Rivaroxaban (riv-a-ROX-a-ban)

Treats and prevents blood clots in the lungs or legs. Also lowers the risk of stroke and blood clots in patients with atrial fibrillation. This medicine is a blood thinner.

Brand Name(s):

Xarelto

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• The 10-milligram (mg) tablets can be taken with or without food. The 15-mg and 20 -mg tablets should be taken with food.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• 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.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

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

• Make sure your doctor knows if you also use St John's wort, azithromycin (Zithromax), carbamazepine (Tegretol), clarithromycin (Biaxin), conivaptan (Vaprisol), diltiazem (Cardizem), erythromycin (Ery-Tab), felodipine (Plendil), phenytoin (Dilantin), ranolazine (Ranexa), rifampin (Rifadin, Rimactane), medicine to treat fungus infections (such as fluconazole, itraconazole, ketoconazole, Diflucan, Nizoral), medicine to treat heart rhythm problems (such as amiodarone, dronedarone, quinidine, verapamil, Cardioquin, Cordarone), or medicine to treat HIV/AIDS (such as indinavir, lopinavir/ritonavir, ritonavir, Crixivan, Kaletra, Norvir).
• Make sure your doctor knows if you use an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil, Aleve, Celebrex, Voltaren), medicine that dissolves blood clots (such as alteplase, reteplase, streptokinase, Activase, Retavase, Streptase), or another blood thinner (such as clopidogrel, enoxaparin, prasugrel, ticagrelor, ticlopidine, warfarin, Brilinta, Coumadin, Effient, Jantoven, Lovenox, Plavix, Ticlid).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or planning to become pregnant during treatment with this medicine. Tell your doctor if you are breastfeeding or if you have kidney disease, liver disease, bleeding problems, blood vessel problems, or a stomach ulcer or bleeding.
• This medicine can cause bleeding. This bleeding is sometimes severe, and in rare case, it could be fatal.
• Bleeding caused by this medicine can cause nerve damage and possibly paralysis if you have any medical procedure in which a needle is used in your spine, such as an epidural or a spinal puncture. If you have any procedure done on your back, tell your doctor right away if you feel numbness or tingling, especially in your legs or feet.
• Make sure any caregiver who treats you knows that you are using this medicine, because of the bleeding risk.
• Be extra careful to avoid injuries until the effects of the medicine have worn off. 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.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Do not stop using this medicine suddenly without asking your doctor. You might have a higher risk of stroke for a short time right after you stop using this medicine.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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, red skin rash
• Blood in your urine
• Bloody or black, tarry stools
• Chest pain, trouble breathing, coughing up blood
• Frequent nosebleeds
• Pain in your lower leg (calf)
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding or bruising
• Vomiting blood or material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Mild skin rash or itching

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