देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
RIVAROXABAN
Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain
B01AF01
RIVAROXABAN 2.5 mg
FILM-COATED TABLET
RIVAROXABAN 2.5 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2019-03-13
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN MEDICHEM 2.5 MG FILM-COATED TABLETS rivaroxaban 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 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 Rivaroxaban Medichem is and what it is used for 2. What you need to know before you take Rivaroxaban Medichem 3. How to take Rivaroxaban Medichem 4. Possible side effects 5. How to store Rivaroxaban Medichem 6. Contents of the pack and other information 1. WHAT RIVAROXABAN MEDICHEM IS AND WHAT IT IS USED FOR You have been given Rivaroxaban Medichem 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. Rivaroxaban Medichem 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.Rivaroxaban Medichem 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. Rivaroxaban Medichem reduces the r पूरा दस्तावेज़ पढ़ें
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 Rivaroxaban Medichem 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 31.65 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light yellow, round biconvex, film-coated tablets marked with "III" on one side. The specific tablet dimensions are 5.95- 6.05 mm of diameter and 2.65 - 2.85 mm of thickness. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rivaroxaban Medichem, 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). Xarelto 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 Rivaroxaban Medichem 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 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). पूरा दस्तावेज़ पढ़ें