Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ursodeoxycholic acid
Galen Ltd
A05AA02
Ursodeoxycholic acid
250mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100; GTIN: 5016298944570
PACKAGE LEAFLET: INFORMATION FOR THE USER URSOGAL ® CAPSULES 250MG (Ursodeoxycholic acid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ursogal is and what it is used for 2. What you need to know before you take Ursogal Capsules 3. How to take Ursogal Capsules 4. Possible side effects 5. How to store Ursogal Capsules 6. Contents of the pack and other information 1. WHAT URSOGAL IS AND WHAT IT IS USED FOR Ursogal Capsules contain ursodeoxycholic acid (UDCA) as the active substance. UDCA is a bile acid normally only found in small amounts in human bile. Ursogal Capsules are used to dissolve gallstones that are rich in cholesterol. Ursogal Capsules are also used in the treatment of a condition called primary biliary cirrhosis and to treat children, aged 6 years to less than 18 years, who have liver problems associated with cystic fibrosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOGAL CAPSULES DO NOT TAKE URSOGAL CAPSULES: - if you have acute inflammation of the gall bladder or biliary tract - if you have a blockage of the biliary tract - if you have frequent episodes of biliary colic (recurrent pain in the upper abdomen) - if your gall bladder does not work correctly - if you have gallstones that are visible on an x-ray - if you are pregnant or you think you might be pregnant - if there is a chance you might become pregnant - if you have a stomach or duodenal ulcer - if you have a stoma because part of your bowel has been removed - if you suffer from any liver problems (apart f Prečítajte si celý dokument
1. NAME OF THE MEDICINAL PRODUCT Ursogal Capsules 250mg/ Ursodeoxycholic Acid Capsules 250mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ursodeoxycholic acid (UDCA) Ph. Eur. 250mg per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. 4.1. THERAPEUTIC INDICATIONS Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are indicated for the dissolution of radiolucent cholesterol-rich gallstones in adults, including the elderly, and children with a functioning gallbladder. Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are indicated for the treatment of primary biliary cirrhosis. Ursogal Capsules 250mg/Ursodeoxycholic Acid Capsules 250mg are indicated for hepatobiliary disorder associated with cystic fibrosis in children aged 6 years to less than 18 years. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Dissolution of radiolucent cholesterol-rich gallstones: _ A daily dose of 8-10mg/kg (2 or 3 capsules of UDCA 250mg per day for most patients) is recommended. Obese patients may require a higher dose of UDCA (up to 15mg/kg/day). This should be taken in two divided doses after meals, with at least half the dose being taken after the evening meal. The time required for dissolution of gallstones is generally in the range of 6-24 months, and is dependent on the size and composition of the stones. Treatment should be regularly monitored (by cholecystograms) and continued for 3-4 months following the disappearance of the gallstones. Stones may recur after successful treatment. The time required to effect stone dissolution may be increased if UDCA is temporarily discontinued (for 3-4 weeks) during treatment. The dose of UDCA for elderly patients and for children should be related to body weight (8-10mg/kg/day). _Treatment of primary biliary cirrhosis: _ A daily dose of 10-15mg/kg (2-5 capsules of UDCA 250mg per day for most patients) is recommended for the treatment of primary biliary cirrhosis in adults and the elderly. This should be taken in two to four divided Prečítajte si celý dokument