Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ursodeoxycholic acid
DE Pharmaceuticals
A05AA02
Ursodeoxycholic acid
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100
PACKAGE LEAFLET: INFORMATION FOR THE USER URSODEOXYCHOLIC ACID 150 MG TABLETS URSODEOXYCHOLIC ACID 300 MG TABLETS URSODEOXYCHOLIC ACID 450 MG TABLETS 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 or pharmacist. - 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 or pharmacist. 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 4. How to take Ursodeoxycholic Acid Tablets 5. Possible side effects 6. How to store 7. Contents of the pack and other information 1. WHAT URSODEOXYCHOLIC ACID IS AND WHAT IT IS USED FOR Ursodeoxycholic Acid influences the composition of the bile, by which cholesterol gallstones can be solved. The effects of Ursodeoxycholic Acid in primary biliary cholangitis and cystic fibrosis can be explained by various mechanisms, such as a protective effect on the liver cells and an effect on the immune system. 1. Ursodeoxycholic Acid Tablets is used in patients: • with small gallstones • who do not want to undergo surgery or are not eligible for gallstone surgery • in whom too much cholesterol has been found in the bile 2. Ursodeoxycholic Acid Tablets is used in patients with primary biliary cholangitis. Primary biliary cholangitis is a disease in which liver tissue is damaged by an impaired drainage of the bile. 3. Ursodeoxycholic Acid Tablets is used in children aged 6 years to 18 years old with liver and biliary diseases caused by cystic fibrosis. Cystic fibrosis, also referred to as mucoviscidosis, is an inherited disorder in which the mucus is particularly tough i Läs hela dokumentet
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 Läs hela dokumentet