Xarelto (Rivaroxaban)

They need to know if you have any of these conditions: -bleeding disorders -bleeding in the brain -blood in your stools (black or tarry stools) or if you have blood in your vomit -history of stomach bleeding -kidney disease -liver disease -low blood counts, like low white cell, platelet, or red cell counts -recent or planned spinal or epidural procedure -take medicines that treat or prevent blood clots -an unusual or allergic reaction to rivaroxaban, 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. 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 blood clot. Be sure to refill your prescription before you run out of medicine. If you are taking this medicine after hip or knee replacement surgery, take it with or without food. If you are taking this medicine for atrial fibrillation, take it with your evening meal. If you are taking this medicine to treat blood clots, take it with food at the same time each day. If you are unable to swallow your tablet, you may crush the tablet and mix it in applesauce. Then, immediately eat the applesauce. You should eat more food right after you eat the applesauce containing the crushed tablet. 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 take your medicine once a day and miss a dose, take the missed dose as soon as you remember. If you take your medicine twice a day and miss a dose, take the missed dose immediately. In this instance, 2 tablets may be taken at the same time. The next day you should take 1 tablet twice a day as directed.

Do not take this medicine with any of the following medications: -defibrotide This medicine may also interact with the following medications: -aspirin and aspirin-like medicines -certain antibiotics like erythromycin, azithromycin, and clarithromycin -certain medicines for fungal infections like ketoconazole and itraconazole -certain medicines for irregular heart beat like amiodarone, quinidine, dronedarone -certain medicines for seizures like carbamazepine, phenytoin -certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin -conivaptan -felodipine -indinavir -lopinavir; ritonavir -NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen -ranolazine -rifampin -ritonavir -SNRIs, medicines for depression, like desvenlafaxine, duloxetine, levomilnacipran, venlafaxine -SSRIs, medicines for depression, like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline -St. John's wort -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 healthcare professional for regular checks on your progress. You may need blood work done while you are taking this medicine. Your condition will be monitored carefully while you are receiving this medicine. It is important not to miss any appointments. Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your healthcare professional. If you are going to need surgery or other procedure, tell your healthcare professional 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 -back pain -redness, blistering, peeling or loosening of the skin, including inside the mouth -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 -signs and symptoms of a blood clot such as chest pain; shortness of breath; pain, swelling, or warmth in the leg -signs and symptoms of a stroke such as changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of coordination Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -dizziness -muscle pain

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.