Components:
Acamprosate
Acamprosate
Method of action:
Other Nervous System Drugs
Other Nervous System Drugs
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Name of the medicinal product

Acamprosate Biogaran

Qualitative and quantitative composition

Acamprosate

Therapeutic indications

The information provided in Therapeutic indications of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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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 divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).

Older people

Acamprosate should not be used in older people

Paediatric population

Acamprosate should not be used in children

The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses.

Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit, therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol.

Contraindications

The information provided in Contraindications of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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−

− Lactating women

− In cases of renal insufficiency (serum creatinine >120 micromol/L)

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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The safety and efficacy of Acamprosate Biogaran has not been established in patients younger than 18 years or older than 65 years. Acamprosate Biogaran is therefore not recommended for use in these populations.

The safety and efficacy of Acamprosate Biogaran 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.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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Acamprosate Biogaran has no influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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According to information collected during clinical trials and spontaneous reports since marketing authorization, the following adverse reactions may occur under treatment with Acamprosate Biogaran.

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 www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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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 is directed to symptoms.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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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 across the blood brain barrier. Acamprosate may act by stimulating GABAergic inhibitory neurotransmission and antagonising excitatory amino-acids, particularly glutamate. Animal experimental studies have demonstrated that acamprosate affects alcohol dependence in rats, decreasing the voluntary intake of alcohol without affecting food and total fluid intake.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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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 of acamprosate are achieved by the seventh day of dosing. Acamprosate is not protein bound.

Oral absorption shows considerable variability and is usually less than 10% of the ingested drug in the first 24 hours. The drug is excreted in the urine and is not metabolised significantly. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate.

The kinetics of acamprosate are not modified in group A or B of the Child-Pugh classification of impaired liver function, a population which is likely to be part of the target population for acamprosate. This is in accordance with the absence of hepatic metabolism of the drug.

Preclinical safety data

The information provided in Preclinical safety data of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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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, soft tissue calcification, renal and cardiac lesions. Acamprosate had no mutagenic or carcinogenic effect, nor any teratogenic or adverse effects on the male or female reproductive systems of animals. Detailed in vitro and in vivo research on acamprosate to detect genetic and chromosomal mutations has not produced any evidence of potential genetic toxicity.

Incompatibilities

The information provided in Incompatibilities of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
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Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Name of the medicinal product
Acamprosate Biogaran
Qualitative and quantitative composition
Acamprosate
Therapeutic indications
The information provided in Therapeutic indications of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.

Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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 divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).

Older people

Acamprosate should not be used in older people

Paediatric population

Acamprosate should not be used in children

The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses.

Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit, therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol.

Contraindications
The information provided in Contraindications of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

−

− Lactating women

− In cases of renal insufficiency (serum creatinine >120 micromol/L)

Special warnings and precautions for use
The information provided in Special warnings and precautions for use of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

The safety and efficacy of Acamprosate Biogaran has not been established in patients younger than 18 years or older than 65 years. Acamprosate Biogaran is therefore not recommended for use in these populations.

The safety and efficacy of Acamprosate Biogaran 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.

Effects on ability to drive and use machines
The information provided in Effects on ability to drive and use machines of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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

Undesirable effects
The information provided in Undesirable effects of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

According to information collected during clinical trials and spontaneous reports since marketing authorization, the following adverse reactions may occur under treatment with Acamprosate Biogaran.

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 www.mhra.gov.uk/yellowcard.

Overdose
The information provided in Overdose of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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 is directed to symptoms.

Pharmacodynamic properties
The information provided in Pharmacodynamic properties of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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 across the blood brain barrier. Acamprosate may act by stimulating GABAergic inhibitory neurotransmission and antagonising excitatory amino-acids, particularly glutamate. Animal experimental studies have demonstrated that acamprosate affects alcohol dependence in rats, decreasing the voluntary intake of alcohol without affecting food and total fluid intake.

Pharmacokinetic properties
The information provided in Pharmacokinetic properties of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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 of acamprosate are achieved by the seventh day of dosing. Acamprosate is not protein bound.

Oral absorption shows considerable variability and is usually less than 10% of the ingested drug in the first 24 hours. The drug is excreted in the urine and is not metabolised significantly. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate.

The kinetics of acamprosate are not modified in group A or B of the Child-Pugh classification of impaired liver function, a population which is likely to be part of the target population for acamprosate. This is in accordance with the absence of hepatic metabolism of the drug.

Preclinical safety data
The information provided in Preclinical safety data of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

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, soft tissue calcification, renal and cardiac lesions. Acamprosate had no mutagenic or carcinogenic effect, nor any teratogenic or adverse effects on the male or female reproductive systems of animals. Detailed in vitro and in vivo research on acamprosate to detect genetic and chromosomal mutations has not produced any evidence of potential genetic toxicity.

Incompatibilities
The information provided in Incompatibilities of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

Not applicable

Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of Acamprosate Biogaran is based on data of another medicine with exactly the same composition as the Acamprosate Biogaran of the medicine (Acamprosate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acamprosate Biogaran directly from the package or from the pharmacist at the pharmacy.
more... close

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Available in countries
See all
close