Pradaxa® (dabigatran etexilate) is an anticoagulant. Anticoagulants work by slowing the clotting process, reducing the chance of clots forming. Having surgery on your leg, such as a hip or knee replacement, carries an increased chance of developing a clot in the deep veins of your leg. If a piece of this breaks off it can travel to your lungs. These clots are called venous thromboembolic events and are the commonest cause of preventable hospital deaths in the UK.

As this medicine affects blood clotting, most side effects are related to signs such as bruising or bleeding. If you are bleeding heavily or for a long time or if you have exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling then please contact your doctor straight away.

Please click on the links below to view the PIL.

Pradaxa®
110mg

Twice daily

Pradaxa®
75mg

Twice daily

Please click on the links below to view the Pradaxa® Summary of Product Characteristics (SmPC).

Pradaxa®
110mg

SmPC

Pradaxa®
75mg

SmPC

Please click on the link below to view the Pradaxa® European Public Assessment Report (EPAR).

Pradaxa®

EPAR

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet.

You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.