Changing from anticoagulant treatment given by injection to treatment with Pradaxa Stop the treatment by injection and then start taking Pradaxa at the time you would have had the next injection.

If you take more Pradaxa than you should
If you take more Pradaxa than recommended, you may have an increased risk of bleeding. Your doctor can perform a blood test to assess the risk of bleeding.
Inform your doctor as soon as possible if you take more than the prescribed dose of Pradaxa. If bleeding occurs, surgical treatment or treatment with blood transfusions may be required.

If you forget to take Pradaxa
Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Do not take a double dose to make up for missed individual doses.

If you stop taking Pradaxa
Do not stop taking Pradaxa without first consulting your doctor, since the risk of developing a blood clot in a vein could be higher if you stop treatment early.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?
Like all medicines, Pradaxa can cause side effects, although not in all patients.

As this medicine affects blood clotting, most side effects are related to signs such as bruising or bleeding. Although rarely reported in clinical trials, major or severe bleeding may occur and, regardless of location, may become disabling, life-threatening or even lead to death.

The side effects are listed below, grouped by how likely they are to happen:

With Pradaxa the following side effects are known:

Common side effects (affects 1 to 10 users in 100):

Uncommon side effects (affects 1 to 10 users in 1,000):

Rare side effects (affects 1 to 10 in 10,000):

Not known (cannot be estimated from the available data):

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?
Keep out of the reach and sight of children.

Do not use Pradaxa after the expiry date which is stated on the carton, blister or bottle. The expiry date refers to the last day of that month.

Blister: Store in the original package in order to protect from moisture.
Bottle: Once opened, the product must be used within 30 days. Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors
What is it?
Pradaxa is a medicine containing the active substance dabigatran etexilate. It is available as capsules (75 mg and 110 mg).

What is it used for?
Pradaxa is used to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee.
The medicine can only be obtained with a prescription.

How is it used?
Treatment with Pradaxa should start with one 110 mg capsule taken one to four hours after the end of the operation. Treatment then continues with two 110 mg capsules (220 mg) once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement. The start of the treatment should be delayed in patients who are still bleeding from the site of surgery. If treatment is not started on the day of the operation, it sho