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Dutasteride, tamsulosin

Sold as Duodart, Dutasteride /tamsulosin gsk, Uromax co, Swifsul, Dutasteride tamsulosin adco, *Duoflow, Duozaq

S4Read from the PI-PIL document and verified

Combination product

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

Background

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Registration

Applicants
5
Registrations
7
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedCertificate held by Glaxosmithkline South Africa (Pty) LtdDuodart, Dutasteride /tamsulosin gsk0,5 mg, 0,5 mg 0,4 mg440850, 450804S4PIPIL
Cipla Medpro (Pty) LtdUromax coNot stated540097S4None
Adcock ingram limited1 of 2 cancelledSwifsul, Dutasteride tamsulosin adco0,5 mg / 0,4 mg,, 0,5 mg / 0,4 mg550032, 550033.032S4PIPIL
Activo Health (Pty) Ltd*DuoflowNot stated560034S4None
Pharma Dynamics (Pty) LtdDuozaq0,5 mg/0,4 mg560796S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Duodart

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg

0,5 mgCapsules44085044/21.12/0850Approved 17 August 2022RegisteredS4PIPIL
Dutasteride 0,5 mg/tamsulosin 0,4 MG gsk

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg

0,5 mg 0,4 mg45080445/21.12/0804RegisteredS4None
Uromax co

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg and TAMSULOSIN HYDROCHLORIDE 0,4 mg

Not listed54009754/18.10/0097RegisteredS4None
Swifsul

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg

0,5 mg / 0,4 mg,Hard gelatine capsules.55003255/21.12/0032Approved 8 August 2023RegistreredS4PIPIL
Dutasteride tamsulosin adco

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE 0,4 mg

0,5 mg / 0,4 mgHard gelatine capsules.550033.03255/21.12/0033.032Approved 8 August 2023CancelledS4PIPIL
*Duoflow

EACH CAPSULE CONTAINS: DUTASTERIDE 0,5 mg, TAMSULOSIN HYDROCHLORIDE 0,4 mg

Not listed56003456/21.12/0034RegisteredS4None
Duozaq 0,5 mg/0,4 MG

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg TAMSULOSIN HYDROCHLORIDE EQUIVALENT TO TAMSULOSIN 0,4 mg

0,5 mg/0,4 mgCapsule56079656/21.12/0796Approved 25 July 2023RegisteredS4PIPIL

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Dutasteride, tamsulosin hydrochloride

  • S4: Dutasteride

    Consolidated Schedules 06 July 2026, line 6141

  • S4: Tamsulosin

    Consolidated Schedules 06 July 2026, line 8100

Pharmacological class: Hormone inhibitors. (class 21.12)

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Duodart, Glaxosmithkline South Africa (Pty) Limited is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsDuodart, Glaxosmithkline South Africa (Pty) LimitedPatient information leaflet (PIL)For patients and carersDuodart, Glaxosmithkline South Africa (Pty) Limited

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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