Main use Active ingredient Manufacturer
Preventing blood clots Dabigatran etexilate Boehringer Ingelheim

How does it work?
Pradaxa capsules contain the active ingredient dabigatran etexilate, which is a type of medicine called a direct thrombin inhibitor. It is used to stop blood clots forming within the blood vessels.

Blood clots usually only form to stop bleeding that has occurred as a result of injury to tissue in the body. However, after hip or knee replacement surgery there is a risk of blood clots forming in the blood vessels. This risk is increased by being immobile for long periods of time following the surgery, as a result of slowed blood flow in the leg and pelvic veins. A clot that forms in the veins of the leg is called a deep vein thrombosis. These dangerous blood clots can travel to the lungs, causing a serious condition called a pulmonary embolism.

People with a type of fast irregular heartbeat called atrial fibrillation (AF) are also at risk of blood clots forming, both within the heart and in the blood vessels. This is because the abnormal heart rhythm disrupts blood flow in the blood vessels. Clots in the heart can detach and travel to the brain, causing a stroke. Clots can also travel in and block other blood vessels around the body.

The blood clotting process is complicated. When blood begins to clot, a cascade of chemicals is activated within the body, resulting in the formation of an enzyme called thrombin. Thrombin is central to the complete process of blood clotting. It causes a protein called fibrinogen to be converted into another called fibrin. Fibrin binds blood cells called platelets together, and this forms the blood clot.

Dabigatran works by binding to thrombin in the clotting process described above and blocking its action. This stops the formation of fibrin, the essential component of blood clots. Dabigatran can therefore prevent blood clots from developing.

What is it used for?
Preventing dangerous blood clots in the veins (venous thromboembolism) in adults who have undergone elective total hip or knee replacement surgery.
Preventing the formation of blood clots that can cause a stroke or blockage of other blood vessels in the body in people with a type of irregular heartbeat called atrial fibrillation (AF). This medicine is licensed to prevent these types of blood clots in people with AF who have one or more of the following additional risk factors:
a history of stroke or blood clots
heart failure
age over 75 years
age over 65 years and either diabetes, high blood pressure or coronary artery disease.
How do I take it?
Pradaxa capsules should be swallowed whole with water. The capsules must not be opened or chewed. They can be taken either with or without food.
The dose prescribed and how often the medicine needs to be taken depends on whether you are taking the medicine to prevent blood clots following surgery, or to prevent a stroke or other blood clot because you have AF. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
If this medicine is being used to prevent blood clots following hip or knee replacement surgery, treatment should be started within one to four hours after the surgery, though this may be delayed if there are any complications with bleeding after surgery. The capsules are taken once daily for 10 days following a knee replacement and for 28 to 35 days following a hip replacement.
Do not stop taking this medicine until you have been advised to by your doctor.
Warning!
As this medicine prevents blood clotting, the most common side effects associated with treatment involve bruising or bleeding. Not all people will experience side effects. However, you should let your doctor know straight away if you notice any sign of bruising or bleeding while you are taking this medicine. This includes any signs of blood in your urine, or any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.
It is important that you tell any health professional treating you, including your dentist, that you are taking this medicine. If you are due to have any surgery it is also important to talk to your doctor in advance about your medicine. For some surgery it is safe to keep taking dabigatran, whereas if you are going to have major surgery with a higher risk of bleeding your doctor may want you to stop taking your dabigatran up to four days before the surgery. Follow the instructions given by your doctor.
Your doctor will want to check your kidney function before you start treatment, because some kidney problems may increase the risk of bleeding with this medicine. If you are taking this medicine on a long-term basis and you are over 75 years of age or have any existing kidney problems, your doctor will also want to check your kidney function at least once a year.
This medicine contains sunset yellow food colouring, which may cause allergic reactions in some people.
Use with caution in
Elderly people.
People who weigh less than 50kg or more than 110kg.
Moderately decreased kidney function.
Liver disorders.
People with an increased tendency to bleed, for example due to blood clotting disorders such as haemophilia.
People with low numbers of blood cells called platelets in their blood (thrombocytopenia).
Active ulcerative diseases of the intestines, eg peptic ulcers or ulcerative colitis.
People with AF who have inflammation in the stomach (gastritis), inflammation of the foodpipe (oesophagitis) or gastro-oesophageal reflux.
People who have recently had a biopsy.
People who have recently had brain, spinal or eye surgery.
People who have recently had a major injury.
People who have recently had bleeding inside the skull or in the gut.
People having spinal or epidural anaesthesia or injection into the spine.
People taking medicines that may increase the risk of bleeding, for example non-steroidal anti-inflammatory drugs (NSAIDs, eg diclofenac).
Bacterial infection of the heart valves and the lining surrounding the heart (bacterial endocarditis).
Not to be used in
People with active severe or dangerous bleeding, or problems with blood clotting.
People with a disease or condition in an organ that increases the risk of bleeding.
People taking other anticoagulant medicines to prevent blood clots, such as warfarin or heparin.
Severely decreased kidney function.
Decreased liver function or liver disease that may be life-threatening.
This medicine is not recommended for people who have an indwelling catheter in their spine for pain relief after the surgery.
This medicine is not recommended for people having surgery for a hip fracture.
This medicine is not recommended for children and adolescents less than 18 years of age, as its safety and efficacy have not been established in this age group.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. For this reason, it should not be used in pregnancy unless considered essential by your doctor, and only if the benefit of its use outweighs the risk to the unborn child. Women who could get pregnant should use a reliable method of contraception to avoid getting pregnant while taking this medicine. Seek further medical advice from your doctor.
It is not known if this medicine passes into breast milk. The manufacturer states that women who need treatment with this medicine should not breastfeed while taking it. Seek further medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common side effects (affect between 1 in 10 and 1 in 100 people)
Low red blood cell count (anaemia).
Nose bleeds (epistaxis).
Bleeding in the gut.
Abdominal pain.
Diarrhoea.
Indigestion.
Feeling sick.
Bruising of the skin.
Uncommon side effects (affect between 1 in 100 and 1 in 1000 people)
Weeping of a surgical wound.
Blood clots which form a solid swelling at the injection site (haematoma).
Bleeding from the rectum.
Bleeding from piles (haemorrhoids).
Ulceration in the gut.
Acid reflux.
Vomiting.
Difficulty or pain when swallowing.
Blood in the urine (haematuria).
Bleeding into a joint (haemarthrosis).
Bleeding inside the skull.
Bleeding underneath the skin.
Bleeding after an operation or injury.
Decrease in the number of platelets in the blood (thrombocytopenia).
Abnormal liver function test results.
Rash or itching.
Rare (affect between 1 in 1000 and 1 in 10,000 people)
Bleeding from an injection site.
Bleeding from a catheter site.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

This medicine must not be used in combination with the following medicines:

ciclosporin
itraconazole
ketoconazole
tacrolimus.
This medicine may enhance the effect of other medicines that affect blood clotting, such as those listed below. For this reason, it is not recommended for use in combination with these medicines:

acenocoumarol
aspirin
bivalirudin
clopidogrel