Medicinal Products

AOTAL 333 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Acamprosate
laboratory: Merck Sante

Enteric coated tablet
Box of 180
All forms

Indication

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

Dosage AOTAL 333 mg Enteric coated tablet Box of 180

The dosage is 2 tablets morning, noon and night, for a subject weighing more than 60 kg.

It is 2 tablets in the morning, one at noon and one in the evening, for a subject weighing less than 60 kg.

It is preferable to administer the tablet at a distance from meals if the digestive tolerance is good (see section Pharmacokinetic properties ).

Treatment with acamprosate should be started as soon as possible after stopping alcohol consumption. Episodic reallabulization does not contraindicate the maintenance of treatment.

Administration of acamprosate during the course of the meal decreases the bioavailability of the drug.

The recommended duration of treatment is one year.

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 ).

Aotal side effects

According to the data collected during the clinical studies and the spontaneous notifications since the marketing authorization, the following undesirable effects can appear under treatment with AOTAL.

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 (≥ 1/10000, <1/1000).

· Very rare (<1/10000).

· 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

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