Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy
There are data from post-marketing pregnancy registry on pregnant women treated with various forms of aciclovir. The reported data do not show an increase in the number of birth defects in children of mothers treated with aciclovir compared to the general population, and the birth defects show no similarity or feature suggesting a common cause.

According to internationally accepted standard tests, embryotoxic or teratogenic effects in rabbits, rats or mice have not been established with systemic administration of aciclovir.

Fetal abnormalities were detected in non-standard studies in rats only after administration of very high maternal toxic doses, subcutaneously. The clinical relevance of these data has not been established.

Aciclovir should be used during pregnancy only when the potential benefits outweigh the potential risks to the fetus.

Breastfeeding
Limited human data suggest that aciclovir passes into breast milk when administered systemically.
However, the dose potentially taken by the infant after topical administration of Aciclovir Vision eye ointment would be negligible.

Fertility
There is no information on the effect of aciclovir on female fertility.
In a study of 20 males with normal sperm count, oral aciclovir administered at doses up to 1 g daily for up to six months was shown to have no clinically relevant effect on sperm count, motility or morphology.

See clinical trial data presented in section 5.3.