Esomeprazole (Truloc, Truloc Otc)
Esomeprazole
Pharma Dynamics (Pty) Ltd
Registration
- Applicant
- Pharma Dynamics (Pty) Ltd
- Certificate holder
- Pharma Dynamics (Pty) Ltd
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Truloc 20 MG | 20 mgGastro-resistant film coated tablet | 47032047/11.4.3/0320Approved 17 November 2025 | Registered | S4 | PIPIL |
| Truloc 40 MG | 40 mgGastro-resistant film coated tablet | 47032147/11.4.3/0321Approved 17 November 2025 | Registered | S4 | PIPIL |
| Truloc otc EACH TABLET CONTAINS: ESOMEPRAZOLE MAGNESIUM EQUIVALENT TO: ESOMEPRAZOLE 20,0 mg | 20 mgGastro-resistant film coated tablet | 57083357/11.4.3/0833Approved 27 January 2026 | Registered | 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 Esomeprazole magnesium
S4: Esomeprazole
- except when indicated 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. (S2)
Consolidated Schedules 06 July 2026, lines 6239 to 6244
S2: Esomeprazole
- when indicated 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 1921 to 1925
S1: Magnesium
- in oral preparations or mixtures containing more than 250 mg of Magnesium per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Consolidated Schedules 06 July 2026, lines 815 to 816
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-[(S)-(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
Drag to rotate. Structure from PubChem CID 9568614.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) 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.