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Omeprazole

Sold as Omepracote, Losec, Altosec, Losec mups, Omez otc, Omeprazole DRL, Omez, Nozer, Sandoz omeprazole, *Omexor, Adco omeprazole, Accord-omeprazole, Omeprazole-safeline, Omiloc ivi, Omiflux, Probitor, Corpocid, Lokit otc, Lokit od, Omehet, Floriteor, Omeprazole hetero, Tumsigon, Gazigon, Gazigon otc, Rapacid mr, Gastrogard, Rapacid, Adco-omeprazole

S4Read from the PI-PIL document and verified
Loading the molecular structure
C17H19N3O3S345.40 g/mol

6-Methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole

Drag to rotate. Structure from PubChem CID 4594.

Background

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Registration

Applicants
16
Registrations
44
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Kyron Animal Health (Pty) LtdOmepracoteNot stated06/02Not determinedNone
Equity Pharmaceutical (Pty) LtdCertificate held by Astrazeneca Pharmaceuticals (Pty) Ltd, Equity Pharmaceuticals (Pty) Ltd.3 of 6 cancelledLosec, Losec mups10 mg, 20 mg, 40290410, 320222, 320223, 320224, V0193, Z0098S4PIPIL
Acino Pharma (Pty) Ltd2 of 3 cancelledAltosec10, 20 mg, 40 mg/10 ml320087, 320703, A400192Not determinedPIPIL
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr Reddyõs Laboratories (Pty) Ltd, Dr. Reddy’s Laboratories (Pty) LtdOmez otc, Omeprazole DRL, Omez10, 20 mg, 40340296, 340297, 340298, 340299, 340300, 340301Not determinedPIPIL
Dezzo Trading 392 (Pty) LtdNozer, Gazigon, Gazigon otc20 mg360420, 560792.791, 560848.847 - RS4S2 to S4 by packPIPIL
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) LtdSandoz omeprazole, Omiflux, Probitor20 mg360430, 430457, 430458S4PIPIL
Unimed Healthcare (Pty) Ltd*OmexorNot stated360446Not determinedNone
Adcock ingram limitedAdco omeprazole, Rapacid mr, Rapacid, Adco-omeprazole10 mg, 20, 40 mg370228, 560913, 560914, 560915, A390466, A390467S4PIPIL
Accord Healthcare (Pty) LtdCancelledAccord-omeprazole40 mg410663Not determinedNone
Safeline Pharmaceuticals (Pty) LtdCancelledOmeprazole-safeline40 mg420515Not determinedNone
Ascendis Pharma (Pty) LtdOmiloc ivi40420600Not determinedNone
Activo Health (Pty) LtdCorpocid10, 20 mg, 40430502, 560835, 560836, 560837Not determinedPIPIL
Teva Pharmaceuticals (Pty) LtdCertificate held by Teva Pharmaceuticals (Pty) Ltd.Lokit otc, Lokit od20mg, 40540021, 540022, 540023Not determinedPIPIL
Hetero Drugs South Africa (Pty) LtdOmehet, Floriteor, Omeprazole hetero20540268, 540269.268, 540270.268Not determinedNone
Austell Pharmaceuticals (Pty) LtdCertificate held by Dezzo Trading 392 (Pty) LtdTumsigon20 mg560791S4PIPIL
Boehringer Ingelheim Animal Health South Africa (Pty) LtdCancelledGastrogardNot statedA05/08Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Omepracote

EACH SYRINGE CONTAINS OMEPRAZOLE 2,28 g

Not listed06/0206/8.4.3/02RegisteredNot determinedNone
Losec 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

10Tablet29041029/11.4.3/0410Approved 29 June 2015CancelledNot determinedPIPIL
Altosec 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20 mgCapsules32008732/11.4.3/0087Approved 25 February 2023RegisteredNot determinedPIPIL
Losec mups 10 MG

EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 10,0 mg

10 mg32022232/11.4.3/0222RegisteredNot determinedNone
Losec mups 20 MG

EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 20,0 mg

20 mg32022332/11.4.3/0223RegisteredNot determinedNone
Losec mups 40

EACH TABLET CONTAINS OMEPRAZOLE MAGNESIUM EQUIVALENT TO OMEPRAZOLE 40,0 mg

40Film-coated tablets.32022432/11.4.3/0224Approved 14 March 2025RegisteredS4PIPIL
Altosec 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

1032070332/11.4.3/0703CancelledNot determinedNone
Omez otc 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

1034029634/11.4.3/0296RegisteredNot determinedNone
Omez otc 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

2034029734/11.4.3/0297RegisteredNot determinedNone
Omeprazole DRL 40

Each Capsule contains: Omeprazole 40 mg

20 mg.Capsule.34029834/11.4.3/0298Approved 5 December 2021RegisteredNot determinedPIPIL
Omez 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

10Capsule34029934/11.4.3/0299Approved 23 April 2024RegisteredNot determinedPIPIL
Omez 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20Capsule34030034/11.4.3/0300Approved 23 April 2024RegisteredNot determinedPIPIL
Omez 40

EACH CAPSULE CONTAINS OMEPRAZOLE 40,0 mg

40Capsule34030134/11.4.3/0301Approved 23 April 2024RegisteredNot determinedPIPIL
Nozer

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

Not listed36042036/11.4.3/0420RegisteredNot determinedNone
Sandoz omeprazole 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20 mgCapsule36043036/11.4.3/0430Approved 4 July 2022RegisteredS4PIPIL
*Omexor

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

Not listed36044636/11.4.3/0446RegisteredNot determinedNone
Adco omeprazole 20

EACH CAPSULE CONTAINS :OMEPRAZOLE 20,0 mg

2037022837/11.4.3/0228RegisteredNot determinedNone
Accord-omeprazole 40 MG injection

EACH VIAL CONTAINS OMEPRAZOLE 40,0 mg

40 mgInjection41066341/11.4.3/0663CancelledNot determinedNone
Omeprazole-safeline injection 40 MG

EACH VIAL CONTAINS OMEPRAZOLE SODIUM EQUIVALENT TO OMEPRAZOLE 40,0 mg

40 mgInjection42051542/11.4.3/0515CancelledNot determinedNone
Omiloc 40 ivi

EACH VIAL CONTAINS OMEPRAZOLE 40,0 mg

4042060042/11.4.3/0600RegisteredNot determinedNone
Omiflux 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

2043045743/11.4.3/0457RegisteredNot determinedNone
Probitor 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

2043045843/11.4.3/0458RegisteredNot determinedNone
Corpocid 20 MG

EACH TABLET CONTAINS OMEPRAZOLE 20,0 mg

20 mgCoated tablet43050243/11.4.3/0502Approved 15 April 2021RegisteredNot determinedPIPIL
Lokit otc

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20mgCapsule54002154/11.4.3/0021Approved 5 October 2021RegisteredNot determinedPIPIL
Lokit od 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20Hard gelatine capsules54002254/11.4.3/0022Approved 12 October 2021RegisteredNot determinedPIPIL
Lokit od 40

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

40Hard gelatine capsules54002354/11.4.3/0023Approved 12 October 2021RegisteredNot determinedPIPIL
Omehet

EACH CAPSULE CONTAINS OMEPRAZOLE (FORM-B) 20,0 mg

Not listed54026854/11.4.3/0268RegisteredNot determinedNone
Floriteor 20

EACH CAPSULE CONTAINS OMEPRAZOLE (FORM-B) 20,0 mg

20540269.26854/14.4.3/0269.268RegisteredNot determinedNone
Omeprazole 20 hetero

EACH CAPSULE CONTAINS OMEPRAZOLE (FORM-B) 20,0 mg

20540270.26854/11.4.3/0270.268RegisteredNot determinedNone
Tumsigon

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20 mgCapsules56079156/11.4.3/0791Approved 28 June 2022RegisteredS4PIPIL
Gazigon

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20 mgCapsules560792.79156/11.4.3/0792.791Approved 28 June 2022RegisteredS4PIPIL
Corpocid 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10 mg

1056083556/11.4.3/0835RegisteredNot determinedNone
Corpocid 20

EACH TABLET CONTAINS OMEPRAZOLE 20,0 mg

2056083656/11.4.3/0836RegisteredNot determinedNone
Corpocid 40

EACH CAPSULE CONTAINS OMEPRAZOLE 40,0 mg

4056083756/11.4.3/0837RegisteredNot determinedNone
Gazigon otc20 mgCapsules560848.847 - R56/11.4.3/0848.847Approved 28 June 2022RegisteredS2PIPIL
Rapacid mr 10

EACH CAPSULE CONTAINS OMEPRAZOLE 10 mg

10Hard gelatine capsules56091356/11.4.3/0913Approved 25 August 2025RegisteredS4PIPIL
Rapacid mr 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

20Hard gelatine capsules56091456/11.4.3/0914Approved 25 August 2025RegisteredS4PIPIL
Rapacid mr 40

EACH CAPSULE CONTAINS OMEPRAZOLE 40,0 mg

40Hard gelatine capsules56091556/11.4.3/0915Approved 25 August 2025RegisteredS4PIPIL
Gastrogard

EACH SYRINGE CONTAINS OMEPRAZOLE 2,28 g

Not listedA05/08A05/11.5/08CancelledNot determinedNone
Rapacid

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

10 mgCapsulesA390466Approved 24 January 2021RegisteredNot determinedPIPIL
Adco-omeprazole 40

EACH CAPSULE CONTAINS: OMEPRAZOLE 40,0 mg

40 mgCapsuleA390467A39/11.4.3/0467Approved 24 January 2021RegisteredNot determinedPIPIL
Altosec 40 mg/10 ML

EACH VIAL CONTAINS OMEPRAZOLE 40,0 mg

40 mg/10 mlA400192A40/11.4.3/0192CancelledNot determinedNone
Losec 20

EACH CAPSULE CONTAINS OMEPRAZOLE 20 mg

20TabletV0193V/11.4.3/193Approved 29 June 2015CancelledNot determinedPIPIL
Losec 40

EACH CAPSULE CONTAINS OMEPRAZOLE 40 mg

40TabletZ0098Z/11.4.3/98Approved 29 June 2015CancelledNot determinedPIPIL

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 Omeprazole magnesium equivalent to omeprazole

  • S4: Omeprazole

    • except when intended for the temporary, short-term relief of heartburn ans hyperacidity, subject to:
    • a maximum daily dose of 20 milligrams
    • a maximum treatment period of 14 days. (S2)

    Consolidated Schedules 06 July 2026, lines 7392 to 7395

  • S2: Omeprazole

    • when intended for the temporary, short-term relief of heartburn and hyperacidity, subject to:
    • a maximum daily dose of 20 milligrams
    • a maximum treatment period of 14 days. (S4)

    Consolidated Schedules 06 July 2026, lines 2457 to 2461

Pharmacological class: Other. (class 11.4.3)

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.

SAHPRA documents

Professional information (PI)For healthcare professionalsLosec 10, Equity Pharmaceutical (Pty) LtdPatient information leaflet (PIL)For patients and carersLosec 10, Equity Pharmaceutical (Pty) Ltd

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

Research articles

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