Urodil 300 Special Precautions

Ursodeoxycholic acid film-coated tablet should be taken under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and y-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.
Dissolution of Cholesterol Gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on the stone size, the gallbladder should be visualized (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gallbladder cannot visualized on x-ray images or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic, ursodeoxycholic acid film-coated tablet should not be used.
Treatment of the Advanced Stages of Primary Biliary Cirrhosis: In very rare cases, decompensation of the hepatic cirrhosis has been observed; which particularly regressed after the treatment discontinued. If diarrhea occurs, the dose must be reduced and in cases of persistent diarrhea, the therapy should be discontinued.
Use in pregnancy & lactation: There are 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 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.