Savaysa (Edoxaban)

They need to know if you have any of these conditions: -bleeding disorders -history of stomach bleeding -mechanical heart valve -kidney disease -liver disease -recent or planned spinal or epidural procedure -an allergic reaction to edoxaban, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Stopping this medicine may increase your risk of a blot clot. Be sure to refill your prescription before you run out of medicine. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Do not take this medicine with any of the following medications: -defibrotide This medicine may also interact with the following medications: -amiodarone -aspirin and aspirin-like medicines -certain antibiotics like azithromycin, clarithromycin, and erythromycin -certain medicines for fungal infections like ketoconazole and itraconazole -certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin -cyclosporine -dronedarone -NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen -quinidine -rifampin -SSRIs, medicines for depression, like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline -SNRIs, medicines for depression, like desvenlafaxine, duloxetine, levomilnacipran, venlafaxine -verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your doctor or health care professional for regular checks on your progress. Notify your doctor or health care professional and seek emergency treatment if you develop breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg. These can be signs that your condition has gotten worse. If you are going to have surgery or other procedure, tell your doctor that you are taking this medicine.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -feeling faint or lightheaded, falls -signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.