COLOFAC Modified release capsule Ref.[27745] 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 MR. Modified release capsule.

Pharmaceutical Form

Modified release capsule.

White, opaque, modified release capsule imprinted with “245”.

Qualitative and quantitative composition

Mebeverine hydrochloride 200 mg.

For 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

Capsule content Modified release granules:

Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic-acid ethyl acrylate copolymer 1:1 dispersion 30%, glycerol triacetate

Capsule shell:

Gelatine, titanium dioxide (E171), printing inks: shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

Pack sizes and marketing

Boxes containing 10 or 60 capsules in PVC-Al press through strips.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 46302/0023

14/08/1998 / 04/07/2003

Drugs

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

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