Expiration date: 12/2025

The composition and form of issue:

Capsules. 1 capsule contains:

Ursodeoxycholic acid 250 mg

excipients: starch maize silica colloidal anhydrous magnesium stearate titanium dioxide gelatin purified water sodium lauryl 

in blister, 25 PCs in a carton 2 or 4 blisters or blistere in 10 PCs., in box 1 blister.

Suspension for oral administration 5 ml

Ursodeoxycholic acid 250 mg

excipients: benzoic acid, purified water xylitol microcrystalline glycerol propylene glycol sodium citrate sodium cyclamate, citric acid anhydrous, sodium chloride, lemon flavor (Givaudan PHL-134488) 

in bottles of 250 ml in box of 1 bottle complete with measuring spoon.

Description pharmaceutical form:

Capsule: hard, opaque gelatin capsules, cap and body in white. The capsule contains powder or granules of white color.

Suspension: homogeneous, white color, containing small bubbles of air, with the scent of lemon.

Description pharmacological action:

Hepatoprotective means, has choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestine and the concentration in the bile increases the solubility of cholesterol in the biliary tract, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases its content of bile acids causes increased gastric and pancreatic secretion, enhances the activity of lipase, has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones in enteral application, decreases the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol from gallstones. Has immunomodulatory effects, effect on immunological reactions in the liver: reduces the expression of some antigens on the membrane of hepatocytes affects the number of T-lymphocytes, formation of IL-2, reduces the number of eosinophils.

Indications:

• dissolution of cholesterol gallstones in the gallbladder
  
• biliary reflux-gastritis
  
• primary biliary cirrhosis in the absence of signs of decompensation (symptomatic treatment).
  

Contraindications:

• hypersensitivity
  
• roentgenologically (high in calcium) gallstones
  
• nonfunctioning gallbladder
  
• acute inflammatory diseases of the gall bladder, bile ducts and intestines
  
• liver cirrhosis in the decompensation stage
  
• expressed by the human kidney, liver, pancreas.
  

Ursodeoxycholic acid has no age restrictions but children under the age of 3 years are encouraged to apply Ursofalk in suspension, because you may have trouble swallowing capsules.

Application of pregnancy and breast-feeding:

The drug is contraindicated during pregnancy and lactation.

Side effects:

Diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcining gallstones, increase in liver transaminases, allergic reactions.

In the treatment of primary biliary cirrhosis can be observed transient decompensation of cirrhosis, which disappears after discontinuation of the drug.

Drug interactions:

Cholestyramine, colestipol, and antacids containing aluminium hydroxide or smectite (aluminium oxide), reduce the absorption ursodeauxiholeva acid in the intestine and thus reduce its effectiveness. If the use of preparations containing at least one of these substances is still necessary, they should be taken at least 2 hours prior to the reception of Ursofalk.

Ursodeoxycholic acid may enhance the absorption of cyclosporin from the gut. Therefore, in patients taking cyclosporine, your doctor should check the concentration of cyclosporine in the blood and, if necessary, to adjust the dose.

In some cases, Ursofalk can reduce the absorption of ciprofloxacin. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, progestins, or increase the saturation of bile with cholesterol and may reduce the ability of Ursofalk to dissolve cholesterol gall stones.

Method of application and dose:

Inside, not liquid, daily in the evening before bedtime with a small amount of liquid.

Children and adults with a body mass less than 34 kg it is recommended to apply Ursofalk in suspension.

Dissolution of cholesterol gallstones. The recommended dose is 10 mg/kg/day.

Special instructions:

In gallstone disease, control of treatment efficiency is performed every 6 months by conducting x-ray examination and ultrasound of the bile ducts to prevent the recurrence of cholelithiasis. When cholestatic liver disease should be periodically to determine the activity of transaminases, alkaline phosphatase and gamma glutamyltranspeptidase in the serum.