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zameds
Loading the molecular structure
C16H25NO2263.37 g/mol

cis-(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 33741.

Registration

Applicants
1
Registrations
2
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Zydus Healthcare (Pty) LtdCertificate held by Zydus Healthcare SA (Pty) LtdTramazac50 mg, 100 mg/2 mlA390318, A390415S5PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Tramazac injection 100 mg/2 ML

EACH 2,0 ml AMPOULE CONTAINS TRAMADOL HYDROCHLORIDE 100,0 mg

100 mg/2 mlInjectionA390318A39/2.9/0318RegisteredS5None
Tramazac 50

EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg

50 mgCapsulesA390415A39/2.9/0415Approved 21 February 2023RegisteredS5PIPIL

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.

Background

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SAHPRA documents

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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