RAZOLE Gastro-resistant tablet Ref.[49819] Active ingredients: Rabeprazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Product name and form

Razole 10 mg Gastro-resistant tablets.

Pharmaceutical Form

Gastro-resistant tablet.

Pink, film-coated, biconvex tablet.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 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

Tablet core:

Mannitol (E421)
Magnesium Oxide, heavy (E530)
Hydroxypropyl Cellulose (E463)
Magnesium Stearate (E572)

Intermediate Layer:

Ethylcellulose (E462)
Magnesium Oxide, heavy (E530)

Tablet coating:

Hypromellose Phthalate
Dibutyl Sebacate
Red Iron Oxide (E172)
Titanium Dioxide (E171)
Talc

Pack sizes and marketing

Aluminium/aluminium blisters in a cardboard carton.

1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 or 120 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0074/073/001

Date of first authorisation: 11th September 2009
Date of last renewal: 11th September 2014

Drugs

Drug Countries
RAZOLE Hong Kong, Ireland
 
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