Download You Have Been Prescribed Pradaxa®

Patient Information Leaflet about Pradaxa® for Atrial Fibrillation
You Have Been
Prescribed Pradaxa®
Your doctor has prescribed Pradaxa® for you. The
purpose of the medication is to minimise the risk that you
will have blood clots. Atrial fibrillation can cause the
formation of blood clots in the heart. If the clots travel to
the brain, they can lead to stroke (cerebral infarct). This
leaflet explains more about atrial fibrillation, what it is,
how it is treated and why anticoagulant therapy plays
such a vital role in preventing stroke. You can also read
about Pradaxa®, how it works, why it is important to take it
and instructions for its use. Finally, the leaflet answers
frequently asked questions about treatment with
Pradaxa®.
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Table of Contents
Living with Atrial Fibrillation and the Risk of Stroke ................... 5
Treating Atrial Fibrillation ............................................................................... 9
Pradaxa® to Protect You Against Stroke ........................................ 13
How Does Pradaxa® Work? ..................................................................... 15
Starting Treatment with Pradaxa® ...................................................... 17
Storage and Use ............................................................................................. 19
Switching from Another Anticoagulant to Pradaxa®........... 23
Why Don’t I Need to Have Regular Tests? .................................. 23
Potential Adverse Effects............................................................................ 25
Risk of Bleeding ............................................................................................... 25
Pradaxa® before Surgery and Dentist Appointments ....... 27
Frequently Asked Questions .................................................................. 28
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Living with Atrial Fibrillation and
the Risk of Stroke
The heartbeat normally follows a regular rhythm. The rhythm is
the result of electrical impulses that are transmitted from the
sinoatrial node – impulse-generating tissue in the right atrium
– through the conduction system. Normal, regular cardiac
rhythm is referred to as sinus rhythm.
In the case of atrial fibrillation, cardiac rhythm is disturbed
such that the heartbeat is irregular, often faster than sinus
rhythm.
Anterior cross-section view of the heart
Pulmonary arteries
Aorta
Superior vena cava
Pulmonary artery
Sinoatrial node
Pulmonary valve
Right atrium
Tricuspid valve
Right chamber
Left atrium
Aortic valve
Mitral valve
Left chamber
Inferior vena cava
Inferior aorta
Papillary muscles
Illustrator: Karin Lodin
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Some people have atrial fibrillation all the time, while others
have it occasionally. Some people notice that they have
atrial fibrillation because they experience more fatigue than
usual, become short of breath quickly or feel discomfort in the
chest, whereas other people do not have any symptoms at
all. Atrial fibrillation falls into three main categories depending
on the duration of the episode.
In paroxysmal atrial fibrillation, the episode spontaneously
converts to sinus rhythm within one week, often during the first
24 hours.
In persistent atrial fibrillation, the episode lasts longer than
one week but may still convert to normal sinus rhythm. Active
drug therapy or cardioversion (see page 11) is usually needed,
but spontaneous conversion is also possible.
In permanent atrial fibrillation, no conversion to sinus rhythm
occurs.
Atrial fibrillation is a common condition around the world
– 180,000 Swedes have it. The prevalence of atrial fibrillation
rises with age.
Atrial fibrillation increases the risk of blood clots, partly
because the blood can become stagnant in the heart and
coagulate more easily. If a clot breaks off and travels to the
brain, it can cause a stroke. The risk of blood clots grows with
age, as well as other conditions such as hypertension and
diabetes. For that reason, the need for anticoagulant therapy
and the most suitable medication vary from one person to
the next. Anticoagulant therapy can reduce the risk of stroke.
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Treating Atrial Fibrillation
Treatment of atrial fibrillation works on two levels – regulating
cardiac rhythm/heart rate and minimising the risk of blood
clots.
The type of treatment that works best for you partly depends
on the kind of atrial fibrillation you have.
Regulating Cardiac Rhythm/Heart Rate
The heart rate can be regulated in a number of different
ways. The most common approach is to prescribe
medication that regulates the heart rate and has some ability
to prevent future episodes of atrial fibrillation. The most
frequently prescribed medications belong to a category of
drugs known as beta-blockers. They can slow down the
heartbeat, as well as prevent both intermittent and new
episodes of atrial fibrillation.
Sometimes such therapy is not effective enough by itself – in
that case, your doctor might prescribe anti-arrhythmics, which
affect the cardiac rhythm more actively, as well.
If you have a rapid heartbeat in connection with atrial
fibrillation, drug therapy to slow it down is very important. The
ideal heart rate varies from one person to another.
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Sinus rhythm can also be restored by means of cardioversion,
which involves delivering an electrical shock to the heart
under EKG monitoring. The procedure, which takes a few
minutes, is performed under anaesthesia. Because
cardioversion works only temporarily, it is normally combined
with various medications that help the heart maintain sinus
rhythm.
If you have severe symptoms and drugs are ineffective, you
and your doctor might want to consider various surgical
procedures. Radiofrequency catheter ablation is the most
common method.
The procedure introduces heat or cold directly into the heart
in order to reduce or totally eliminate episodes of atrial
fibrillation.
Minimising the Risk of Blood Clots
If you have risk factors for stroke in addition to atrial fibrillation,
you will need treatment with anticoagulants as well. Various
assessment scales are available to determine your risk of
stroke. Your doctor can use one of the scales to decide
whether or not to prescribe anticoagulant therapy in your
case.
Treating cardiac rhythm and the risk of blood clots can
minimise the dangers posed by atrial fibrillation.
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Pradaxa® to Protect You against
Stroke
The effectiveness of anticoagulant therapy in reducing the risk
of stroke due to atrial fibrillation has been known ever since
the 1970s. The disadvantage of the most frequent treatment
method is that it increases the risk of bleeding and requires
very different doses from one patient to another. Certain
foods and other medications also influence the effectiveness
of the method. As a result, the anticoagulant effect must be
monitored on a regular basis to establish the proper dose.
If your doctor prescribes Pradaxa® for atrial fibrillation, you will
take one capsule morning and night. You will not need to
have regular tests. To guarantee that you have the best
possible protection against stroke, make sure to take Pradaxa®
as prescribed. Pradaxa® also increases the risk of bleeding.
In addition to atrial fibrillation, smoking and other factors
affect the risk of blood clots and stroke as well. Tell your doctor
if you are a smoker. Support is available to help you stop
smoking.
Treatment with Pradaxa® often lasts for the rest of a patient’s
life.
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How does Pradaxa® Work?
The ability of the blood to coagulate is regulated by various
factors that circulate in it. Most coagulation factors are
proteins.
Pradaxa® reduces the ability of the blood to coagulate by
inhibiting thrombin, a protein required for the formation of
blood clots.
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Starting Treatment with Pradaxa ®
It is important that you take one capsule at approximately the
same time every morning and night. If you miss a dose, you
can go ahead and take a capsule up until six hours before
the next one is scheduled. If you don’t remember in time, just
wait and take the next dose as usual. Never take two capsules
to make up for missing a dose. Swallow the capsule whole
without opening, crushing or chewing on it.
Your diet has no effect on treatment with Pradaxa®.
If you miss several doses the same week, consult with your
clinic. If you aren’t sure whether you took Pradaxa® or not one
day, err on the side of caution – take too little rather than too
much.
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Storage and Use
Follow these instructions when taking a capsule out of the
bubble pack:
• Remove the aluminium foil on the back
• Do not push the capsule through the foil
• Do not remove the foil until you need a capsule
The capsules are sensitive to moisture. Keep the medication
in its original container at room temperature in a dry area. Do
not store it in the bathroom.
Information Card
Your clinic will give you an information card stating that you
are being treated with Pradaxa®. Keep the card in your
possession at all times for as long as the therapy lasts. If you
are in an accident, the card will let caregivers know right away
that you are taking Pradaxa®. You can also have a Pradaxa
necklace if you like. Order it from your healthcare provider,
pharmacy or www.pradaxapatient.se
Exercise and Travel
Exercise is a healthy activity that you should engage in as
often as you have time for and are able to handle. However,
we do not recommend diving or martial arts.
Keep Pradaxa® in your carry-on luggage when you fly. Take
enough capsules for the entire trip. You do not need a
doctor’s certificate to take Pradaxa® with you when you travel
abroad.
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Other Medications and Natural Remedies in Combination
with Pradaxa®
Do not take natural remedies that contain St. John’s wort –
they will make Pradaxa® less effective. Do not take Naproxen,
Voltaren or other anti-inflammatories unless your doctor has
approved them. Use of such drugs, especially on a regular
basis, increases the risk of bleeding.
Alvedon, Panodil and other painkillers that contain
paracetamol are fine to take along with Pradaxa®. Make sure
to let your doctor and dentist know that you are taking
Pradaxa®. You should also tell your doctor if you are taking any
non-prescription medications or natural remedies.
Some combinations of drugs are unsuitable or require a
reduction of your Pradaxa® dose. Ask your doctor or
pharmacy if you are uncertain about what to do.
Pregnancy
Because women of childbearing age account for only a
small percentage of patients who have taken Pradaxa®, little
is known about the effect of Pradaxa® on pregnancy. If you
become pregnant while being treated with Pradaxa®, stop
taking it and contact your doctor as soon as possible.
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Switching from Another
Anticoagulant to Pradaxa®
If you are already taking another anticoagulant, it is up to your
doctor to decide how long you should wait before starting on
Pradaxa®.
Why Don’t I Need to Have
Regular Tests?
The effect of Pradaxa® does not differ significantly from one
person to another and is not influenced by diet. So you do not
need to regularly measure its effectiveness by means of
blood tests – you can rest assured that you are obtaining the
expected protection against stroke as long as you are taking
the same dose of Pradaxa® every day as prescribed.
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Potential Adverse Effects
All medications can cause adverse effects. Pradaxa® has
been taken by many people and is generally tolerated well
by the body.
The most common adverse effect of Pradaxa® is indigestion,
usually temporary. You can try taking the capsule with a glass
of water at mealtime. If the indigestion persists, you should talk
to your doctor.
Risk of Bleeding
Since Pradaxa® is an anticoagulant, it increases the risk of
bleeding somewhat. It is important not to stop taking it without
talking to your doctor.
If you experience unexpected bleeding from your mouth,
nose, urinary tract, etc., contact your clinic for advice. If the
bleeding is profuse or does not stop on its own, or if you
sustain a heavy blow to the abdomen, breast or skull, go to
the nearest emergency room. They will check to make sure
that you don’t have any internal bleeding.
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Pradaxa® before Surgery and
Dentist Appointments
Make sure to let your doctor and dentist know that you are
taking Pradaxa®. You might have to stop taking Pradaxa®
temporarily prior to certain examinations and types of surgery.
Your doctor or nurse will tell you how long to wait before you
can start taking the medication again.
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Frequently Asked Questions
What should I do if I forget to take a capsule?
The medication is most effective if you take it at the same
times every day. If you suddenly realise that you have missed
a dose of Pradaxa®, you can go ahead and take a capsule
up to six hours before the next one is scheduled. If you don’t
remember in time, skip the dose and take the next dose as
usual. Never take two capsules at the same time to
compensate for a missed dose.
What should I do if I am vomiting?
If you are vomiting because of stomach flu, etc., contact your
doctor or nurse for advice.
Does the medication have any adverse effects?
The risk of adverse effects is low. Because Pradaxa® affects
blood coagulation, contact your care provider if you
experience
bleeding that does not stop within a reasonable period of
time. You should also get in touch with your provider if you
have blood in the urine or stool, an unexplained bruise, etc.
Can I eat whatever I want?
Yes, no problem. Diet does not influence the effectiveness of
Pradaxa.
Can I drink alcohol?
Yes, you can use alcohol even though you are taking
Pradaxa®, but moderation is always recommended if you
drink while undergoing any type of anticoagulant therapy.
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Can I take Pradaxa® along with my other medications?
Generally speaking, yes, given that Pradaxa® and other
medications have little or no effect on each other. However,
avoid medications that affect blood coagulation or that
contain ketoconazole, itraconazole, dronedarone (skin and
hair treatment is fine), cyclosporine, tacrolimus, or St. John’s
wort. If you are using verapamil, your dose of Pradaxa® needs
to be reduced. Talk to your doctor for additional information.
Can I eat and drink at the same time as I am taking
Pradaxa®?
Yes, the effectiveness of the medication is not affected by
diet. It is up to you whether you want to take Pradaxa® along
with food, but you should always swallow the capsule whole
along with a glass of water or other beverage. Do not crush,
open or chew on the capsule. Taking Pradaxa® together with
food or a tall glass of water can relieve any indigestion
caused by the medication.
Is it possible to have a stroke even though I am taking
Pradaxa®?
Pradaxa® is an effective drug but does not provide one
hundred per cent protection against stroke. The risk of stroke is
generally very small, but contact your doctor immediately if
you experience symptoms that you think might be a stroke.
What do I do if I have taken too many capsules?
Contact your doctor, nurse or the Poisons Information Centre
(dial 112) for advice any time you have taken too much
medication.
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This leaflet was compiled in collaboration with Camilla Nilsson, research nurse at the
Anticoagulation Unit of the Skåne University Hospital Coagulation Clinic, Kristina
Hagwall, Internal Medicine Specialist, Cardiologist, in charge of the atrial fibrillation
school at Danderyd Hospital, and Rickard Ekesbo, primary care physician at the
Dalby Health Centre. Illustrator: Karin Lodin Photographer: Fredrik Hjerling
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CV-12-112, October 2012