Dothiepin
Sold as Prothiaden, Dosulepin biotech, Thaden
3-(6H-Benzo[c][1]benzothiepin-11-ylidene)-N,N-dimethylpropan-1-amine
Drag to rotate. Structure from PubChem CID 3155.
Background
Registration
- Applicants
- 3
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Abbott Laboratories S.A. (Pty) Ltd | Prothiaden | 25 mg, 75 mg | F0161, K0003 | S5 | None |
| Arya Pharma (Pty) Ltd | Dosulepin biotech | 25, 75 | Z0162, Z0163 | S5 | None |
| Pharmacare limited û woodmead | Thaden | 25, 75 | Z0171, Z0301 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Prothiaden 25 MG EACH CAPSULE CONTAINS DOTHIEPIN HYDROCHLORIDE 25,0 mg | 25 mg | F0161F/1.2/161 | Registered | S5 | None |
| Prothiaden 75 MG EACH TABLET CONTAINS DOTHIEPIN HYDROCHLORIDE 75,0 mg | 75 mg | K0003K/1.2/3 | Registered | S5 | None |
| Dosulepin 25 biotech EACH TABLET CONTAINS DOTHIEPIN HYDROCHLORIDE 25 mg | 25 | Z0162Z/1.2/162 | Registered | S5 | None |
| Dosulepin 75 biotech EACH TABLET CONTAINS DOTHIEPIN HYDROCHLORIDE 75 mg | 75 | Z0163Z/1.2/163 | Registered | S5 | None |
| Thaden-25 EACH CAPSULE CONTAINS DOTHIEPIN HYDROCHLORIDE 25 mg | 25 | Z0171Z/1.2/171 | Registered | S5 | None |
| Thaden - 75 EACH TABLET CONTAINS DOTHIEPIN HYDROCHLORIDE 75 mg | - 75 | Z0301Z/1.2/301 | Registered | 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 Dothiepin hydrochloride
S5: Dothiepin
Consolidated Schedules 06 July 2026, line 9393
Pharmacological class: Psychoanaleptics (antidepressants). (class 1.2)
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
SAHPRA has not published a professional information or patient information leaflet for this product.