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Ursodeoxycholic acid film-coated tablet should be taken under medical supervision.
During the first 3 months treatment, liver function parameters AST (SGOT), ALT (SGPT) and γ-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 asses therapeutic progress and for timely detection on any calcification of the gallstones, depending on 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 be 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 partially regressed after the treatment discontinued. If diarrhea occurs, the dose must be reduced and in cases of persistent diarrhea, the therapy should be discontinued.
