Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVAROXABAN
BAYER CO. (MALAYSIA) SDN. BHD.
RIVAROXABAN
14 Tablets; 28tablet Tablets
BAYER AG
XARELTO ® Rivaroxaban (15 and 20 mg film-coated tablets) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Xarelto_ is used for 2. How _Xarelto_ works 3. Before you use _Xarelto_ 4. How to use _Xarelto_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Xarelto_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT _XARELTO_ IS USED FOR Xarelto is used in adults to: - prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation. - treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs. Xarelto is used in children and adolescents below 18 years and with a body weight of 30 kg or more to: - treat blood clots and prevent re- occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots. HOW _XARELTO_ WORKS Xarelto _ _ contains the active substance rivaroxaban and belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots. BEFORE YOU USE _XARELTO _ - When you must not use it DO NOT TAKE _XARELTO_ - if you are allergic to rivaroxaban or any of the other ingredients of this medicine - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to k Read the complete document
Date of text revision : Aug 2023 Reference : E.Junior 1 XARELTO ® FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Xarelto 15 mg film-coated tablet Xarelto 20 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XARELTO 15 MG Each film-coated tablet contains 15 mg rivaroxaban. Excipient(s): Each 15 mg film-coated tablet contains 25.4 mg lactose monohydrate, see section 4.4. XARELTO 20 MG Each film-coated tablet contains 20 mg rivaroxaban. Excipient(s): Each 20 mg film-coated tablet contains 22.9 mg lactose monohydrate, see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). XARELTO 15 MG Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side. XARELTO 20 MG Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Date of text revision : Aug 2023 Reference : E.Junior 2 _Paediatric population _ Xarelto 15 mg Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Xarelto 20 mg Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral a Read the complete document