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

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.

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.

The concomitant intake of alcohol and acamprosate does not affect the pharmacokinetics of either alcohol or acamprosate. Administering acamprosate with food diminishes the bioavailability of the drug compared with its administration in the fasting state.

In clinical trials, acamprosate has been safely administered in combination with antidepressants, anxiolytics, hypnotics and sedatives, and non-opioid analgesics

Pharmacokinetic studies have been completed and show no interaction between acamprosate and diazepam, disulfiram, oxazepam, tetrabamate, meprobamate or imipramine.

There is no information available on the concomitant administration of acamprosate with diuretics.

Pregnancy

There is no adequate data from the use of Campral in pregnant women. Animal studies do not indicate any evidence of foetotoxicity or tetragenicity. Campral must therefore only be used during pregnancy after a careful benefit/risk assessment, when the patient cannot abstain from drinking alcohol without being treated with acamprosate and when there is consequently a risk of foetotoxicity or teratogenicity due to alcohol.

Breast-feeding

It is known that Campral is excreted in the milk of lactating animals. It is not known whether acamprosate is excreted in human milk. There are no adequate data from the use of acamprosate in infants. Campral must therefore not be used in breastfeeding women.

If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decision must be made whether to discontinue nursing or to discontinue Campral, taking into account the importance of the medicinal product to the woman.

Fertility

In animal studies, no adverse effects on fertility were observed. Whether or not acamprosate affects the fertility in humans is unknown.

Campral has no influence on the ability to drive and use machines.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.