Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVAROXABAN
GENPHARMA SDN. BHD
RIVAROXABAN
30 Tablets
Alembic Pharmaceuticals Limited (Formulation Division)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RIVALTO TABLETS Rivaroxaban 15 mg and 20 mg _ WHAT IS IN THIS LEAFLET 1. What _RIVALTO _ is used for 2. How _RIVALTO _ works _3._ _ _ Before you use _RIVALTO _ _4._ _ _ How to use _RIVALTO _ 5. While you are using it 6. Side effects _7._ _ _ Storage and disposal of _RIVALTO _ 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT RIVALTO IS USED FOR Prevents blood clots in brain (stoke) and other blood vessels in your body if you have a irregular form of 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 blood clots of your legs and/or lungs. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed Rivalto for another reason. Rivalto is a prescription medicine. It should only be used in adults under medical supervision. HOW RIVALTO WORKS The active substance is rivaroxaban. It belongs to a group of medicines called antithrombotic. It works by inhibiting the blood clotting protein called Factor Xa, thus reducing the tendency of blood to form clots. BEFORE YOU USE RIVALTO - _When you must not take it _ Do not take Rivalto: • 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 keep it open • if you have a liver disease which leads to an increased risk of bleeding • if you are pregnant or Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT RIVALTO 15 MG TABLETS RIVALTO 20 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg rivaroxaban. Each film-coated tablet contains 20 mg rivaroxaban. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Rivalto 15 mg film-coated tablets are Round, brown, film-coated biconvex tablets debossed with ‘504’ on one side and plain on the other side. Rivalto 20 mg film-coated tablets are Triangle shaped, brown, film-coated tablets debossed with ‘505’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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.) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism _ The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Therapy with rivaroxaban should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4). If a dose is missed the patient should take rivaroxaban immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE _ The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE as indicated in the table below. DOSING SCHEDULE MAXIMUM DAILY DOSE Day 1- Læs hele dokumentet