Ursofalk capsules 250mg №25×4

Name:
Ursofalk caps 250mg bl in pack No. 25×4 Main active ingredient Ursodeoxycholic acid Release formcapsules CompositionThe active substance of the drug is ursodeoxycholic acid. One capsule contains 250 mg of ursodeoxycholic acid. Excipients – corn starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, purified water, sodium lauryl sulfate.
Description:
Ursofalk® 250 mg capsules are white, opaque, hard gelatin capsules containing white compressed powder or granules. Ursofalk® capsules at a dosage of 250 mg are available in packs of 50 capsules (2 blisters x 25 capsules) or 100 capsules (4 blisters x 25 capsules) in a cardboard box. Dosage Dosage Approximately 10 mg of ursodeoxycholic acid per 1 kg of body weight daily as follows: up to 60 kg 2 capsules 61-80 kg 3 capsules 81-100 kg 4 capsules over 100 kg 5 capsules Take the capsules without chewing with a little water or other fluids 1 time per day, at bedtime. The capsules should be taken regularly. Duration of treatment Generally, the duration of treatment to dissolve the stones is 6-24 months. If the size of the stones does not decrease after 12 months of treatment, the drug should not be continued. Every 6 months, the doctor must monitor the success of the treatment. At subsequent examinations, whether calcification of stones has occurred in the interim. If this happens, the use of Ursofalk® should be discontinued. For the treatment of biliary reflux gastritis Take 1 capsule 1 time per day, in the evening, at bedtime, without chewing and with a small amount of water or other liquid. The duration of treatment is usually 10-14 days. Depending on the course of the disease, your doctor will determine how long you should take the drug. For the symptomatic treatment of primary biliary cirrhosis Dosage The daily dose depends on body weight and varies from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid/kg body weight). In the first 3 months of treatment with Ursofalk®, 250 mg capsules, the daily dose should be divided into several doses. You must take Ursofalk® 250 mg capsules in the morning, afternoon and evening. After improving the results of laboratory parameters (liver tests), the daily dose of the drug can be taken once, in the evening. Body weight (kg) Daily dose (mg/kg body weight) Ursofalk®, capsules 250 mg First 3 months Later Morning Afternoon Evening Evening (1 time per day) 47-62 12-16 1 1 1 3 63-78 13- 16 1 1 2 4 79-93 13-16 1 2 2 5 94-109 14-16 2 2 2 6 over 110 2 2 3 7 Capsules should be taken without chewing with a small amount of water or other liquid. The capsules must be taken regularly. The use of Ursofalk 250 mg capsules in primary biliary cirrhosis can be unlimited in duration. Note: In patients with primary biliary cirrhosis, clinical symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, treatment should be continued by taking one capsule of Ursofalk® daily, then the dose should be gradually increased (increasing the daily dose by one capsule weekly) until the recommended dosage regimen is reached again. For the treatment of hepatobiliary disease associated with fibrocystic degeneration in children aged 6 to 18 years: Dosage: The recommended daily dose is 20 mg per 1 kg of body weight, divided into 2-3 doses. If necessary, the doctor may increase the dose to 30 mg per 1 kg of body weight. Body weight kg Daily dose (mg/kg body weight) Ursofalk®, capsules 250 mg Morning Afternoon Evening 20 – 29 17-25 1 – 1 30 – 39 19-25 1 1 1 40 – 49 20-25 1 1 2 50 – 59 21-25 1 2 2 60 – 69 22-25 2 2 2 70 – 79 22-25 2 2 3 80 – 89 22-25 2 3 3 90 – 99 23-25 3 3 3 100 – 109 23-25 3 3 4 >110 3 4 4 If you feel that the effect of Ursofalk® 250 mg capsules is too strong or too weak, please tell your doctor. If you have taken more Ursofalk® capsules than your doctor has prescribed You may experience diarrhea as a result of an overdose. Please tell your doctor immediately if diarrhea persists, as a dose reduction may be necessary. If you suffer from diarrhea, drink enough fluids to restore the water-salt balance. If you forget to take Ursofalk® 250 mg capsules Do not increase the number of capsules on your next dose, just continue the prescribed dosing regimen. If you stop taking Ursofalk® 250 mg capsules Always talk to your doctor if you decide to stop treatment with Ursofalk®, 250 mg capsules or stop treatment early. If you have any further questions on the use of this medicine, ask your doctor. Indications for use Ursodeoxycholic acid is the active ingredient in Ursofalk® 250 mg capsules. It is a naturally occurring bile acid found in small amounts in human bile. Ursofalk® capsules at a dosage of 250 mg are used: – to dissolve cholesterol stones. These stones must be radiolucent (not visible on plain radiographs) and not exceed 15 mm in diameter. Despite the presence of stones, gallbladder function must be preserved; – for the treatment of an inflammatory process in the stomach caused by a reverse flow of bile acids (bile reflux gastritis); – for the treatment of primary biliary cirrhosis (PBC) in patients without decompensated liver cirrhosis (diffuse chronic liver disease in the stage when reduced liver function is not able to be compensated); – for the treatment of hepatobiliary disease associated with fibrocystic degeneration (cystic fibrosis) in children aged 6 to 18 years. What you need to know before you start taking Do not take if: – you have a hypersensitivity to the active substance or other ingredients of this medicine; – you have acute inflammatory diseases of the gallbladder or bile ducts; – you have an obstruction of the bile ducts (blockage of the common bile duct or cystic duct); – you have calcification of gallstones; – you have impaired contractility of the gallbladder; – you suffer from frequent cramping pains in the upper abdomen; – Your child has bile duct obstruction and reduced bile secretion (biliary atresia), even after surgery. Please tell your healthcare provider about any of the above conditions. You should also tell your doctor if you have previously experienced any of these conditions. Additional precautions Ursofalk® 250 mg capsules should be used under medical supervision. Your healthcare provider should monitor liver function every 4 weeks for the first three months of treatment. After that, the control should be carried out every 3 months. When used to dissolve cholesterol gallstones, your doctor should schedule you for a gallbladder scan after 6 to 10 months of treatment. Women taking Ursofalk® to dissolve stones should use non-hormonal methods of contraception, as hormonal contraceptives may contribute to the formation of gallstones. In the treatment of primary biliary cirrhosis, in rare cases, symptoms may worsen at the beginning of treatment, for example, itching may increase. In this case, you should contact your doctor to reduce the initial dose. Tell your doctor if you have diarrhea. In this case, it may be necessary to reduce the dose of the drug or stop taking Ursofalk®, 250 mg capsules. Use during pregnancy and lactation Before using any medicine, you should consult your doctor. Fertility Animal studies have not shown an effect of ursodeoxycholic acid on fertility. Data on the effect of ursodeoxycholic acid on human fertility after treatment with ursodeoxycholic acid are not available. Period of pregnancy There are no data on the use of ursodeoxycholic acid in pregnant women. Animal studies have provided evidence of reproductive toxicity in early pregnancy. Ursofalk capsules should not be used during pregnancy unless absolutely necessary. Women of childbearing potential Women of childbearing potential should only take this medicine if they are using effective contraception. It is recommended to use non-hormonal contraceptives or oral contraceptives with a low estrogen content. In patients taking Ursofalk to dissolve gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives can increase gallstone formation. Before starting treatment, the possibility of pregnancy should be excluded. Breast-feeding period According to the few described cases of the use of the drug in breast-feeding women, the concentrations of ursodeoxycholic acid in breast milk are very low, and adverse reactions are probably not expected in breast-feeding infants. Side effects Like all medicines, Ursofalk can cause side effects and may not be suitable for all patients. Common side effects (may affect less than 1 in 10 patients and more than 1 in 100 patients): – Soft, frequent loose stools or diarrhea. Very rare side effects (occur less than 1 in 10,000 patients): – during treatment for primary biliary cirrhosis: severe pain in the upper abdomen, on the right side, severe exacerbations (decompensation) of cirrhosis of the liver, which partially decreases after stopping treatment ; – calcification of gallstones; – urticaria. If the listed adverse reactions occur, as well as a reaction not indicated in the instructions for use, you should consult a doctor. Interactions with other drugs Please tell your doctor if you are taking or have recently taken any medicines containing the substances listed below. When interacting with Ursofalk®, the effectiveness of these drugs may change. It is possible to reduce the effect of the following drugs while taking them with Ursofalk®, 250 mg capsules: – cholestyramine, cholestipol (affecting blood lipids); aluminum hydroxide and / or smectite (aluminum oxide) containing antacids (agents that reduce the acidity of gastric juice). If you are taking a preparation containing any of these active substances, you should take it 2 hours before or after taking Ursofalk® capsules. – ciprofloxacin, dapsone (antibiotics), nitrendipine (to lower blood pressure) and other drugs that are metabolized in a similar way. Your doctor may change the doses of these drugs. It is possible to change the effect of the following drugs when used simultaneously with Ursofalk®, capsules 250 mg: – cyclosporine (reduces the activity of the immune system). If you are taking ciclosporin, your doctor will monitor your blood levels and your dose may need to be adjusted. – rosuvastatin (lowers blood cholesterol levels). If you are taking Ursofalk® 250 mg capsules to dissolve cholesterol stones, please tell your doctor if you are also taking medicines containing estrogen or cholesterol-lowering medicines such as those containing clofibrate. These drugs may promote the formation of gallstones, which is the opposite effect of ursodeoxycholic acid, which is used to dissolve gallstones. Please tell your doctor or pharmacist about all medicines you are taking, even if they are available without a prescription. Your doctor will determine which drugs and at what dosage are your priorities at the moment. Storage conditions Store at a temperature not exceeding 25 ° C. Keep all medicines out of the reach of children. Buy Ursofalk capsules 250mg №25×4 Ursofalk capsules 250mg №25×4