Amitriptyline (Trepiline, Noriline)
Amitriptyline
Pharmacare limited û woodmead
Registration
- Applicant
- Pharmacare limited û woodmead
- Certificate holder
- Pharmacare limited
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Trepiline - 10 EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 10 mg | 10 mg, 25 mgTablets | J0219J/1.2/219Approved 28 July 2017 | Registered | S5 | PIPIL |
| Trepiline - 25 EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 25 mg | 10 mg, 25 mgTablets | J0220J/1.2/220Approved 28 July 2017 | Registered | S5 | PIPIL |
| Noriline 10 MG EACH TABLE CONTAINS AMITRIPTYLINE HYDROCHLORIDE 10 mg | 10 mg | Y0270Y/1.2/270 | Cancelled | Not determined | None |
| Noriline 25 MG EACH TABLE CONTAINS AMITRIPTYLINE HYDROCHLORIDE 25 mg | 25 mg | Y0271Y/1.2/271 | Cancelled | Not determined | 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, 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.
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.
N,N-Dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine
Drag to rotate. Structure from PubChem CID 2160.
SAHPRA documents
Schedule Verification
This medication's schedule (S5) 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.