Flecainide (Tambocor Cr, Flecaine, Flecaine Cr, Tambocor)
Flecainide
Inova Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Inova Pharmaceuticals (Pty) Ltd
- Certificate holder
- Inova Pharmaceuticals (Pty) Ltd.
- Registrations
- 11
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tambocor cr 50 EACH CAPSULE CONTAINS FLECAINIDE ACETATE 50,0 mg | 50. 100. 150 or 200 mgCapsules | 37019837/6.2/0198Approved 5 September 2021 | Registered | S4 | PIPIL |
| Tambocor cr 100 EACH CAPSULE CONTAINS FLECAINIDE ACETATE 100,0 mg | 50. 100. 150 or 200 mgCapsules | 37019937/6.2/0199Approved 5 September 2021 | Registered | S4 | PIPIL |
| Tambocor cr 150 EACH CAPSULE CONTAINS FLECAINIDE ACETATE 150,0 mg | 50. 100. 150 or 200 mgCapsules | 37020037/6.2/0200Approved 5 September 2021 | Registered | S4 | PIPIL |
| Tambocor cr 200 EACH CAPSULE CONTAINS FLECAINIDE ACETATE 200,0 mg | 50. 100. 150 or 200 mgCapsules | 37020137/6.2/0201Approved 5 September 2021 | Registered | S4 | PIPIL |
| Flecaine injection EACH 1,0 ml SOLUTION CONTAINS: FLECAINIDE ACETATE 10,0 mg | Injection | 51026351/6.2/0263 | Registered | S4 | None |
| Flecaine cr 50 | 50. 100. 150 or 200 mgCapsules | 51030851/6.2/0308Approved 5 September 2021 | Registered | S4 | PIPIL |
| Flecaine cr 100 | 50. 100. 150 or 200 mgCapsules | 51030951/6.2/0309Approved 5 September 2021 | Registered | S4 | PIPIL |
| Flecaine cr 150 | 50. 100. 150 or 200 mgCapsules | 51031051/6.2/0310Approved 5 September 2021 | Registered | S4 | PIPIL |
| Flecaine cr 200 | 50. 100. 150 or 200 mgCapsules | 51031151/6.2/0311Approved 5 September 2021 | Registered | S4 | PIPIL |
| Tambocor injection EACH 1 ml LIQUID CONTAINS : FLECAINIDE ACETATE 10 mg | Injection | S0016S/6.2/16 | Registered | S4 | None |
| Tambocor EACH TABLET CONTAINS FLECAINIDE ACETATE 100 mg | 100mg / 10mg/mlTablets / injection | S0017S/6.2/17Approved 20 April 2012 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Flecainide acetate
S4: Flecainide
Consolidated Schedules 06 July 2026, line 6343
Pharmacological class: Cardiac depressants. (class 6.2)
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.
N-(Piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide
Drag to rotate. Structure from PubChem CID 3356.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.