Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
edoxaban tosilate
Berlin-Chemie AG
B01AF03
edoxaban
Antithrombotic agents
Stroke; Venous Thromboembolism
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Revision: 11
Authorised
2017-04-19
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER ROTEAS 15 MG FILM-COATED TABLETS ROTEAS 30 MG FILM-COATED TABLETS ROTEAS 60 MG FILM-COATED TABLETS edoxaban 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 Roteas is and what it is used for 2. What you need to know before you take Roteas 3. How to take Roteas 4. Possible side effects 5. How to store Roteas 6. Contents of the pack and other information 1. WHAT ROTEAS IS AND WHAT IT IS USED FOR Roteas contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking the activity of factor Xa, which is an important component of blood clotting. Roteas is used in adults to: - PREVENT BLOOD CLOTS IN THE BRAIN (stroke) AND OTHER BLOOD VESSELS IN THE BODY if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke or high blood pressure; - TREAT BLOOD CLOTS IN THE VEINS OF THE LEGS (deep vein thrombosis) AND IN THE BLOOD VESSELS IN THE LUNGS (pulmonary embolism), and to PREVENT BLOOD CLOTS FROM RE-OCCURRING in the blood vessels in the legs and/or lungs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROTEAS DO NOT TAKE ROTEAS - if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6); - if you are actively bleeding; - if you have a disease or condition that increases the risk of serious bl Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets Roteas 30 mg film-coated tablets Roteas 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Roteas 15 mg film-coated tablets Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). Roteas 30 mg film-coated tablets Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate). Roteas 60 mg film-coated tablets Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Roteas 15 mg film-coated tablets Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. Roteas 30 mg film-coated tablets Pink, round-shaped film-coated tablets (8.5 mm diameter) _ _ debossed with “DSC L30”. Roteas 60 mg film-coated tablets Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Roteas is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Roteas is indicated in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism _ The recommended dose is 60 mg edoxaban once daily. Therapy with edoxaban in NVAF patients should be continued long term. _ _ _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) _ The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section 5.1). Edoxaban and initial parenteral anticoagulant should not be Lesen Sie das vollständige Dokument