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Ursodeoxycholic acid should not be used in patients:
1. with radio-opaque calcified gall-stones,
2. with acute inflammation of the gall bladder or biliary tract.
3. with occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct)
4. with frequent episodes of biliary colic
Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia
2. Special warnings and precautions for use
Ursodeoxycholic acid should be taken under medical supervision.
During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months.
3 .Interaction with other medicinal products and other forms of interaction
Ursodeoxycholic acid should not be administered concomitantly with charcoal, colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after ursodeoxycholic acid.
4. Pregnancy and 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. Ursodeoxycholic acid must not be used during pregnancy.
No effects on ability to drive and use machines have been observed.
In clinical trials, reports of pasty stools or diarrhoea during ursodeoxycholic acid therapy were common.Very rarely, severe right upper abdominal pain has occurred during the treatment of primary biliary cirrhosis.Ursodeoxycholic acid may give rise to nausea and vomiting. The frequency of these effects are not known.
During treatment with ursodeoxycholic acid, calcification of gallstones can occur in very rare cases making them unable to be dissolved by bile acid therapy and resulting in surgery for some patients.
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