Pradaxa

Dabigatran is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.

Dabigatran is also used after hip replacement surgery to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).

Dabigatran is also used to treat DVT or pulmonary embolism (PE), and to lower your risk of having a repeat DVT or PE.

Dabigatran may also be used for purposes not listed in this medication guide.

You should not take dabigatran if you are allergic to it, or if you have:

• an artificial heart valve; or
• active bleeding from a surgery, injury, or other cause.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a genetic spinal defect;
• you have a spinal catheter in place;
• you have a history of spinal surgery or repeated spinal taps;
• you have recently had a spinal tap or epidural anesthesia;
• you are taking an NSAID--Advil, Aleve, Motrin, and others; or
• you are using other medicines to treat or prevent blood clots.

Dabigatran may cause you to bleed more easily, especially if:

• you have a stomach ulcer or bleeding in your stomach or intestines;
• you have kidney disease (especially if you also take dronedarone or ketoconazole);
• you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);
• you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
• you are older than 75.

Tell your doctor if you have ever had:

• kidney disease;
• a bleeding disorder that is inherited or caused by disease;
• antiphospholipid syndrome (also called Hughes syndrome or "sticky blood syndrome"), an immune system disorder that increases the risk of blood clots;
• a stomach ulcer; or
• if you have been taking rifampin.

Tell your doctor if you are pregnant or if you become pregnant. Taking dabigatran during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.

You should not breast-feed while using dabigatran.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine with a full glass of water. You may take dabigatran with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.

If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours.

Your kidney function may need to be checked before and during treatment with dabigatran.

Do not stop taking dabigatran without your doctor's advice. Stopping the medication can increase your risk of stroke.

If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.

Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine.

Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.

Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

To best prevent a stroke, try not to miss any doses.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Avoid alcohol. Heavy drinking can increase your risk of stomach bleeding.

Get emergency medical help if you have signs of an allergic reaction: hives; pain or tight feeling in your chest, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

• any bleeding that will not stop;
• headache, weakness, dizziness, or feeling like you might pass out;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• blood in your urine or stools, black or tarry stools;
• cough with bloody mucus or vomit that looks like coffee grounds;
• pink or brown urine;
• joint pain or swelling; or
• heavy menstrual bleeding.

Common side effects may include:

• stomach pain or discomfort;
• indigestion; or
• nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

When you start or stop taking dabigatran, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect dabigatran. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about dabigatran.