Država: Malta
Jezik: engleski
Izvor: Medicines Authority
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
B01AF01
RIVAROXABAN 2.5 mg
FILM-COATED TABLET
RIVAROXABAN 2.5 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2023-01-16
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER XABAREM 2.5 MG FILM-COATED TABLETS rivaroxaban 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 Xabarem is and what it is used for 2. What you need to know before you take Xabarem 3. How to take Xabarem 4. Possible side effects 5. How to store Xabarem 6. Contents of the pack and other information 1. WHAT XABAREM IS AND WHAT IT IS USED FOR You have been given Xabarem because - you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests. Xabarem reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels. Xabarem will not be given to you on its own. Your doctor will also tell you to take either: • acetylsalicylic acid or • acetylsalicylic acid plus clopidogrel or ticlopidine. or - you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms. Xabarem reduces the risk in adults of getting blot clots (atherothrombotic events). Xabarem will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid. Page 2 of 9 In some cases, if you get Xabarem after a procedure to open a narrowed or closed artery of your leg to restore blood flow, your doctor may also prescribe clopidogrel Pročitajte cijeli dokument
Page 1 of 31 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xabarem 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient with known effect Each film-coated tablet contains 23.25 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light yellow, round film-coated tablets, debossed with ‘2.5’ on one side and plain on the other side, with diameter 6.1 mm ± 5%. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xabarem, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Xabarem, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2.5 mg twice daily. • _ACS _ Patients taking Xabarem 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. Treatment should be regularly evaluated in the individual patient weighing the risk for Page 2 of 31 ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1). Treatment with Xabarem should be started as soon as possible after stabilisation of the ACS event (including revascularisation procedures); at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued. Pročitajte cijeli dokument