Description

Trade name:

Ursofalk

Compound:

Each hard capsule contains:

Ursodeoxycholic acid 250 mg.

Auxiliary components:

Gelatin, colloidal silicon dioxide anhydrous, magnesium stearate, corn starch, sodium dodecyl sulfate, titanium dioxide, purified water.

Properties:

Hepatoprotective agent, has a choleretic effect. Reduces cholesterol synthesis in the liver, its absorption in the intestine and concentration in bile, increases the solubility of cholesterol in the biliary system, stimulates the formation and secretion of bile. Reduces the lithogenicity of bile, increases the content of bile acids in it; causes increased gastric and pancreatic secretion, increases lipase activity, has a hypoglycemic effect. Causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which promotes the mobilization of cholesterol from gallstones. Has an immunomodulatory effect, affects immunological reactions in the liver: reduces the expression of some antigens on the membrane of hepatocytes, affects the number of T-lymphocytes, the formation of interleukin-2, reduces 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. Chronic active hepatitis with cholestatic syndrome. Acute hepatitis, cystic fibrosis, congenital bile duct atresia. Biliary reflux esophagitis and gastritis. Biliary dyspeptic syndrome in cholecystopathy and biliary dyskinesia. Prevention and treatment of cholestatic syndrome caused by taking hormonal contraceptives.

Method of administration and dosage:

Dissolution of cholesterol gallstones:

Doses:

Up to 60 kg 2 capsules per day;

61 – 80 kg 3 capsules per day;

81-100 kg 4 capsules per day;

Over 100 kg 5 capsules per day.

The drug should be taken daily in the evening, before bedtime (the capsules are not chewed), with a small amount of liquid. The duration of treatment is 6-12 months. To prevent recurrent cholelithiasis, it is recommended to take the drug for several months after the stones have dissolved.

Treatment of biliary reflux gastritis: 1 capsule of Ursofalk daily in the evening before bedtime, without chewing and with a small amount of water. The course of treatment is 10-14 days. In severe cases of the disease, the course can be extended.

Symptomatic treatment of primary biliary cirrhosis: the daily dose depends on body weight and ranges from 3 to 7 capsules (approximately 14 ± 2 mg ursodeoxycholic acid per 1 kg of body weight). During the first 3 months of treatment, the drug should be taken in several doses during the day. After improvement of liver function tests, the daily dose can be taken once in the evening.

The capsules should be taken regularly, without chewing, with a small amount of liquid. The use of the drug for the treatment of primary biliary cirrhosis can be continued for an unlimited time.

In patients with primary biliary cirrhosis, clinical symptoms may rarely worsen at the start of treatment, for example, itching may become more frequent. In this case, treatment should be continued with one capsule daily, then the dosage should be gradually increased (increasing the daily dose by one capsule weekly) until the recommended dosage regimen is again reached.

Contraindications:

X-ray positive (high calcium) gallstones; non-functioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; liver cirrhosis in the decompensation stage; severe dysfunction of the kidneys, liver, pancreas; hypersensitivity to the components of the drug. Pregnancy and lactation.

Precautions:

Liver function should be monitored during the first 3 months. Monitoring these parameters allows early detection of liver dysfunction. This also applies to patients with late stages of primary biliary cirrhosis. It also allows rapid assessment of whether a patient with primary biliary cirrhosis is responding to treatment. When used to dissolve cholesterol gallstones: in order to assess treatment progress and to detect early signs of stone calcification depending on the size of the stones, the gallbladder should be visualized (oral cholecystography) with examination of opacities in a standing and supine position (ultrasound) 6-10 months after the start of treatment. If the gallbladder cannot be visualized on X-ray images or in cases of stone calcification, weak contractility of the gallbladder or frequent attacks of colic, Ursofalk should not be used. When treating patients with late stages of primary biliary cirrhosis: cases of decompensation of liver cirrhosis have been reported extremely rarely. Partial reversal of decompensation manifestations has been reported after discontinuation of therapy. In patients with diarrhea, the dosage of the drug should be reduced.

Side effects:

Gastrointestinal disorders: Unformed stool or diarrhea were often observed. In the treatment of primary biliary cirrhosis, acute pain in the right upper abdomen was very rarely observed. Liver and biliary tract disorders: Calcination of gallstones may rarely occur. In the treatment of advanced stages of primary biliary cirrhosis, decompensation of liver cirrhosis was rarely observed, which disappeared after discontinuation of the drug. Skin and subcutaneous tissue disorders: Rarely – urticaria. If any of the side effects listed in the instructions worsens, or you notice other side effects not listed in the instructions, please inform your doctor. Drug interactions: 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. Ursodeoxycholic acid can increase the absorption of cyclosporine from the intestine. Therefore, in patients taking cyclosporine, the doctor should check the concentration of cyclosporine in the blood and adjust the dose of cyclosporine if necessary. In some cases, Ursofalk can reduce the absorption of ciprofloxacin. Hypolipidemic drugs (especially clofibrate), estrogens, neomycin or progestins increase the saturation of bile with cholesterol and can reduce the ability to dissolve cholesterol gallstones.