Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
RIVAROXABAN
Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 München , Germany
B01AF01
RIVAROXABAN 10 mg
FILM-COATED TABLET
RIVAROXABAN 10 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2017-10-23
PACKAGE LEAFLET: INFORMATION FOR THE USER RIVAROXABAN DENK 10 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 the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots. - treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood ves- sels 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 b Baca dokumen lengkap
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Rivaroxaban Denk 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 95.6 mg lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink, round, biconvex film-coated tablets, engraved with “10” on one side, plain on the other with a diameter of 9.1 mm approximately. 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 thromboem- bolism which is determined by the type of orthopaedic surgery. 2 _ _ • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recom- mended. • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recom- mended. If a dose is missed the patient should take Rivaroxaban Denk 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 _ The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE. Short duration of therapy (at least 3 months Baca dokumen lengkap