Chemical formula: C₅H₁₁NO₄S Molecular mass: 181.21 g/mol PubChem compound: 71158
There is no adequate data from the use of acamprosate in pregnant women. Animal studies do not indicate any evidence of foetotoxicity or tetragenicity. Acamprosate 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 acamprosate and when there is consequently a risk of foetotoxicity or teratogenicity due to alcohol.
It is known that acamprosate 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. Acamprosate 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 acamprosate, taking into account the importance of the medicinal product to the woman.
In animal studies, no adverse effects on fertility were observed. Whether or not acamprosate affects the fertility in humans is unknown.
Acamprosate has no influence on the ability to drive and use machines.
According to information collected during clinical trials and spontaneous reports since marketing authorization, the following adverse reactions may occur under treatment with acamprosate.
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).
Very common: Diarrhoea
Common: Abdominal pain, nausea, vomiting, flatulence
Common: Pruritus, maculo-papular rash
Not known: Vesiculo-bullous eruptions
Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.
Common: Frigidity or impotence
Common: Decreased libido
Uncommon: Increased libido
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