Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Obeticholic acid
Intercept Pharma UK & Ireland Ltd
A05AA04
Obeticholic acid
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100; GTIN: 00369516000042
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OCALIVA 5 MG 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 (also known as primary biliary cirrhosis), 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 a complete blockage of the biliary tract (liver, gall bladder and bile ducts). _ _ WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking OCALIVA. If you experience itching that is d Pročitajte cijeli dokument
OBJECT 1 OCALIVA 5MG FILM-COATED TABLETS Summary of Product Characteristics Updated 17-Apr-2018 | Intercept Pharma UK & Ireland 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 mg 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 mg film-coated tablets Yellow, 7.6 mm X 7.4 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 (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. 4.2 Posology and method of administration Posology Prior to initiation of treatment with obeticholic acid the patient's hepatic status must be known. The starting dose and dosage titration by PBC patient population is shown in Table 1. Table 1: Dosage Regimen by PBC Patient Population STAGING/CLASSIFICATION NON-CIRRHOTIC OR CHILD-PUGH CLASS A CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOTIC STARTING DOSAGE 5 MG ONCE DAILY 5 MG ONCE WEEKLY DOSAGE TITRATION For patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 6 MONTHS of treatment and the patient is tolerating obeticholic acid, titrate up to 10 MG ONCE D Pročitajte cijeli dokument