RIVAROXABAN

Do not stop taking rivaroxaban unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different “blood thinning” or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, pain/warmth/swelling in the legs.

People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Ask your doctor about the benefits and risks before any spinal procedure. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

Pregnancy Risk: Category C (Risk cannot be ruled out)

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

Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, slurred speech, weakness on one side of the body, changes in the amount of urine.

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.

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 alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

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.

Interactions:

Some products that may interact with this drug include: mifepristone, 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 cobicistat, conivaptan, certain azole antifungals (itraconazole, ketoconazole, posaconazole), 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 a poison control center or emergency room immediately.

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.

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.

Brands:

Available Brands

• Xarelto [ Bayer ]