País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
cholic acid
Theravia
A05AA03
cholic acid
Bile acids and derivatives
Digestive System Diseases; Metabolism, Inborn Errors
Orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults.
Revision: 13
Authorised
2013-09-12
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ORPHACOL 50 MG HARD CAPSULES ORPHACOL 250 MG HARD CAPSULES Cholic acid This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. 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 Orphacol is and what it is used for 2. What you need to know before you take Orphacol 3. How to take Orphacol 4. Possible side effects 5. How to store Orphacol 6. Contents of the pack and other information 1. WHAT ORPHACOL IS AND WHAT IT IS USED FOR Orphacol contains cholic acid, a bile acid which is normally produced by the liver. Certain medical conditions are caused by defects in bile acid production and Orphacol is used to treat infants from one month to 2 years of age, children, adolescents and adults with these medical conditions. The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORPHACOL _ _ DO NOT TAKE ORPHACOL - if you are allergic to cholic acid or any of the other ingredients of this medicine (listed in section 6). - if you are taking phenobarbital or primidone, a medicine to treat epilepsy. WARNINGS AND PRECAUTIONS During your treatment, your doctor will carry out various blood and urine tests at different time to see how your body is handling this medicine and Leer el documento completo
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Orphacol 50 mg hard capsules Orphacol 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Orphacol 50 mg capsules Each hard capsule contains 50 mg of cholic acid. Orphacol 250 mg capsules Each hard capsule contains 250 mg of cholic acid. Excipient(s) with known effect: Lactose monohydrate (145.79 mg per capsule of 50 mg and 66.98 mg per capsule of 250 mg). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Orphacol 50 mg capsules Oblong, opaque, blue and white capsule. Orphacol 250 mg capsules Oblong, opaque, green and white capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ 5 -C 27 -steroid oxidoreductase deficiency or Δ 4 -3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored by an experienced gastroenterologist/hepatologist or a paediatric gastroenterologist/hepatologist in the case of paediatric patients. In case of persistent lack of therapeutic response to cholic acid monotherapy, other treatment options should be considered (see section 4.4). Patients should be monitored as follows: 3-monthly during the first year, 6-monthly during the subsequent three years and annually thereafter (see below). 3 Posology The dose must be adjusted for each patient in a specialised unit according to blood and/or urine chromatographic bile acid profiles. _3β-Hydroxy-Δ_ _5_ _-C_ _27_ _-steroid oxidoreductase deficiency _ The daily dose ranges from 5 to 15 mg/kg in inf Leer el documento completo