VESOMNI Modified release tablets Ref.[10456] Active ingredients: Solifenacin Tamsulosin

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

Product name and form

Vesomni 6 mg/0.4 mg modified release tablets.

Pharmaceutical Form

Modified release tablet

Each tablet is round, approximately 9 mm in diameter, red film-coated and debossed with “6/0.4”.

Qualitative and quantitative composition

Each tablet contains a layer of 6 mg solifenacin succinate, corresponding to 4.5 mg solifenacin free base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Solifenacin

Solifenacin is a competitive, specific cholinergic-receptor antagonist. In vitro and in vivo pharmacological studies indicate that solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor.

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

Mannitol (E421)
Maltose
Macrogol 7.000.000
Macrogol 8000
Magnesium stearate (E470b)
Butylhydroxytoluene (E321)
Colloidal silica anhydrous (E551)
Hypromellose (E464)
Iron oxide red (E172)

Pack sizes and marketing

Aluminium blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Ltd., SPACE, 68 Chertsey road, Woking, Surrey, GU21 5BJ, UK

Marketing authorization dates and numbers

PL 00166/0404

Date of first authorisation: 06 May 2013

Date of latest renewal: 06 May 2018

Drugs

Drug Countries
VESOMNI Austria, Brazil, Spain, Croatia, Ireland, Netherlands, Poland, Romania, United Kingdom

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