CAMPRAL Enterocoated tablet Ref.[7684] Active ingredients: Acamprosate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Product name and form

Campral EC.

Pharmaceutical Form

Enterocoated tablets.

Campral tablets are white and round with ‘333’ engraved on one side and approximately 10 mm in diameter.

Qualitative and quantitative composition

Each tablet contains acamprosate (I.N.N.) calcium 333.0 mg as the active ingredient.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Acamprosate has a chemical structure similar to that of amino acid neuromediators, such as taurine or gamma-amino-butyric acid (GABA), including an acetylation to permit passage across the blood brain barrier. Acamprosate may act by stimulating GABAergic inhibitory neurotransmission and antagonising excitatory aminoacids, particularly glutamate. It is indicated as therapy to maintain abstinence in alcohol-dependent patients.

List of Excipients

Crospovidone (KOLLIDON CL)
Microcrystalline cellulose (AVICEL PH 101)
Magnesium silicate (COMPRESSIL)
Sodium starch glycolate (EXPLOTAB)
Anhydrous colloidal silica (AEROSIL 200)
Magnesium stearate
Anionic copolymer of methacrylic and acrylic acid ethyl ester (EUDRAGIT L30 D)
Propylene glycol

Pack sizes and marketing

Aluminium/PVC sheets of blisters presented in cartons of 168 tablets.

Marketing authorization holder

Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Marketing authorization dates and numbers

PL 11648/0289

Date of first authorisation: 18 December 1995
Date of latest renewal: 24 October 2007


Drug Countries
CAMPRAL Austria, Australia, Canada, Estonia, Spain, Ireland, Netherlands, Poland, Turkey, United Kingdom

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