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Alendronic acid, colecalciferol (Forsacole, Orthocole)

Alendronic acid, colecalciferol

Abex Pharmaceutica (Pty) Ltd

S3Read from the PI-PIL document and verified

Registration

Applicant
Abex Pharmaceutica (Pty) Ltd
Registrations
2
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Forsacole 5 600

EACH TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EQUIVALENT TO ALENDRONIC ACID 70,0 mg COLECALCIFEROL 140,0 μg

5 60057065457/3.2/0654RegisteredNot determinedNone
Orthocole 5 600

EACH TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EQUIVALENT TO ALENDRONIC ACID 70,0 mg COLECALCIFEROL 140,0 μg

5600 IUTablet570655.65457/3.2/0655.654Approved 22 July 2025RegisteredS3PIPIL

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.

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 verified from official 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.

Background

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Research articles

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