Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy

Tiotropium
There is a very limited amount of data from the use of tiotropium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see 5.3).

Olodaterol
For olodaterol no clinical data on exposed pregnancies are available. Preclinical data for olodaterol revealed effects typical for beta-adrenergic agonists at high multiples of the therapeutic doses (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Spiolto Respimat during pregnancy.

Like other beta2-adrenergic agonists, olodaterol a component of Spiolto Respimat may inhibit labour due to a relaxant effect on uterine smooth muscle.

Breast-feeding
Clinical data from nursing women exposed to tiotropium and/or olodaterol are not available.

In animal studies for both tiotropium and olodaterol the substances and/or their metabolites have been detected in the milk of lactating rats, but it is not known whether tiotropium and/or olodaterol passes into human breast milk.

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Spiolto Respimat should be made taking into account the benefit of breast-feeding to the child and the benefit of Spiolto Respimat therapy to the woman.


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 5.3).