Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
RIVAROXABAN
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany
B01AF01
RIVAROXABAN 2.5 mg
FILM-COATED TABLET
RIVAROXABAN 2.5 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2017-10-23
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN DENK 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 Rivaroxaban Denk is and what it is used for 2. What you need to know before you take Rivaroxaban Denk 3. How to take Rivaroxaban Denk 4. Possible side effects 5. How to store Rivaroxaban Denk 6. Contents of the pack and other information 1. WHAT RIVAROXABAN DENK IS AND WHAT IT IS USED FOR You have been given Rivaroxaban Denk 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 Denk 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 Denk 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. Rivaroxaban Denk contains the active substance rivaroxaban and belongs to a group of medi- cines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIVAROXABAN DENK DO NOT TAKE RIVAROXABAN DENK • if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6). • if you ar Baca dokumen lengkap
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Rivaroxaban Denk 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 23.9 mg lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, round, biconvex film-coated tablet, engraved with “RVX” on one side, plain on the other with a diameter of 6.1 mm approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rivaroxaban Denk, 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 sec- tions 4.3, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2.5 mg twice daily. Patients taking Rivaroxaban Denk 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 is- chaemic 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 Rivaroxaban Denk 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 discon- tinued. 2 _ _ _Co-administration with antiplatelet therapy _ In patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of rivaroxaban 2.5 mg twice daily should be evaluated depend Baca dokumen lengkap