URISPAS Film-coated tablet Ref.[9722] Active ingredients: Flavoxate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Recordati Pharmaceuticals Limited, Origin, Western Road, Bracknell, RG12 1US, United Kingdom

Product name and form

Urispas 200 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White, film-coated tablets embossed with ‘F 200’.

Qualitative and quantitative composition

Each tablet contains as active ingredient: flavoxate hydrochloride 200 mg.

Excipient with known effect: Each tablet contains 64 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Flavoxate

Flavoxate is an antispasmodic selective to the urinary tract. Flavoxate has been shown to have a direct antispasmodic action on smooth muscle fibres.

List of Excipients

Tablet Core:

Lactose monohydrate
Sodium starch glycolate
Povidone
Talc
Magnesium stearate
Cellulose microcrystalline

Tablet Coating:

Hypromellose
Cellulose microcrystalline
Macrogol 6000
Macrogol stearate
Magnesium stearate
Titanium dioxide (E171)

Pack sizes and marketing

PVC/aluminium blister strips in pack sizes of 84, 90, 100 and 250 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Recordati Pharmaceuticals Limited, Origin, Western Road, Bracknell, RG12 1US, United Kingdom

Marketing authorization dates and numbers

PL 25046/0006

Date of first authorisation: 30 May 1997
Date of latest renewal: 14 August, 2007

Drugs

Drug Countries
URISPAS France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, Turkey, United Kingdom, South Africa

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