Dabigatran

If you have atrial fibrillation (a condition where the heart beats irregularly, and can lead to blood clots and stroke) and are taking dabigatran to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking dabigatran without talking to your doctor. Continue to take dabigatran even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of dabigatran. If you need to stop taking dabigatran, your doctor may prescribe another anticoagulant ('blood thinner') to help prevent a blood clot from forming and causing you to have a stroke.

If you have an epidural, spinal anesthesia, or a shot in your spine while taking a 'blood thinner' such as dabigatran, you could get a blood clot near your spine that can cause paralysis. Tell your doctor if you have a tube in your spine or if you have had spine problems, back surgery, or an epidural shot before. Tell your doctor and pharmacist if you are taking any of the following: anagrelide, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, ketoprofen, and naproxen, cilostazol, clopidogrel, dipyridamole, eptifibatide, heparin, prasugrel, ticagrelor, ticlopidine, tirofiban, or warfarin. Call your doctor immediately if you experience back pain, muscle weakness, numbness or tingling (especially in your legs), or trouble controlling your bowels or bladder.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dabigatran.

Your doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Dabigatran is used to prevent or treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE) and to prevent strokes in certain adults who have atrial fibrillation (a condition where the heart beats irregularly, and can lead to blood blots and stroke). Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by stopping blood from clotting.

Dabigatran comes as a capsule and pellets to take by mouth. It is taken 1 to 2 times daily. Take dabigatran capsules with or without food. If it upsets your stomach, take it with food. Give dabigatran pellets before meals. Take dabigatran at around the same times every day. Take dabigatran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a whole glass of water; do not split, chew, or crush them. Do not open the capsules and sprinkle the contents on food or into drinks.

Take dabigatran pellets with soft foods (e.g. baby rice cereal, mashed carrots, mashed bananas, or applesauce) or apple juice. Do not mix the pellets with milk or foods that contain dairy. To prepare a dose of dabigatran pellets with soft food, sprinkle the entire packet of pellets on soft food. Give the entire mixture within 30 minutes of sprinkling the pellets on the soft food. Alternatively you can give dabigatran pellets to your child along with apple juice. Spoon the pellets into your child's mouth and offer them as much apple juice as necessary to swallow the pellets. Or you can mix the pellets in small amount of apple juice and have your child drink the entire mixture. If pellets stick to the cup, add a small amount of apple juice and give it to your child. Repeat as necessary until all of the pellets are gone. Do not store the mixture of dabigatran pellets and soft food or apple juice; use within 30 minutes after mixing.

If a child does not take the entire dose of dabigatran pellets, do not give another dose at this time. Continue with the next dose at the scheduled time.

Continue to take dabigatran even if you feel well. Do not stop taking dabigatran without talking to your doctor. If you suddenly stop taking dabigatran, the risk that you will have clot or a stroke may increase.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking dabigatran,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking dabigatran. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have had a valve in your heart replaced or if you have recently noticed any unusual bruising or bleeding. Your doctor probably will tell you not to take dabigatran.
• tell your doctor if you have or have ever had a bleeding problem, bleeding or an ulcer in your stomach or intestine; or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking dabigatran, call your doctor.
• talk to your doctor about the risks and benefits of taking dabigatran if you are 75 years of age or older.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dabigatran.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if you remember the missed dose less than 6 hours before your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Dabigatran may cause side effects. Tell your doctor if any of these symptoms occur:

• stomach pain
• upset stomach
• heartburn
• nausea

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• unusual bruising or bleeding
• pink or brown urine
• red or black, tarry stools
• coughing up blood
• vomiting material that is bloody or looks like coffee grounds
• bleeding from the gums, frequent nosebleeds
• heavy menstrual bleeding
• bleeding from a cut that lasts longer than normal
• joint pain or swelling
• headache
• dizziness or feeling faint
• weakness
• hives, rash, itching
• difficulty breathing or swallowing
• chest pain or tightness
• swelling of the face, throat, tongue, lips, eyes, arms, hands, feet, ankles, or lower legs

Dabigatran may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not store dabigatran capsules in a pillbox or pill organizer. Store it at room temperature and away from excess heat and moisture. Open only one bottle of dabigatran capsules at a time. Finish your opened bottle of dabigatran capsules before opening a new bottle. Dispose of any capsules that are left in the container 4 months after you opened it. Keep the individual dabigatran pellet packets sealed in the aluminum bag until you are ready to use them. Dispose of any unused pellet packets 6 months after opening the aluminum bag.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• unusual bruising or bleeding
• pink or brown urine
• red or black, tarry stools
• vomiting material that is bloody or looks like coffee grounds
• coughing up blood

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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