Pregnancy: There is limited clinical data relating to women exposed to acetylcysteine during pregnancy. Animal studies do not suggest any direct or indirect harmful effects on the pregnancy, embryo/fetal development, birth or postnatal development.
As a precautionary measure, it is preferable to avoid use of Acetylcysteine (Fluimucil) during pregnancy. Prior to use in pregnancy, the potential risks should be weighed against the potential benefits.
Lactation: There is no available information on the excretion in breast milk. A risk to the child cannot be excluded. The product should only be used during pregnancy and lactation after the benefit/risks have been weighed up carefully. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from Acetylcysteine (Fluimucil) therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Fertility: No data are available on the effect of acetylcysteine on human fertility. Animal studies do not indicate harmful effects with respect to fertility for humans at the recommended doses.