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

Therapeutic indications

Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.

Posology and method of administration

Posology

Adults within the age range 18-65 years:

  • 2 tablets three times daily with meals (2 tablets morning, noon and night) in subjects weighing 60kg or more.
  • In subjects weighing less than 60kg, 4 tablets divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).

Older people

Acamprosate should not be used in older people.

Paediatric population

Acamprosate should not be used in children.

The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses.

Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit, therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol.

Overdose

Acute overdose is usually mild. In the reported cases, the only symptom, which can be reasonably related to overdose is diarrhoea. No case of hypercalcaemia has ever been reported. Treatment of overdose is directed to symptoms.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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