The information highlighted (if any) are the most recent updates for this brand.
Hypersensitivity to the active substance or to any of the excipients listed in Description; Second- or third- degree atrio-ventricular block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker); Bradycardia <50 beats per minute (bpm); Permanent AF with an AF duration ≥ 6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician; Patients in unstable hemodynamic conditions; History of, or current heart failure or left ventricular systolic dysfunction; Patients with liver and lung toxicity related to the previous use of amiodarone; Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see Interactions); Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I and III antiarrhythmics (see Interactions); QTc Bazett interval ≥ 500 milliseconds; Severe hepatic impairment; Severe renal impairment (CrCl <30ml/min); Co-administration with dabigatran.