Expiration date: 05/2025

The composition and form of issue

Capsules:

1 capsule contains ursodeoxycholic acid 250 mg,

excipients: starch maize, silica colloidal anhydrous, magnesium stearate,

composition capsules: gelatin, metilgidroksibenzoat, propilgidroksibenzoat, titanium dioxide.,

packaging 50 or 100 PCs.

Pharmacological action:

Urdoxa – hepatoprotective drug. Also has choleretic, cholelitolitic, cholesterol-lowering, and immunomodulatory effects.

Embedded in the membrane of hepatocytes, stabilizes its structure and protects the hepatocytes from the damaging effects of bile salts, thus reducing their cytotoxic effect. Contributes to the partial or complete dissolution of cholesterol gallstones when administered orally

Indications:

• Cholesterol gallstones, 
  
• hepatitis (chronic, including atypical forms of chronic autoimmune, acute viral), 
  
• non-alcoholic steatohepatitis, toxic (including alcohol, drugs) liver, 
  
• primary biliary cirrhosis and cystic fibrosis of the liver 
  
• primary sclerosing cholangitis, 
  
• atresia of the intrahepatic bile ducts, 
  
• cholestasis during parenteral nutrition, 
  
• biliary dyskinesia, 
  
• biliary reflux-gastritis and reflux-esophagitis, 
  
• chronic opisthorchiasis, 
  
• prevention of liver damage when using hormonal contraceptives and cytostatics.
  

Contraindications:

Hypersensitivity, acute inflammatory diseases of the gall bladder, bile ducts and intestines, complete obstruction of biliary tract, obyzvestvleniya gallstones, cirrhosis of the liver decompensation expressed by the human kidney, pancreas, pregnancy and lactation, children age.

Method of application and doses

The dosage regimen and duration of treatment are individually. The average dose of 8-10 mg/kg/day. The daily dose is taken orally once in the evening (with liquid squeezed enough liquid).

Side effects

Back pain, abdominal pain, diarrhea (can be dose-dependent).

Rarely calcining gallstones, transient (transient) increase in liver transaminaz, constipation, nausea, vomiting, alopecia, dizziness, exacerbation of pre-existing psoriasis, allergic reactions, including hives.

Special instructions

For successful litholysis with ursodeoxycholic acid is necessary to observe the following conditions: the stones must be pure cholesterol, i.e. not throw a shadow on the radiograph, the size of the stones should not exceed 15-20 mm, the gallbladder should be fully retain its function of the gall bladder should be filled with stones not more than half the patency of the cystic duct should be retained, common bile duct should be free from stones.

When using ursodeoxycholic acid to dissolve gallstones in the first 3 months of treatment is necessary every 4 weeks to determine the activity of liver transaminases. In the future these studies can be carried out at intervals of 3 months. 

To monitor the effectiveness of treatment is recommended every 6 months for a x-ray and ultrasound examination of the biliary tract. 

To prevent a recurrence of cholelithiasis treatment should continue several months after the dissolution of cholesterol gallstones.

Storage conditions 

In protected from light place, at temperature not above 25°C.

Shelf life – 3 years.