Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rivaroxaban
Bayer Plc
B01AF01
Rivaroxaban
15mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5010605180088 5010605180095 5010605180057 5010605180125
Page 1 of 8 v018_0 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ XARELTO 15 MG FILM-COATED TABLETS XARELTO 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 Xarelto is and what it is used for 2. What you need to know before you take Xarelto 3. How to take Xarelto 4. Possible side effects 5. How to store Xarelto 6. Contents of the pack and other information 1. WHAT XARELTO IS AND WHAT IT IS USED FOR Xarelto 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. Page 2 of 8 v018_0 Xarelto Pročitajte cijeli dokument
OBJECT 1 XARELTO 15MG FILM-COATED TABLETS Summary of Product Characteristics Updated 13-Jun-2018 | Bayer plc 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 Xarelto 15 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 15 mg rivaroxaban. Excipient with known effect Each film-coated tablet contains 24.13 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). Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle 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 Xarelto 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 Xarelto 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 recomm Pročitajte cijeli dokument