PRIMIDONE Tablets Ref.[7908] Active ingredients: Primidone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: SERB, 40 avenue George V, 75008, Paris, France

Product name and form

Mysoline 50mg Tablets.

Primidone SERB 50mg Tablets.

Pharmaceutical Form

Tablet.

White or virtually white, round, biconvex, uncoated tablets intagliated with a single M on one side and plain on the reverse.

Qualitative and quantitative composition

Each tablet contains 50mg primidone.

For full list of excipients see section 6.1.

Active Ingredient Description
Primidone

Primidone is an anticonvulsant. Although the precise mode of action of primidone is unknown, in common with other anticonvulsants, effects on the neuronal membrane particularly with respect to alteration of ionic fluxes are likely to play a fundamental role.

List of Excipients

Carmellose calcium
Gelatin
Magnesium stearate
Povidone K30
Purified water
Stearic acid

Pack sizes and marketing

HDPE bottle containing 100 tablets, with a white HDPE, tamper-evident, child resistant push-on cap with a white LDPE liner.

Marketing authorization holder

SERB, 40 avenue George V, 75008, Paris, France

Marketing authorization dates and numbers

PL 26080/0002

02/06/2010

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