Ursofalk Use In Pregnancy & Lactation

Capsule: If the patient is pregnant or breast-feeding, if the patient thinks she is pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
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 (Ursofalk) 250 mg capsules during pregnancy unless the doctor thinks it is absolutely necessary.
Women of child-bearing potential: Even if the patient is not pregnant, the patient should discuss this possibility with the doctor as women of child-bearing age should only be treated if they are using a reliable method of contraception. Non-hormonal methods of contraception or low-dose oestrogen contraceptives ("the Pill") are recommended. The patient should use an effective non-hormonal method of contraception if she is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, as hormonal contraceptives may encourage the formation of gallstones.
The doctor will check that the patient is not pregnant before starting the treatment.
Breast-feeding: There are only a few documented cases of Ursodeoxycholic acid (Ursofalk) use in breast-feeding women. Levels of Ursodeoxycholic acid (Ursofalk) in milk are very low and probably no adverse reactions will occur in breastfed infants.
Film-coated tablet: 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. Ursofalk 500 mg film-coated tablets must not be used during pregnancy unless clearly necessary.
Women of childbearing potential should be treated only if they are using reliable contraception. Non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk 500 mg film-coated tablets 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.
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.