Known hypersensitivity to dabigatran or dabigatran etexilate or to any of the excipients of Pradaxa.
Patients with severe renal impairment (CrCl <30 mL/min); haemorrhagic manifestations, with a bleeding diathesis or spontaneous or pharmacological impairment of haemostasis; organ lesions at risk of clinically significant bleeding, including haemorrhagic stroke within the last 6 months; concomitant treatment with systemic ketoconazole (see Interactions). Prosthetic heart valve replacement.