CAMPRAL EC

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.

According to information collected during clinical trials and spontaneous reports since marketing authorization, the following adverse reactions may occur under treatment with Campral. The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data) Gastrointestinal disorders: Very common: Diarrhoea Common: Abdominal pain, nausea, vomiting, flatulence Skin and subcutaneous tissue disorders: Common: Pruritus, maculo-papular rash Not known: Vesiculo-bullous eruptions Immune system disorders: Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.

Reproductive system and breast disorders:

Common: Frigidity or impotence.

Psychiatric disorders:

Common: Decreased libido Uncommon: Increased libido Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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The safety and efficacy of Campral has not been established in patients younger than 18 years or older than 65 years. Campral is therefore not recommended for use in these populations. The safety and efficacy of Campral has not been established in patients with severe liver insufficiency (Childs-Pugh Classification C).

Because the interrelationship between alcohol dependence, depression and suicidality is well- recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for such symptoms.

Excipients:

This medicine contains less than 1mmol sodium (23mg) per dosage unit, that is to say it is essentially ‘sodium free’ Abuse and dependence Non-clinical studies suggest that acamprosate has little or no abuse potential. No evidence of dependence on acamprosate was found in any clinical study thus demonstrating that acamprosate has no significant dependence potential.

6) − In cases of renal insufficiency (serum creatinine >120 micromol/L)