Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy:
The safety of this medicinal product for use in human pregnancy has not been established. There are no known human data for the effects of pilocarpine on foetal survival and development. Studies in animals have shown reproductive toxicity (see section 5.3).
Salagen is not recommended during pregnancy and in women of child bearing potential not using contraception.
Breastfeeding:
Animal studies have shown excretion of pilocarpine in milk at concentrations similar to those seen in plasma. It is not known whether pilocarpine is secreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue from Salagen therapy.
Fertility:
The effects of pilocarpine on male and female fertility are not known. Studies in mice, rats and dogs have shown adverse effects on spermatogenesis. A study in rats has also indicated a possible impairment of female fertility (see section 5.3). The safety margin for the effects on fertility is unknown.
Based on the results of available studies in animals (see section 5.3) as a precautionary meaure, Salagen tablets should be administered to individual human males who are attempting to father a child, only, if the expected benefit justifies potential impairment of fertility.