PRADAXA (pra dax a)
(dabigatran etexilate mesylate)
Read this Medication Guide before you start taking PRADAXA and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of talking with your doctor about your
medical condition or your treatment.
What is the most important
information I should know about PRADAXA?
For people taking PRADAXA for atrial fibrillation:
People with atrial fibrillation (a type of irregular
heartbeat) are at an increased risk of forming a blood clot in the
heart, which can travel to the brain, causing a stroke, or to other
parts of the body. PRADAXA lowers your chance of having a stroke by
helping to prevent clots from forming. If you stop taking PRADAXA,
you may have increased risk of forming a clot in your blood.
Do not stop taking PRADAXA without talking to the doctor who
prescribes it for you. Stopping PRADAXA increases your risk of having
PRADAXA may need to be stopped, if possible,
prior to surgery or a medical or dental procedure. Ask the doctor
who prescribed PRADAXA for you when you should stop taking it. Your
doctor will tell you when you may start taking PRADAXA again after
your surgery or procedure. If you have to stop taking PRADAXA, your
doctor may prescribe another medicine to help prevent a blood clot
- 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 your body.
You may have a higher risk of bleeding if
you take PRADAXA and:
- are over 75 years old
- 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,
- aspirin or aspirin containing products
- long-term (chronic) use of non-steroidal anti-inflammatory
- warfarin sodium (Coumadin®, Jantoven®)
- a medicine that contains heparin
- clopidogrel bisulfate (Plavix®)
- prasugrel (Effient®)
- have certain kidney problems and also take the medicines
dronedarone (Multaq®) or ketoconazole tablets
Tell your doctor
if you take any of these medicines. Ask your doctor or pharmacist
if you are not sure if your medicine is one listed above.
- PRADAXA can increase your risk of bleeding because it lessens
the ability of your blood to clot. While you take PRADAXA:
- you may bruise more easily
- it may take longer for any bleeding to stop
Call your doctor or get medical
help right away if you have any of these signs or symptoms of bleeding:
- unexpected bleeding or bleeding that lasts a long time,
- unusual bleeding from the gums
- nose bleeds that happen often
- menstrual bleeding or vaginal bleeding that is heavier than
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or get larger
- cough up blood or blood clots
- vomit blood or your vomit looks like "coffee grounds"
- unexpected pain, swelling, or joint pain
- headaches, feeling dizzy or weak
Take PRADAXA exactly as prescribed.
Do not stop taking PRADAXA without first talking to the doctor who
prescribes it for you. Stopping PRADAXA may increase your risk of
PRADAXA may need to be stopped,
if possible, for one or more days before any surgery, or medical or
dental procedure. If you need to stop taking PRADAXA for any reason, talk to the doctor who prescribed PRADAXA
for you to find out when you should stop taking it. Your doctor will
tell you when to start taking PRADAXA again after your surgery or
Spinal or epidural blood
clots (hematoma). People who take a blood thinner medicine
(anticoagulant) like 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
- 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 doctor should watch you closely for
symptoms of spinal or epidural blood clots. Tell your doctor 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).
See "What are the possible side effects
of PRADAXA?" for more information about side effects.
What is PRADAXA?
PRADAXA is a prescription
blood thinner medicine that lowers the chance of blood clots forming
in your body. PRADAXA is used to:
- reduce the risk of stroke and blood clots in people who
have a medical condition called 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.
- treat blood clots in the veins of your legs (deep vein thrombosis)
or lungs (pulmonary embolism) and reduce the risk of them occurring
PRADAXA is not for use in people
with artificial (prosthetic) heart valves.
It is not known if PRADAXA is safe and works in children.
Who should not take PRADAXA?
take PRADAXA if you:
- currently have certain types of abnormal bleeding. Talk
to your doctor before taking PRADAXA if you currently have unusual
- have had a serious allergic reaction to PRADAXA. Ask your
doctor if you are not sure.
- have ever had or plan to have a valve in your heart replaced
What should I tell
my doctor before taking PRADAXA?
Before you take PRADAXA, tell your doctor if
- have kidney problems
- have ever had bleeding problems
- have ever had stomach ulcers
- have any other medical condition
- are pregnant or plan to become pregnant. It is not known
if PRADAXA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if PRADAXA passes into your breast milk.
all of your doctors and dentists that you are taking PRADAXA. They
should talk to the doctor who prescribed PRADAXA for you, before you
have any surgery, or medical or
doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal
Some of your other medicines may
affect the way PRADAXA works. Certain medicines may increase your
risk of bleeding. See "What is the most important
information I should know about PRADAXA?"
Especially tell your doctor if you take:
- rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
Know the medicines you take. Keep a list of them
and show it to your doctor and pharmacist when you get a new medicine.
How should I take
Take PRADAXA exactly as prescribed by your
- Do not take PRADAXA more often than your doctor tells you
- You can take PRADAXA with or without food.
- You should take PRADAXA with a full glass of water.
PRADAXA comes in a bottle or in a blister
Only open 1 bottle of PRADAXA at a time.
Finish your opened bottle of PRADAXA before opening a new bottle.
After opening a bottle of PRADAXA, use within
4 months. See "How should I store PRADAXA?"
When it is time for you to take a dose of
PRADAXA, only remove your prescribed dose of PRADAXA from your open
bottle or blister package.
Tightly close your bottle of PRADAXA right
away after you take your dose.
- Swallow PRADAXA capsules whole. Do not break, chew, or empty
the pellets from the capsule.
- If you miss a dose of PRADAXA, 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 at the same time.
- Your doctor will decide how long you should take PRADAXA. Do not stop taking PRADAXA without first talking with your
doctor. Stopping PRADAXA may increase your risk of stroke.
- Do not run out of PRADAXA. Refill your prescription before
you run out. If you plan to have surgery, or a medical or a dental
procedure, tell your doctor and dentist that you are taking PRADAXA.
You may have to stop taking PRADAXA for a short time. See "What is
the most important information I should know about PRADAXA?"
- If you take too much PRADAXA, go to the nearest hospital
emergency room or call your doctor.
- Call your doctor or healthcare provider right away if you
fall or injure yourself, especially if you hit your head. Your doctor
or healthcare provider may need to check you.
What are the possible
side effects of PRADAXA?
PRADAXA can cause serious side effects, including:
- See "What is the most important information I should know
- Allergic Reactions. In some people, PRADAXA can cause symptoms
of an allergic reaction, including hives, rash, and itching. Tell
your doctor or get medical help right away if you get any of the following
symptoms of a serious allergic reaction with PRADAXA:
- chest pain or chest tightness
- swelling of your face or tongue
- trouble breathing or wheezing
- feeling dizzy or faint
Common side effects of PRADAXA include:
- indigestion, upset stomach, or burning
- stomach pain
Tell your doctor 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 doctor or pharmacist.
Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store PRADAXA?
- Store PRADAXA at room temperature between 59°F to 86°F (15°C
to 30°C). After opening the bottle, use PRADAXA within 4 months. Safely
throw away any unused PRADAXA after 4 months.
Keep PRADAXA in the original bottle or blister
package to keep it dry (protect the capsules from moisture). Do not
put PRADAXA in pill boxes or pill organizers.
Tightly close your bottle of PRADAXA right
away after you take your dose.
Keep PRADAXA and
all medicines out of the reach of children.
General information about
are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use PRADAXA for a condition for which it
was not prescribed. Do not give your PRADAXA to other people, even
if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most
important information about PRADAXA. If you would like more information,
talk with your doctor. You can ask your pharmacist or doctor for information
about PRADAXA that is written for health professionals.
For more information, go to www.PRADAXA.com
or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257
or (TTY) 1-800-459-9906, or scan here to go to www.PRADAXA.com.
are the ingredients in PRADAXA?
Active ingredient: dabigatran etexilate mesylate
Inactive ingredients: acacia, dimethicone,
hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The
capsule shell is composed of carrageenan, FD&C Blue No. 2 (150
mg strength only), FD&C Yellow No. 6, hypromellose, potassium
chloride, titanium dioxide, and black edible ink.
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Boehringer Ingelheim Pharmaceuticals,
Ridgefield, CT 06877 USA
Revised: September 2014
The brands listed above are trademarks of their respective
owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals,
Inc. The owners of these brands are not affiliated with and do not
endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.
Copyright 2014 Boehringer Ingelheim Pharmaceuticals,
ALL RIGHTS RESERVED
Boehringer Ingelheim Pharmaceuticals Inc.