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Pregnancy: There is a limited amount of data from the use of tiotropium in pregnant women. For olodaterol no clinical data on exposed pregnancies are available.
Preclinical studies with tiotropium do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see Pharmacology: Toxicology under Actions).
Preclinical data for olodaterol revealed effects typical for beta-adrenergic agonists at high multiples of the therapeutic doses (see Pharmacology: Toxicology under Actions).
As a precautionary measure, it is preferable to avoid the use of SPIOLTO RESPIMAT during pregnancy.
The inhibitory effect of beta-adrenergic agonists, like olodaterol a component of SPIOLTO RESPIMAT on uterine contraction should be taken into account.
Lactation: Clinical data from nursing women exposed to tiotropium and/or olodaterol are not available.
In preclinical studies for both tiotropium and olodaterol the substances and/or its metabolites have been detected in the milk of lactating rats, but it is not known whether tiotropium and/or olodaterol pass into human breast milk.
Therefore, SPIOLTO RESPIMAT should not be used in nursing women unless the expected benefit outweighs any possible risk to the infant.
Fertility: Clinical data on fertility are not available for tiotropium and olodaterol or the combination of both components. Preclinical studies performed with the individual components tiotropium and olodaterol showed no indication of any adverse effect on fertility (see Pharmacology: Toxicology under Actions).
