1.  What dabigatran is

The active ingredient is the chemical in the medicine that makes the medicine work.

Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names.

The active ingredient of this medicine is dabigatran (pronounced da-BIG-a-tran). It is also known by the brand name Pradaxa.

2. What dabigatran is for

Dabigatran is used to prevent blood clots forming in the leg veins after hip or knee replacement surgery. The medical term for these blood clots is deep vein thrombosis (DVT).

A blood clot in the legs can travel through the bloodstream to the lungs, where it can block an artery. This is a serious condition known as a pulmonary embolism. It may be life threatening.   

3. Who can take dabigatran

People can be prescribed dabigatran through the Pharmaceutical Benefits Scheme (PBS) to prevent blood clots forming after hip or knee replacement surgery.

You may be given another medicine instead to prevent blood clots (see Section 8: Other medicines available).

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4. When to take dabigatran

It is important that you have enough dabigatran capsules to complete your course of treatment.

You will usually be given this medicine 1 to 4 hours after surgery. You will need to continue taking it every day for the prescribed number of days.

Dabigatran must be taken each day at about the same time for:

• 28 to 35 days following a hip replacement
• 10 days following a knee replacement.

You may be given enough dabigatran capsules to complete your course of treatment when you leave hospital.

Other hospitals will give you only a small supply of dabigatran capsules and you will need to either:

• visit your GP to get a prescription to complete your course, or
• visit your local pharmacist to fill the dabigatran prescription given to you in hospital.

It is important that you do not accidentally take dabigatran capsules from the hospital and dabigatran capsules you get from your GP or pharmacist at the same time.

Finish the dabigatran capsules from the hospital before you start taking the capsules from your GP or pharmacist. 

Make sure you tell your GP or pharmacist the date of your surgery and ask them the date when you should stop taking the capsules.

Write this date on the box and do not take any dabigatran capsules after this date.

5. How to take dabigatran

Always take dabigatran exactly as prescribed.

The first dose is a single capsule that is usually given 1 to 4 hours after surgery.

After that, the daily dose is two capsules taken together. Each capsule contains 110 milligrams of medicine, so the total dose is 220 milligrams.

If you have kidney problems, or are taking other medicines that thin your blood, your doctor will prescribe a lower dose of 150 milligrams (two capsules of 75 milligrams).

You should take your daily dose at about the same time each day. Swallow the two capsules with water. They can be taken with or without food.

If you forget to take a dabigatran capsule, do not take a double dose the next day because this will increase the risk of bleeding.

6. Important side effects to consider

For a list of possible side effects, see the consumer medicine information (CMI) leaflet for dabigatran.

Ask your doctor about the possible side effects of this medicine before you use it.

Always tell your doctor about any changes to your condition if you are taking a new medicine.

You can also discuss side effects with a pharmacist, by calling the Adverse Medicines Event (AME) Line on 1300 134 237 (Mon–Fri, 9am–5pm).

All medicines can have side effects. Sometimes the side effects are serious, but most of the time they are not.

For dabigatran and other blood thinning medicines, the main risk is bleeding.

You may find that some blood seeps through the dressing after your operation. Some seepage is normal, but if you think that the bleeding is excessive speak to your doctor about it.  

You should seek urgent medical attention if you have:

• bleeding that won’t stop
• nosebleeds that last for longer than 10 minutes
• unexplained or severe bruising.

Internal bleeding is harder to detect, but can be very serious. If you experience any of the following, contact your doctor immediately or go to the emergency department at your nearest hospital:

• blood in your urine
• red or black faeces
• headaches that are unusual for you.

If you experience any serious injury, you are at greater risk of internal bleeding. You must get immediate medical attention, particularly if you hit your head.

A clinical trial is a research study conducted with patients, which compares one treatment with one or more other treatments, to assess its effectiveness and safety.

Dabigatran has been tested in clinical trials, but it is a new medicine so the full range of side effects is not known. You should be aware of this and see your doctor straight away if you have any concerns.

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7. What else you should know about dabigatran

If you stop taking dabigatran too early you are at greater risk of developing a blood clot in the veins of your leg. Make sure that you take it for the number of days that your doctor, pharmacist or nurse has told you.

While you are taking dabigatran, you should talk to your doctor before taking other medicines that can increase your risk of bleeding. These include:

• aspirin
• medicines that reduce pain and inflammation like:
• • ibuprofen (Advil, Brufen, Nurofen, Rafen)
  • diclofenac (Fenac, Voltaren)
  • naproxen (Naprogesic, Naproleve, Naprosyn, Proxen).

If you have a mild headache or other pain, or fever associated with a cold, you may use paracetamol (Panadol, Panamax).

Your hospital doctor will consider any other health problems you might have before prescribing dabigatran for you.

Dabigatran may not be suitable for you if you have:

• severely reduced kidney function
• severe liver disease
• had a stroke in the previous 6 months
• very high blood pressure
• a medical condition that increases your risk of bleeding.

Some other medicines can interact with dabigatran. You should talk to your doctor before taking any other medicine from a pharmacy, supermarket or health food store.   

8. Other medicines available

Remember that risks and benefits differ between medicines and from person to person.

Some medicines to prevent blood clots after hip or knee replacement surgery are given as a daily injection. They include dalteparin (Fragmin), enoxaparin (Clexane) and fondaparinux (Arixtra).

Dabigatran is a new blood thinning (anticoagulant) medicine that is available in capsule form. Another new anticoagulant — called rivaroxaban (Xarelto) — is available in tablet form. These two medicines work in slightly different ways, but in clinical trials both were found to be about as effective as a daily injection of enoxaparin. The risk of bleeding was also similar.

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9. What does dabigatran cost?

Most medicines prescribed by your doctor are covered by the PBS. This means that the Australian Government pays part of the cost of your medicine.

You will need to pay the full price if the medicine is not available on the PBS, or is not available on the PBS for your specific condition.

For more information see pbs.gov.au.

The full cost of dabigatran to the Australian Government varies depending on the strength of the capsules and the size of the pack.

The costs are as follows:

• $81.16 for 75 mg dabigatran capsules (pack size 20 capsules)
• $228.21 for 75 mg dabigatran capsules (pack size 60 capsules)
• $81.16 for 110 mg dabigatran capsules (pack size 20 capsules)
• $228.21 for 110 mg dabigatran capsules (pack size 60 capsules).
  

If you get dabigatran through the Pharmaceutical Benefits Scheme (PBS), the Australian Government pays most of the cost and you will pay only a part, called the co-payment.

At the time of publication, the co-payment for people who are entitled to get dabigatran through the PBS was:

• $33.30 for people without a concession card
• $5.40 for concession card holders.

If you are not eligible to get dabigatran through the PBS, you will need to pay the full price for a prescription.

10. Other ways to prevent blood clots

In addition to taking an anticoagulant medicine such as dabigatran, you should wear compression stockings while you are recovering from hip or knee replacement surgery. These further reduce your risk of blood clots. 

You will also be given a program of exercises to help with your recovery.

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