Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
There are limited amount of data (less than 300 pregnancy outcomes) for the use of FORLAX in pregnant women.
No effects during pregnancy are anticipated, since systemic exposure to FORLAX is negligible. FORLAX can be used during pregnancy.
Lactation: There are no data on the excretion of FORLAX in breast milk.
No effects on the breast-feeding newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to FORLAX is negligible. FORLAX can be used during breast-feeding.
Fertility: No fertility studies were conducted with FORLAX however since macrogol 4000 is not significantly absorbed no effect on fertility is anticipated.