Tramadol (Zytram)
Tramadol
Mundipharma (Pty) Ltd
Registration
- Applicant
- Mundipharma (Pty) Ltd
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zytram 150 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 150,0 mg | 150 mg | 54048354/2.9/0483 | Registered | S5 | None |
| Zytram 200 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 200,0 mg | 200 mg | 54048454/2.9/0484 | Registered | S5 | None |
| Zytram 300 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 300,0 mg | 300 mg | 54048554/2.9/0485 | Registrered | S5 | None |
| Zytram 400 MG EACH TABLET CONTAINS TRAMADOL HYDROCHLORIDE 400,0 mg | 400 mg | 54048654/2.9/0486 | Registrered | S5 | None |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.
Consolidated Schedules listings for Tramadol hydrochloride
S5: Tramadol
Consolidated Schedules 06 July 2026, line 9725
Pharmacological class: Other analgesics. (class 2.9)
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.
cis-(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol
Drag to rotate. Structure from PubChem CID 33741.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.