For people taking Brand 2® for atrial fibrillation: Do not stop taking Brand 2 without talking to the doctor who prescribes it for you. Stopping Brand 2 increases your risk of having a stroke.
Brand 2® may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking Brand 2® and when you may start taking it again1. If you have to stop taking Brand 2®, your doctor may prescribe another medicine to help prevent a blood clot from forming.
Brand 2® can cause bleeding which can be serious and sometimes lead to death. Don’t take Brand 2® if you:
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Currently have abnormal bleeding;
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Have ever had an allergic reaction to it;
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Have had or plan to have a valve in your heart replaced
Your risk of bleeding with Brand 2® may be higher if you:
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Are 75 years old or older
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Have kidney problems
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Have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
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Take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
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Have kidney problems and take dronedarone or ketoconazole tablets
Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:
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Any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
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Unusual or unexpected bruising
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Coughing up or vomiting blood; or vomit that looks like coffee grounds
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Pink or brown urine; red or black stools (looks like tar)
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Unexpected pain, swelling, or joint pain
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Headaches and feeling dizzy or weak
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Spinal or epidural blood clots (hematoma)
Tell your doctor about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome (APS).
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Brand 2® will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with Brand 2®.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Brand 2® passes into your breast milk. You and your doctor should decide if you will take Brand 2® or breastfeed.
Take Brand 2® exactly as prescribed. It is important to tell your doctors about all medicines (prescription and over‑the‑counter), vitamins, and supplements you take. Some medicines may affect the way Brand 2® works.
Brand 2® can cause indigestion, stomach upset or burning, and stomach pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
CL-PX-100052 November 2019
Please see full Prescribing Information and Medication Guide.
