Ursodez, capsules 250 mg 50 pcs

Hepatoprotector. It has a choleretic effect. Reduces the synthesis of cholesterol in the liver, its absorption in the intestine and its concentration in the bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids.

Increases gastric and pancreatic secretion, increases lipase activity. It has hypoglycemic effect.

It causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has immunomodulatory effects, affects immunological reactions in the liver: decreases the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, interleukin-2 formation, decreases the number of eosinophils.

Indications

dissolution of cholesterol gallstones;

– biliary reflux gastritis;

– primary biliary cirrhosis of the liver in the absence of signs of decompensation (symptomatic treatment).

Pharmacological effect

Hepatoprotector. Has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestines and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and excretion of bile. Reduces the lithogenicity of bile and increases the content of bile acids.

Causes increased gastric and pancreatic secretion, enhances lipase activity. Has a hypoglycemic effect.

Causes partial or complete dissolution of cholesterol stones when taken orally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones.

It has an immunomodulatory effect, affects immunological reactions in the liver: it reduces the expression of certain antigens on the hepatocyte membrane, affects the number of T-lymphocytes, the formation of interleukin-2, and reduces the number of eosinophils.

Special instructions

In case of cholelithiasis, the effectiveness of treatment is monitored every 6 months by conducting x-ray and ultrasound examination of the biliary tract in order to prevent relapses of cholelithiasis.

In case of cholestatic liver diseases, the activity of transaminases, alkaline phosphatase and gamma-glutamyl transpeptidase in blood serum should be periodically determined.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of ursodeoxycholic acid on the ability to drive vehicles and operate machinery.

Active ingredient

Ursodeoxycholic acid

Composition

Hard gelatin capsules, size No. 0, white, opaque;

the contents of the capsules are white or almost white powder.

1 capsule ursodeoxycholic acid 250 mg

Excipients:

pregelatinized starch (starch 1500) – 73 mg,

colloidal silicon dioxide (Aerosil) – 5 mg,

magnesium stearate – 2 mg.

Composition of the capsule shell:

titanium dioxide, gelatin.

Pregnancy

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Contraindications

– X-ray positive (high calcium content) gallstones;

– non-functioning gallbladder;

– acute inflammatory diseases of the gallbladder, bile ducts and intestines;

— liver cirrhosis in the stage of decompensation;

– severe renal dysfunction;

– severe liver dysfunction;

– severe dysfunction of the pancreas;

– pregnancy;

– lactation period (breastfeeding);

– adults and children weighing up to 34 kg;

– hypersensitivity to the components of the drug.

Side Effects

From the digestive system: diarrhea, nausea, pain in the epigastric region and right hypochondrium, calcification of gallstones, increased activity of liver transaminases.

When treating primary biliary cirrhosis, transient decompensation of liver cirrhosis may occur, which disappears after discontinuation of the drug.

Other: allergic reactions.

Interaction

Cholestyramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce the absorption of ursodeoxycholic acid in the intestine and thus reduce its absorption and effectiveness. If the use of drugs containing at least one of these substances is still necessary, they should be taken at least 2 hours before taking Ursodez.

Ursodeoxycholic acid may enhance the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the physician should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary.

In some cases, Ursodez may reduce the absorption of ciprofloxacin.

Lipid-lowering drugs (especially clofibrate), estrogens, neomycin or gestagens increase the saturation of bile with cholesterol and may reduce the ability to dissolve cholesterol gallstones.

Overdose

No cases of overdose have been identified.

In case of overdose, symptomatic treatment is carried out.

Manufacturer

North Star NAO, Russia