Skip to main content

Site notifications

FLECAINIDE GXMED (JAMP Pharma Pty Ltd)

Product name
FLECAINIDE GXMED
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
flecainide acetate
Registration type
New generic medicine
Indication

[TRADE NAME] is indicated for:

    Supraventricular arrhythmias:
    1. due to pre-excitation syndromes, e.g., Wolff-Parkinson-White and Lown-Ganong- Levine syndromes
    2. due to dual AV nodal pathways in patients with debilitating symptoms
    3. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms

Although flecainide 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, Flecainide JAMP should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.