ProUrsan 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 that the growth and development of the baby may be affected. The patient should not take Ursodeoxycholic acid (ProUrsan) 250 mg capsules during pregnancy unless the doctor thinks it is absolutely 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) 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: There are only a few documented cases of Ursodeoxycholic acid (ProUrsan) use in breastfeeding women. Levels of Ursodeoxycholic acid (ProUrsan) in milk are very low and probably no adverse reactions will occur 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.