Do not stop taking dabigatran unless directed by your doctor. If you have to stop taking it, you may have a higher risk of forming a serious blood clot. Serious blood clots can cause a stroke, heart attack, or blood clot in the legs or lungs. Your doctor may direct you to take a different "blood thinning" or anti-platelet medication to reduce your risk. Get medical help right away if you have any of the following symptoms: weakness on one side of the body, slurred speech, sudden vision changes, confusion, chest/jaw/left arm pain, shortness of breath, unusual sweating, pain/warmth/swelling in the legs.
People taking this medication may bleed near the spinal cord after certain spinal procedures (such as spinal/epidural anesthesia, spinal puncture). Bleeding in this area can cause paralysis that lasts a long time or is even permanent. Talk with your doctor about the benefits and risks before having any of these procedures. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).
Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke or heart attack. Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body.
Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to prevent blood clots from forming in your legs or lungs after hip or knee replacement surgery.
See also Warning section.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dabigatran and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor. Swallow the capsules whole with a full glass of water (8 ounces/240 milliliters). Do not crush, chew, or break open the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Do not put this medication in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture. See also Storage section for more important details.
Dabigatran is usually taken once a day to prevent clots after surgery or twice a day to prevent clots from irregular heartbeat (atrial fibrillation). Avoid antacids within 24 hours after surgery, or dabigatran may not work as well. It is very important to take it exactly as directed. Do not increase your dose or take this drug more often than directed. Do not stop taking this medication without consulting your doctor.
The dosage is based on your medical condition, kidney function, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
See also Warning section.
Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, stroke, frequent falls/injuries.
It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may tell you to stop this medication before surgery. Follow your doctor's directions carefully.
Avoid getting injections into the muscles. If you must have an injection into the muscle (for example, a flu shot), ask for it to be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.
This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.
This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you.
Older adults may be at greater risk for bleeding while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: mifepristone.
Other medications can affect the removal of dabigatran from your body, which may affect how dabigatran works. Examples include dronedarone, ketoconazole, rifampin, and St. John's wort, among others.
Aspirin, aspirin-like drugs (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen, celecoxib) may have effects similar to dabigatran. These drugs may increase the risk of bleeding problems if taken during treatment with dabigatran. Carefully check all prescription/nonprescription product labels (including drugs applied to the skin such as pain-relieving creams) since the products may contain NSAIDs or salicylates. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you have been prescribed low-dose aspirin and related drugs (such as clopidogrel, ticlopidine) for specific medical reasons such as heart attack or stroke prevention, ask your doctor if you should continue taking them or if your prescription should be changed. Consult your doctor or pharmacist for more details.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.
Do not share this medication with others.
Laboratory and/or medical tests (such as kidney/liver function, clotting times) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is less than 6 hours until the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
See also How To Use section.
Store at room temperature away from light and moisture. Do not store in the bathroom. Open only one bottle at a time, and once the bottle is opened, the medication must be thrown away after 4 months. If your capsules are in a blister package, then keep the capsules in the blister package until you are ready to take the medication. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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