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Edoxaban tablet 15mg, 30 mg, 60 mg What Edoxaban is and what it is used for: Edoxaban belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking the activity of factor Xa, which is an important component of blood clotting. Edoxaban is used in adults to: • prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor, such as heart failure, previous stroke or high blood pressure; • treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs. What you need to know before you use Edoxaban: Do not use Edoxaban: • if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6); • if you are actively bleeding; • if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes); • if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open; • if you have a liver disease which leads to an increased risk of bleeding; • if you have uncontrolled high blood pressure; • if you are pregnant or breast feeding. Warnings and precautions: Talk to your doctor or pharmacist before taking Edoxaban: • if you have an increased risk of bleeding, as could be the case if you have any of the following conditions: • endstage kidney disease or if you are on dialysis; • severe liver disease; • bleeding disorders; • a problem with the blood vessels in the back of your eyes (retinopathy); • recent bleeding in your brain (intracranial or intracerebral bleeding); • problems with the blood vessels in your brain or spinal column; • if you have a mechanical heart valve. • Edoxaban 15 mg is only to be used when changing from Edoxaban 30 mg to a vitamin K antagonist (e.g. warfarin) (see section 3. How to take Edoxaban). Take special care with Edoxaban: • if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk for blood clots), tell your doctor who will decide if the treatment may need to be changed. • If you need to have an operation, • it is very important to take Edoxaban before and after the operation exactly at the times you have been told by your doctor. If possible, Edoxaban should be stopped at least 24 hours before an operation. Your doctor will determine when to restart Edoxaban. In emergency situations your physician will help determine the appropriate actions regarding Edoxaban. Children and adolescents Edoxaban is not recommended in children and adolescents under 18 years of age. There is no information on its use in children and adolescents. Other medicines and Edoxaban: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are taking any of the following: • some medicines for fungal infections (e.g. ketoconazole); • medicines to treat abnormal heart beat (e.g. dronedarone, quinidine, verapamil); • other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban); • antibiotic medicines (e.g. erythromycin); • medicines to prevent organ rejection after transplantation (e.g. ciclosporin); • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid); • antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors; If any of the above apply to you, tell your doctor before taking Edoxaban, because these medicines may increase the effects of Edoxaban and the chance of unwanted bleeding. Your doctor will decide, if you should be treated with Edoxaban and if you should be kept under observation. If you are taking any of the following: • some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital); • St John’s Wort, a herbal product used for anxiety and mild depression; • rifampicin, an antibiotic medicine. If any of the above apply to you, tell your doctor before taking Edoxaban, because the effect of Edoxaban may be reduced. Your doctor will decide if you should be treated with Edoxaban and if you should be kept under observation. How to use Edoxaban: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to take: The recommended dose is one 60 mg tablet once daily. If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor; If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily; If your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily. How to take the tablet Swallow the tablet, preferably with water. Edoxaban can be taken with or without food. Your doctor may change your anticoagulant treatment as follows: Changing from vitamin K antagonists (e.g. warfarin) to Edoxaban Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Edoxaban. Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Edoxaban Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Edoxaban at the time of the next scheduled dose. Changing from parenteral anticoagulants (e.g. heparin) to Edoxaban Stop taking the anticoagulant (e.g. heparin) and start Edoxaban at the time of the next scheduled anticoagulant dose. Changing from Edoxaban to vitamin K antagonists (e.g. warfarin) o If you currently take 60 mg Edoxaban: Your doctor will tell you to reduce your dose of Edoxaban to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Edoxaban. o If you currently take 30 mg (dose reduced) Edoxaban: Your doctor will tell you to reduce your dose of Edoxaban to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Edoxaban. Changing from Edoxaban to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Edoxaban and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Edoxaban. Changing from Edoxaban to parenteral anticoagulants (e.g. heparin) Stop taking Edoxaban and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Edoxaban. Patients undergoing cardioversion: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Edoxaban at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body. Possible side effects: Stop using the product and seek immediate medical attention if you develop urticaria, rash, tightness of the chest, wheezing, hypotension Like other similar medicines (medicines to reduce blood clotting), Edoxaban may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious. If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. How to store Edoxaban: • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month. • This medicine does not require any special storage conditions. • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. A valid prescription should be available upon delivery
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