SPECIFIC REVERSAL TREATMENT

For people taking PRADAXA for atrial fibrillation: Do not stop taking PRADAXA Capsules without talking to the healthcare provider who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped, if possible, before surgery or a medical or dental procedure. Your healthcare provider will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming.

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you:

• currently have abnormal bleeding;
• have had a serious allergic reaction to any of the ingredients in PRADAXA;
• have had or plan to have a valve in your heart replaced.

Your risk of bleeding with PRADAXA may be higher if you:

• are 75 years old or older
• have kidney problems
• have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
• take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
• have kidney problems and take dronedarone or ketoconazole tablets

Call your healthcare provider or get medical help right away if you have any of these signs or symptoms of bleeding:

• any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
• unusual or unexpected bruising
• coughing up or vomiting blood; or vomit that looks like coffee grounds
• pink or brown urine; red or black stools (looks like tar)
• unexpected pain, swelling, or joint pain
• headaches and feeling dizzy or weak

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

• a thin tube called an epidural catheter is placed in your back to give you certain medicine
• you take NSAIDs or a medicine to prevent blood from clotting
• you have a history of difficult or repeated epidural or spinal punctures
• you have a history of problems with your spine or have had surgery on your spine

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots. Tell your healthcare provider right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Tell your healthcare provider about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome (APS).

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with PRADAXA.

Tell your healthcare provider if you are a female who is able to become pregnant. Talk with your healthcare provider about pregnancy planning during treatment with PRADAXA. Talk with your healthcare provider about your risk for severe bleeding from the uterus if you are treated with blood thinner medicines, including PRADAXA.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You should not breastfeed during treatment with PRADAXA Capsules. Talk to your healthcare provider about the best way to feed your baby during treatment with PRADAXA Capsules.

Take PRADAXA exactly as prescribed. It is important to tell your healthcare provider about all medicines (prescription and over-the-counter), vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.

PRADAXA 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-100064 06.28.2021