Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of levodopa/carbidopa/entacapone in pregnant women. Studies in animals have shown reproductive toxicological effects from the individual substances (see section 5.3). The potential risk to humans is unknown. Lecigon is not recommended during pregnancy or in women of childbearing potential not using contraception unless the benefits for the mother outweigh the possible risks to the foetus.

Breastfeeding
Levodopa and possibly levodopa metabolites are excreted in human milk. There is evidence that lactation is suppressed during treatment with levodopa.
It is unknown whether carbidopa and entacapone or their metabolites are excreted in human milk.
Animal studies have shown excretion of carbidopa and entacapone in breast milk, but it is unknown whether they are excreted in human milk.

There is insufficient information on the effects of levodopa/carbidopa/entacapone or their metabolites in newborns/infants. Breastfeeding should therefore be avoided during treatment with Lecigon.

Fertility
No negative effects on fertility have been observed in preclinical studies with carbidopa, levodopa or entacapone as individual substances. No fertility studies in animals have been conducted with the combination of levodopa, carbidopa and entacapone.