Amitriptyline
Sold as Amineurin, Amitriptyline austell, Zivigan, Gulf amitriptyline, Saroten, Trepiline, Gsa-amitriptyline, Adco-amitryptiline, Amitriptyline HCL kiara, Noriline
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.
Background
Registration
- Applicants
- 8
- Registrations
- 15
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Oethmaan Biosims (Pty) Ltd | Amineurin | 50 | 310454 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Amitriptyline austell | 10 mg | 491017 | Not determined | None |
| Dezzo Trading 392 (Pty) Ltd | Zivigan | 10 mg, 25 mg, 50 mg | 570728, 590597, 590598 | Not determined | None |
| Gulf Drug Company (Pty) Ltd | Gulf amitriptyline | 25 | A400605 | Not determined | None |
| H. Lundbeck (Pty) Ltd | Saroten | 10MG, 25MG | B0707, B0715 | Not determined | None |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited2 of 4 cancelled | Trepiline, Noriline | 10 mg, 25 mg, 10 mg, 25 mg | J0219, J0220, Y0270, Y0271 | S5 | PIPIL |
| Adcock ingram limited1 of 2 cancelled | Gsa-amitriptyline, Adco-amitryptiline | 10, 25 | M0157, M0158 | Not determined | None |
| Kiara Health (Pty) Ltd | Amitriptyline HCL kiara | 25 | W0060 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Amineurin 50 EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 50,0 MG | 50 | 31045431/1.2/0454 | Registered | Not determined | None |
| Amitriptyline 10 MG austell EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE: EQUIVALENT TO AMITRIPTYLINE 8,84 mg | 10 mg | 49101749/1.2/1017 | Registered | Not determined | None |
| Zivigan 10 MG EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 10 mg | 10 mg | 57072857/1.2/0728 | Registered | Not determined | None |
| Zivigan 25 MG EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 25,0 mg | 25 mg | 59059759/1.2/0597 | Registered | Not determined | None |
| Zivigan 50 MG EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 50,0 mg | 50 mg | 59059859/1.2/0598 | Registered | Not determined | None |
| Gulf amitriptyline 25 EACH TABLET CONTAINS AMITRIPTYLINE 25,0 mg | 25 | A400605A40/1.2/0605 | Registered | Not determined | None |
| Saroten tablets 25mg TABLET AMITRIPTYLINE HYDROCHLORIDE A 25 MG | 25MGTablets | B0707 | Old Medicine | Not determined | None |
| Saroten tablets 10mg TABLET AMITRIPTYLINE HYDROCHLORIDE A 10 MG | 10MGTablets | B0715 | Old Medicine | Not determined | None |
| 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 |
| Gsa-amitriptyline 10 EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 10 mg | 10 | M0157M/1.2/157 | Registered | Not determined | None |
| Adco-amitryptiline 25 EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 25 mg | 25 | M0158M/1.2/158 | Cancelled | Not determined | None |
| Amitriptyline HCL 25 kiara EACH TABLET CONTAINS AMITRIPTYLINE HYDROCHLORIDE 25,0 mg | 25 | W0060W/1.2/60 | Registered | Not determined | None |
| 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.
SAHPRA documents
Schedule Verification
Trepiline - 10, Pharmacare limited û woodmead is scheduled S5 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.