VESICARE Oral suspension Ref.[7101] Active ingredients: Solifenacin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Product name and form

Vesicare 1 mg/ml oral suspension.

Pharmaceutical Form
Oral suspension. A white to off-white coloured aqueous, homogeneous suspension with an orange flavour.

Qualitative and quantitative composition

Vesicare oral suspension contains 1 mg/ml solifenacin succinate, equivalent to 0.75 mg/ml solifenacin.

Excipients with known effect:

Methyl parahydroxybenzoate (E218) 1.6 mg/ml.

Propyl parahydroxybenzoate (E216) 0.2 mg/ml.

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per maximum daily dose (10 ml Vesicare oral suspension). Ethanol originates from the natural orange flavour.

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.

List of Excipients
Polacrilin potassium Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Propylene glycol (E1520) Simethicone emulsion 30%; consisting of simethicone, polyethylene glycol sorbitan tristearate (E436), methylcellulose (E461), polyethylene glycol stearate, glycerides, xanthan gum (E415), benzoic acid (E210), sorbic acid (E200), sulphuric acid (E513) and water Carbomer Xylitol (E967) Acesulfame potassium (E950) Natural orange flavour; consisting of orange essential oils, natural flavouring substances, ethanol, propylene glycol (E1520), butylated hydroxyanisol (E320) and water Sodium hydroxide Purified water

Pack sizes and marketing

150 ml Vesicare oral suspension in amber polyethylene terephthalate (PET) bottle with polyethylene (PE) screw-cap with a pulp and vinylseal liner, packed in a carton.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Marketing authorization dates and numbers

PL 00166/0406

28/06/2015

Drugs

Drug	Countries
VESICARE	Austria, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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