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The eMC  

Last Updated 25 Feb 2014

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Pradaxa 110mg capsules

Pradaxa (prad-ax-a) is a medicine which is used in prevention of a stroke and prevention of blood clots. Pradaxa contains dabigatran etexilate mesilate. It is supplied by Boehringer Ingelheim Limited.

The information in this Medicine Guide for Pradaxa varies according to the condition being treated and the particular preparation used.

There are 2 preparations of Pradaxa available. If Pradaxa 110mg capsules is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Pradaxa

Pradaxa 110mg capsules

Information specific to Pradaxa 110mg capsules when used in prevention of blood clots

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Your medicine

Pradaxa is used to prevent blood clots from forming in people who have had a knee or hip replacement.

Pradaxa is also used in the prevention of stroke in people who are considered to be at a high risk of having one.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Pradaxa:

  • swallow the medicine whole with a glass of water
  • this medicine can be taken with or without food
  • you must not open the capsule as this may increase the chances of side effects
  • if you miss a dose and it is more than six hours until the next dose, take Pradaxa as soon as you remember. If it is less than six hours until the next dose, you should wait and take Pradaxa at the time when you would usually take this medicine

If you are having problems taking this form of Pradaxa, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are not having any problems with this medicine, do not stop taking it, even if you feel better, unless you have completed the course or you are advised to stop taking it by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Pradaxa:

  • store the medicine in the original container to protect it from moisture
  • if your medicine comes in a bottle make sure that the container is closed tightly
  • if your medicine comes in a bottle you must dispose of any remaining medicine 30 days after you first opened it. It is a good idea to make a note of the date when you opened it

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Pradaxa is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone who weighs less than 50 Kg or more than 110 Kg.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects
  • to check that this medicine is having the desired effect

Over time it is possible that Pradaxa can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Pradaxa has become unsuitable, it is important that the prescriber is contacted immediately.

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A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who take Pradaxa:

  • bleeding - seek immediate medical advice if you get any bleeding

Common: More than 1 in 100 people who take Pradaxa:

  • abnormal laboratory test results
  • anaemia
  • bleeding from the skin
  • blood in the urine
  • diarrhoea
  • gastrointestinal bleeding
  • genital or urinary bleeding
  • indigestion
  • liver problems
  • major bleeding
  • nausea
  • nose bleed
  • stomach pain

Uncommon: More than 1 in 1000 people who take Pradaxa:

Rare: More than 1 in 10,000 people who take Pradaxa:

The frequency of these side-effects is unknown:

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Pradaxa:

The following types of medicine may interact with Pradaxa:

If you are taking Pradaxa and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Pradaxa:

If you have been prescribed Pradaxa you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Pradaxa:

  • this medicine is unlikely to affect driving ability or the ability to operate machinery

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Pradaxa:

  • there are no specific foods that you must exclude from your diet when taking Pradaxa
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Alcohol can interact with certain medicines.

In the case of Pradaxa:

  • there are no known interactions between alcohol and Pradaxa
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Pradaxa:

  • you should only take this medicine during pregnancy if your doctor thinks that you need it
  • if you are taking Pradaxa and you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while taking Pradaxa

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Pradaxa, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Pradaxa:

  • women who are taking Pradaxa should not breast-feed

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Pradaxa contains:

  • acacia
  • carrageenan
  • dimeticone 350
  • hydroxypropyl cellulose
  • hypromellose
  • indigo carmine (E132)
  • industrial methylated spirits
  • iron oxide black (E172)
  • isopropyl alcohol
  • N-butyl alcohol
  • potassium chloride
  • propylene glycol
  • purified water
  • shellac
  • sunset yellow (E110)
  • talc
  • tartaric acid
  • titanium dioxide

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Pradaxa before, do not take Pradaxa. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Pradaxa, Version 23, last updated 25 Feb 2014