Pregnancy: The effect on pregnancy and lactation has not been investigated in humans. Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses.
SIFROL should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: The excretion of SIFROL into the breast milk has not been studied in women. In rats, the concentration of drug was higher in the breast milk than in plasma. As SIFROL treatment inhibits secretion of prolactin in humans inhibition of lactation is expected. In consequence, SIFROL should not be used during breast-feeding.
Fertility: No studies on the effect on human fertility have been conducted. In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist. However, these studies did not indicate direct or indirect harmful effects with respect to male fertility.