PARIET Gastro-resistant tablet Ref.[50850] Active ingredients: Rabeprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom

Product name and form

PARIET 10 mg gastro-resistant tablet.

Pharmaceutical Form

Gastro-resistant tablet.

Pink, film coated biconvex tablet with ‘E 241’ printed on one side.

Qualitative and quantitative composition

10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rabeprazole

Rabeprazole belongs to the class of anti-secretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonist properties, but suppress gastric acid secretion by the specific inhibition of the H+/K+ -ATPase enzyme (the acid or proton pump).

List of Excipients

Core tablet: Mannitol, magnesium oxide, low-substituted hyprolose, hyprolose, magnesium stearate.

Undercoating: ethylcellulose, magnesium oxide.

Enteric coating: hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), red iron oxide (E172), carnauba wax.

Printing ink: White Shellac, black iron oxide (E172), Dehydrated Ethyl Alcohol, 1-Butanol.

Pack sizes and marketing

Blister strips (aluminium/aluminium).

Pack sizes: 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 112 or 120 tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom

Marketing authorization dates and numbers

PL 10555/0010

06/05/2008

Drugs

Drug Countries
PARIET Austria, Australia, Brazil, Canada, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Singapore, Turkey, United Kingdom, South Africa

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