Pregnancy: There is a very limited amount of data from the use of tiotropium in pregnant women. Pre-clinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of SPIRIVA RESPIMAT/SPIRIVA RESPIMAT re-usable during pregnancy.
Breast-feeding: It is unknown whether tiotropium bromide is excreted in human breast milk. Despite studies in rodents which have demonstrated that excretion of tiotropium bromide in breast-milk occurs only in small amounts, use of SPIRIVA RESPIMAT/SPIRIVA RESPIMAT re-usable is not recommended during breast-feeding. Tiotropium bromide is a long-acting compound. A decision on whether to continue/discontinue breast-feeding or to continues/discontinue therapy with SPIRIVA RESPIMAT/SPIRIVA RESPIMAT re-usable should be made taking into account the benefit of breast-feeding to the child and the benefit of SPIRIVA RESPIMAT/SPIRIVA RESPIMAT re-usable therapy to the woman.
Fertility: Clinical data on fertility are not available for tiotropium. A pre-clinical study performed with tiotropium showed no indication of any adverse effect on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).