Information for:

UK & IRELAND HEALTHCARE PROFESSIONALS

Click here if you are a healthcare professional and would like more information on Pradaxa® (dabigatran etexilate)


Information intended for:

PATIENTS PRESCRIBED PRADAXA®/ MEMBERS OF THE PUBLIC IN THE UK & IRELAND

Click here for more information on Pradaxa®


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For patients who have had deep vein thrombosis (DVT) or pulmonary embolism (PE)

Pradaxa® (dabigatran etexilate) is used to treat blood clots in the veins of the legs and lungs in adults, and to prevent these conditions from occurring again.

Pradaxa® is a type of medicine called an anticoagulant and is designed to reduce the chance of blood clots forming. It does this by working to stop blood cells from clumping together. In some people, clotting occurs when it shouldn't and may cause a deep vein thrombosis (DVT), which is a blood clot that forms in a deep vein, usually in the leg. When a DVT occurs, the blood flow in the vein is partially or completely blocked by the blood clot. If a piece of it breaks off, it can travel to another part of the body such as the lungs, causing a blockage in a blood vessel in the lungs. This is caused a 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 experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.

Patient Information Leaflets (PIL)

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using this medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

If you are in the UK, click the below links to access this information

If you are in Ireland, click the below links to access this information

Summary of Product Characteristics (SmPC)

The Summary of Product Characteristics (SmPC) tells healthcare professionals, such as doctors, pharmacists and nurses, how to prescribe and use this medicine correctly. The SmPC is based on clinical trials that a pharmaceutical company has carried out, and gives information about dose, use and possible side effects.

If you are in the UK, click the below links to access this information

If you are in Ireland, click the below links to access this information

European Product Assessment Report (EPAR)

The European Public Assessment Report (EPAR) provides public information on a medicine, including how it was assessed by the European Medicines Authority (EMA).

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