Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ursodeoxycholic acid
Laboratoires Mayoly Spindler
A05AA; A05AA02
Ursodeoxycholic acid
500 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bile acid preparations; ursodeoxycholic acid
Not marketed
2017-10-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CHOLURSO 500 MG FILM-COATED 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, 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 Cholurso 500 mg film-coated tablets is and what it is used for 2. What you need to know before you take Cholurso 500 mg film-coated tablets 3. How to take Cholurso 500 mg film-coated tablets 4. Possible side effects 5. How to store Cholurso 500 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT CHOLURSO 500 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Cholurso contains the active substance ursodeoxycholic acid. Ursodeoxycholic acid is a chemical present naturally in the body and it helps to control the amount of cholesterol in the blood. CHOLURSO IS USED – to dissolve gallstones caused by excess cholesterol in the gall bladder (in patients for whom surgery is not an option), where the gallstones are not visible on a plain x-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s). – for the treatment of a condition where the bile ducts in the liver become damaged leading to a build- up of bile. This may cause scarring of the liver. The liver should not be so damaged that it is not functioning properly. This condition is called primary biliary cholangitis. – for the treatment of liver disease associated with a condition called cystic fibrosis in children and adolescents aged 6 to 18 years. 2. W Read the complete document
Health Products Regulatory Authority 25 April 2022 CRN00CJLQ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cholurso 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ursodeoxycholic acid. Excipient with known effect: soya lecithin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White oblong tablet (19 mm long, 8.8 mm wide) with a score line on each side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of primary biliary cholangitis (PBC, also known as primary biliary cirrhosis) in adult patients without decompensated cirrhosis. - Dissolution of radiolucent cholesterol gallstones in patients for whom surgical treatment is not indicated. The gallstones must not produce any shadows on the radiograph, and should not be of a greater diameter than 15 mm, and the gall bladder, despite the gallstone(s), must be functioning. Paediatric population Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route. For patients weighing less than 47 kg or patients who are unable to swallow Cholurso 500 mg film-coated tablets, other formulations with ursodeoxycholic acid (e g oral suspension) should be checked for availability. The following daily dose is recommended for the various indications: _For treatment of primary biliary cholangitis (PBC) _ _Stage I-III _ The daily dose is dependent on body weight and ranges from 1½ to 3½ film-coated tablets (12-16 mg ursodeoxycholic acid per kg of body weight). During the first 3 months of treatment, Cholurso 500 mg film-coated tablets should be taken at mealtime in divided doses throughout the day. If liver function improves, the total daily dose can be taken once daily in the evening. Body weight (kg) Daily dose (mg/kg Body weight Cholurso 250 mg film-coated tablets First 3 months Read the complete document