Dabigatran Oral Capsules (Pradaxa)

What is this medication?

DABIGATRAN (DA bi GAT ran) is an anticoagulant (blood thinner). It is used to lower the chance of stroke in people with a medical condition called atrial fibrillation. It is also used to treat or prevent blood clots in the lungs or in the veins.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Pradaxa

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• antiphospholipid antibody syndrome
• history of stomach bleeding
• mechanical heart valve
• kidney disease
• recent or planned spinal or epidural procedure
• an allergic reaction to dabigatran, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Do not cut, crush or chew this medicine or empty the pellets from the capsule. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses or stopping this medicine can increase your risk of a blood clot or stroke. Keep taking this medicine unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is less than 6 hours away, skip the missed dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• defibrotide

This medicine may also interact with the following:

• aspirin and aspirin-like medicines
• certain medicines that prevent or treat blood clots like heparin, warfarin, enoxaparin, dalteparin, apixaban, and rivaroxaban
• clopidogrel
• dronedarone
• ketoconazole
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• prasugrel
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. You may need blood work done while you are taking this medicine. Your condition will be monitored carefully while you are receiving this medicine. It is important not to miss any appointments.

Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your health care provider.

If you are going to need surgery or other procedure, tell your health care provider that you are using this medicine.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medicines and doses you take on the card.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• stomach pain
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Get rid of any unused medicine 4 months after opening.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What is Pradaxa used for?

Pradaxa® is a type of blood thinner. It treats and prevents blood clots. It can also prevent a stroke if you have atrial fibrillation without a heart valve issue. You might take Pradaxa to prevent blood clots after an operation to replace your hip. Or you may take Pradaxa when you have a blood clot in your leg or lung. Then, you may take it to prevent another blood clot in the future.

How do you know that Pradaxa is working?

A provider can do a blood test to see how well Pradaxa is working in your body. Unlike some other blood thinners, Pradaxa doesn’t require frequent blood tests. Studies have shown predictable results with Pradaxa.

How long does Pradaxa stay in your system?

Pradaxa can stay in your system for a couple of days. That’s why healthcare providers may ask you to stop taking it a few days before surgery. Only stop taking Pradaxa if your provider tells you to.

Can Pradaxa be crushed?

No. You shouldn’t crush or chew the capsule because that would put too much of the drug into your system at once. Swallow the whole capsule without doing anything to it. Take it with a full glass of water.

A note from Cleveland Clinic

We’re lucky to have more options than ever before for treating and preventing blood clots. And you’re even luckier if you can take one that doesn’t require frequent blood draws to check clotting. But don’t get too comfortable and casual Pradaxa. Follow the instructions on the packaging and from your provider. Don’t be afraid to ask questions if anything isn’t clear.