URDOC 100

Composition: Each film-coated tablet contains:
Ursodeoxycholic acid . . . . . . . . . . . . . . . 100 mg
Presentation:
Box of 10 blisters x 10 film-coated tablets.
Indications:
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.

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Dosage and administration	Dosage: – Dissolution of cholesterol gallstones: 8 – 10 mg/kg once daily at bed time or in 2 – 3 divided doses after meals (with one dose always being taken after the evening meal). The duration of treatment: 6 – 24 months depending on stone size and composition. – Primary biliary cirrhosis: 13 – 15 mg/kg daily in 2 – 4 divided doses. Administration: Oral administration.
Contraindications	– Hypersensitivity to ursodeoxycholic acid or any of excipients of the formulation. – Patients with complete occlusion of the common bile duct (Choleretic activity may exacerbate the symptoms). – Patients with radiopaque calcified gallstones. – Patients with acute cholecystitis or cholangitis or impaired contractility of the gall bladder. – Patients with frequent episodes of biliary colic. – Patients with acute peptic ulcer. – Patients with ulcerative colitis or inflammatory disease of the bowel such as Crohn's disease. – Patients with liver or intestine problems which impede the flow of bile, e.g. occlusion of the biliary tract, intrahepatic cholestasis, extrahepatic cholestasis, removal of a part of the small intestine. – Patients with acute or chronic hepatitis or severe liver disease. – Pregnant or suspected pregnant women.
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. When Urdoc 100 tablets are used to dissolve cholesterol gallstones, in order to assess the progress of treatment and timely detect any calcification of gallstones, oral cholecystography is required after 6 – 10 months of treatment. If diarrhea occurs, the dose should be reduced and in case of prolonged diarrhea, stop taking this medicine immediately. Excessive dietary intake of calories and cholesterol should be avoided; a low cholesterol diet will probably improve the effectiveness of ursodeoxycholic acid tablets. Urdoc 100 contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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. – Ursodeoxycholic acid can increase the absorption of ciclosporin from the intestine. In patients treated with ciclosporin, blood concentrations of this substance should be monitored and the ciclosporin dose should be adjusted if necessary. – Ursodeoxycholic acid can reduce the absorption of ciprofloxacin. – Ursodeoxycholic acid has been shown to reduce peak plasma concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine. – Ursodeoxycholic acid interacts with dapsone and decreases its therapeutic effects. – Ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes. – Birth control pills, oestrogenic hormones and clofibrate may increase biliary lithiasis, whereas ursodeoxycholic acid is used for dissolution of gallstones.
Undesirable effects (ADRs)	Ursodeoxycholic acid is usually well tolerated, there was no significant change in liver function. Common, ADR > 1/100 Gastrointestinal disorders: Diarrhoea, pasty stools. Rare, ADR < 1/1000 Gastrointestinal disorders: Abdominal pain, constipation, heartburn, epigastric pain. Skin disorders: Rash. General disorders: Malaise, dizziness. Investigations: Increased ALT, ALP, AST, γ-GT. Blood system disorders: Leukopenia, hyperbilirubinemia. Very rare, ADR < 1/10000 Hepatobiliary disorders: Calcification of gallstones. Skin and subcutaneous disorders: Urticaria. Not known: Gastrointestinal disorders: Nausea, vomiting. Skin and subcutaneous disorders: Itching.
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. Treatment: There is no specific treatment, diarrhea should be treated symptomatically with restoration of fluid and electrolyte balance. However, ion-exchange resins can be used to bind bile acids in the intestine. It is recommended that liver function tests are monitored.
Pharmacodynamic properties	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.
Pharmacokinetic properties	– Ursodeoxycholic acid is well absorbed from the gastro-intestinal tract and up to 50 – 60% is metabolized via enterohepatic circulation. – Peak plasma concentration was reached about 60 minutes after oral administration with another peak recorded after 3 hours. – Ursodeoxycholic acid is partially conjugated with glycine and taurine in the liver before excreted in the bile. Ursodeoxycholic acid is metabolized to lithocholic acid, of which a portion is directly excreted in the feces. The remainder is reabsorbed and mainly conjugated and sulfated in the liver before excreted in the feces.
Storage conditions, shelf-life, quality specification of the medicine	Storage conditions: Protect from humidity and light, below 30 degrees C. Shelf – life: 36 months from the manufacture date. Quality specification: In house specification.

URDOC 100

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