Diclofenac (Flenodic Sr, Flenodic, Flenodic Im, Motifine)
Diclofenac
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Flenodic 100 sr EACH TABLET CONTAINS DICLOFENAC SODIUM 100,0 mg | 100 | 30016030/3.1/0160 | Registered | Not determined | None |
| Flenodic 25 EACH TABLET CONTAINS DICLOFENAC SODIUM 25,0 mg | 25Tablets | 30016630/3.1/0166Approved 20 February 2025 | Registered | S3 | PIPIL |
| Flenodic im EACH AMPOULE CONTAINS DICLOFENAC SODIUM 25,0 mg | 25 mg/mlInjection | 42041142/3.1/0411Approved 6 November 2025 | Registered | S3 | PIPIL |
| Motifine EACH CAPSULE CONTAINS DICLOFENAC SODIUM 75,0 mg | 75 mgCapsules, hard. | 45115045/3.1/1150Approved 21 July 2023 | Registered | S2 | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Diclofenac sodium
S3: Diclofenac
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
- except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
- except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days. (S2)
Consolidated Schedules 06 July 2026, lines 3415 to 3427
S2: Diclofenac
- when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S3)
- when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days;
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 1807 to 1821
S1: Diclofenac
- when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S3)
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
- except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 day; (S2)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 365 to 379
Pharmacological class: Antirheumatics (anti-inflammatory agents). (class 3.1)
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.
2-[2-(2,6-Dichloroanilino)phenyl]acetic acid
Drag to rotate. Structure from PubChem CID 3033.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) 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.