ULCESEP Hard gelatin capsule Ref.[51141] Active ingredients: Omeprazole

Source: Medicines Authority (MT)  Publisher: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A., By ASAC Pharma, C/Sagitario, 14, 03006 Alicante (Spain)

Product name and form

Ulcesep Capsules 20mg.

Pharmaceutical Form

Hard gelatin capsules.

Ulcesep Capsules 20mg: hard gelatin capsules containing omeprazole 20mg as enteric coated granules.

Qualitative and quantitative composition

Each capsule contains omeprazole 20 mg.

For excipients, see 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

Saccarose, phtalate of hydroxy propyl methyl cellulose, maize starch, hydroxy propyl methyl cellulose, lactose, hydroxypropyl cellulose, crystallized disodium phosphate, sodium laurilsulfate, phtalate diethyl, Covering hard gelatin, colorants (C.I. 73015, C.I. 47005, C.I. 77891).

Pack sizes and marketing

Ulcesep Capsules are provided in Aluminium-PVC/Aluminium foil blister packs.

Packs of 28 capsules.

Marketing authorization holder

ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A., By ASAC Pharma, C/Sagitario, 14, 03006 Alicante (Spain)

Marketing authorization dates and numbers

MA120/00101

21st December 2007

Drugs

Drug Countries
ULCESEP Spain, Malta

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