Ursofalk, 500 mg 50 pcs.

Hepatoprotector. It has a choleretic effect.

Limits 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 lithogenicity of bile and increases the content of bile acids in it. Causes increased gastric and pancreatic secretion, increases the activity of lipase.

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 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

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

Ursofalk is taken under the supervision of a doctor.

During the first 3 months of treatment, liver function indicators should be monitored: the activity of transaminases, alkaline phosphatase and GGT in the blood serum 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 is possible to quickly determine whether a patient with primary biliary cirrhosis is responding to treatment.

When used to dissolve cholesterol gallstones

In order to assess progress in treatment and to promptly detect signs of calcification of stones depending on the size of the 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 cases of calcified stones, poor contractility of the gallbladder or frequent attacks of colic, Ursofalk should not be used.

When treating patients in the later stages of primary biliary cirrhosis

Cases of decompensation of liver cirrhosis have been reported extremely rarely. After cessation of therapy, a partial reverse development of the manifestations of decompensation was noted.

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

No effect on the ability to drive vehicles and moving machinery was detected.

Active ingredient

Ursodeoxycholic acid

Composition

1 caps. – ursodeoxycholic acid 250 mg.

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);

– hypersensitivity to the components of the drug.

Side Effects

Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100-<1/10), infrequently (≥1/1000-<1/100), rarely (≥1/10,000-<1/1000), very rarely (<1/10,000).

From the digestive system: often in clinical studies – loose stools or diarrhea; very rarely in the treatment of primary biliary cirrhosis – acute pain in the right upper abdomen.

From the liver and biliary tract: very rarely – calcification of gallstones; in the treatment of advanced stages of primary biliary cirrhosis – decompensation of liver cirrhosis, which disappears after discontinuation of the drug.

From the skin and subcutaneous tissues: very rarely – urticaria.

If any of these adverse reactions worsens, or any other adverse reactions occur, the patient should inform the doctor.

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 Ursofalk.

Overdose

No cases of overdose have been identified.

Recommendations for use

The drug is taken 1 time per day (at night) orally. The capsule is swallowed without opening the shell and washed down with water. The average daily dose of Ursofalk is calculated based on the patient’s body weight and is 10 mg/kg/day. If the dosage exceeds the average, you can divide the daily dose into 2 – 3 doses. It is recommended to take the drug for a long time – from several months to 2 years, without interruptions in treatment.

Storage conditions

The drug should be stored out of the reach of children at temperatures up to 25°C.

Shelf life

5 years.

Manufacturer

Dr Falk, Germany