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The only NOAC with a specifi c reversal agent – Praxbind ® – for use in rare emergency situations1–5


More independently verifi ed real-world evidence vs warfarin than any other NOAC 6


Safety benefi ts and stroke protection compared with warfarin for patients with non-valvular AF 7–9


Expect


more from your


NOAC Now with


ANTICOAGULATE WITH CONFIDENCE NOAC: Non-vitamin K antagonist oral anticoagulant.


due, or at the time of discontinuation in case of continuous treatment; if switching from Pradaxa to VKA adjust the starting time of the VKA based on CrCL; if switching from VKA to Pradaxa stop VKA and give Pradaxa once INR <2.0. Cardioversion patients can stay on Pradaxa whilst being cardioverted. No relevant use of Pradaxa in the paediatric population in the indication. Pradaxa can be taken with or without food. Pradaxa should be swallowed as a whole with a glass of water to facilitate delivery to the stomach. Patients should be instructed not to open the capsule as this may increase the risk of bleeding. Contraindications: Hypersensitivity impairment


to (CrCL < 30 mL/min); active clinically intracranial haemorrhage, known or any component; signifi cant suspected severe bleeding; oesophageal renal lesion or


condition, if considered a signifi cant 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


varices,


arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specifi c circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter; hepatic impairment or liver disease expected to have any impact on survival; concomitant systemic ketoconazole, cyclosporine, itraconazole, dronedarone; prosthetic heart


valves requiring anticoagulant treatment. Warnings and Precautions:


Not recommended if liver enzymes > 2 ULN. Haemorrhagic risk: Close clinical surveillance (signs of bleeding or anaemia) is recommended throughout the treatment period, especially when haemorrhagic risk is increased or risk factors combined. Factors which may increase haemorrhagic risk: age ≥ 75 years; moderate renal impairment (CrCL 30 – 50 mL/min); P-glycoprotein inhibitor co-medication; body weight < 50 kg; acetylsalicylic acid (aspirin); NSAID; clopidogrel; selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs); other drugs


which may impair haemostasis; diseases/procedures associated with a risk of bleeding such as coagulation disorders, thrombocytopenia or functional platelet defects, recent biopsy, major trauma, bacterial endocarditis, oesophagitis, gastritis or gastroesophageal refl ux. Concomitant


use of ticagrelor. The measurement of dabigatran related


anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional risk factors. Patients who develop acute renal failure must discontinue Pradaxa. If severe bleeding occurs, discontinue treatment and investigate the source of the bleeding. Avoid or use with caution medicinal products which may increase the risk of haemorrhage. The use of fi brinolytic medicinal products for the treatment of acute ischaemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the ULN according to the local reference range. Avoid concomitant administration with P-gp inducers. Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding therefore surgical interventions may require the temporary discontinuation of dabigatran etexilate; prescribers should consult the Summary of Product Characteristics for


further


information. Procedures such as spinal anaesthesia may require complete haemostatic function. The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters. After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the fi rst dose of dabigatran etexilate; these patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma. Treat with caution patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. Myocardial infarction. Contains Sunset Yellow (E110) which may cause allergic reactions. Interactions: Anticoagulants and antiplatelet aggregation medicinal products; P-gp inhibitors e.g. amiodarone, quinidine, verapamil, clarithromycin, ticagrelor co-administration (close clinical surveillance); verapamil co-administration - reduce Pradaxa dose to 220 mg (see above) close clinical surveillance is recommended; caution when co-administered with posaconazole; not recommended for concomitant treatment tacrolimus, protease inhibitors including ritonavir and its combinations with


other protease inhibitors; avoid with P-gp inducers e.g. rifampicin, St John’s wort, carbamazepine, phenytoin; SSRIs or SNRIs. Dabigatran etexilate and dabigatran are not metabolised by cytochrome CYP450 system,


therefore related medicinal product


interactions not expected. Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials and concomitant PPI treatment did not appear


to reduce the effi cacy of Pradaxa. Ranitidine administration together with


Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran. Fertility, pregnancy and lactation: Avoid pregnancy during treatment. Do not use in pregnancy unless clearly necessary. Discontinue breast-feeding during treatment. Undesirable effects: Most commonly


reported adverse reactions are bleedings


occurring in total in approximately 16.6 % in patients with atrial fi brillation treated for the prevention of stroke and SEE. Common (≥ 1/100 to <1/10): anaemia; epistaxis; gastrointestinal haemorrhage; abdominal pain; diarrhoea; dyspepsia; nausea; skin haemorrhage; genitourological haemorrhage, including haematuria. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes and NHS price: 110 mg 60 capsules £51.00 150 mg 60 capsules £51.00 Legal category POM MA numbers: 110 mg EU/1/08/442/007 (60 capsules) 150 mg EU/1/08/442/011 (60 capsules) Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Prepared in December 2015.


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).


UK/DBG-151270 December 2015


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