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XATRAL XL Prolonged release tablets (2017)

Active ingredients: Alfuzosin

Product Name and Form

Xatral XL 10 mg prolonged release tablets.

Pharmaceutical form

Prolonged release tablet.

Round biconvex, three layer tablet: one white layer between two yellow layers.

Qualitative and Quantitative Composition

Each tablet contains 10mg alfuzosin hydrochloride.

Excipient: Hydrogenated castor oil

For a full list of excipients, see section 6.1.

Chemical substance
Description
Alfuzosin

Alfuzosin is an orally active quinazoline derivative. It is a selective, peripherally acting antagonist of postsynaptic alpha-1-adrenoceptors. In vitro pharmacological studies have documented the selectivity of alfuzosin for the alpha-1-adrenoreceptors located in the prostate, bladder base and prostatic urethra.

List of excipients

Ethylcellulose
Hydrogenated Castor Oil
Hypromellose
Yellow Ferric Oxide (E172)
Magnesium Stearate
Microcrystalline Cellulose
Povidone
Silica Colloidal Hydrated
Mannitol

Pack sizes and Marketing

Boxes with 10, 30, 50, 100 and 500 tablets in pvc/foil blister strips.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

02 April 2009

Marketing authorization number:

PL 04425/0657