Pradaxa® SmPCs and risk minimisation materials
Before prescribing Pradaxa®, you should refer to the SmPC, which you can access at the links below:
For UK Healthcare professionals
For IRE Healthcare professionals
You can also access the current Pradaxa® Prescriber Guides online via the links above. The Prescriber Guides provide recommendations for the use of Pradaxa® in order to minimise the risk of bleeding. In particular it is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa® and providing guidance on how to manage that risk.
DVT: deep vein thrombosis
NVAF: non-valvular atrial fibrillation
NYHA: New York Heart Association
PE: pulmonary embolism
SmPC: summary of product characteristics
VTE: venous thromboembolism
- Pradaxa® 110mg hard capsules Summary of Product Characteristics.
- Pradaxa® 150mg hard capsules Summary of Product Characteristics.
- Pradaxa® 75mg hard capsules Summary of Product Characteristics.
- Stangier J. Clin Pharmacokinet 2008;47(5):285-295.
- Rubboli A. Eur J Intern Med 2019;62:e11-e12.
- SMC Advice (672/11). Dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa®). Published August 2011.
- NICE Technology Appraisal Guidance (TA249). Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. Published March 2012.
- MIMS.co.uk (accessed August2020).