For patients with non-valvular atrial fibrillation
Pradaxa® (dabigatran etexilate) is used to prevent blood clots in the brain (stroke) and other blood vessels in the body in adults who have an abnormal heartbeat called ‘non-valvular atrial fibrillation’ and are considered to be at risk of stroke.
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. This helps to reduce your risk of stroke, because blood clots are less likely to travel to blood vessels such as those carrying blood to the brain, causing a stroke.
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.
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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 European Medicines Authority (EMA).