Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
RIVAROXABAN
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
B01AF01
RIVAROXABAN 20 mg
FILM-COATED TABLET
RIVAROXABAN 20 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2018-01-05
Page 1 of 11 Package leaflet: Information for the patient Rivaroxaban Sandoz 15 mg film-coated tablets Rivaroxaban Sandoz 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 Sandoz is and what it is used for 2. What you need to know before you take Rivaroxaban Sandoz 3. How to take Rivaroxaban Sandoz 4. Possible side effects 5. How to store Rivaroxaban Sandoz 6. Contents of the pack and other information 1. What Rivaroxaban Sandoz is and what it is used for Rivaroxaban Sandoz 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 Sandoz 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 Sandoz 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 yo Lue koko asiakirja
Page 1 of 37 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivaroxaban Sandoz 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of rivaroxaban. Excipients with known effects Each film-coated tablet contains 56.999 mg of lactose (as monohydrate) and 0.720 mg of sunset yellow FCF aluminium lake (E 110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Orange coloured, round, biconvex film-coated tablet marked with ‘20’ on one side, with a diameter of 7 mm. 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 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 Posology Prevention of stroke and systemic embolism in adults Page 2 of 37 The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Therapy with rivaroxaban 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 rivaroxaban 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 in adults The recommended dose for the Lue koko asiakirja