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);

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– chronic hepatitis of different genesis;

– primary sclerosing cholangitis, cystic fibrosis (cystic fibrosis);

– non-alcoholic steatohepatitis;

– alcoholic liver disease;

– biliary dyskinesia.

Active ingredient

Ursodeoxycholic acid

Composition

1 capsule – ursodeoxycholic acid 250 mg.

Interaction

Colestiramine, colestipol and antacids containing aluminum hydroxide or smectite (aluminum oxide) reduce 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 h before taking Ursofalk.

Directions for use

The drug is taken once a day (at night) orally. The capsule is swallowed without opening the membrane, with water. Average daily dose of Ursofalk is calculated 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 pauses in treatment.

Special Instructions

The drug Ursofalk is administered under the supervision of a physician.

In the first 3 months of treatment, liver function parameters should be monitored: serum transaminase activity, ALP and GGT every 4 weeks, and then every 3 months. Monitoring of these parameters allows early detection of liver dysfunction. This also applies to patients in the later stages of primary biliary cirrhosis. In addition, it should also be determined as quickly as possible whether a patient with primary biliary cirrhosis is responding to ongoing treatment.

When used to dissolve cholesterol gallstones

In order to evaluate the progress of treatment and for early detection of signs of gallstone calcinosis depending on the size of the stones, the gallbladder must be imaged (oral cholecystography) with observation of darkening in standing and supine positions (ultrasound) 6-10 months after the start of treatment.

If the gallbladder cannot be visualized on X-rays or in cases of calcification of stones, poor gallbladder contractility or frequent attacks of colic, Ursofalk should not be used.

In treatment of patients in advanced stages of primary biliary cirrhosis

In extremely rare cases of decompensation of liver cirrhosis have been observed. After discontinuation of therapy, a partial reversal of decompensation manifestations was observed.

In patients with diarrhea, the drug dose should be reduced. In persistent diarrhea, treatment should be discontinued.

Influence on driving and operating ability

There have been no effects on driving and operating ability of vehicles and moving machinery.

Contraindications

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

– non-functioning gallbladder;

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

– decompensated liver cirrhosis;

– Severe renal impairment;

– Severe liver impairment;

– Severe pancreatic impairment;

– pregnancy;

– period of lactation (breast-feeding);

– hypersensitivity to the components of the drug.

Side effects

Definition of the incidence of adverse reactions: very common (≥1/10), common (≥1/100-< 1/10), infrequent (≥1/1000-< 1/100), rare (≥1/10 000-< 1/1000), very rare (< 1/10 000).

Digestive system disorders: often in clinical trials – unformed stools or diarrhea; very rare in the treatment of primary biliary cirrhosis – acute pain in the right upper abdomen.

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

Skin and subcutaneous tissue disorders: very rare – urticaria.

If any of the above adverse reactions worsen, or any other adverse reactions occur, the patient should inform the physician.

Overdose

No cases of overdose have been identified.

Pregnancy use

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

Similarities

Ursosan, Urdoxa, Ursoliv, Exchol, Ursodez, Grinterol, Urcevel, Ursodeoxycholic acid