CAMPRAL Enterocoated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Campral EC.
Qualitative and quantitative composition
Each tablet contains acamprosate (I.N.N.) calcium 333.0 mg as the active ingredient. For the full list of excipients, see section 6.1.
Pharmaceutical form
Enterocoated tablets. Campral tablets are white and round with 333 engraved on one side and approximately 10 mm in diameter.
Therapeutic indications
Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.
Posology and method of administration
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 ...
Contraindications
*Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lactating women (see section 4.6). In cases of renal insufficiency (serum creatinine >120 micromol/L).
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
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 ...
Fertility, pregnancy and lactation
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 ...
Effects on ability to drive and use machines
Campral has no influence on the ability to drive and use machines.
Undesirable effects
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 ...
Overdose
Acute overdose is usually mild. In the reported cases, the only symptom, which can be reasonably related to overdose is diarrhoea. No case of hypercalcaemia has ever been reported. Treatment of overdose ...
Pharmacodynamic properties
Acamprosate (calcium acetylhomotaurinate) has a chemical structure similar to that of amino acid neuromediators, such as taurine or gamma-amino-butyric acid (GABA), including an acetylation to permit passage ...
Pharmacokinetic properties
Acamprosate absorption across the gastrointestinal tract is moderate, slow and sustained and varies substantially from person to person. Food reduces the oral absorption of acamprosate. Steady state levels ...
Preclinical safety data
In the preclinical studies, signs of toxicity are related to the excessive intake of calcium and not to acetylhomotaurine. Disorders of phosphorus/calcium metabolism have been observed including diarrhoea, ...
List of excipients
Crospovidone (KOLLIDON CL) Microcrystalline cellulose (AVICEL PH 101) Magnesium silicate (COMPRESSIL) Sodium starch glycolate (EXPLOTAB) Anhydrous colloidal silica (AEROSIL 200) Magnesium stearate Anionic ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/PVC sheets of blisters presented in cartons of 168 tablets.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Marketing authorization number(s)
PL 11648/0289
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 December 1995 Date of latest renewal: 24 October 2007
Date of revision of the text
September 2019
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