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 rivaroxaban, or you have severe bleeding.

How to Use This Medicine:
Tablet

• Take this medicine as directed, and take it at the same time each day.
• 10-milligram (mg) tablet: Take with or without food.
• 15-mg or 20-mg tablet: Take with food.
• If you cannot swallow the tablets, you may crush the tablet and mix it with applesauce. Eat some food after you swallow the mixture.
• Tube feeding: You may crush the tablet and mix the medicine in 50 milliliters (mL) of water before giving it via the tube. This must be followed by a feeding.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  
  • Ask your doctor or pharmacist if you are not sure what to do if you miss a dose.
  • Once-daily dose: If you miss a dose or forget to use your medicine, use it as soon as you can on the same day. Do not use extra medicine to make up for a missed dose.
  • Twice-daily dose to treat a blood clot (15-mg tablet): If you miss a dose or forget to use your medicine, use it as soon as you can on the same day. You may take 2 doses at the same time to make up for the missed dose. This is only for people who take a total of 30 mg per day.
• 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 foods and medicines can affect how rivaroxaban works. Tell your doctor if you are using any of the following:
  
  • NSAID medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Ketoconazole, itraconazole, lopinavir, ritonavir, indinavir, conivaptan, carbamazepine, phenytoin, rifampin, St John's wort
  • Another blood thinner (including clopidogrel, enoxaparin, heparin, warfarin)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, or an artificial heart valve.
• This medicine may increase your risk of bleeding. Be careful to avoid injuries that could cause bleeding. Stay away from rough sports or other situations where you could be bruised, cut, or hurt. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.
• This medicine may cause nerve damage if you have a medical procedure done to your back, including anesthesia or a spinal puncture. This is more likely to happen if you have a history of back injury, back surgery, problems with your spine, or procedures or punctures to your back. Tell your doctor if you are also taking another blood thinner, because this also increases the risk.
• Do not stop using this medicine suddenly without asking your doctor. You might have a higher risk of stroke for a short time after you stop using this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine.
• 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
• Blistering, peeling, or red skin rash
• Decrease in how much or how often you urinate
• Heavy menstrual bleeding, or vaginal bleeding
• Red or brown urine, bloody or black, tarry stools
• Unusual bleeding or bruising, including frequent nosebleeds
• Vomiting blood or material that looks like coffee grounds

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