Flecainide

Sold as Tambocor cr, Flecaine, Flecaine cr, Tempacin cr, Cardirest, Flecainide cr kiara, Tambocor

C₁₇H₂₀F₆N₂O₃414.34 g/mol

N-(Piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide

Drag to rotate. Structure from PubChem CID 3356.

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Registration

Applicants: 4
Registrations: 19
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Inova Pharmaceuticals (Pty) LtdCertificate held by Inova Pharmaceuticals (Pty) Ltd.	Tambocor cr, Flecaine, Flecaine cr, Tambocor	50, 100, 150 or 200 mg, injection, 100mg / 10mg/ml	370198, 370199, 370200, 370201, 510263, 510308, 510309, 510310, 510311, S0016, S0017	S4	PI PIL
Activo Health (Pty) Ltd	Tempacin cr	50, 100, 150, 200	540421, 540422, 540423, 540424	S4	None
Ipharma (Pty) Ltd	Cardirest	50, 100	560095, 560096	S4	None
Kiara Health (Pty) Ltd	Flecainide cr kiara	100, 200	560784, 560785	S4	None

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	PI PIL
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	PI PIL
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	PI PIL
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	PI PIL
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	PI PIL
Flecaine cr 100	50. 100. 150 or 200 mgCapsules	51030951/6.2/0309Approved 5 September 2021	Registered	S4	PI PIL
Flecaine cr 150	50. 100. 150 or 200 mgCapsules	51031051/6.2/0310Approved 5 September 2021	Registered	S4	PI PIL
Flecaine cr 200	50. 100. 150 or 200 mgCapsules	51031151/6.2/0311Approved 5 September 2021	Registered	S4	PI PIL
Tempacin 50 cr EACH CAPSULE CONTAINS FLECAINIDE ACETATE 50,0 mg	50	54042154/6.2/0421	Registrered	S4	None
Tempacin 100 cr EACH CAPSULE CONTAINS FLECAINIDE ACETATE 100,0 mg	100	54042254/6.2/0422	Registrered	S4	None
Tempacin 150 cr EACH CAPSULE CONTAINS FLECAINIDE ACETATE 150,0 mg	150	54042354/6.2/0423	Registrered	S4	None
Tempacin 200 cr EACH CAPSULE CONTAINS FLECAINIDE ACETATE 200,0 mg	200	54042454/6.2/0424	Registrered	S4	None
Cardirest 50 EACH TABLET CONTAINS FLECAINIDE ACETATE 50,0 mg	50	56009556/6.5/0095	Registered	S4	None
Cardirest 100 EACH TABLET CONTAINS FLECAINIDE ACETATE 100,0 mg	100	56009656/6.5/0096	Registered	S4	None
Flecainide cr 100 kiara EACH CAPSULE CONTAINS FLECAINIDE ACETATE EQUIVALENT TO FLECAINIDE 100,0 mg	100	56078456/6.2/0784	Registered	S4	None
Flecainide cr 200 kiara EACH CAPSULE CONTAINS FLECAINIDE ACETATE EQUIVALENT TO FLECAINIDE 200,0 mg	200	56078556/6.2/0785	Registered	S4	None
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	PI PIL

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

SAHPRA documents

Professional information (PI)For healthcare professionalsTambocor cr 50, Inova Pharmaceuticals (Pty) Ltd Patient information leaflet (PIL)For patients and carersTambocor cr 50, Inova Pharmaceuticals (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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