Aclidinium bromide

Pregnancy

There are no data available on the use of aclidinium bromide in pregnant women.

Studies in animals have shown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide. Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.

Nursing Mothers

It is unknown whether aclidinium bromide/metabolites are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Carcinogenesis, Mutagenesis and Fertility

Fertility

Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide. It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.