Medicinal Products

ACAMPROSATE BIOGARAN 333 mg gastro-resistant film-coated tablet box of 60

Generic drug from Aotal
Therapeutic class: Toxicology
active ingredients: Acamprosate
laboratory: Biogaran

Enteric coated film-coated tablet
All forms

Indication

Acamprosate is indicated in the "maintenance of abstinence in alcohol-dependent patients". It must be associated with psychological care.

Dosage ACAMPROSATE BIOGARAN 333 mg gastro-resistant film-coated tablet box of 60

Acamprosate is indicated in the "maintenance of abstinence in alcohol-dependent patients". It must be associated with psychological care.

Against indications

Acamprosate is contraindicated:

· In patients with known hypersensitivity to acamprosate or to any of the excipients;

· In case of renal insufficiency (creatinine> 120 μmol / l);

· In breastfeeding women (see section Pregnancy and breastfeeding ).

Adverse effects Acamprosate Biogaran

According to data collected during clinical studies and spontaneous reports since the marketing authorization, the following side effects may occur with acamprosate treatment.

Adverse reactions were classified according to the frequency used below:

· Very common (≥ 1/10).

· Frequent (≥ 1/100, <1/10).

· Uncommon (≥ 1/1000, <1/100).

· Rare (≥ 1/10 000, <1/1 000).

· Very rare (<1 / 10, 000).

· Undetermined (can not be estimated based on available data).

Gastrointestinal disorders

· Very common: diarrhea.

· Common: abdominal pain, nausea, vomiting, flatulence

Skin and subcutaneous tissue disorders

· Common: pruritus, maculopapular rash.

· Undetermined: vesicobullous eruptions.

Immune system disorders

· Very rare: hypersensitivity reactions including urticaria, angioedema, anaphylactic reaction.

Disorders of reproductive organs and breast

· Frequent: frigidity and impotence.

Psychiatric disorders

· Common: decreased libido

· Uncommon: increased libido

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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