Zofenopril, hydrochlorothiazide (Zantipres Co, Zofaril Co)
Zofenopril, hydrochlorothiazide
Menarini South Africa (Pty) Ltd
Every registration of this product has been cancelled.
Registration
- Applicant
- Menarini South Africa (Pty) Ltd
- Certificate holder
- Lebasi Pharmaceuticals (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zantipres co 30 mg/12,5 MG Each Tablet contains: ZOFENOPRIL CALCIUM 30,0 mg & HYDROCHLOROTHIAZIDE 12,5 mg | 30 mg/12,5 mgTablet | 55001855/7.1.3/0018Approved 14 February 2023 | Cancelled | S3 | PIPIL |
| Zofaril co 30 mg/12,5 MG Each Tablet contains: ZOFENOPRIL CALCIUM 30,0 mg & HYDROCHLOROTHIAZIDE 12,5 mg | 30 mg/12,5 mgTablet | 550019.01855/7.1.3/0019.018Approved 14 February 2023 | Cancelled | 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.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Zofenopril calcium, & hydrochlorothiazide
S4: Calcium
- when indicated for the treatment of hyperphosphataemia; (S0)
- except in oral preparations or mixtures containing more than1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
- except in preparations thereof for injection; (S3)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 5618 to 5628
S4: Zofenopril
Consolidated Schedules 06 July 2026, line 8418
S3: Calcium
- in preparations thereof for injection; (S0)
- except in oral preparations or mixtures containing more than1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
- except when indicated for the treatment of hyperphosphataemia; (S4)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 3262 to 3272
S3: Hydrochlorothiazide
Consolidated Schedules 06 July 2026, line 3721
S1: Calcium
- in oral preparations or mixtures containing more than 1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)
- except in preparations thereof for injection; (S3)
- except when indicated for the treatment of hyperphosphataemia; (S4)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 302 to 312
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.