Pradaxa contains the active ingredient dabigatran etexilate mesylate, which is a direct thrombin inhibitor. It is formulated as oral capsules available in 75 mg, 110 mg, and 150 mg strengths. Key inactive ingredients include hydroxypropyl cellulose, hypromellose, and sugar spheres consisting of sucrose and corn starch. It is intended for oral administration.

How should I use this medication?

Take this medication by mouth with a full glass of water. Do not cut, crush, or chew this medication 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 medication can increase your risk of a blood clot or stroke. Keep taking this medication unless your care team 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 care team about the use of this medication 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.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication 4 months after opening. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication 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 side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding -Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting -Heavy periods Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Nausea -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.

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

They need to know if you have any of these conditions: -Antiphospholipid antibody syndrome -Bleeding disorder -Having or recent surgery -Kidney disease -Mechanical heart valve -Stomach bleeding -An unusual or allergic reaction to dabigatran, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Defibrotide This medication may also interact with the: -Aspirin and aspirin-like medications -Certain medications that prevent or treat blood clots, such as heparin, warfarin, enoxaparin, dalteparin, apixaban, and rivaroxaban -Clopidogrel -Dronedarone -Ketoconazole -NSAIDs, medications for pain and inflammation, such as 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 care team for regular checks on your progress. You may need blood work done while you are taking this medication. Your condition will be monitored carefully while you are receiving this medication. It is important not to miss any appointments. Avoid sports and activities that might cause injury while you are using this medication. 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 care team. If you are going to need surgery or other procedure, tell your care team that you are using this medication. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What are the most serious risks of this medication?

Do not stop taking this medication without first talking to your care team. Stopping it can increase the risk of blood clots and stroke. Ask your care team if you should stop this medication before surgery or other procedures, such as dental work. They will tell you when to stop taking it. They will also tell you when you should start taking it again. They may prescribe another medication to prevent blood clots from forming. People who take this medication and have a spinal procedure are at risk of forming a blood clot in the space around the brain or spinal cord. This could cause paralysis (not being able to move). The risk is higher in people who have spinal problems or injuries, have had spinal surgery in the past, and for those with a tube (catheter) in their back. Taking other medications that also affect bleeding, such as NSAIDs or other blood thinners, can also increase the risk. Your care team will watch you closely. Let them know right away if you feel pain, tingling, or numbness in your legs or feet.