Paroxetine
Sold as Xixia paroxetine, Adco-paroxetine, Paroxetine oethmaan, Deparoc, Sedarin, Serrapress, Paroxetine unicorn, Lenio, Texine, Apex paroxetine, Aropax cr, Paxotene, Paxil, Xet, Austell paroxetine, Aryaxel
(3S,4R)-3-(1,3-Benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine
Drag to rotate. Structure from PubChem CID 43815.
Background
Registration
- Applicants
- 13
- Registrations
- 21
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris South Africa (Pty) Ltd | Xixia paroxetine | 20 | 290556 | S5 | None |
| Adcock ingram limited | Adco-paroxetine | 20 mg | 360096 | S5 | PIPIL |
| Oethmaan Biosims (Pty) Ltd | Paroxetine oethmaan | 20, 40 | 360160, 360161 | S5 | None |
| Pharmacare limited û woodmeadCancelled | Deparoc | 20 mg | 370595 | S5 | None |
| Biotech Laboratories (Pty) Ltd | Sedarin | Not stated | 370665 | S5 | None |
| Pharma Dynamics (Pty) Ltd | Serrapress | 20 mg | 380069 | S5 | PIPIL |
| Unicorn Pharmaceuticals (Pty) Ltd | Paroxetine unicorn | 20 mg | 380072 | S5 | PIPIL |
| Aurogen South Africa (Pty) Ltd | Lenio | 20 mg, 30 mg | 420208, 420209 | S5 | None |
| Unimed Healthcare (Pty) Ltd | Texine | 20 mg, 30 mg | 420210, 420211 | S5 | None |
| Camox Pharmaceuticals (Pty) LtdCancelled | Apex paroxetine, Paxotene | 20 mg -, 20 mg | A380474, A380706 | S5 | None |
| Glaxosmithkline South Africa (Pty) Limited | Aropax cr, Paxil | 12,5, 20, 25 | A380612, A380613, A390078 | S5 | PIPIL |
| Zydus Healthcare (Pty) Ltd | Xet, Aryaxel | 20 | A390216, A400712 | S5 | None |
| Austell Pharmaceuticals (Pty) Ltd | Austell paroxetine | 20 mg, 30 mg | A390640, A390641 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Xixia paroxetine 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 | 29055629/1.2/0556 | Registered | S5 | None |
| Adco-paroxetine 20 MG EACH TABLET CONTAINS PAROXETINE 20,0 mg | 20 mgFilm-coated tablets. | 36009636/1.2/0096Approved 21 February 2021 | Registered | S5 | PIPIL |
| Paroxetine 20 oethmaan EACH TABLET CONTAINS PAROXETINE 20,0 mg | 20 | 36016036/1.2/0160 | Registered | S5 | None |
| Paroxetine 40 oethmaan EACH TABLET CONTAINS PAROXETINE 40,0 mg | 40 | 36016136/1.2/0161 | Registered | S5 | None |
| Deparoc 20 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mg | 37059537/1.2/0595 | Cancelled | S5 | None |
| Sedarin EACH TABLET CONTAINS: PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | Not listed | 37066537/1.2/0665 | Registered | S5 | None |
| Serrapress 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mgFilm coated tablets | 38006938/1.2/0069Approved 10 October 2023 | Registered | S5 | PIPIL |
| Paroxetine unicorn 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mgTablets. | 38007238/1.2/0072 | Registered | S5 | PIPIL |
| Lenio 20 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE 20,0 mg | 20 mg | 42020842/1.2/0208 | Registered | S5 | None |
| Lenio 30 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE 30,0 mg | 30 mg | 42020942/1.2/0209 | Registered | S5 | None |
| Texine 20 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE 20,0 mg | 20 mg | 42021042/1.2/0210 | Registered | S5 | None |
| Texine 30 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE 30,0 mg | 30 mg | 42021142/1.2/0211 | Registered | S5 | None |
| Apex - paroxetine 20 MG tablets EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mg -Tablets | A380474A38/1.2/0474 | Cancelled | S5 | None |
| Aropax cr 12,5 each tablet CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 12,5 mg | 12,5Controlled release tablet | A380612A38/1.2/0612Approved 19 December 2023 | Registered | S5 | PIPIL |
| Aropax cr 25 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 25,0 mg | 25Controlled release tablet | A380613A38/1.2/0613Approved 19 December 2023 | Registered | S5 | PIPIL |
| Paxotene 20 MG tablets EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mgTablets | A380706A38/1.2/0706 | Cancelled | S5 | None |
| Paxil 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 | A390078A39/1.2/0078 | Registered | S5 | None |
| Xet 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 | A390216A39/1.2/0216 | Registered | S5 | None |
| Austell paroxetine 20 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 mg | A390640A39/1.2/0640 | Registered | S5 | None |
| Austell paroxetine 30 MG EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 30,0 mg | 30 mg | A390641A39/1.2/0641 | Registered | S5 | None |
| Aryaxel 20 EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg | 20 | A400712A40/1.2/0712 | 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 Paroxetine hydrochloride equivalent to paroxetine
S5: Paroxetine
Consolidated Schedules 06 July 2026, line 9618
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.