Amlodipine, telmisartan
Sold as Twynsta, Amtelip, Amlotel, Stytem, Kardotel, Tesamolot, Tesdyn, Tensitev, Telinod, Telmisartan/amlodipine cospharm, Tensiotel
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 10
- Registrations
- 39
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale | Twynsta | 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg | 440857, 440858, 440859, 440860 | S3 | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd. | Amtelip | 40/5, 40/10, 80/5 | 500155, 500156, 500157 | S3 | PIPIL |
| Innovata pharmaceuticalsCertificate held by Innovata Pharmaceuticals (Pty) Ltd | Amlotel, Tensiotel | 40/5, 40/10, 80/5, 80/10 | 500344, 500345, 500346, 500347, 610738, 610739, 610740, 610741 | S3 | PIPIL |
| Activo Health (Pty) Ltd | Stytem | 40/5, 40/10, 80/5, 80/10 | 500509, 500510, 500511, 500512 | S3 | None |
| Cipla Medpro (Pty) Ltd | Kardotel | 40/5, 40/10, 80/5, 80/10 | 500513, 500514, 500515, 500516 | S3 | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Tesamolot | 40/5 | 530250 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Tesdyn | 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg | 550668, 550669, 550670, 550671 | Not determined | None |
| Teva Pharmaceuticals (Pty) LtdCertificate held by Teva Pharmaceuticals (Pty) Ltd. | Tensitev | 40/5; 40/10; 80/5; 80/10mg | 570341, 570342, 570343 | Not determined | PIPIL |
| Adcock ingram limited | Telinod | 40/5, 40/10, 80/5, 80/10 | 570574, 570575, 570576, 570577 | Not determined | PIPIL |
| Cospharm Investments (Pty) Ltd | Telmisartan/amlodipine cospharm | 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg | 600244, 600245, 600246, 600247 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Twynsta 40/5 MG tablet EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 40,0 mg | 40/5 mgTablet | 44085744/7.1.3/0857 | Registered | S3 | None |
| Twynsta 40/10 MG tablet EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 40,0 mg | 40/10 mgTablet | 44085844/7.1.3/0858 | Registered | S3 | None |
| Twynsta 80/5 MG tablet EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 80,0 mg | 80/5 mgTablet | 44085944/7.1.3/0859 | Registered | S3 | None |
| Twynsta 80/10 MG tablet EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 80,0 mg | 80/10 mgTablet | 44086044/7.1.3/0860 | Registered | S3 | None |
| Amtelip 40/5 Each Tablet contains: Telmisartan 40 mg Amlodipine (As Besylate Salt) 5 mg | 40/5Tablets | 50015550/7.1.3/0155Approved 4 May 2023 | Registered | S3 | PIPIL |
| Amtelip 40/10 Each Tablet contains: Telmisartan 40 mg Amlodipine (As Besylate Salt) 10 mg | 40/10Tablets | 50015650/7.1.3/0156Approved 4 May 2023 | Registered | S3 | PIPIL |
| Amtelip 80/5 Each Tablet contains Telmisartan 80 mg & Amlodipine (As besylate salt) 5 mg | 80/5Tablets | 50015750/7.1.3/0157Approved 4 May 2023 | Registered | S3 | PIPIL |
| Amlotel 40/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 40,0 mg | 40/5Uncoated tablets | 50034450/7.1.3/0344Approved 30 April 2024 | Registered | S3 | PIPIL |
| Amlotel 40/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 40,0 mg | 40/10Uncoated tablets | 50034550/7.1.3/0345Approved 30 April 2024 | Registered | S3 | PIPIL |
| Amlotel 80/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 80,0 mg | 80/5Uncoated tablets | 50034650/7.1.3/0346Approved 30 April 2024 | Registered | S3 | PIPIL |
| Amlotel 80/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 80,0 mg | 80/10Uncoated tablets | 50034750/7.1.3/0347Approved 30 April 2024 | Registered | S3 | PIPIL |
| Stytem 40/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg and TELMISARTAN 40,0 mg | 40/5 | 50050950/7.1.3/0509 | Registered | S3 | None |
| Stytem 40/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 40,0 mg | 40/10 | 50051050/7.1.3/0510 | Registered | S3 | None |
| Stytem 80/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 80,0 mg | 80/5 | 50051150/7.1.3/0511 | Registered | S3 | None |
| Stytem 80/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 80,0 mg | 80/10 | 50051250/7.1.3/0512 | Registered | S3 | None |
| Kardotel 40/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 40,0 mg | 40/5 | 50051350/7.1.3/0513 | Registered | S3 | None |
| Kardotel 40/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 40,0 mg | 40/10 | 50051450/7.1.3/0514 | Registered | S3 | None |
| Kardotel 80/5 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 80,0 mg | 80/5 | 50051550/7.1.3/0515 | Registered | S3 | None |
| Kardotel 80/10 EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 80,0 mg | 80/10 | 50051650/7.1.3/0516 | Registered | S3 | None |
| Tesamolot 40/5 EACH TABLET CONTAINS TELMISARTAN 40,0 mg, AMLODIPINE BESILATE EQUIVALENT TO AMLODIPINE 5,0 mg | 40/5 | 53025053/7.1.3/0250 | Registered | Not determined | None |
| Tesdyn 40/5 MG EACH TABLET CONTAINS TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 40/5 mg | 55066855/7.1.3/0668 | Registered | Not determined | None |
| Tesdyn 40/10 MG EACH TABLET CONTAINS TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 40/10 mg | 55066955/7.1.3/0669 | Registered | Not determined | None |
| Tesdyn 80/5 MG EACH TABLET CONTAINS TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 80/5 mg | 550670 | Registered | Not determined | None |
| Tesdyn 80/10 MG EACH TABLET CONTAINS TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 80/10 mg | 55067155/7.1.3/0671 | Registered | Not determined | None |
| Tensitev 40/10 Each tablet contains: Telmisartan 40,0 mg; Amlodipine Besilate equivalent to Amlodipine 10,0 mg | 40/5; 40/10; 80/5; 80/10mgTablets. | 57034157/7.1.3/0341Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Tensitev 80/5 Each Tablet contains: Telmisartan 40,0 mg, Amlodipine Besilate equivalent to Amlodipine 5,0 mg | 40/5; 40/10; 80/5; 80/10mgTablets. | 57034257/7.1.3/0342Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Tensitev 80/10 Each Tablet contains: Telmisartan 40,0 mg, Amlodipine Besilate equivalent to Amlodipine 10,0 mg | 40/5; 40/10; 80/5; 80/10mgTablets. | 57034357/7.1.3/0343Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Telinod 40/5 Each Tablet contains: Telmisartan 40,0 mg; Amlodipine Besilate equivalent to Amlodipine 5,0 mg | 40/5Tablets | 57057457/7.1.3/0574Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Telinod 40/10 Each Tablet contains: Telmisartan 40,0 mg, Amlodipine Besilate equivalent to Amlodipine 10,0 mg | 40/10Tablets | 570575Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Telinod 80/5 Each Tablet contains: Telmisartan 80,0 mg , Amlodipine Besilate equivalent to Amlodipine 5,0 mg | 80/5Tablets | 57057657/7.1.3/0576Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Telinod 80/10 Each Tablet contains: Telmisartan 80,0 mg; Amlodipine Besilate equivalent to Amlodipine 10,0 mg | 80/10Tablets | 570577Approved 24 June 2025 | Registered | Not determined | PIPIL |
| Telmisartan/amlodipine 40/5 MG cospharm EACH TABLET CONTAINS: TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 40/5 mg | 60024460/7.1.3/0244 | Registered | Not determined | None |
| Telmisartan/amlodipine 40/10 MG cospharm EACH TABLET CONTAINS: TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 40/10 mg | 60024560/7.1.3/0245 | Registered | Not determined | None |
| Telmisartan/amlodipine 80/5 MG cospharm EACH TABLET CONTAINS: TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 80/5 mg | 60024660/7.1.3/0246 | Registered | Not determined | None |
| Telmisartan/amlodipine 80/10 MG cospharm EACH TABLET CONTAINS: TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 80/10 mg | 60024760/7.1.3/0247 | Registered | Not determined | None |
| Tensiotel 40/5 EACH TABLET CONTAINS: TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 40/5 | 61073861/7.1.3/0738 | Registered | Not determined | None |
| Tensiotel 40/10 EACH TABLET CONTAINS: TELMISARTAN 40,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 40/10 | 61073961/7.1.3/0739 | Registered | Not determined | None |
| Tensiotel 80/5 EACH TABLET CONTAINS: TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg | 80/5 | 61074061/7.1.3/0740 | Registered | Not determined | None |
| Tensiotel 80/10 EACH TABLET CONTAINS: TELMISARTAN 80,0 mg AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg | 80/10 | 61074161/7.1.3/0741 | Registered | Not determined | 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 medium.
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 Amlodipine besylate equivalent to amlodipine, telmisartan
S3: Amlodipine
Consolidated Schedules 06 July 2026, line 3138
S3: Telmisartan
Consolidated Schedules 06 July 2026, line 4286
Pharmacological class: Other hypotensives. (class 7.1.3)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.