Fluimucil Use In Pregnancy & Lactation

Effervescent tab/Powd for oral soln: Pregnancy: Data from a limited number of exposed pregnant women showed no adverse effects on pregnancy or the health of the foetus or the newborn.
No experience from epidemiological studies is available.
Animal studies do not indicate direct or indirect toxicity with any effect on pregnancy, embryonic development, development of the foetus and/or postnatal development.
Caution is indicated when used in pregnancy.
Lactation: There are no studies showing whether or not acetylcysteine passes into breast milk.
Fluimucil should not be used during breast-feeding, unless absolutely necessary.
Syrup: Pregnancy: There are limited data about the use of acetylcysteine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of Fluimucil Syrup during pregnancy.
The benefit-risk balance should be assessed before using the product during pregnancy.
Breast-feeding: It is not known whether acetylcysteine and its metabolites are excreted in breast milk.
A risk to the breastfed infant cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fluimucil Syrup therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available concerning the effect of acetylcysteine in human fertility. Animal studies do not indicate any harmful effects with respect to human fertility at the recommended dose.