Dabigatran, Oral

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KEY POINTS

• This medicine is taken by mouth to treat or prevent blood clots in people with certain conditions. Take it exactly as directed. Do not stop taking this medicine unless your healthcare provider approves. Stopping this medicine increases your risk of having a stroke.
• This medicine increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: thrombin inhibitor; anticoagulant

Generic and brand names: dabigatran, oral; Pradaxa

What is this medicine used for?

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)
• Reduce the risk of blood clots after hip replacement surgery
• Treat deep vein thrombosis and pulmonary embolism and reduce the risk of forming another blood clot

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A heart valve replacement
• Bleeding problems
• Kidney or liver problems
• Ulcers

Also tell your provider if you have recently had surgery for brain or spinal cord problems, or if you have had a lumbar puncture.

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.

How do I use it?

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. Do not run out of this medicine. Refill your prescription before you run out.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine comes in a bottle or a blister package. If you have the blister package, remove your dose right before you take it.

Take this medicine regularly each day. You may take this medicine with or without food. Do not break, crush, or chew the capsules. Swallow them whole with a full glass of water.

What if I miss a dose?

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.

What if I overdose?

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 bowel movements, vomiting blood, bleeding that won't stop.

What should I watch out for?

Do not stop taking this medicine without talking to the healthcare provider who prescribed it for you. Stopping this medicine increases your risk of having blood clots, including a stroke. If you have to stop taking this medicine, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming. Do not stop taking this medicine unless your healthcare provider tells you to.

If you take this medicine and receive spinal anesthesia or have a spinal tap, you may get a blood clot that can cause paralysis. Your risk is higher if you:

• Have had problems or surgery on your spine
• Have an injection or catheter in your back
• Take NSAIDs or medicine to prevent blood clots

Talk with your healthcare provider if you have recently had or will be having a spinal or epidural procedure. If you have a spinal or epidural procedure or spinal puncture while you are taking this medicine, tell your healthcare provider right away if you have back pain, bowel or bladder control problems, or tingling, numbness, and muscle weakness, especially in your legs and feet.

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. Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Report any unusual bruising or bleeding to your healthcare provider right away.

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 and checkups 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.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. You may need to stop taking this medicine or take a different medicine before certain surgeries or procedures. Talk with the healthcare provider who prescribed this medicine about this.

What are the possible side effects?

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 these 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; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; confusion.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; black or tarry bowel movements; blood in your urine or vomit; severe stomach pain, nausea, or vomiting; unusually heavy menstrual period or vaginal bleeding; frequent nosebleeds; coughing up blood; fast or irregular heartbeat; chest pain; severe dizziness or fainting; shortness of breath; unusual tiredness or weakness; unexpected joint pain or swelling.

Other: Heartburn, mild stomach pain, diarrhea, mild nausea.

What products might interact with this medicine?

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:

• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and rifampin (Rifadin)
• Antidepressants such as duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Aspirin and other salicylates
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), lapatinib (Tykerb), nilotinib (Tasigna), omacetaxine (Synribo), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vinblastine
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Eliglustat (Cerdelga)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), argatroban, bivalirudin, cilostazol (Pletal), clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), dipyridamole/aspirin (Aggrenox), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, lepirudin (Refludan), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Mefloquine
• Mirabegron (Myrbetriq)
• Natural remedies such as angelica, anise, arnica, capsicum, celery, chamomile, clove, fenugreek, fish oil, garlic, ginger, ginkgo, ginseng, horse chestnut, horseradish, licorice, passionflower, red clover, St. John’s wort, turmeric, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Vitamin E or multivitamins that contain vitamin E

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

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.

How should I store this medicine?

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 medicine must be used within 4 months. Discard any unused medicine in the bottle after 4 months.

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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.