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PRADAXA® (dabigatran etexilate)
MINIMUM PRODUCT INFORMATION – SPAF Indication
Indication: Prevention of stroke, systemic embolism and reduction of vascular mortality in patients with non-valvular atrial fibrillation with
one or more of the following risk factors: previous stroke, transient ischemic attack, or systemic embolism, left ventricular ejection fraction
< 40%, symptomatic heart failure, ≥ New York Heart Association Class 2, age ≥75 years, age ≥65 years associated with one of the
following: diabetes mellitus, coronary artery disease or hypertension. Dosage: Usually 150 mg twice daily. Patients with: age ≥ 75 years,
moderate renal impairment (CrCL 30-50 ml /min), concomitant treatment with strong P-gp inhibitors 110 mg twice daily. Take capsule
whole with water, with or without food. Assess renal function: prior to treatment initiation, in clinical situations that could lead to renal
function decline, and at least once a year in patients with moderate renal impairment. Contraindications: Known hypersensitivity to
dabigatran or dabigatran etexilate or to one of the excipient; Patients with severe renal impairment (CrCl < 30mL/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; Prosthetic heart valve replacement. Warnings and Precautions: (see full datasheet) Haemorrhagic risk:
moderate renal impairment (30-50 mL/min CrCL), selected P-gp inhibitor comedication, acetylsalicylic acid, NSAIDs, clopidogrel,
congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease,
recent gastrointestinal bleeding, recent biopsy or major trauma, recent intracranial haemorrhage, brain, spinal or ophthalmic surgery,
bacterial endocarditis, age ≥ 75 years. Concomitant administration with: unfractionated heparins and heparin derivatives, low molecular
weight heparins, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone,
rivaroxaban, prasugrel, ticagrelor, vitamin K antagonists, selective serotonin re-uptake inhibitors, selective serotonin norepinephrine re-
uptake inhibitors and the P-gp inhibitors amiodarone, verapamil, dronedarone, itraconazole, tacrolimus, cyclosporin, ritonavir, tipranavir,
nelfinavir and saquinavir, P-gp inducers. Surgical interventions may require temporary discontinuation of PRADAXA. Pregnancy
(Category C). Lactation. Children. Patients < 50 kg. Adverse Effects: Bleeding and signs of bleeding, anaemia, abnormal liver function
tests, dyspepsia, gastritis-like symptoms, diarrhoea, nausea. For less common adverse reactions see full datasheet. Presentation: 75
mg, 110 mg and 150 mg capsules in bottles or blisters of 60 capsules. Distributed in New Zealand by Boehringer Ingelheim (NZ) Ltd, 42
Ormiston Road, East Tamaki. Dated: 21/12/2012. PRADAXA is a Prescription Medicine. PRADAXA is fully funded with no special
authority. Before prescribing PRADAXA please review the data sheet at

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