BACLOFEN Tablet Ref.[7783] Active ingredients: Baclofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Product name and form

Baclofen Tablets 10 mg.

Pharmaceutical Form

Tablet.

A 7 mm flat bevelled edge tablet marked “BN” breakline “10” on one side and “G” on the reverse.

Qualitative and quantitative composition

Each tablet contains baclofen 10 mg.

Excipient with known effect: Each tablet contains 40 mg lactose monohydrate.

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

The tablet contains:

Microcrystalline cellulose
Lactose monohydrate
Anhydrous calcium hydrogen phosphate
Colloidal anhydrous silica
Magnesium stearate
Sodium starch glycollate (type A)

Pack sizes and marketing

Baclofen Tablets are available either in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler, or in PVDC aluminium foil blisters. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180 and for the polypropylene containers pack sizes of 50, 250 and 500 are also available.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0158

Date of first authorisation: 10/10/1986
Date of latest renewal: 05/10/2005

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