Mebeverine

Chemical formula: C₂₅H₃₅NO₅  Molecular mass: 429.557 g/mol  PubChem compound: 4031

Pregnancy

There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Mebeverine is not recommended during pregnancy.

Nursing mothers

It is unknown whether mebeverine or its metabolites are excreted in human milk. The excretion of mebeverine in milk has not been studied in animals. Mebeverine should not be used during breast-feeding.

Carcinogenesis, mutagenesis and fertility

Fertility

There are no clinical data on male or female fertility; however, animal studies do not indicate harmful effects of mebeverine.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect of mebeverine on the ability to drive or to use machines.

Adverse reactions


The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data.

Allergic reactions mainly but not exclusively limited to the skin have been observed.

Immune system disorders: Hypersensitivity (anaphylactic reactions).

Skin and subcutaneous tissue disorders: Urticaria, angioedema, face oedema, exanthema.

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