Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Astellas Pharma Ltd., SPACE, 68 Chertsey road, Woking, Surrey, GU21 5BJ, UK
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”. |
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) |
Aluminium blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.
Astellas Pharma Ltd., SPACE, 68 Chertsey road, Woking, Surrey, GU21 5BJ, UK
PL 00166/0404
Date of first authorisation: 06 May 2013
Date of latest renewal: 06 May 2018
| Drug | Countries | |
|---|---|---|
| VESOMNI | Austria, Brazil, Spain, Croatia, Ireland, Netherlands, Poland, Romania, United Kingdom |
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