ProUrsan Forte Use In Pregnancy & Lactation

Pregnancy: There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation (see Pharmacology: Toxicology: Preclinical safety data under Actions). Ursodeoxycholic Acid (ProUrsan Forte) must not be used during pregnancy unless clearly necessary.
Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursodeoxycholic Acid (ProUrsan Forte) for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis.
The possibility of a pregnancy must be excluded before beginning treatment.
Breast-feeding: According to few documented cases of breastfeeding women milk levels of ursodeoxycholic acid are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility: Animal studies did not show an influence of ursodeoxycholic acid on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human data on fertility effects following treatment with ursodeoxycholic acid are not available.