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Pregnancy: There is a limited amount of data from the use of tiotropium in pregnant women. Pre-clinical/animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see Pharmacology: Toxicology under Actions).
As a precautionary measure, it is preferable to avoid the use of SPIRIVA/SPIRIVA RESPIMAT during pregnancy.
Lactation: Clinical data from nursing women exposed to tiotropium are not available. Based on lactating rodent studies, a small amount of tiotropium is excreted into breast milk.
Therefore, SPIRIVA/SPIRIVA RESPIMAT should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.
Fertility: Clinical data on fertility are not available for tiotropium. A non-clinical study performed with tiotropium showed no indication of any adverse effect on fertility. (see Pharmacology: Toxicology under Actions).
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