| OLD
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults within the age range 18-65years:
- 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).
Children and the Elderly: Acamprosate should not be administered to children and
the elderly. 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.
NEW
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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).
Children and the Elderly: Acamprosate should not be administered to children and the elderly. 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.
OLD
4.3 CONTRAINDICATIONS
Acamprosate is contraindicated:
− in patients with a known hypersensitivity to the drug
− in pregnant women and lactating women
− in cases of renal insufficiency (serum creatinine >120 micromol/L)
− in cases with severe hepatic failure (Childs- Pugh Classification C)
NEW
4.3 CONTRAINDICATIONS
Acamprosate is contraindicated:
− in patients with a known hypersensitivity to acamprosate or to any of the excipients
− lactating women (see section 4.6)
− in cases of renal insufficiency (serum creatinine >120 micromol/L)
OLD
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acamprosate does not constitute treatment for the withdrawal period. 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. 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.
NEW
4.4 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 of Campral 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 alcoholdependent 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.
OLD
4.5 INTERACTIONS WITH OTHER MEDICAMENTS 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 with its administration in the fasting state. Pharmacokinetic studies have been completed and show no interaction between acamprosate and diazepam, disulfiram or imipramine. There is no information available on the concomitant administration of acamprosate with diuretics.
NEW
4.5 INTERACTIONS WITH OTHER MEDICAMENTS 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 with its administration in the fasting state. In clinical trials, acamprosate has been safely administered in combination with antidepressants, anxiolytics, hypnotics and sedatives, and non-opioid analgesics. Pharmacokinetic studies have been completed and show no interaction
between acamprosate and diazepam, disulfiram, oxazepam, tetrabamate, meprobamate or imipramine. There is no information available on the concomitant administration of acamprosate with diuretics.
OLD
4.6 PREGNANCY AND LACTATION
Although animal studies have not shown any evidence of foetotoxicity or teratogenicity, the safety of acamprosate has not been established in pregnant women. Acamprosate should not be administered to pregnant women. Acamprosate is excreted in the milk of lactating animals. Safe use of acamprosate has not been
demonstrated in lactating women. Acamprosate should not be administered to breast feeding women.
NEW
4.6 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 pregnancy after a careful benefit/risk assessment, when the patient cannot abstain from drinking alcohol without being treated
with alcohol and when there is consequently a risk of foetotoxicity or tetragenecity due to alcohol.
Lactation
It is known that Campral is excreted in the milk of lactating animals. It is not known whether acamprosate is excreted in human milk. There are no adequate data from the use of acamprosate in infants. Campral must therefore not be used in breastfeeding women. Campral must therefore not be used in breastfeeding women.
If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decision must be made whether to discontinue nursing or to discontinue Campral, taking into account the importance of the medicinal product to
the woman.
Fertility
In animal studies, no adverse effects on fertility were observed. Whether or not
acamprosate affects the fertility in humans is unknown.
OLD
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Acamprosate should not impair the patient’s ability to drive or operate machinery.
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4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Campral has no influence on the ability to drive and use machines.
OLD
4.8 UNDESIRABLE EFFECTS
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) Within each frequency grouping, undesirable effects are presented in order
of decreasing seriousness.
Gastrointestinal disorders:
Very common: Diarrhoea
Common: Abdominal pain, nausea, vomiting
Skin and subcutaneous tissue disorders:
Common: Pruritus, maculo-papular rash
Rare: Bullous skin reactions
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
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4.8 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 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
OLD
4.9 OVERDOSE
Five cases of overdose associated with acamprosate therapy have been reported in humans, including one patient who ingested 43g of acamprosate. After gastric lavage all patients had an uneventful recovery. Diarrhoea was observed in two cases. No case of hypercalcaemia was reported in the course of these overdoses.
However, should this occur, the patients should be treated for acute hypercalcaemia.
NEW
4.9 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 is directed to symptoms
OLD
10. Date of the Revision of the Text
16 November 2007
NEW
10. Date of the Revision of the Text
07 December 2011
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