Type of medicine: thrombin inhibitor
Generic and brand names: dabigatran, oral; Pradaxa
This medicine is taken by mouth to reduce the risk of stroke and blood clots in people with atrial fibrillation (a certain kind of irregular heartbeat).
It may be used for other conditions as determined by your healthcare provider.
Before taking this medicine, tell your healthcare provider if you have ever had:
Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.
Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.
Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider. Do not stop taking this medicine unless your healthcare provider approves. Take it regularly each day.
You may take this medicine with or without food. Do not break, crush, or chew the capsules. Swallow them whole.
If you miss a dose, take it as soon as you remember unless your next scheduled dose is less than 6 hours away. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.
Symptoms of an acute overdose may include: blood in the urine or stools, vomiting blood, bleeding that won't stop.
While taking this medicine, you may bleed more easily and it may take longer for you to stop bleeding. Avoid activities where you could be bruised, cut, or injured. Report any unusual bruising or bleeding to your healthcare provider right away.
If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may need to stop taking this medicine several days before surgery. Do not stop taking this medicine unless your healthcare provider tells you to.
Do not take products that contain aspirin without your healthcare provider's approval while you are taking this medicine. Aspirin may increase the risk of bleeding. Also, do not drink alcohol or take other prescription medicines, nonprescription medicines, or natural remedies unless your healthcare provider approves.
You may need to have blood tests to see how this medicine affects you. Keep all appointments.
Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening: (Report this to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.) Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); Serious bleeding that cannot be stopped by applying pressure to the spot that is bleeding.
Serious (report these to your healthcare provider right away): Unusual bleeding or bruising; black or tarry stools; blood in your urine or vomit; unusually heavy menstrual period or vaginal bleeding; severe headache or confusion; fast or irregular heartbeat; chest pain; fainting; shortness of breath; unusual weakness or tiredness; unexpected pain, swelling, or discomfort in a joint.
Other: Heartburn, stomach pain, back pain, dizziness, fever, diarrhea, nausea, vomiting, cough.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:
Store this medicine at room temperature in the original package. Do not store or place the capsules in any other container, such as pill boxes or pill organizers. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Open only one bottle of this medicine at a time. Once the bottle is opened, the product must be used within 60 days.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
