Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
RIVAROXABAN
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany
B01AF01
RIVAROXABAN 20 mg
FILM-COATED TABLET
RIVAROXABAN 20 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2017-10-23
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN DENK 15 MG FILM-COATED TABLETS RIVAROXABAN DENK 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 Rivaroxaban Denk is and what it is used for 2. What you need to know before you take Rivaroxaban Denk 3. How to take Rivaroxaban Denk 4. Possible side effects 5. How to store Rivaroxaban Denk 6. Contents of the pack and other information 1. WHAT RIVAROXABAN DENK IS AND WHAT IT IS USED FOR Rivaroxaban Denk contains the active substance rivaroxaban and 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. Rivaroxaban Denk 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 RIVAROXABAN DENK DO NOT TAKE RIVAROXABAN DENK • if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6). • 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 ble Perskaitykite visą dokumentą
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Rivaroxaban Denk 15 mg film-coated tablets Rivaroxaban Denk 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rivaroxaban Denk 15 mg: Each film-coated tablet contains 15 mg rivaroxaban. Rivaroxaban Denk 20 mg: Each film-coated tablet contains 20 mg rivaroxaban. Excipient with known effect: Rivaroxaban Denk 15 mg: Each film-coated tablet contains 16.32 mg lactose monohydrate. Rivaroxaban Denk 20 mg: Each film-coated tablet contains 21.76 mg lactose monohydrate. See section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Rivaroxaban Denk 15 mg are red, round, biconvex film-coated tablets, engraved with ‘15’ on one side, plain on the other with a diameter of 6.1 mm approximately. Rivaroxaban Denk 20 mg are brown – red, round, biconvex film-coated tablets, engraved with ‘20’ on one side, plain on the other with a diameter of 6.1 mm approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrilla- tion 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. 2 _ _ Therapy with Rivaroxaban Denk should be continued long term provided the benefit of pre- vention of stroke and systemic embolism outweighs the risk of bleeding (see section 4.4). If a dose is missed the patient should take Rivaroxaban Denk immediately and continue on the following day with the once daily intake as recommended. The dose should not be doub Perskaitykite visą dokumentą