RABEPRAZOLE ACCORD Gastro-resistant tablet Ref.[7344] Active ingredients: Rabeprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Rabeprazole 10mg Gastro-resistant Tablets.

Pharmaceutical Form

Gastro-resistant tablet.

10mg: Pink, coated, elliptical, biconvex tablet.

Qualitative and quantitative composition

Rabeprazole 10mg gastro-resistant tablet contains rabeprazole sodium 10mg corresponding to 9.42mg 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:

Povidone
Hydroxypropyl cellulose, low subst.
Magnesium oxide, light
Mannitol (E421)
Magnesium stearate

Undercoating:

Ethyl cellulose
Magnesium oxide, light

Enteric coating:

Methacrylic acid-ethyl acrylate copolymer
Talc
Polysorbate 80
Sodium laurilsulfate
Propylene glycol
Iron oxide yellow (E172)
Titanium dioxide (E171)
Iron oxide red (E172) (10 mg tablets only)

Pack sizes and marketing

Blister packs (Al-OPA-PVC/Al).

Tablet cotainers (HDPE) with plastic closure (LDPE) and a desiccant.

Tablet containers (HDPE) with a plastic screw cap with an integrated desiccant.

Pack sizes:

Blister packs: 7, 14, 20, 28, 30, 56, 60, 98, 100 and 120 tablets.

Tablet containers: 30, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

20075/1235

14/07/2010 / 01/06/2015

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.