|Dosage and administration||
– Hypersensitivity to ursodeoxycholic acid or any of excipients of the formulation.
|Warnings and precautions for use||
During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored every 4 weeks, thereafter every 3 months.
|Recommendation for pregnancy and breastfeeding||
Ursodeoxycholic acid should not be taken during pregnancy and lactation.
|Effects on ability to drive and use machines||
Urdoc 100 has no influence on ability to drive and use machines.
|Interactions, incompatibilities of medicine||
– Ursodeoxycholic acid should not be administered concomitantly with activated charcoal, cholestyramine, 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. If the use of a medication containing one of these substances is required, it must be taken at least 2 hours before or after ursodeoxycholic acid use.
|Undesirable effects (ADRs)||
Ursodeoxycholic acid is usually well tolerated, there was no significant change in liver function.
|Overdose and management||
Symptoms: Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces.
Ursodeoxycholic acid is a gallstone dissolving agent which decreases the cholesterol content of bile. This may be due to the reduction of cholesterol synthesis in the liver or the decrease of cholesterol absorption, or both.
– Ursodeoxycholic acid is well absorbed from the gastro-intestinal tract and up to 50 – 60% is metabolized via enterohepatic circulation.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each film-coated tablet contains:
Ursodeoxycholic acid . . . . . . . . . . . . . . . 100 mg
Box of 10 blisters x 10 film-coated tablets.
Urdoc 100 containing ursodeoxycholic acid is indicated:
– For the dissolution of cholesterol gallstones in patients with active gall bladder.
– In the treatment of primary biliary cirrhosis.