Patient Information Leaflet about Pradaxa® for Atrial Fibrillation

You Have Been Prescribed Pradaxa®

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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 ContentsLiving 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

Pulmonary arteries Aorta

Superior vena cava

Sinoatrial nodePulmonary artery

Pulmonary valve

Right atrium

Left atrium

Tricuspid valve

Aortic valve

Mitral valve

Right chamber Left chamber

Inferior vena cava

Papillary musclesInferior aorta

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

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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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.

Treating Atrial Fibrillation

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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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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.

Pradaxa® to Protect You against Stroke

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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.

How does Pradaxa® Work?

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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.

Starting Treatment with Pradaxa ®

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Follow these instructions when taking a capsule out of the bubble pack:

• Removethealuminiumfoilontheback

•Donotpushthecapsulethroughthefoil

•Donotremovethefoiluntilyouneedacapsule

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 CardYour 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 TravelExercise 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.

Storage and Use

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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.

PregnancyBecause 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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If you are already taking another anticoagulant, it is up to your doctor to decide how long you should wait before starting on Pradaxa®.

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.

Switching from Another Anticoagulant to Pradaxa®

Why Don’t I Need to Have Regular Tests?

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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.

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.

Potential Adverse Effects

Risk of Bleeding

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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.

Pradaxa® before Surgery and Dentist Appointments

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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.

Frequently Asked Questions

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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

CV-12-112, October 2012