LANSOPRAZOLE Gastro-resistant capsules Ref.[7290] Active ingredients: Lansoprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland

Product name and form

Lansoprazole 15 mg Gastro-Resistant Capsules.

Pharmaceutical Form

Lansoprazole 15 mg: opaque yellow cap and body capsules. Each capsule contains white or almost white spherical microgranules.

Qualitative and quantitative composition

Each capsule contains 15 mg lansoprazole.

Excipient with known effect: Each 15 mg capsule contains 100.474 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lansoprazole

Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach. The inhibition is dose-dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.

List of Excipients

Sugar spheres (sucrose and maize starch)
Sodium laurilsulphate
Meglumine
Mannitol (E421)
Hypromellose
Macrogol
Talc
Polysorbate 80
Titanium dioxide (E171)
Methacrylic Acid-Ethyl Acrylate Copolymer, 1:1, Dispersion 30%

Capsule shell:

Gelatin
Titanium dioxide (E171)
Quinoline yellow (E104) – only 15 mg capsules

Pack sizes and marketing

Al/Al blister.

Pack sizes: 7, 14, 28, 56 and 98 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland

Marketing authorization dates and numbers

PL 30306/0148

08/10/2008

Renewal Approved: 26/06/2013

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