Metformin (Bigsens, Bigsens Xr, Metformin Cr Zydus)
Metformin
Zydus Healthcare (Pty) Ltd
Registration
- Applicant
- Zydus Healthcare (Pty) Ltd
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bigsens 1 000 EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 1000,0 mg | 1 000 | 41019341/21.2/0193 | Registered | S3 | None |
| Bigsens xr EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 500,0 mg | Not listed | 51068351/21.2/0683 | Registered | S3 | None |
| Metformin cr zydus EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 500,0 mg | Not listed | 510684.68351/21.2/0684.683 | Registered | S3 | None |
| Bigsens xr 750 EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 750,0 mg | 750 | 55067255/21.2/0672 | Registered | S3 | None |
| Bigsens xr 1 000 EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 1 000,0 mg | 1 000 | 55067355/21.2/0673 | Registered | S3 | None |
| Metformin cr 750 zydus EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 750,0 mg | 750 | 550674.67255/21.2/0674.672 | Registered | S3 | None |
| Metformin cr 1 000 zydus EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 1 000,0 mg | 1 000 | 550675.67355/21.2/0675.673 | Registered | S3 | None |
| Bigsens 500 EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 500,0 mg | 500 | A390638A39/21.2/0638 | Registered | S3 | None |
| Bigsens 850 EACH TABLET CONTAINS METFORMIN HYDROCHLORIDE 850,0 mg | 850 | A390639A39/21.2/0639 | 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, matched to the Consolidated Schedules by ingredient, confidence high.
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 Metformin hydrochloride
S3: Metformin
Consolidated Schedules 06 July 2026, line 3938
Pharmacological class: Oral hypoglycaemics. (class 21.2)
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.
3-(Diaminomethylidene)-1,1-dimethylguanidine
Drag to rotate. Structure from PubChem CID 4091.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.