ARELIX Tablet Ref.[8907] Active ingredients: Piretanide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2017  Publisher: Sanofi-Aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Arelix 6mg Tablets.

Pharmaceutical Form

Tablet.

Yellow-white, oblong scored tablets imprinted on one side with the Hoechst logo and having the identifying code ARE imprinted on the unscored side.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 6 mg piretanide.

For full list of excipients, see Section 6.1.

Active Ingredient Description
Piretanide

Piretanide is a loop diuretic for the management of fluid retention and treatment of mild to moderate hypertension.

List of Excipients

Maize starch
Microcrystalline cellulose
Magnesium stearate
Colloidal anhydrous silica

Pack sizes and marketing

Aluminium/PVC blister packs of 20 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0540/030/003

Date of first authorisation: 12 May 1983
Date of last renewal: 07 October 2010

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