Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ticagrelor
AstraZeneca UK Ltd
B01AC24
Ticagrelor
90mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5000455019676
Patient Information Leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ BRILIQUE 90 MG FILM-COATED TABLETS ticagrelor _ _ 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 Brilique is and what it is used for 2. What you need to know before you take Brilique 3. How to take Brilique 4. Possible side effects 5. How to store Brilique 6. Contents of the pack and other information 1. WHAT BRILIQUE IS AND WHAT IT IS USED FOR WHAT BRILIQUE IS Brilique contains an active substance called ticagrelor. This belongs to a group of medicines called antiplatelet medicines. WHAT BRILIQUE IS USED FOR Brilique in combination with acetylsalicylic acid (another antiplatelet agent) is to be used in adults only. You have been given this medicine because you have had: • a heart attack, or • unstable angina (angina or chest pain that is not well controlled). It reduces the chances of you having another heart attack, stroke or dying from a disease related to your heart or blood vessels. HOW BRILIQUE WORKS Brilique affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged. However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because: • the clot can cut off the blood supply completely; this can cause a heart attack (myocardial infarction) or stroke, or • the clot can partly block the blood vessels to the heart; this Baca dokumen lengkap
OBJECT 1 BRILIQUE 90 MG FILM COATED TABLETS Summary of Product Characteristics Updated 24-May-2018 | AstraZeneca UK Limited 1. Name of the medicinal product Brilique 60 mg film-coated tablets Brilique 90 mg film-coated tablets 2. Qualitative and quantitative composition Brilique 60 mg film-coated tablets Each film-coated tablet contains 60 mg ticagrelor. Brilique 90 mg film-coated tablets Each film-coated tablet contains 90 mg ticagrelor. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). Brilique 60 mg film-coated tablets Round, biconvex, pink tablets marked with '60' above 'T' on one side and plain on the other. Brilique 90 mg film-coated tablets Round, biconvex, yellow tablets marked with '90' above 'T' on one side and plain on the other. 4. Clinical particulars 4.1 Therapeutic indications Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1). 4.2 Posology and method of administration Posology Patients taking Brilique should also take a daily low maintenance dose of ASA 75-150 mg, unless specifically contraindicated. _Acute coronary syndromes _ Brilique treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Treatment with Brilique 90 mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated (see section 5.1). _History of myocardial infarction _ Brilique 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1). Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Brilique 90 mg or other adenosine diph Baca dokumen lengkap