Dabigatran capsule

What is this medicine?

DABIGATRAN helps to prevent platelets in your blood from sticking together and forming a blood clot. Dabigatran is used to prevent blood clots and to reduce the risk of stroke in people with a certain type of heart rhythm disorder. Dabigatran is also used to treat or prevent blood clots in the veins of your legs (deep vein thrombosis, or DVT), or the veins in your lungs (pulmonary embolism, or PE).

What should my health care professional know before I take this medicine?

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

• an artificial heart valve; or

• any active bleeding from a surgery, injury, or other cause.

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

• you have a stomach ulcer;

• you have recent or recurring 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.

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.

To make sure dabigatran is safe for you, tell your doctor if you have:

• kidney disease;

• a history of stomach ulcer or bleeding; or

• if you are older than 75.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take this medicine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take this medicine with a full glass of water. You may take dabigatran with or without food. Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

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. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.

Do not stop taking dabigatran without your doctor's advice. Stopping the medication can increase your risk of stroke. Your doctor may recommend another medication to prevent blood clots if you need to stop taking dabigatran. Your kidney function may need to be checked with blood tests before and during treatment with dabigatran. Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.

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 bottle tightly closed when not in use.

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.

What if I miss a dose?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Try not to miss any doses of dabigatran to best prevent a stroke.

What may interact with this medicine?

Before you take dabigatran, tell your doctor if you also take rifampin (Rifater, Rifamate, Rimactane, Rifadin).

Tell your doctor about all your current medicines and any you start or stop using, especially other medicines used to treat or prevent blood clots, such as:

• abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;

• alteplase, reteplase, tenecteplase, urokinase;

• apixaban, argatroban, bivalirudin, desirudin, lepirudin, rivaroxaban; or

• dalteparin, enoxaparin, heparin, tinzaparin.

This list is not complete. Other drugs may interact with dabigatran, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What should I watch for while using this medicine?

You should not take dabigatran if you have an artificial heart valve, or if you have any active bleeding from a surgery, injury, or other cause.

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. Avoid activities that may increase your risk of bleeding or injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

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

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these 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, feeling like you might pass out;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• blood in your urine or stools, black or tarry stools;

• coughing up blood 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

• heartburn.

This is not a complete list of side effects and others may occur.

Where can I keep my medicine?

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 bottle tightly closed when not in use.