Cholemax Use In Pregnancy & Lactation

Oral suspension: Animal studies did not show an influence of UDCA on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human data on fertility effects following treatment with UDCA are not available.
Pregnancy: Capsule: Category B.
For safety reasons, treatment should not be carried out during the first trimester of pregnancy. As with any drug, if the patient is pregnant seeks the advice of a health care professional before using this product.
Oral suspension: There are no or limited amounts of data on the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation (see Pharmacology: Toxicology: Preclinical safety data under Actions). UDCA suspension 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 UDCA 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.
Lactation/Breast-feeding: Capsule: Since there are insufficient data on the passage of ursodeoxycholic acid into breast-milk, it must not be used during breast-feeding.
Oral suspension: 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.