Felodipine
Sold as Plendil, Felodure, Felodipine kiara, Hexal-felodipine
5-O-Ethyl 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Drag to rotate. Structure from PubChem CID 3333.
Background
Registration
- Applicants
- 3
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Astrazeneca Pharmaceuticals (Pty) LtdCancelled | Plendil, Felodure | 2,5 mg, 5 mg, 10 mg | 290662, 330068, 330069, 330070, Y0294, Y0295 | S3 | None |
| Kiara Health (Pty) Ltd | Felodipine kiara | 5, 10 | 350231, 360302 | S3 | None |
| Sandoz South Africa (Pty) LtdCancelled | Hexal-felodipine | 5 | 360303 | S3 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Plendil 2,5 MG EACH TABLET CONTAINS FELODIPINE 2,5 mg | 2,5 mg | 29066229/7.1/0662 | Cancelled | S3 | None |
| Felodure 2,5 MG EACH TABLET CONTAINS FELODIPINE 2,5 mg | 2,5 mg | 33006833/7.1/0068 | Cancelled | S3 | None |
| Felodure 5 MG EACH TABLET CONTAINS FELODIPINE 5,0 mg | 5 mg | 33006933/7.1/0069 | Cancelled | S3 | None |
| Felodure 10 MG EACH TABLET CONTAINS FELODIPINE 10,0 mg | 10 mg | 33007033/7.1/0070 | Cancelled | S3 | None |
| Felodipine 10 kiara EACH TABLET CONTAINS FELODIPINE 10,0 mg | 10 | 35023135/7.1/0231 | Registered | S3 | None |
| Felodipine 5 kiara EACH TABLET CONTAINS FELODIPINE 5,0 mg | 5 | 36030236/7.1/0302 | Registered | S3 | None |
| Hexal-felodipine 5 EACH TABLET CONTAINS FELODIPINE 5,0 mg | 5 | 36030336/7.1/0303 | Cancelled | S3 | None |
| Plendil 5 MG EACH TABLET CONTAINS FELODIPINE 5,0 mg | 5 mg | Y0294Y/7.1/294 | Cancelled | S3 | None |
| Plendil 10 MG EACH TABLET CONTAINS FELODIPINE 10,0 mg | 10 mg | Y0295Y/7.1/295 | Cancelled | S3 | None |
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, 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Felodipine
S3: Felodipine
Consolidated Schedules 06 July 2026, line 3559
Pharmacological class: Vasodilators, hypotensive, antihypertensive medicines include other antihypertensive medicines e.g. ACE-inhibitors, ARBs, RAAS, etc] (class 7.1)
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.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.