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Known hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients of the product.
Severe renal impairment (CrCl <30 mL/min).
Haemorrhagic manifestations, patients with a bleeding diathesis, or patients with 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.
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