TAKING PRADAXA CAPSULES
IN THIS SECTION, WE WILL EXPLORE:
- How to take and store your PRADAXA prescription
- Helpful tips and information on how to start and stay on track
Taking and Storing PRADAXA Capsules
It’s important to take PRADAXA exactly as your healthcare provider prescribed
Keep PRADAXA Capsules in its original container, never in a pill box or pill organizer.
*Capsules not actual size
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An important part of reducing your risk of blood clots forming in your body
Making sure you are taking and storing PRADAXA correctly is important. So be sure to read the information below very carefully.
Remember, always take any medicine, including PRADAXA Capsules, exactly as prescribed by your doctor. Do not stop taking PRADAXA without first talking to the healthcare provider who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke or forming blood clots.
While you’re taking PRADAXA:
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Your healthcare provider will decide how long you should take PRADAXA. Do not stop taking PRADAXA Capsules without first talking with your healthcare provider. Stopping PRADAXA may increase your risk of having a stroke or forming blood clots
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Take PRADAXA Capsules exactly as prescribed by your healthcare provider
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Take PRADAXA Capsules twice a day (approximately every 12 hours)
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If you miss a dose of PRADAXA Capsules, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of PRADAXA Capsules at the same time
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Swallow PRADAXA Capsules whole. Do not break, chew, or empty the pellets from the capsule
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You can take PRADAXA Capsules with or without food
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You should take PRADAXA Capsules with a full glass of water
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Do not run out of PRADAXA Capsules. Refill your prescription before you run out. If you plan to have surgery, or a medical or a dental procedure, tell your healthcare provider that you are taking PRADAXA. You may have to stop taking PRADAXA for a short time
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If you take too much PRADAXA Capsules, go to the nearest hospital emergency room or call your healthcare provider
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Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you
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PRADAXA Capsules comes in a bottle or in a blister package
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Only open 1 bottle of PRADAXA Capsules at a time. Finish your opened bottle of PRADAXA Capsules before opening a new bottle
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After opening a bottle of PRADAXA Capsules, use within 4 months
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When it is time for you to take a dose of PRADAXA Capsules, only remove your prescribed dose of PRADAXA Capsules from your open bottle or blister package
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Tightly close your bottle of PRADAXA Capsules right away after you take your dose
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PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you:
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currently have abnormal bleeding
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have ever had an allergic reaction to it
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have had or plan to have a valve in your heart replaced
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Tell all of your healthcare providers that you are taking PRADAXA Capsules. They should talk to the healthcare provider who prescribed PRADAXA for you, before you have any surgery, or medical or dental procedure
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Tell your healthcare provider right away about changes in your medical history, which may mean PRADAXA may not be right for you, including if you:
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have kidney problems
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have ever had bleeding problems
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have ever had stomach ulcers
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have any other medical condition
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have antiphospholipid syndrome (APS)
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are pregnant, are able to become pregnant, or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby
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are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk
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Tell your healthcare provider about all the medicines you take, including prescription and nonprescription (over-the-counter) medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way PRADAXA works. Some medicines can increase your risk of bleeding, including:
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aspirin or aspirin-containing products
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long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
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warfarin sodium
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a medicine that contains heparin
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clopidogrel bisulfate
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prasugrel
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if you have kidney problems and take dronedarone or ketoconazole tablets
PRADAXA can cause bleeding, which can be serious and sometimes lead to death. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in the body.
While you take PRADAXA, you may bruise more easily and it may take longer for any bleeding to stop. Call your healthcare provider or seek immediate medical care if you have any of the following signs or symptoms of bleeding:
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any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
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unusual or unexpected bruising
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coughing up or vomiting blood; or vomit that looks like coffee grounds
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pink or brown urine; red or black stools (looks like tar)
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unexpected pain, swelling, or joint pain
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headaches and feeling dizzy or weak
Common side effects of PRADAXA include:
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indigestion, upset stomach, or burning
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stomach pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of PRADAXA. For more information, ask your healthcare provider or pharmacist.
Storing PRADAXA
PRADAXA must be kept dry. To protect it from moisture, PRADAXA comes in either a bottle with a special cap or in a blister pack with each dose sealed separately. When storing PRADAXA, please follow these instructions carefully:
- Store PRADAXA at room temperature between 68° F to 77° F (20° C to 25° C). After opening the bottle, use PRADAXA Capsules within 4 months. Safely throw away any unused PRADAXA Capsules after 4 months
- Keep PRADAXA Capsules in the original bottle or blister package to keep it dry (protect the capsules from moisture). Do not put PRADAXA Capsules in pill boxes or pill organizers
- Tightly close your bottle of PRADAXA Capsules right away after you take your dose
Keep PRADAXA Capsules and all medicines out of the reach of children.
Staying On Track
Helpful tips and information to help you start and stay on treatment
Managing your treatment can be challenging, but following the plan that your healthcare provider has developed is important to your health. Staying organized, communicating effectively with your doctor, learning about your condition, making healthy choices, and taking time to enjoy the things you love, can help your treatment journey.
"I’ve been taking PRADAXA for many years. I do my best to stay active but I don’t push myself too far. Right now, life is good."
When reducing risk of stroke, it’s important to stay the course
You may be at risk of stroke, even without any noticeable symptoms
Atrial fibrillation (AFib) is most often a chronic condition, and your risk of stroke may not go away. That’s why it’s important to continue to take PRADAXA, as prescribed by your doctor, to reduce your risk of stroke. Stopping PRADAXA may increase your risk of having a stroke or forming blood clots.
Your medicine
Organize your medicines. Keep them in the same place. Use a calendar to keep track of what to take and when. Keep PRADAXA stored in its original bottle or blister pack. Learn about storing PRADAXA
Keep your medical history and medication list updated. Some medicines may change the way PRADAXA or other medicines work in your body. Other medicines can increase your risk of bleeding and other side effects. Include all prescription, nonprescription (over-the-counter) medicines, vitamins, herbs, and other supplements on your list and make sure to share this information with your healthcare provider.
Make sure you understand how to take your medicine. It’s important to take your medicine exactly as prescribed by your healthcare provider. Learn how to take PRADAXA
Your Healthcare Provider
Keep up with scheduled doctor's visits. You’ll need to work closely with your healthcare team to manage your condition and reduce your risk of stroke. Your team may include:
Your primary care provider – the person who cares for your general health. This may be a family physician, internist, nurse practitioner, or physician’s assistant
A cardiologist – a doctor who specializes in treating conditions that affect the heart
An electrophysiologist – a cardiologist who works specifically with heart rhythm disorders (also called arrhythmias), such as AFib
If you need a ride to and from doctor's visits, consider asking a trusted friend or family member to come along. Or ask your doctor’s office about local transportation services
Review your treatment options with your healthcare provider. PRADAXA was the first approved alternative to warfarin, also known as Coumadin® or Jantoven®, for reducing risk of stroke in people with AFib not caused by a heart valve problem. The Doctor Discussion Guide is an easy way to start the conversation. Learn about PRADAXA
Learn more about your condition. Understanding AFib and its related complications can help you feel empowered. And it can help you better express your needs to your doctor and loved ones
Yourself
Get the support you need. When you’re facing a potentially serious medical condition, getting support from others is key. You shouldn’t feel shy or embarrassed about involving family and friends
Take advantage of your most important partner, your doctor. The Doctor Discussion Guide can help you have a more productive conversation with your doctor
Stay active. Exercise is an important part of staying healthy. Talk to your doctor before starting any exercise program to ensure you’re doing activities that are safe for you
Make time to relax. Try planning a special day out with a friend or loved one, a trip to a favorite place, or another activity you enjoy
Plan for travel. Talk to your doctor about changes in your routine, such as traveling. If you travel by plane, carry your medicines instead of checking them with your luggage
Manage your stress. Being diagnosed with a medical condition can cause stress. If left unmanaged, stress can actually make the situation worse by interfering with sleep and healthy eating habits, for instance
DVT and PE: Stay on track with treatment
Take PRADAXA exactly as prescribed
Deep vein thrombosis (DVT) and pulmonary embolism (PE) are serious conditions that can be life threatening. That’s why it’s important to continue to take PRADAXA, as prescribed by your doctor, to treat DVT and PE, and to reduce the risk of recurrence.
Your medicine
Organize your medicines. Keep them in the same place. Use a calendar to keep track of what to take and when. Keep PRADAXA stored in its original bottle or blister pack. Learn about storing PRADAXA
Keep your medical history and medication list updated. Some medicines may change the way PRADAXA or other medicines work in your body. Other medicines can increase your risk of bleeding and other side effects. Include all prescription, nonprescription (over-the-counter) medicines, vitamins, herbs, and other supplements on your list and make sure to share this information with your doctor.
Make sure you understand how to take your medicine. It’s important to take your medicine exactly as prescribed by your doctor. Learn how to take PRADAXA
Your doctor
Keep up with scheduled doctor's visits. You’ll need to work closely with your healthcare team to manage your condition and reduce your risk of stroke. Your team may include:
Your primary care provider – the person who cares for your general health. This may be a family physician, internist, nurse practitioner, or physician’s assistant
A specialist - you may be referred to a specialist, such as a vascular surgeon or an interventional radiologist, once your primary care provider has evaluated you and your symptoms
If you need a ride to and from doctor's visits, consider asking a trusted friend or family member to come along. Or ask your doctor’s office about local transportation services
Review your treatment options with your healthcare provider. On the basis of 3 clinical trials, PRADAXA is approved to treat blood clots in the veins of your legs (DVT) or lungs (PE) in patients who have been treated with an injectable blood thinner for 5 to 10 days, and to reduce the risk of recurrence. The Doctor Discussion Guide is an easy way to start the conversation. Learn about PRADAXA
Learn more about your condition. Understanding DVT and PE and their related complications can help you feel empowered. And it can help you better express your needs to your doctor and loved ones
Yourself
Get the support you need. When you’re facing a potentially serious medical condition, getting support from others is key. You shouldn’t feel shy or embarrassed about involving family and friends
Take advantage of your most important partner, your doctor. The Doctor Discussion Guide can help you have a more productive conversation with your doctor
Stay active. Exercise is an important part of staying healthy. Talk to your doctor before starting any exercise program to ensure you’re doing activities that are safe for you
Make time to relax. Try planning a special day out with a friend or loved one, a trip to a favorite place, or another activity you enjoy
Plan for travel. Talk to your doctor about changes in your routine, such as traveling. If you travel by plane, carry your medicines instead of checking them with your luggage
Manage your stress. Being diagnosed with a medical condition can cause stress. If left unmanaged, stress can actually make the situation worse by interfering with sleep and healthy eating habits, for instance
Pradaxa® (dabigatran etexilate) is a prescription medicine that is used to:
- reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. 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.
- treat blood clots in the veins of your legs (deep vein thrombosis) and lungs (pulmonary embolism) after you have been treated with an injectable medicine to treat your blood clots for 5 to 10 days.
- reduce your risk of blood clots from happening again in the veins of your legs and lungs after you have received treatment for blood clots.
PRADAXA is not for use in people with artificial (prosthetic) heart valves.
For people taking PRADAXA for atrial fibrillation: Do not stop taking PRADAXA Capsules without talking to the healthcare provider who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped, if possible, before surgery or a medical or dental procedure. Your healthcare provider will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming.
PRADAXA can cause bleeding which can be serious and sometimes lead to death.
Don’t take PRADAXA if you:
- currently have abnormal bleeding.
- have had a serious allergic reaction to any of the ingredients in PRADAXA.
- have had or plan to have a valve in your heart replaced.
Your risk of bleeding with PRADAXA may be higher if you:
- are 75 years old or older.
- have kidney problems.
- have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer.
- take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners.
- have kidney problems and take dronedarone or ketoconazole tablets.
Call your healthcare provider or get medical help right away if you have any of these signs or symptoms of bleeding:
- any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time.
- unusual or unexpected bruising.
- coughing up or vomiting blood; or vomit that looks like coffee grounds.
- pink or brown urine; red or black stools (looks like tar).
- unexpected pain, swelling, or joint pain.
- headaches and feeling dizzy or weak.
Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
- a thin tube called an epidural catheter is placed in your back to give you certain medicine.
- you take NSAIDs or a medicine to prevent blood from clotting.
- you have a history of difficult or repeated epidural or spinal punctures.
- you have a history of problems with your spine or have had surgery on your spine.
If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots. Tell your healthcare provider right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).
Tell your healthcare provider about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome (APS).
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with PRADAXA.
Tell your healthcare provider if you are a female who is able to become pregnant. Talk with your healthcare provider about pregnancy planning during treatment with PRADAXA. Talk with your healthcare provider about your risk for severe bleeding from the uterus if you are treated with blood thinner medicines, including PRADAXA.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You should not breastfeed during treatment with PRADAXA Capsules. Talk to your healthcare provider about the best way to feed your baby during treatment with PRADAXA Capsules.
Take PRADAXA exactly as prescribed. It is important to tell your healthcare provider about all medicines (prescription and over-the-counter), vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.
PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
CL-PX-100064 06.28.2021