FLOMAXTRA Film-coated prolonged-release tablet Ref.[27753] Active ingredients: Tamsulosin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom

Product name and form

Flomaxtra XL, 400 micrograms, film-coated prolonged-release tablet.

Pharmaceutical Form

Film-coated prolonged-release tablet.

Approximately 9 mm, round, bi-convex, yellow, film-coated tablets debossed with the code ‘04’.

Qualitative and quantitative composition

Each tablet contains as active ingredient tamsulosin hydrochloride 400 micrograms, equivalent to 367 micrograms tamsulosin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tamsulosin

Tamsulosin binds selectively and competitively to post-synaptic α1-adrenoreceptors, prevailingly their subtypes designated α1A and α1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow.

List of Excipients

Core:

Macrogol (containing butylhydroxytoluene)
Magnesium stearate

Film-coat:

Hypromellose
Macrogol
Yellow iron oxide (E172)

Pack sizes and marketing

Aluminium foil blister packs containing 30 tablets.

Marketing authorization holder

Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom

Marketing authorization dates and numbers

PL 00166/0199

Date of first authorisation: 11 July 2005
Date of latest renewal: 07 April 2009

Drugs

Drug Countries
FLOMAXTRA Australia, United Kingdom

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