COMPOSITION

Each capsule contains ursodeoxycholic acid 300 mg.

THERAPEUTIC INDICATIONS

- Uncomplicated cholelithiasis, when cholesterol gallstones in gallbladder by impossibility of their surgical or endoscopic removal;
- Nonalcoholic steatohepatitis;
- Acute and chronic viral hepatitis;
- Toxic liver injuries;
- Chronic active hepatitis;
- Alcohol-induced liver injuries;
- Primary biliary cirrhosis;
- Primary sclerosing cholangitis;
- Cystic fibrosis;
- Congenital intrahepatic atresia of biliary tracts;
- Cholestasis by parenteral nutrition;
- Biliary reflux-gastritis and reflux-esophagitis;
- Biliary dyspeptic syndrome;
- Biliary dyskinesia;
- For prophylaxy ofliver injuries by use of hormonal contraceptives or treatment with cytostatic agents, formations of bilious concrements when patients with adiposity fast losing body weight.

CONTRAINDICATIONS

Choludexan is indicated in case of raised sensitivity to the medicine, and also: for acute inflammatory diseases of gallbladder and bilious channels; for nonfunctioning gallbladder; for cholelithiasis (with high Ca2+); for bilious-gastroenteric fistula; for chronic hepatites; fot acute cholecystitis; for acute cholangitis; for inflammatory processes in large and small intestine; for liver cirrhosis in a stage of decompensation; for hepatic and/or renal insufficiency; for pancreatitis; for gallbladder empyema.

ADVERSE EFFECTS

Diarrhea (may be dose dependant), spinal pain.
Rare – calcination of cholelithes, increase of hepatic transaminase activity, alopecia, constipation, dizzinesses, nausea, vomiting, allergic reactions.

DOSAGE AND ADMINISTRATION

Choludexan is prescribed once daily before bedtime or twice a day. Ingest a whole capsule not
chewing with the sufficient quantity of liquid.
Dosage scheme:
- for treatment of acute and chronic liver diseases for dissolution of gallstones Choludexan is prescribed in a doze of 10-15 mg/kg of body weight a day continuously.
- for treatment of chronic liver diseases Choludexan is prescribed in a doze of 10-15 mg/kg of body weight a day, duration of treatment is from several months till 2 years.
- for dissolution of gallstones Choludexan is prescribed in a doze of 10-15 mg/kg of body weight a day, duration of treatment is from 6 months till 2 years. If within 12 months from the beginning of treatment reduction of gallstones is not observed, reception of preparation is considered to be inexpedient.
- for prevention of repeated cholelithiasis is recommended reception of the preparation in a doze of 300 mg 2 times a day for several months (on average for 3 months).
- for treatment of biliary reflux-gastritis and a reflux-esophagitis it is prescribed 300 mg (1 capsule) of Choludexan before bedtime. Duration of treatment usually makes 10-14 days.

DRUG INTERACTIONS

The antacids containing aluminium ions and ion-exchange resins (cholesteramine), reduce absorption of the medicine.
Hypolipidaemic drugs (especially clofibrate), estrogen, neomicin or progestins increase saturation of bile with cholesterol and can reduce ability of the medicine to dissolve cholesteric bilious concrements.

PREGNANCY AND LACTATION

Administration during pregnancy is contraindicated.
If there is a necessity to use Choludexan during lactation the question of breast feeding termination should be taken in consideration as there is no data on excretion of ursodeoxycholic acid with breast milk.

MANUFACTURED FORM

Hard gelatin capsules for oral use. 10 capsules are in a blister. 2 blisters are in carton box together with the leaflet.