For doctors
What is it and how is it used?
What is Pradaxa:

Pradaxa is a medicine which is used to prevent the formation of blood clots. It works by blocking a substance in the body which is involved in blood clot formation.

What Pradaxa is used for:

Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery.

What do you have to consider before using it?
Do NOT take Pradaxa

Take special care with Pradaxa

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. For instance:

Taking Pradaxa with food and drink

Pradaxa can be taken with or without food.
Do not open the capsule.

Pregnancy and breast-feeding

The effects of Pradaxa on pregnancy and the unborn child are not known. You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.

You should not breast-feed while you are taking Pradaxa.

Driving and using machines

The effect of Pradaxa on the ability to drive and use machines is not known. Your doctor will tell you when you can start to drive.

Important information about some of the ingredients of Pradaxa

Pradaxa hard capsules contain a colorant with the name sunset yellow, which may cause allergic reactions.

How is it used?
When taking Pradaxa capsules out of the blister pack, please observe the following instructions

When taking Pradaxa capsules out of the bottle, please observe the following instructions

The generally recommended dose of Pradaxa is 220 mg once a day (taken as 2 capsules of 110 mg).

If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking amiodarone-, quinidine- or verapamil-containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking verapamil containing medicines and your kidney function is decreased by more than half you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.

After knee replacement surgery

You should start treatment with Pradaxa within 1 – 4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 10 days.

After hip replacement

You should start treatment with Pradaxa within 1 – 4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 28 – 35 days.

For both surgery types, treatment should not be started if there is bleeding from the site of operation. If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once daily.

Always take Pradaxa exactly as your doctor has told you. You should check with your doctor if you are not sure. The capsule should be swallowed with some water. Do not chew the capsule.

Changing from treatment with Pradaxa to anticoagulant treatment given by injection Do not start treatment with injectable anticoagulant medicines (for example, hep