Campral ec - abbreviated prescribing information

PRESCRIBING INFORMATION (UK)
Campral EC acamprosate
Presentation: Off-white round enteric-coated tablets, containing 333mg acamprosate
calcium.
Indications: Maintenance of abstinence in alcohol-dependent patients. It should be
combined with counselling.
Dosage and Administration: Adults ≥ 60kg: 6 tablets per day (2 tablets taken three times
daily with meals) Adults < 60kg: 4 tablets per day (2 tablets in the morning, 1 at noon and 1
at night with meals). Recommended treatment period is one year, starting as soon as
possible after the withdrawal period. Treatment should be maintained if the patient relapses.
Elderly and children: Not recommended.
Contraindications: Known hypersensitivity to the drug; renal insufficiency (serum creatinine
> 120 micromol/L); lactating women.
Warnings and precautions: Does not prevent the harmful effects of continuous alcohol
abuse; continued alcohol abuse negates the therapeutic benefit; regular monitoring of mental
status for symptoms of depression or suicidality is recommended. The safety and efficacy of
Campral have not been established in patients with severe liver insufficiency (Childs-Pugh
Classification C). Safety and efficacy are also not established in those under 18 or over 65
years old.
Interactions: None observed in pharmacokinetic studies with diazepam, disulfiram,
oxazepam, tetrabamate, meprobamate or imipramine. In clinical trials, Campral has been
safely administered with antidepressants, anxiolytics, hypnotics, sedatives and non-opioid
analgesics. The concomitant intake of alcohol and Campral does not affect the
pharmacokinetics of either alcohol or Campral; administration with food diminishes the
bioavailability of Campral compared with administration in a fasting state. There is no
information on administration of Campral with diuretics.
Pregnancy: Campral should only be used during pregnancy after a careful benefit/risk
assessment, when the patient cannot abstain from drinking alcohol without being treated with
Campral, and when there is a consequential risk of foetotoxicity or teratogenicity due to
alcohol.
Undesirable Effects: Very common: diarrhoea; Common: abdominal pain, nausea, vomiting,
flatulence, pruritus, maculo-papular rash, frigidity or impotence, decreased libido; Uncommon:
increased libido; Very rare: hypersensitivity reactions including urticaria, angio-oedema or
anaphylactic reactions; Unknown frequency: vesiculo-bullous eruptions. Prescribers should
consult the summary of product characteristics for full details of side effects.
Overdose: In reported cases, the related symptom is diarrhoea. Treatment of overdose is
directed to symptoms.
Legal Category: POM
Package Quantities and Basic NHS Price:
168 blister packed tablets Price £28.80
Marketing Authorisation Number/Holder: PL 13466/0001, Merck Santé s.a.s, 37 rue Saint
Romain, 69379 Lyon Cedex 08, France
Further information is available from: Merck Serono Ltd, Bedfont Cross, Stanwell Road,
Feltham, Middlesex, TW14 8NX, UK.
Date of preparation: February 2012


Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Merck
Serono Limited - Tel: +44(0)20 8818 7373 or email: [email protected].

Source: http://www.alcoholconcern.org.uk/assets/files/PolicyandCampaigns/Campral-approved-PI-UK-Feb-2012.pdf