Ursaklin capsules 250mg №10×6

Name: Ursaklin caps 250mg Producer: State enterprise “AKADEMPHARM”, Belarus Manufacturing plant: State enterprise “AKADEMPHARM” 220141, Minsk, st. Academician V.F. Kuprevicha, d. 5, building 3, Republic of Belarus, tel./fax 8(017) 268-63-64 To report adverse reactions on the manufacturer’s website academpharm.by, an electronic application form is presented Country of origin: Belarus Main active ingredient: Ursodeoxycholic acid Release form: White hard gelatin capsules. The contents of the capsules are a mixture of powder and granules of white or almost white color, odorless or with a slight specific odor. Hard gelatin capsules 250 mg. 10 or 14 capsules in a blister pack made of PVC film and aluminum foil. 2 or 4 blister packs No. 14 or 6 blister packs No. 10 with instructions for medical use are placed in a cardboard pack. Release of the drug: By prescription Pharmacological action: Pharmacodynamics A small amount of ursodeoxycholic acid is present in human bile. After oral administration, it reduces the saturation of bile with cholesterol, inhibiting its absorption in the intestine and reducing secretion into bile. Presumably, due to the dispersion of cholesterol and the formation of liquid crystals, the gradual dissolution of gallstones occurs. According to modern concepts, it is believed that the effect of ursodeoxycholic acid in liver diseases and cholestasis is due to the relative replacement of lipophilic, toxic bile acids with hydrophilic cytoprotective non-toxic ursodeoxycholic acid, an improvement in the secretory capacity of hepatocytes and immunoregulatory processes. Indications for use: – For the dissolution of x-ray negative cholesterol gallstones no larger than 15 mm in diameter in patients with a functioning gallbladder despite the presence of gallstone(s) in it(s). – For the treatment of gastritis with bile reflux. – For the symptomatic treatment of primary biliary cirrhosis in the absence of decompensated liver cirrhosis. – For the treatment of hepatobiliary disorders in cystic fibrosis in children aged 6 to 18 years. Use during pregnancy and lactation: Women of reproductive age can be treated only with reliable contraception. Patients of childbearing age taking a drug to dissolve gallstones should use effective non-hormonal methods of contraception, as hormonal oral contraceptives can promote the formation of gallstones. Before starting treatment, the possibility of pregnancy should be excluded. There are no or limited data on the use of ursodeoxycholic acid during pregnancy. Animal studies have demonstrated reproductive toxicity with high doses of ursodeoxycholic acid administered early in gestation. The use of Ursaclin by women during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. The decision to use Ursaclin is made by the attending physician. According to the latest data, the level of ursodeoxycholic acid that enters breast milk is very low, so the development of adverse reactions in breastfed infants is unlikely. If it is necessary to prescribe the drug during lactation, the final decision can only be made by a doctor. Precautions: Ursaclin capsules should only be taken under medical supervision. With long-term (more than 1 month) taking Ursaclin every 4 weeks in the first 3 months of treatment, then every 3 months, a biochemical blood test should be performed to determine the activity of hepatic transaminases and gamma-glutamyl transferase. If elevated levels persist, the drug should be discontinued. After complete dissolution of the calculi, it is recommended to continue treatment for at least 3 months to dissolve the remnants of calculi that are too small to be detected. Monitoring the effectiveness of treatment is carried out every 6 months by conducting X-ray and ultrasound examination of the biliary tract in order to prevent recurrence of cholelithiasis. The drug is not recommended in cases where the gallbladder cannot be visualized on x-rays or in cases of calcification of stones, weak contractility of the gallbladder or frequent attacks of biliary colic. In patients with primary biliary cirrhosis, in rare cases, after the start of treatment, the condition may worsen, which is associated with increased itching. In this case, the dose should be reduced to 250 mg per day and then gradually increased to the recommended dose. Cases of decompensated cirrhosis of the liver have been extremely rare. After the cessation of therapy, a partial regression of the manifestations of decompensation was noted. In case of diarrhea, the dose should be reduced. In case of persistent diarrhea, treatment should be discontinued. Despite the fact that Ursaklin has no age restrictions for use, the drug is not prescribed for children under the age of 6 years due to possible difficulties in swallowing the capsules. During treatment, women of childbearing age should use effective non-hormonal methods of contraception. Interactions with other drugs: Colestyramine, colestipol and antacids containing aluminum hydroxide and / or smectite (aluminum oxide) 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 Ursaclin. 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. In a clinical study involving healthy volunteers, the combined use of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in a slight increase in plasma concentrations of rosuvastatin. The clinical significance of this interaction and interactions with other statins is unknown. In some cases, Ursaclin may reduce the absorption of ciprofloxacin. In some cases, Ursaclin can reduce peak plasma concentrations (Cmax) and the area under the concentration-time pharmacokinetic curve (AUC) of nitrendipine, a calcium antagonist. An increase in the dose of nitrendipine may be required. UDCA influences the metabolism of dapsone by cytochrome P450 3A enzymes. These observations are consistent with the results obtained in vitro, and may indicate the ability of ursodeoxycholic acid to induce enzymes of the cytochrome P450 3A system. However, induction has not been observed in well-designed interaction studies with budesonide, which is a well-known cytochrome P450 3A substrate. Therefore, precautions should be taken when co-administering drugs metabolized by this enzyme and dosage adjustments may be required. The drug can affect the absorption of cyclosporine in the intestine. Therefore, in patients taking this drug at the same time, it is necessary to monitor the level of cyclosporine and adjust its dose. Your doctor must be informed about all medicines you are taking. Talk to your doctor before taking any medicine during treatment with Ursaclin. Contraindications: – hypersensitivity to the active substance or other ingredients that make up this medicinal product; – X-ray positive (high in calcium) gallstones; – obstruction of the biliary tract (occlusion of the common bile duct or cystic duct) – reduced contractility of the gallbladder; – frequent episodes of biliary colic; – acute inflammatory diseases of the gallbladder or bile ducts; – children under 6 years of age; – unsuccessful portoenterostomy or unrecovered bile flow in children with biliary atresia. Composition: 1 capsule contains the active substance: ursodeoxycholic acid – 250 mg; excipients: corn starch, pregelatinized corn starch, anhydrous colloidal silicon dioxide, magnesium stearate; capsule shell: gelatin, titanium dioxide (E 171) Dosage and administration: There are no age restrictions on the use of the drug. For patients who weigh less than 47 kg or who have difficulty swallowing capsules, ursodeoxycholic acid in the form of a suspension should be used. To dissolve cholesterol gallstones Approximately 10 mg ursodeoxycholic acid/kg body weight, equivalent to: up to 60 kg – 500 mg 61-80 kg – 750 mg 81-100 kg – 1000 mg Over 100 kg – 1250 kg Capsules to be swallowed whole with a glass of water water, 1 time per day in the evening before going to bed. Capsules should be taken regularly. The time required for gallstones to dissolve is usually 6-24 months. If a decrease in the size of gallstones is not observed after 12 months of administration, therapy should not be continued. The success of the treatment should be checked every 6 months by ultrasound or X-ray. Additional studies need to be checked so that stones do not calcify over time. If this happens, treatment should be discontinued. For the treatment of gastritis with bile reflux 250 mg 1 time per day with some liquid in the evening before bedtime. Usually, for the treatment of gastritis with bile reflux, the drug is taken for 10-14 days. The duration of use depends on the condition of the patient. The doctor must decide on the duration of treatment in each case individually. For the symptomatic treatment of primary biliary cirrhosis (PBC) The daily dose depends on body weight and varies from 750 mg to 1750 mg (14±2 mg/kg of body weight). In the first 3 months of treatment, the drug should be taken by distributing the daily dose into 3 doses during the day. With improvement in liver function, the daily dose can be taken 1 time per day in the evening. Body weight (kg) 47 – 62 Daily dose (mg / kg body weight) – 12 – 16 Distribution of the drug intake: First 3 months Morning – 250 mg Day – 250 mg Evening – 250 mg Later: Evening (1 time per day) – 750 mg Body weight (kg) 63 – 78 Daily dose (mg / kg body weight) – 13 – 16 Distribution of the drug intake: First 3 months Morning – 250 mg Day – 250 mg Evening – 500 mg Later: Evening (1 time per day) – 1000 mg Body weight (kg) 79 – 93 Daily dose (mg / kg body weight) – 13 – 16 Distribution of the drug intake: First 3 months Morning – 250 mg Day – 500 mg Evening – 500 mg Later: Evening (1 time per day) – 1250 mg Body weight (kg) 94 – 109 Daily dose (mg / kg body weight) – 14 – 16 Distribution of the drug intake: First 3 months Morning – 500 mg Day – 500 mg Evening – 500 mg Later: Evening (1 time per day) – 1500 mg Body weight (kg) more than 110 Daily dose (mg / kg body weight) – Distribution of the drug intake: First 3 months Morning – 500 mg Day – 500 mg Evening – 750 mg Later: Evening (1 time per day) – 1750 mg The capsules should be swallowed whole with a liquid. It is necessary to observe the regularity of reception. The use of the drug in primary biliary cirrhosis can be unlimited in time. In patients with primary biliary cirrhosis, in rare cases, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. If it happened. Therapy should be continued, taking 250 mg per day, and then gradually increase the dose (increasing the daily dose by 250 mg weekly) until the prescribed dosing regimen is reached. Use in children Cholesterol gallstones and primary biliary cirrhosis are very rare in children. Efficacy and safety data are not available in this population. If necessary, the dose should be adjusted according to body weight. For children with cystic fibrosis aged 6 to 18 years, the dosage is 20 mg / kg / day and is divided into 2-3 doses, followed by an increase in dose to 30 mg / kg / day, if necessary. Body weight (kg) 20 – 29 Daily dose (mg / kg body weight) – 17-25 Distribution of the drug intake: First 3 months Morning – 1 Day – Evening – 1 Body weight (kg) 30 – 39 Daily dose (mg / kg body weight) – 19-25 Distribution of drug intake: First 3 months Morning – 1 Day – 1 Evening – 1 Body weight (kg) 40 – 49 Daily dose (mg / kg body weight) – 20-25 Distribution of drug intake: First 3 months Morning – 1 Day – 1 Evening – 2 Body weight (kg) 50 – 59 Daily dose (mg / kg body weight) – 21-25 Distribution of drug intake: First 3 months Morning – 1 Day – 2 Evening – 2 Body weight ( kg) 60 – 69 Daily dose (mg / kg body weight) – 22-25 Distribution of the drug intake: First 3 months Morning – 2 Day – 2 Evening – 2 Body weight (kg) 70 – 79 Daily dose (mg / kg body weight ) – 22-25 Distribution of drug intake: First 3 months Morning – 2 Day – 2 Evening – 3 Body weight (kg) 80 – 89 Daily dose (mg / kg body weight) – 22-25 Distribution of drug intake: First 3 months Morning – 2 Day – 3 Evening – 3 Body weight (kg) 90 – 99 Daily dose (mg / kg body weight) – 23-25 Distribution of the drug intake: First 3 months Morning – 3 Day – 3 Evening – 3 Body weight (kg) 100 – 109 Daily dose (mg / kg body weight) – 23-25 Distribution of drug intake: First 3 months Morning – 3 Day – 3 Evening – 4 more than 110 Daily dose (mg / kg body weight) – Distribution of drug intake: First 3 months Morning – 3 Day – 4 Evening – 4 Side effect: Ursaklin fairly well tolerated by patients. Frequency of side effects: very often (> 1/10); often (>1/100, but <1/10); infrequently (> 1/1000, but < 1/100); rarely (>1/10000, but <1/1000); very rarely (<1/10000). When using ursodeoxycholic acid, the following side effects are possible: Gastrointestinal disorders: often - diarrhea, dyspepsia, rarely - pain in the epigastric region and right hypochondrium. On the part of the liver and biliary tract: very rarely - calcification of stones, decompensation of cirrhosis of the liver, which disappears after discontinuation of the drug. Hypersensitivity reactions: very rarely - itching, allergic rash (urticaria). In the treatment of primary biliary cirrhosis, decompensation of liver cirrhosis was very rarely observed, which partially regressed after discontinuation of treatment. In case of any unusual reactions, you should stop taking the drug and consult your doctor. Storage conditions: In a place protected from light and moisture at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children. Shelf life from date of manufacture: 2 years. Do not use after the expiration date. Buy Ursaklin capsules 250mg No. 10x6