Amlodipine, telmisartan (Amlotel)
Amlodipine, telmisartan
Innovata pharmaceuticals
Registration
- Applicant
- Innovata pharmaceuticals
- Certificate holder
- Innovata Pharmaceuticals (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 |
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, read from the product's PI-PIL leaflet.
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) 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.