Ursofalk - 250 mg 20 Capsules

Dissolution of cholesterol gallbladder stones, biliary reflux gastritis, primary biliary cirrhosis in the absence of signs of decompensation.

Tradename : Ursofalk

Ursofalk

Composition : Each hard capsule contains :

Ursodeoxycholic Acid 250mg

Auxiliary components :

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

Properties: Hepatoprotective agent, has a choleretic effect. Reduces the synthesis of cholesterol 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 an increase in gastric and pancreatic secretion, enhances lipase activity, has a hypoglycemic effect. It causes partial or complete dissolution of cholesterol stones when administered enterally, reduces the saturation of bile with cholesterol, which contributes to the mobilization of cholesterol from gallstones. It has an immunomodulator effect, affects immunological reactions in th liver: reduces the expression of some antigens on the membrane of hepatocytes, affects the

number of T-lymphocytes, the formation of interleukin-2,

Indications: dissolution of cholesterol stones of the gallbladder, biliary reflux gastritis, primary biliary cirrhosis in the absence of signs of decompensation.

Mode of application: Dissolving cholesterol gallstones :

Body weight No. of capsules

Up to 60 kg 261 -80 kg 381 -100 kg 4

Over 100 kg 5

The drug must be taken daily in the evening, before bedtime (the capsules are not chewed), with a small amount of liquid. Duration of treatment is 6-12 months. For the prevention of recurrent cholelithiasis, it is recommended to take the drug for several months after the stones dissolve.

Treatment of biliary reflux gastritis: 1 capsule of Ursofalk daily in the evening before bedtime, without chewing and drinking a little 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). In the first 3 months of treatment, taking the drug should be divided into several doses throughout the day. After improvement of liver parameters, the daily dose of the drug can be taken once, in the evening.

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 indefinitely.

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

Contraindications: X-ray positive (high calcium) gallstones nonfunctioning gallbladder; acute inflammatory diseases of the gallbladder, bile ducts and intestines; cirrhosis of the liver in the stage of decompensation; severe violations of the kidneys, liver, pancreas; hypersensitivity to drug components.

Precautions: during the first 3 months, monitor liver function. Monitoring of these parameters allows detecting liver dysfunction in the early stages. This also applies to patients with advanced stages of primary biliary cirrhosis. In addition, it can quickly determine whether a patient with primary biliary cirrhosis is responding to treatment. When used to dissolve cholesterol gallstones: in order to assess the progress of treatment and for the timely detection of signs of calcification of stones, depending on the size of the stones, the gallbladder should be visualized (oral

cholecystography) with examination of the 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 stone calcification, weak contractility of the gallbladder or frequent attacks of colic, the drug Ursofalk should not be used. In the treatment of patients in the late stages of primary biliary cirrhosis: cases of decompensation of liver cirrhosis were extremely rare. After discontinuation of therapy, there was a partial reverse development of the manifestations of decompensation. In patients with diarrhea, the dosage should be reduced.

Side effects : Gastrointestinal disorders: loose stools or diarrhea were common. In the treatment of primary biliary cirrhosis, acute pain in the right upper abdomen was very rarely observed. Liver and biliary tract disorders: Calcification of gallstones may rarely occur. In the treatment of advanced stages of primary biliary cirrhosis, decompensation of liver cirrhosis was rarely observed, which disappears after discontinuation of the drug. Violations of th skin and subcutaneous tissues: rarely urticaria. If any of the side effects indicated in the instructions are aggravated, or you notice other side effects not indicated 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 must be taken at least 2 hours before taking Ursofalk. Ursodeoxycholic acid can 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, Ursofalk can reduce the absorption of ciprofloxacin. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, or progestins increase cholesterol saturation in bile and may decrease the ability to dissolve cholesterol gallstones.

Pregnancy and lactation : The drug is contraindicated during pregnancy. The dru can be used during pregnancy only in case where the potential benefit to the mother outweighs the potential risk to the fetus. The are no data on the excretion of ursodeoxycholic acid in breast milk. If necessary, the use of ursodeoxycholic acid during lactation should stop breastfeeding.

Storage method : Store at a temperature not exceeding 30C in a dry place out of the reach of children.

Packaging : the cardboard box consists of 2 blisters of 10 hard capsules each, and paper instructions.