Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Medicines Authority
RIVAROXABAN
Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain
B01AF01
RIVAROXABAN 10 mg
FILM-COATED TABLET
RIVAROXABAN 10 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2019-03-13
193 PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN MEDICHEM 15 MG FILM-COATED TABLETS RIVAROXABAN MEDICHEM 20 MG FILM-COATED TABLETS rivaroxaban This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Medichem is and what it is used for 2. What you need to know before you take Rivaroxaban Medichem 3. How to take Rivaroxaban Medichem 4. Possible side effects 5. How to store Rivaroxaban Medichem 6. Contents of the pack and other information 1. WHAT RIVAROXABAN MEDICHEM IS AND WHAT IT IS USED FOR Rivaroxaban Medichem 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 Medichem 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 MEDICHEM DO NOT TAKE RIVAROXABAN MEDICHEM - if you are Izlasiet visu dokumentu
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Rivaroxaban Medichem 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 27.90 mg lactose (as monohydrate), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light red, round biconvex, film-coated tablets marked with "I" on one side. The specific tablet dimensions are 5.95- 6.05 mm of diameter and 2.70- 2.90 mm of thickness. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. 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 VTE in adult patients undergoing elective hip or knee replacement surgery_ The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established. The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended. If a dose is missed the patient should take Rivaroxaban Medichem immediately and then continue the following day with once daily intake as before. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE_ Izlasiet visu dokumentu