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    / Unipharm Trading Ltd


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    60 X 400 mg

    not in the basket chart

    Dosage

    The recommended dose is 400 mg twice daily in adults. It should be taken one tablet with the morning meal and one tablet with the evening meal. Please refer to the license holder for further details


    Indications

    For the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, it should only be prescribed after alternative treatment options have been considered. It should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients;
    -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
    -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.
    -QTc Bazett interval ≥500 milliseconds
    -Severe hepatic impairment
    -Severe renal impairment (CrCl <30 ml/min)
    -Pregnancy
    -Co-administration with dabigatran


    Special Precautions

    Please refer to the license holder for further details.


    Side Effects

    Please refer to the license holder for further details.


    Drug interactions

    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Please refer to the license holder for further details.


    Overdose

    Please refer to the license holder for further details.


    Important notes

    Please refer to the license holder for further details.


    Manufacturer
    Unipharm Ltd.
    Licence holder
    CLOSE