Known hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients of the product. Severe renal impairment (CrCl < 30ml/min). Haemorrhagic manifestations, patients with a bleeding diathesis, or patients with spontaneous or pharmacological impairment of haemostasis. Prosthetic heart valve replacement. Hepatic impairment or liver disease expected to have any impact on survival. Concomitant treatment with systemic ketoconazole or dronedarone (see Precautions).
Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.