国家: 马耳他
语言: 英文
来源: Medicines Authority
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
B01AF01
RIVAROXABAN 15 mg
FILM-COATED TABLET
RIVAROXABAN 15 mg
POM
ANTITHROMBOTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-03-07
PACKAGE LEAFLET: INFORMATION FOR THE USER ENKIA 15 MG FILM-COATED TABLETS ENKIA 20 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 Enkia is and what it is used for 2. What you need to know before you take Enkia 3. How to take Enkia 4. Possible side effects 5. How to store Enkia 6. Contents of the pack and other information 1. WHAT ENKIA IS AND WHAT IT IS USED FOR Enkia contains the active substance rivaroxaban. Enkia 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. Enkia 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. Rivaroxaban 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENKIA DO NOT TAKE ENKIA - if you are allergic to rivaroxaban or any of the other ingredients of this medicine (l 阅读完整的文件
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enkia 15 mg film-coated tablets Enkia 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 mg film-coated tablet contains 15 mg rivaroxaban. Each 20 mg film-coated tablet contains 20 mg rivaroxaban. Excipients with known effect: lactose. Each 15 mg film-coated tablet contains 27.84 mg lactose (as monohydrate). Each 20 mg film-coated tablet contains 37.12 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Enkia 15 mg film-coated tablets appear as light-brown, round, biconvex film-coated tablets with a diameter of 6 mm, debossed with “E” on one side and plain on the other side. Enkia 20 mg film-coated tablets appear as dark red, round, biconvex film-coated tablets with a diameter of 7 mm, plain on both sides. 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). Paediatric population _Enkia 15 mg film-coated tablets _ Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. _Enkia 20 mg film-coated tablets _ 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 anticoagulation treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 2 Posology _Prevention of stroke and systemic embolism in adults _ The rec 阅读完整的文件