Ursoliv/Ursoliv 500 Use In Pregnancy & Lactation

Ursoliv: Should not be used during pregnancy and lactation without medical advice.
Ursoliv 500: Animal studies did not show an influence of UDCA on Fertility, Pregnancy and Lactation. Human data on fertility effects following treatment with UDCA are not available.
Pregnancy: There are no or limited amounts of data from the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation. Ursodeoxycholic acid (Ursoliv) must not be used during pregnancy unless clearly necessary.
Women of childbearing potential: 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 (Ursoliv) 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.
Breastfeeding: According to few documented cases of breastfeeding women milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.