OMEZ Capsule Ref.[50944] Active ingredients: Omeprazole

Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Dr. Reddys Laboratories (Pty) Ltd., Block B, 204 Rivonia Road, Morningside, Sandton 2057

Product name and form

OMEZ 10, 10 mg, capsule.

OMEZ 20, 20 mg, capsule.

OMEZ 40, 40 mg, capsule.

Pharmaceutical Form
Capsule. OMEZ 10: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque yellow coloured body. “Omeprazole 10 mg” imprinted with black ink on cap and “R157” imprinted with black ink on body. OMEZ 20: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque iron grey coloured body. “Omeprazole 20 mg” imprinted with black ink on cap and “R158” imprinted with black ink on body. OMEZ 40: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque yellow coloured cap and opaque purple coloured body. “Omeprazole 40 mg” imprinted with black ink on cap and “R159” imprinted with black ink on body.

Qualitative and quantitative composition

OMEZ 10: Each capsule contains omeprazole 10 mg.

OMEZ 20: Each capsule contains omeprazole 20 mg.

OMEZ 40: Each capsule contains omeprazole 40 mg.

Contains sugar (mannitol).

For the full list of excipients, see Section 6.1.

Active Ingredient	Description
Omeprazole	Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

List of Excipients
Crospovidone Hydroxypropyl methyl cellulose Magnesium stearate Mannitol Meglumine Methacrylic acid co-polymer (Type C) Poloxamer Povidone Triethyl citrate. Capsule shells: D&C red #28 FD&C blue #1 FD&C red #40 FD&C yellow #6 Gelatin Titanium dioxide In addition the 10 mg and 40 mg capsule shells also contain Yellow iron oxide and the 20 mg capsule shells contain black iron oxide. The black printing ink: Black iron oxide D&C Yellow No. 10 aluminium lake FD&C Blue No. 1 aluminium lake FD&C Blue No. 2 aluminium lake FD&C Red No. 40 aluminium lake Pharmaceutical glaze Propylene glycol

Pack sizes and marketing

OMEZ 10: Blister packaging containing 30 or 100 capsules. White HDPE bottles containing 30 or 100 capsules.

OMEZ 20: Blister packaging containing 14, 30 or 100 capsules. White HDPE bottles containing 14, 30, 100 or 1000 capsules.

OMEZ 40: Blister packaging containing 14, 28, 30 or 100 capsules. White HDPE bottles containing 30, 100 or 500 capsules.

Marketing authorization holder

Dr. Reddy’s Laboratories (Pty) Ltd., Block B, 204 Rivonia Road, Morningside, Sandton 2057

Marketing authorization dates and numbers

OMEZ 10: 34/11.4.3/0299
OMEZ 20: 34/11.4.3/0300
OMEZ 40: 34/11.4.3/0301

15 June 2001

Drugs

Drug	Countries
OMEZ	Albania, Romania, South Africa

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.