Ursocaps capsules 250mg №10×5

Name Ursocaps caps. The main active substance Release form Soft gelatin capsules, 10 capsules in a blister pack, 5 blister packs in a pack. Dosage 250 mg. Indications for use – Symptomatic treatment of primary biliary cirrhosis (PBC) in the absence of signs of decompensation; – dissolution of cholesterol gallstones. Cholesterol stones should not appear as opacities on radiographs and should not exceed 15 mm in diameter. Despite the presence of stones, gallbladder function should not be impaired; – toxic (including alcoholic, medicinal) liver damage; – cholestatic liver disease in children; – hepatitis (chronic, active, including atypical forms of chronic autoimmune, chronic and acute viral); – treatment of gastritis with bile reflux. Method of administration and doses For various indications for use, the following daily dosing regimens are recommended: For the dissolution of cholesterol gallstones, approximately 10 mg of ursodeoxycholic acid per 1 kg of human body weight: up to 60 kg 2 capsules up to 80 kg 3 capsules up to 100 kg 4 capsules over 100 kg 5 capsules Capsules should be taken in the evening, before going to bed, without chewing and drinking a small amount of liquid. Capsules should be used regularly. The duration of treatment for the dissolution of stones is 6-12 months. If the size of the stones does not decrease after 12 months, treatment should not be continued. The success of the treatment should be monitored by ultrasound or X-ray every 6 months. At a subsequent examination, it should be checked whether calcification of stones has occurred in the period of time. If this happens, treatment should be discontinued. For the treatment of gastritis with bile reflux: one capsule is prescribed, which is taken daily, in the evening, at bedtime, without chewing and with a small amount of liquid. The treatment period is 10-14 days. In general, the duration of use depends on the course of the disease. For symptomatic treatment of primary biliary cirrhosis (PBC): The daily dose of the drug depends on the patient’s body weight, and varies from 3 to 7 capsules (14±2 mg of ursodeoxycholic acid per 1 kg of body weight). In the first 3 months of treatment with Ursocaps, 250 mg capsules, the drug intake should be divided throughout the day. After improving liver performance, the daily dose of the drug can be taken once, in the evening. Capsules should be taken without chewing with a small amount of liquid. It is necessary to observe the regularity of reception. The use of Ursocaps capsules for the treatment of primary biliary cirrhosis may not be limited in time. In patients with primary biliary cirrhosis, in rare cases, at the beginning of treatment, clinical symptoms may worsen, for example, itching may become more frequent. In this case, treatment should be continued by taking one capsule of Ursocaps daily, then the dosage should be gradually increased (increasing the daily dose by one capsule weekly) until the recommended dosage regimen is reached again. Chronic liver diseases: in a daily dose of 10 mg / kg to 12-15 mg / kg (2-5 drops) for 4-6 weeks. Toxic and alcoholic liver damage: 10-15 mg / kg / day for 14-21 days. Use during pregnancy and lactation There is not enough data on the use of ursodeoxycholic acid, especially in the first trimester of pregnancy. Animal studies have shown signs of teratogenicity during early pregnancy. Do not use Ursocaps capsules during pregnancy unless absolutely necessary. The decision on this can only be made by a doctor after a benefit / risk assessment. Women of childbearing age should only take this medicine if they are using reliable contraception. Before starting treatment, the possibility of pregnancy should be excluded. It is not known whether ursodeoxycholic acid passes into mother’s milk. During lactation, the drug should not be taken. If there is a need for treatment with Ursocaps, capsules 250 mg, breast-feeding should be discontinued. Precautions In cholelithiasis, the effectiveness of treatment is monitored every 6 months. by conducting X-ray and ultrasound examination of the biliary tract in order to prevent recurrence of cholelithiasis. – Positive results can be obtained only in the presence of purely cholesterol (X-ray negative) gallstones no larger than 15-20 mm in size, with preserved gallbladder function and patency of the cystic and common bile ducts. With long-term (more than 1 month) treatment, it is necessary to conduct a biochemical blood test every month to determine the activity of hepatic transaminases, alkaline phosphatase, gamma-glutamyl transferase and bilirubin (especially in the first 3 months of therapy). If elevated levels persist, the drug should be discontinued. After complete dissolution of the calculi, it is recommended to continue application for at least 3 months in order to promote the dissolution of residual calculi that are too small to be detected. If within 6-12 months. after the start of therapy, partial dissolution of stones did not occur, it is unlikely that the treatment will be effective. The detection during treatment of a non-visualized gallbladder is evidence that the complete dissolution of the calculi did not occur, and treatment should be discontinued. If the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder or frequent bouts of colic, Ursocaps should not be used. Interaction with other drugs Colestyramine, cholestyrol and antacids containing aluminum hydroxide bind ursodeoxycholic acid in the intestine, reduce its absorption and weaken its effectiveness. If necessary, simultaneous treatment with the above drugs is recommended to use them 2 hours before or after taking Ursocaps. Lipid-lowering drugs (especially clofibrate), estrogens, neomycin, progestins can increase the saturation of bile with cholesterol and reduce the ability of ursodeoxycholic acid to dissolve cholesterol gallstones. Ursocaps may increase intestinal absorption of cyclosporine. Therefore, it is necessary in people taking this drug at the same time to control the level of cyclosporine and adjust its dose. In some cases, Ursocaps may reduce the absorption of ciprofloxacin. Ursodeoxycholic acid reduces peak plasma concentrations (Cmax) and the area under the concentration-time pharmacokinetic curve (AUG) of nitrendipine, a calcium antagonist. From the report on the interaction with diaphenylsulfone (reduced therapeutic effect) and in-vitro studies, it can be assumed that ursodeoxycholic acid affects the metabolism of diaphenylsulfone by cytochrome P450 3A4 enzymes. Therefore, precautions should be observed in the case of co-administration of drugs metabolized by this enzyme and adjustment may be required. Contraindications – hypersensitivity; – X-ray positive (high in calcium) gallstones; – acute inflammatory diseases of the gallbladder, bile ducts and intestines, Crohn’s disease; – non-functioning gallbladder; – complete obstruction of the biliary tract; – cirrhosis of the liver in the stage of decompensation; – pronounced violations of the function of the kidneys, liver, pancreas; – bile-gastrointestinal fistula; – acute cholecystitis; – acute cholangitis; – pregnancy; – lactation period; – children’s age up to 6 years; – frequent biliary colic. One capsule contains: ursodeoxycholic acid – 250 mg. Excipients: lecithin (Solek B-10), beeswax, sunflower oil. The composition of the capsule shell: gelatin, glycerin, purified water, methyl para-hydroxybenzoate, titanium dioxide, dye: sunset yellow E-110. Overdose In case of overdose, diarrhea may occur. In general, other overdose symptoms are unlikely because the absorption of ursodeoxycholic acid decreases as the dose is increased and thus it is excreted in the feces. If diarrhea occurs, the dose should be reduced; if diarrhea persists, treatment should be discontinued. Preventive special measures are not required, and the consequences of diarrhea should be treated symptomatically by restoring fluid and water-salt balance. Side effects Ursocaps is well tolerated by patients. The evaluation of undesirable effects is based on the following data on the frequency of occurrence: very often (> 1/10), often (> 1/100 to <1/10) not often (> 1/1, 000 to <1/100), rarely ( >1/10,000 to <1/1000), very rare (<1/10,000). Gastrointestinal Disorders: In clinical studies, reports of pasty stools or diarrhea are very common. Very rarely, during the treatment of primary biliary cirrhosis, severe pain occurred in the abdomen, on the right side. Liver and biliary tract disorders Calcification of stones may very rarely occur during treatment with ursodeoxycholic acid. During the treatment of advanced stages of primary biliary cirrhosis, decompensation of liver cirrhosis is very rarely observed, which disappears after discontinuation of the drug. Hypersensitivity reactions: In very rare cases, an allergic rash (urticaria) may occur. In case of any unusual reactions, you should stop taking the drug and consult a doctor. Storage conditions Buy Ursocaps capsules 250mg No. 10x5