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Amlotel

Amlodipine, telmisartan

S3Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Registration

Applicants
1
Registrations
4
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Innovata pharmaceuticalsCertificate held by Innovata Pharmaceuticals (Pty) LtdAmlotel40/5, 40/10, 80/5, 80/10500344, 500345, 500346, 500347S3PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Amlotel 40/5

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 40,0 mg

40/5Uncoated tablets50034450/7.1.3/0344Approved 30 April 2024RegisteredS3PIPIL
Amlotel 40/10

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 40,0 mg

40/10Uncoated tablets50034550/7.1.3/0345Approved 30 April 2024RegisteredS3PIPIL
Amlotel 80/5

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 5,0 mg TELMISARTAN 80,0 mg

80/5Uncoated tablets50034650/7.1.3/0346Approved 30 April 2024RegisteredS3PIPIL
Amlotel 80/10

EACH TABLET CONTAINS AMLODIPINE BESYLATE EQUIVALENT TO AMLODIPINE 10,0 mg TELMISARTAN 80,0 mg

80/10Uncoated tablets50034750/7.1.3/0347Approved 30 April 2024RegisteredS3PIPIL

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Amlotel 40/5, Innovata pharmaceuticals is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAmlotel 40/5, Innovata pharmaceuticalsPatient information leaflet (PIL)For patients and carersAmlotel 40/5, Innovata pharmaceuticals

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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