Ursodez, 500 mg capsules 30 pcs

Liver cirrhosis, Gallstone disease

– dissolution of small and medium cholesterol stones with a functioning gallbladder;

– biliary reflux gastritis;

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

– chronic hepatitis of different genesis;

– primary sclerosing cholangitis;

– cystic fibrosis (cystic fibrosis);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Indications

— dissolution of small and medium-sized cholesterol stones with a functioning gallbladder;

– biliary reflux gastritis;

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

— chronic hepatitis of various origins;

– primary sclerosing cholangitis;

– cystic fibrosis (cystic fibrosis);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Pharmacological effect

hepatoprotective, choleretic, cholelitholytic.

Special instructions

The use of the drug Ursodez® should be carried out under the supervision of a physician.

During the first 3 months of treatment, liver function parameters (transaminases, alkaline phosphatase and GGT) in the blood serum should be monitored every 4 weeks, and then every 3 months. Monitoring these parameters makes it possible to identify liver dysfunction in the early stages. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, it can quickly determine whether a patient with primary biliary cirrhosis is responding to treatment.

Used to dissolve cholesterol gallstones

In order to assess progress in treatment, as well as to promptly detect signs of calcification of stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in the standing and supine position (ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on x-rays or in the case of calcified stones, poor contractility of the gallbladder or frequent attacks of colic, Ursodez® should not be used.

Treatment of patients in advanced stages of primary biliary cirrhosis

Cases of decompensation of liver cirrhosis have been reported extremely rarely. After cessation of therapy, regression of decompensation manifestations was noted.

Long-term therapy with ursodeoxycholic acid in high doses (28-30 mg/kg/day) can lead to the development of serious side effects in patients with primary sclerosing cholangitis.

In patients with diarrhea, the dose of the drug should be reduced. If diarrhea persists, treatment should be discontinued.

Impact on the ability to drive vehicles and operate machinery

There was no effect on the ability to drive vehicles and machinery.

Active ingredient

Ursodeoxycholic acid

Composition

1 caps. ursodeoxycholic acid 500 mg

Excipients:

croscarmellose sodium (primellose) – 16 mg,

Hydroxypropyl methylcellulose (hypromellose) – 14 mg,

magnesium stearate – 5 mg.

Composition of the capsule shell:

body: titanium dioxide – 2%, gelatin – up to 100%; cap: titanium dioxide – 1.7434%, sunset yellow dye – 0.4183%, gelatin – up to 100%.

Contraindications

X-ray positive (high calcium) 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 pancreatic dysfunction;

adults and children weighing up to 34 kg;

children under 3 years of age (for this dosage form);

hypersensitivity to the components of the drug.

The drug should be prescribed with caution for cholelithiasis and cholestatic liver diseases.

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 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, cyclosporine blood concentrations should be checked and the dose of cyclosporine adjusted 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