OMEPRAZOLE Gastro-resistant capsules Ref.[7023] Active ingredients: Omeprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Omeprazole 10mg Gastro-resistant Capsules.

Pharmaceutical Form

Gastro-resistant capsules, hard.

Hard gelatine capsules of size 3, Opaque yellow cap and body containing white to off-white spherical pellets.

Qualitative and quantitative composition

Each capsule contains 10mg omeprazole.

Excipient with known effect: Contains sucrose, see section 4.4.

Each 10mg omeprazole capsule contains 51 to 58mg of sucrose.

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

Sugar spheres (consisting of corn starch and sucrose)
Sodium lauryl sulfate
Disodium phosphate
Mannitol
Hypromellose
Polyethylene glycol 6000
Talc
Polysorbate 80
Titanium dioxide
Eudragit L30-D55 (poly(methacrylic acid, ethyl acrylate))

Capsules consist of gelatin and contain the colours quinoline yellow (E104) and titanium dioxide (E171).

Pack sizes and marketing

OPA/Aluminium/PVC: Aluminium blister; OPA/Aluminium/PVC: PET/Aluminium blister:

Pack sizes: 7’s, 10’s, 14’s, 15’s, 20’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s

HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant:

Pack size: 30, 90

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 00142/0516

22.03.2002

Drugs

Drug Countries
OMEPRAZOLE Nigeria

© 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.