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Voltaren

Diclofenac

S3Read from the PI-PIL document and verified
Loading the molecular structure
C14H11Cl2NO2296.10 g/mol

2-[2-(2,6-Dichloroanilino)phenyl]acetic acid

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 3033.

Registration

Applicants
1
Registrations
7
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Novartis South Africa (Pty) Ltd2 of 7 cancelledVoltaren25, 50, 75, 100, dropsG0083, H0034, H0225, L0126, R0224, Y0346, Y0347S3PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Voltaren 25

EACH TABLET CONTAINS DICLOFENAC SODIUM 25 mg

25Tablets/ ampoules/ suppositoriesG0083G/3.1/83Approved 20 May 2025RegisteredS3PIPIL
Voltaren 75 ampoules

EACH 3 ml AMPOULE CONTAINS DICLOFENAC SODIUM 75 mg

75AmpoulesH0034H/3.1/34RegisteredNot determinedPIPIL
Voltaren 50 suppositories

EACH SUPPOSITORY CONTAINS DICLOFENAC SODIUM 50 mg

50SuppositoriesH0225H/3.1/225CancelledNot determinedNone
Voltaren 100 suppositories

EACH SUPPOSITORY CONTAINS DICLOFENAC SODIUM 100 mg

100SuppositoriesL0126L/3.1/126RegisteredNot determinedNone
Voltaren 25 suppositories

EACH 1 g SUPPOSITORY CONTAINS DICLOFENAC SODIUM 25,0 mg

25SuppositoriesR0224R/3.1/224RegisteredNot determinedNone
Voltaren 75 tablets

EACH TABLET CONTAINS DICLOFENAC SODIUM 75 mg

75TabletsY0346Y/3.1/346RegisteredNot determinedPIPIL
Voltaren drops

EACH 1 ml SUSPENSION CONTAINS DICLOFENAC RESINATE EQUIVALENT TO 15 mg DICLOFENAC SODIUM

DropsY0347Y/3.1/347CancelledNot determinedNone

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 Diclofenac sodium

  • S3: Diclofenac

    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
    • except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
    • except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days. (S2)

    Consolidated Schedules 06 July 2026, lines 3415 to 3427

  • S2: Diclofenac

    • when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S3)
    • when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days;
    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
    • except when intended for veterinary use. (S3)

    Consolidated Schedules 06 July 2026, lines 1807 to 1821

  • S1: Diclofenac

    • when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S3)
    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
    • except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 day; (S2)
    • except when intended for veterinary use. (S3)

    Consolidated Schedules 06 July 2026, lines 365 to 379

Pharmacological class: Antirheumatics (anti-inflammatory agents). (class 3.1)

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

Voltaren 25, Novartis South Africa (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsVoltaren 25, Novartis South Africa (Pty) LtdPatient information leaflet (PIL)For patients and carersVoltaren 25, Novartis South Africa (Pty) Ltd

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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