Rivaroxaban is used along with low-dose aspirin to help prevent heart attack, stroke, and death in people with a certain heart problem (coronary artery disease - CAD) or in people who have reduced blood flow to the arms/legs (peripheral artery disease - PAD), including those people who recently had surgery for PAD. For patients with PAD, this medication may also help reduce the risk of blood vessel blockage to the hands/legs/feet and reduce the risk of amputation.

Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

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 with or without food as directed by your doctor, usually twice daily. Take a low-dose aspirin (usually 75-100 milligrams) once a day as directed by your doctor. Follow your doctor's directions carefully.

If you are unable to swallow whole tablets, you may crush the tablet and mix it with applesauce. Eat the entire mixture right away. Do not prepare a supply for future use.

If you are giving this medication through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

See also Warning section.

Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any signs of serious bleeding, including:

• nosebleeds that happen often or don't stop
• unusual tiredness/weakness
• unusual pain/swelling/discomfort
• unusual bruising
• prolonged bleeding from cuts or gums
• unusually heavy/prolonged menstrual flow
• pink/dark urine
• coughing up blood
• vomit that is bloody or looks like coffee grounds
• severe headache
• dizziness/fainting
• bloody/black/tarry stools
• difficulty swallowing

Get medical help right away if you have any signs of very serious bleeding, including:

• vision changes
• confusion
• trouble speaking
• weakness on one side of the body

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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:

• cancer
• liver disease
• kidney disease
• bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain)
• stroke
• artificial heart valves
• recent major injury/surgery
• blood disorders (such as anemia, hemophilia, thrombocytopenia)
• frequent falls/injuries
• a certain eye problem (retinopathy)
• a certain clotting disorder (antiphospholipid syndrome)
• certain hereditary enzyme problems (such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)

Before having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking rivaroxaban before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you.

Older adults may be more sensitive to the side effects of this drug, especially bleeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breastfeeding.

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 are:

• mifepristone
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/enoxaparin)
• certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine)

Other medications can affect the removal of rivaroxaban from your body, which may affect how rivaroxaban works. Examples include cobicistat, dronedarone, ritonavir, certain azole antifungals (itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (such as lopinavir), rifamycins (such as rifampin), 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 or naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 75-100 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

Do not share this medication with others.

Lab and/or medical tests (such as hematocrit/hemoglobin, red blood cell count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Use/discard the crushed tablet mixture within 4 hours. (See also How to Use section.)

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.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).