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Xarelto 20mg Tablets
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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RIVAROXABAN - ORAL

(RIV-a-ROX-a-ban)

WARNING: Tell your doctor you are using rivaroxaban before having certain spinal procedures (spinal puncture or spinal/epidural anesthesia). Using this medication before these procedures has rarely caused major bleeding or blood clots in or around the spine. This effect may cause loss of muscle function (paralysis) that can be permanent. The risk is increased if you have a history of spinal surgery, or spinal deformity, or receive pain medication through a tube placed in the spine (epidural catheter). Also, the risk is higher if you use other "blood thinning" or anti-platelet medications such as aspirin, clopidogrel, warfarin, or nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen or naproxen. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you have any symptoms such as tingling, numbness (especially in the legs), or muscle weakness. If you have a certain irregular heartbeat (atrial fibrillation), you have a higher chance of forming a blood clot in the heart that can travel to the brain and cause a stroke, or to other parts of the body. If you are taking rivaroxaban to prevent these harmful blood clots and have to stop taking it, you may have a higher risk of forming a blood clot. Your doctor may direct you to take a different "blood thinning" or anti-platelet medication to reduce your risk. Get medical help right away if you have any of the following symptoms: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, slurred speech, sudden vision changes, or confusion.

USES: This medication is used to prevent harmful blood clots (for example, in your legs or lungs) from forming after hip or knee replacement surgery. Rivaroxaban is also approved for use to help prevent strokes and harmful blood clots that may form due to a certain irregular heartbeat (atrial fibrillation). In Canada, this medication is also used to treat harmful blood clots in the legs. Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking rivaroxaban and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor. If you are taking this medication to prevent harmful blood clots after knee or hip replacement surgery, the dose is usually taken once a day with or without food. If you are taking this drug to prevent strokes and harmful blood clots that may form due to an irregular heartbeat, the dose is usually taken once a day with the evening meal. If you are taking rivaroxaban to treat harmful blood clots, the dose is usually taken twice a day with food for 3 weeks. After 3 weeks of treatment for harmful blood clots, you will continue to take this medication, usually once a day with food. Carefully follow your doctor's directions. Do not increase your dose, take it more often, or stop taking it unless you are told to do so by your doctor. The dosage and length of treatment is based on your medical condition and response to treatment. The dosage may also be based on other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

SIDE EFFECTS: See also Warning section. Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor immediately if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, difficulty swallowing. Seek immediate medical attention if any of these rare but very serious signs of bleeding occur: vision changes. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rivaroxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), stroke, recent major injury/surgery, blood disorders (such as anemia, hemophilia, thrombocytopenia), frequent falls/injuries, certain eye problem (retinopathy), certain hereditary enzyme problems (such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption). It is important that all your doctors and dentists know that you take rivaroxaban. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are using this medication. This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit or avoid alcoholic beverages. This medication can cause bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, contact your doctor immediately. Your doctor may need to check you for hidden bleeding that could be serious. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin, enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as venlafaxine). Other medications can affect the removal of rivaroxaban from your body, which may affect how rivaroxaban works. Examples include certain azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), rifamycins (such as rifampin), HIV protease inhibitors (such as lopinavir, ritonavir), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Consult your doctor or pharmacist for more details.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as hematocrit/hemoglobin, red blood cell count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you are taking this medication once a day and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. If you are taking this medication twice a day and miss a dose, take it as soon as you remember. If you missed the morning dose and it is near the time of the evening dose, you may take both doses together. Then resume your usual dosing schedule.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your medication can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.

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