Omeprazole (Losec, Losec Mups)
Omeprazole
Equity Pharmaceutical (Pty) Ltd
Registration
- Applicant
- Equity Pharmaceutical (Pty) Ltd
- Certificate holder
- Astrazeneca Pharmaceuticals (Pty) Ltd
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Losec 10 EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg | 10Tablet | 29041029/11.4.3/0410Approved 29 June 2015 | Cancelled | Not determined | PIPIL |
| Losec mups 10 MG EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 10,0 mg | 10 mg | 32022232/11.4.3/0222 | Registered | Not determined | None |
| Losec mups 20 MG EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 20,0 mg | 20 mg | 32022332/11.4.3/0223 | Registered | Not determined | None |
| Losec mups 40 EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 40,0 mg | 40Film-coated tablets. | 32022432/11.4.3/0224Approved 14 March 2025 | Registered | S4 | PIPIL |
| Losec 20 EACH CAPSULE CONTAINS OMEPRAZOLE 20 mg | 20Tablet | V0193V/11.4.3/193Approved 29 June 2015 | Cancelled | Not determined | PIPIL |
| Losec 40 EACH CAPSULE CONTAINS OMEPRAZOLE 40 mg | 40Tablet | Z0098Z/11.4.3/98Approved 29 June 2015 | Cancelled | Not determined | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Omeprazole magnesium equivalent to omeprazole
S4: Omeprazole
- except when intended for the temporary, short-term relief of heartburn ans hyperacidity, subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S2)
Consolidated Schedules 06 July 2026, lines 7392 to 7395
S2: Omeprazole
- when intended for the temporary, short-term relief of heartburn and hyperacidity, subject to:
- a maximum daily dose of 20 milligrams
- a maximum treatment period of 14 days. (S4)
Consolidated Schedules 06 July 2026, lines 2457 to 2461
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.
6-Methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
Drag to rotate. Structure from PubChem CID 4594.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.