When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to edoxaban.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how edoxaban works. Tell your doctor if you are using any of the following:
  
  • Another blood thinner, such as clopidogrel, heparin, prasugrel, warfarin
  • NSAID pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, or naproxen)
  • Rifampin

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, spine problems or a history of back surgery, heart valve disease, or an artificial heart valve.
• This medicine increases your risk for bleeding and it may take longer than usual for bleeding to stop. This can be life-threatening. You may also bruise more easily. Take precautions to avoid injury, and be careful using sharp objects, such as razors.
• This medicine may increase the risk for blood clots in your spine or back if you have an epidural or spinal puncture. This could lead to paralysis.
• Do not stop using this medicine suddenly without asking your doctor. You risk of stroke is higher if you stop using this medicine suddenly.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests. Your doctor will tell you how to do this safely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, numbness, tingling, or muscle weakness in your legs or feet, loss of bladder or bowel control
• Bleeding that does not stop, bruising, or weakness
• Bleeding from your gums or nose, heavy menstrual bleeding
• Coughing up blood, vomiting blood or material that looks like coffee grounds
• Pink or red urine, red or black stools
• Sudden or severe headache, confusion, nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088