VENTRA Gastro-resistant capsule, hard Ref.[49656] Active ingredients: Esomeprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Ethypharm, 194, Bureaux de la Colline Bâtiment D, 92213 Saint-Cloud Cedex, France

Product name and form

Ventra 20 mg gastro-resistant capsules, hard.

Pharmaceutical Form
Gastro-resistant capsule, hard. Capsule with an opaque yellow cap and an opaque white body imprinted in black with “20 mg” both on the cap and on the body. The capsule contains off-white to greyish spherical microgranules.

Qualitative and quantitative composition

Each capsule contains 20 mg of esomeprazole (as magnesium dihydrate).

Excipients with known effect: each capsule contains 8.05 mg of sucrose, 1.85 micrograms methyl-p-hydroxybenzoate (E218), 0.56 microgram of propyl-p-hydroxybenzoate (E216) and 7.4 ng of sodium benzoate (E211).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Esomeprazole	Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

List of Excipients
Capsule content: Sugar spheres (sucrose and maize starch) Hypromellose Dimethicone emulsion 35% containing dimethicone, propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaureate, octylphenoxy polyethoxy ethanol and propylene glycol Polysorbate 80 Mannitol Diacetylated monoglycerides Talc Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 % containing copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate and polysorbate 80 Triethyl citrate Stearoyl macrogolglycerides Capsule shell: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Printing ink: Black iron oxide (E172) Shellac Ammonia Propylene glycol Potassium hydroxide

Pack sizes and marketing

HDPE bottles containing a silica gel desiccant and closed with a child resistant white PP cap. The opening of bottle is sealed with an aluminium induction seal.

Pack sizes: 28, 30, 90 or 98 capsules.

PA-Aluminium-PVC/Aluminium foil blisters

Pack sizes: 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100 or 140 capsules

Not all pack sizes may be marketed.

Marketing authorization holder

Ethypharm, 194, Bureaux de la Colline – Bâtiment D, 92213 Saint-Cloud Cedex, France

Marketing authorization dates and numbers

PL 06934/0156

12/11/2010

Drugs

Drug	Countries
VENTRA	Hong Kong, United Kingdom

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