Hidrasec Use In Pregnancy & Lactation

Capsule: Fertility: No effect on fertility has been observed during fertility studies conducted in male and female rats.
Pregnancy: Animal studies have not shown any direct or indirect harmful effects with respect to reproductive toxicity. Clinical data on the use of racecadotril during pregnancy are very limited. As a precaution, it is therefore preferable to avoid the use of Hidrasec during pregnancy, regardless of trimester.
Breast-feeding: In the absence of data on the passage of racecadotril into breast milk and on account of its pharmacological properties and the immaturity of the neonatal digestive tract, Hidrasec should not be administered during breast-feeding.
Granules for oral suspension: Fertility: Fertility studies conducted with racecadotril on rats demonstrate no impact on fertility.
Pregnancy: There are no adequate data from the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo-foetal development, childbirth/delivery or postnatal development. However, since no specific clinical studies are available, racecadotril should not be administered to pregnant women.
Lactation: Due to the lack of information regarding racecadotril excretion in human milk, this medicinal product should not be administered to breastfeeding women.