Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVAROXABAN
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
RIVAROXABAN
30 Tablets; 60 Tablets
Dr Reddys Laboratories Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RIVAXORED (RIVAROXABAN TABLETS 2.5MG) _RIVAROXABAN _(2.5MG) 1 WHAT IS IN THIS LEAFLET 1. What _Rivaxored _ is used for 2. How _Rivaxored _ works _3._ _ _ Before you use _Rivaxored _ _4._ _ _ How to use _Rivaxored _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Rivaxored _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT _RIVAXORED _IS USED FOR You have been given Rivaxored because (1) You have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease and/or peripheral artery disease which causes symptoms. Rivaxored reduces the risk in adults of getting blot clots [major atherothrombotic events (cardiovascular death, myocardial infarction and stroke)]. Rivaxored will not be given to you on its own. Your doctor will also tell you to take acetylsalicylic acid. HOW _RIVAXORED _WORKS Rivaxored 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 _RIVAXORED _ - _When you must not use it _ DO NOT TAKE _RIVAXORED _ - 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 an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke) - if you have coronary artery disease and/or peripheral artery disease and previously had a bleeding in your br Läs hela dokumentet
PACK INSERT 1 1. NAME OF THE MEDICINAL PRODUCT RIVAXORED (Rivaroxaban Tablets 2.5 mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient with known effect Each 2.5mg film-coated tablet contains lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Light Yellow colored, round biconvex film coated tablets, engraved with ‘2,5’ on one side and plain on other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rivaxored, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of major atherothrombotic events (cardiovascular death, myocardial infarction & stroke) in adult patients with coronary artery disease (CAD) and/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. _CAD _ and _/_ or _PAD _ Patients taking Rivaxored 2.5 mg twice daily should also take a daily dose of 100 mg ASA. Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk for thrombotic events versus the bleeding risks. If a dose is missed the patient should continue with the regular dose as recommended at the next scheduled time. The dose should not be doubled to make up for a missed dose _ _ _Converting from Vitamin K Antagonists (VKA) to Rivaxored _ When converting patients from VKAs to Rivaxored, International Normalised Ratio (INR) values could be falsely elevated after the intake of Rivaxored. The INR is not valid to measure the anticoagulant activity of Rivaxored, and therefore should not be used (see section 4.5). _Converting from Rivaxored to Vitamin K antagonists (VKA) _ There is a potential for inadequate anticoagulation during the transition from Rivaxored to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Rivaxored c Läs hela dokumentet