COLMIFEN Tablet Ref.[28172] Active ingredients: Baclofen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Colmifen 10 mg tablets.

Pharmaceutical Form

Tablet.

White, round, flat, scored tablets.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 10 mg baclofen.

Excipient(s) with known effect:

This product contains 67.3 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Baclofen

Baclofen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, chemically unrelated to other antispastic agents.

List of Excipients

Microcrystalline cellulose
Povidone
Lactose monohydrate
Maize starch
Pregelatinised starch
Magnesium stearate
Talc
Colloidal silicon dioxide

Pack sizes and marketing

PVC/Aluminium blisters. Pack-sizes of 60 and 100 tablets.

PP containers with PE closure. Pack-size of 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

12198

Date of first authorization: 19 May 1989
Date of latest renewal: 30 September 2011

Drugs

Drug Countries
COLMIFEN Cyprus, Malta, Singapore

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