Pradaxa® (dabigatran etexilate) is an anticoagulant. Anticoagulants work by slowing the clotting process, reducing the chance of clots forming. Deep vein thrombosis (DVT) is a clot that occurs in a deep vein, usually of the thigh or calf. If a piece of it breaks off it can travel to the blood vessels of the lungs. When the vessels become blocked by the clot the lungs are unable to fully oxygenate the blood. This is called pulmonary embolism (PE).

For patients with a DVT or PE, Pradaxa® stops the clot from getting bigger, whilst the body’s natural processes work to break it down. In some cases, Pradaxa® can be taken long term to reduce the risk of formation of another clot in the future.

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®
150mg

Twice daily

Pradaxa®
110mg

Twice daily

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

Pradaxa®
150mg

SmPC

Pradaxa®
110mg

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.