MEDOPRAZOLE Gastro-resistant capsule, hard Ref.[51165] Active ingredients: Omeprazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medoprazole 20 mg gastro-resistant capsules, hard.

Pharmaceutical Form

Gastro-resistant capsule, hard.

White hard gelatin capsules size “2” with opaque white cap and opaque white body.

Qualitative and quantitative composition

Each capsule contains 20 mg omeprazole.

Excipient with known effect: 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 pellets (Mannitol (E421), Hydroxyl propyl methyl cellulose, Methacrylic acid copolymer dispersion, Sodium lauryl sulphate, Disodium hydrogen ortho phosphate, Diethyl phthalate, Sucrose, Titanium dioxide (E171), Povidone K-30, Calcium Carbonate, Talc, Polysorbate 80, Sodium hydroxide) gelatine and titanium dioxide (E171).

Pack sizes and marketing

Pack sizes:

PVC/Al blisters in carton boxes of 10, 14 or 20 capsules.

PVC/Al blisters in carton boxes of 30, 56, 60 or 100 capsules.

PVC securitainers of 100 capsules are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

17551

11.02.1998 / 03.12.2010

Drugs

Drug Countries
MEDOPRAZOLE Cyprus, Malta

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