COLOFAC Coated tablet Ref.[27744] Active ingredients: Mebeverine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Colofac Tablets 135 mg.

Pharmaceutical Form

Coated tablets (Tablets).

Round white sugar coated tablets, with no superficial markings.

Qualitative and quantitative composition

Mebeverine hydrochloride 135mg.

Excipients with known effect: Lactose and Sucrose.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Mebeverine

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.
List of Excipients

Lactose
Starch (potato)
Povidone
Talc
Magnesium stearate
Sucrose
Gelatin
Acacia
Carnauba wax

Pack sizes and marketing

Boxes containing 10, 15, 84 or 100 tablets in blister strips.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0021

14 March 1978/21 April 2005

Drugs

Drug Countries
COLOFAC Austria, Australia, Ireland, Malta, New Zealand, United Kingdom, South Africa
 
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