Ketoprofen (Fastum)
Ketoprofen
Menarini South Africa (Pty) Ltd
Registration
- Applicant
- Menarini South Africa (Pty) Ltd
- Certificate holder
- Menarini South Africa (Pty) Ltd
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Variants
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S3; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Ketoprofen
S3: Ketoprofen
- except when intended for application to the skin; (S1)
- except when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, subject to a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2)
- except when intended for the emergency treatment of acute gout attacks or for the treatment of post- traumatic conditions, subject to a maximum dose of 75 milligrams of ketoprofen per day and a maximum treatment period of 5 days; (S2)
- except in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S2)
Consolidated Schedules 06 July 2026, lines 3836 to 3858
S2: Ketoprofen
- when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours;
- when intended for the emergency treatment of acute gout attacks or for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days;
- in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S3)
- except when intended for application to the skin. (S1)
Consolidated Schedules 06 July 2026, lines 2191 to 2220
S1: Ketoprofen
- when intended for application to the skin; (S3)
- except when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2)
- except when intended for the emergency treatment of acute gout attacks; (S2)
- except when intended for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days; (S2)
- except in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S2)
Consolidated Schedules 06 July 2026, lines 596 to 624
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-(3-Benzoylphenyl)propanoic acid
Drag to rotate. Structure from PubChem CID 3825.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) 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.