Cimetidine (Secadine, Bio-cimetidine, Mexiena)
Cimetidine
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Secadine tablets 200 MG EACH TABLET CONTAINS :CIMETIDINE 200 mg | 200 mgTablets | 27010227/11.4.3/0102 | Registered | Not determined | None |
| Secadine tablets 400 MG EACH TABLET CONTAINS :CIMETIDINE 400,0 mg | 400 mgTablets | 27010327/11.4.3/0103 | Registered | Not determined | None |
| Bio-cimetidine 200 EACH TABLET CONTAINS CIMETIDINE 200,0 mg | 200Film-coated tablets | 31067931/11.4.3/0679Approved 28 March 2024 | Registered | S3 | PIPIL |
| Bio-cimetidine 400 EACH TABLET CONTAINS CIMETIDINE 400,0 mg | 400Film-coated tablets | 31068031/11.4.3/0680Approved 28 March 2024 | Registered | S3 | PIPIL |
| Mexiena EACH TABLET CONTAINS CIMETIDINE 200,0 mg | 200 mgFilm-coated tablets | 56074056/11.4.3/0740Approved 20 August 2024 | Registered | S2 | PIPIL |
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 Cimetidine
S3: Cimetidine
- except when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum daily dose (per 24 hours) of 800 milligrams and a maximum treatment period of 2 weeks. (S2)
Consolidated Schedules 06 July 2026, lines 3332 to 3334
S2: Cimetidine
- when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum daily dose of 800 milligrams and a maximum treatment period of 2 weeks. (S3)
Consolidated Schedules 06 July 2026, lines 1740 to 1742
Pharmacological class: Other. (class 11.4.3)
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.
1-Cyano-2-methyl-3-[2-[(5-methyl-1H-imidazol-4-yl)methylsulfanyl]ethyl]guanidine
Drag to rotate. Structure from PubChem CID 2756.
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.