Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ursodeoxycholic acid
Galen Ltd
A05AA02
Ursodeoxycholic acid
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100; GTIN: 5016298934564
PACKAGE LEAFLET: INFORMATION FOR THE USER URSODEOXYCHOLIC ACID TABLETS 150MG (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 Ursodeoxycholic Acid is and what it is used for 2. What you need to know before you take Ursodeoxycholic Acid Tablets 3. How to take Ursodeoxycholic Acid Tablets 4. Possible side effects 5. How to store Ursodeoxycholic Acid Tablets 6. Contents of the pack and other information 1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR Ursodeoxycholic Acid Tablets contain ursodeoxycholic acid (UDCA) as the active substance. UDCA is a bile acid normally only found in small amounts in human bile. Ursodeoxycholic Acid Tablets are used to dissolve gallstones that are rich in cholesterol. They can also be used 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 URSODEOXYCHOLIC ACID TABLETS DO NOT TAKE URSODEOXYCHOLIC ACID TABLETS - 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 Lire le document complet
1. NAME OF THE MEDICINAL PRODUCT Ursogal Tablets 150mg/ Ursodeoxycholic Acid Tablets 150mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ursodeoxycholic acid (UDCA) Ph. Eur. 150mg per tablet. Excipient(s) with known effect: 98mg of lactose per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. 4.1. THERAPEUTIC INDICATIONS Ursogal Tablets 150mg/Ursodeoxycholic Acid Tablets 150mg are indicated for the dissolution of radiolucent cholesterol-rich gallstones in adults, including the elderly, and children with a functioning gallbladder. Ursogal Tablets 150mg/Ursodeoxycholic Acid Tablets 150mg 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 (3 or 4 tablets of UDCA 150mg 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). _Children with cystic fibrosis aged 6 years to less than 18 years: _ 20mg/kg/day in 2-3 divided doses, with a further increase to 30mg/kg/day if necessary. Method of administration For oral use. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. UDCA should not Lire le document complet