Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Obeticholic acid
ADVANZ PHARMA Limited
A05AA04
obeticholic acid
Bile and liver therapy
Liver Cirrhosis, Biliary
Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Revision: 17
Authorised
2016-12-12
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OCALIVA 5 M G FILM-COATED TABLETS OCALIVA 10 MG FILM-COATED TABLETS obeticholic 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, 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 Ocaliva is and what it is used for 2. What you need to know before you take Ocaliva 3. How to take Ocaliva 4. Possible side effects 5. How to store Ocaliva 6. Contents of the pack and other information 1. WHAT OCALIVA IS AND WHAT IT IS USED FOR Ocaliva contains the active substance obeticholic acid (farnesoid X-receptor agonist) which helps to improve how your liver works by reducing the production and build up of bile in the liver and also reducing inflammation. This medicine is used to treat adult patients with a type of liver disease known as primary biliary cholangitis, either by itself or together with another medicine, ursodeoxycholic acid. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OCALIVA _ _ DO NOT TAKE OCALIVA - if you are allergic to obeticholic acid or any of the other ingredients of this medicine (listed in section 6). - if you have primary biliary cholangitis with liver cirrhosis with symptoms such as fluid in the belly or confusion (decompensated liver cirrhosis). - if you have a complete blockage of the biliary tract (liver, gallbladder and bile Leggi il 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 Ocaliva 5 mg film-coated tablets Ocaliva 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ocaliva 5 mg film - coated tablets Each film-coated tablet contains 5 mg of obeticholic acid. Ocaliva 10 m g film - coated tablets Each film-coated tablet contains 10 mg of obeticholic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Ocaliva 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT’ on one side and ‘5’ on the other side. Ocaliva 10 m g film-coated tablets Yellow, 8 mm × 7 mm triangular tablet debossed with ‘INT’ on one side and ‘10’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ocaliva is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prior to initiation of treatment with obeticholic acid the patient’s hepatic status must be known. Whether the patient has decompensated cirrhosis (including Child-Pugh Class B or C) or has had a prior decompensation event should be determined prior to initiation of treatment because obeticholic acid is contraindicated in these patients (see sections 4.3 and 4.4) _._ The starting dose of obeticholic acid is 5 mg once daily for the first 6 months. 3 After the first 6 months, for patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and who are tolerating obeticholic acid, increase to a maximum dose of 10 mg once daily. No dose adjustment of concomitant UDCA is re Leggi il documento completo