There is no adequate data on the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation. Film-coated tablet 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 estrogen oral contraceptive measures are recommended. However, in patients taking ursodeoxycholic acid film-coated tablet 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.
It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, ursodeoxycholic acid film-coated tablet should not be taken during lactation.
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