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Flec-EM (Emcure Pharmaceuticals Pty Ltd)
Product name
Flec-EM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
159 working days (255)
Active ingredients
flecainide acetate
Registration type
New generic medicine
Indication
Flec-EM (uncoated tablets) is indicated for:
Supraventricular arrhythmias:
- Due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes
- Due to dual AV nodal pathways in patients with debilitating symptoms
- Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
Although Flec-EM may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, Flec-EM should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.
Use of Flec-EM in chronic atrial fibrillation has not been adequately studied and is not recommended.
Life threatening ventricular arrhythmias not controlled by other drugs.
Flec-EM tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.