOPIRAMATE 25,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets. | 41071141/2.5/0711Approved 8 September 2022 | Registered | S3 | PIPIL |
| Epitoz 50 EACH TABLET CONTAINS TOPIRAMATE 50,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets. | 41071241/2.5/0712Approved 8 September 2022 | Registered | S3 | PIPIL |
| Epitoz 100 EACH TABLET CONTAINS TOPIRAMATE 100,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets. | 41071341/2.5/0713Approved 8 September 2022 | Registered | S3 | PIPIL |
| Topiramate 25 unicorn EACH TABLET CONTAINS TOPIRAMATE 25,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets | 42027742/2.5/0277Approved 8 September 2022 | Registered | S3 | PIPIL |
| Topiramate 50 unicorn EACH TABLET CONTAINS TOPIRAMATE 50,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets | 42027842/2.5/0278Approved 8 September 2022 | Registered | S3 | PIPIL |
| Topiramate 100 unicorn EACH TABLET CONTAINS TOPIRAMATE 100,0 mg | 25 mg / 50 mg /100 mgFilm-coated tablets | 42027942/2.5/0279Approved 8 September 2022 | Registered | S3 | PIPIL |
| Zydus topiramate sprinkles 25 EACH SPRINKLE CAPSULE CONTAINS TOPIRAMATE 25,0 mg | 25 | 42045342/2.5/0453 | Registered | S3 | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S3, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Topiramate
S3: Topiramate
Consolidated Schedules 06 July 2026, line 4341
Pharmacological class: Anticonvulsants, including anti-epileptics. (class 2.5)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
[(1R,2S,6S,9R)-4,4,11,11-Tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.02,6]dodecan-6-yl]methyl sulfamate
Drag to rotate. Structure from PubChem CID 5284627.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.