Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
flecainide acetate, Quantity: 50 mg
Boucher & Muir Pty Ltd
Flecainide acetate
Tablet, uncoated
Excipient Ingredients: pregelatinised maize starch; maize starch; microcrystalline cellulose; croscarmellose sodium; magnesium stearate
Oral
60 tablets
(S4) Prescription Only Medicine
1. Supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes. b) due to dual AV nodal pathways in patients with debilitating symptoms. c) 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 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.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,Flecainide Sandoz tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,Prescribers should also consult the "Precautions" section of this Product Information.
Visual Identification: White circular biconvex tablets embossed C on one face and the identifying letters FI on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-11-20
1 FLECAINIDE SANDOZ 15112016 Consumer Medicine Information FLECAINIDE SANDOZ _FLECAINIDE ACETATE _ _ _ Tablets 50 mg & 100 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Flecainide Sandoz. This leaflet answers some common questions about Flecainide Sandoz. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au . Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Flecainide Sandoz against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT FLECAINIDE SANDOZ IS USED FOR Flecainide Sandoz contains flecainide acetate. It belongs to a group of medicines called antiarrhythmics, which slow down the impulses that cause the heart to beat in an irregular or abnormal way. Flecainide Sandoz is used to treat a heart condition called arrhythmia, which is an irregular or abnormal heart beat. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Flecainide Sandoz is only available with a doctor's prescription. Flecainide Sandoz is not addictive. 2 FLECAINIDE SANDOZ 15112016 BEFORE YOU TAKE FLECAINIDE SANDOZ _ _ Flecainide Sandoz is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE FLECAINIDE SANDOZ IF YOU: are allergic to any medicine containing flecainide acetate or any of the ingredients listed at the end of this leaflet have severe heart, liver or kidney disease unless your doctor says it is suitable for you. DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you take it after the expiry date has passed, it may not work as well. DO NOT TAKE IT IF THE PACKAGING IS TORN OR SHOWS SIGNS O Read the complete document
FLECAINIDE SANDOZ 1 AUSTRALIAN PRODUCT INFORMATION FLECAINIDE SANDOZ FLECAINIDE ACETATE TABLETS 1 NAME OF THE MEDICINE Flecainide acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flecainide Sandoz 50 mg tablets contain 50 mg of flecainide acetate. Flecainide Sandoz 100 mg tablets contain 100 mg of flecainide acetate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 50 MG TABLETS: White, circular, biconvex, uncoated tablets embossed “C” on one face and the identifying letters “FI” on the reverse. 100 MG TABLETS: White, circular, biconvex, uncoated tablets embossed with a breakline and the identifying letters “C” above the line and “FJ” below; the reverse embossed with a breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flecainide Sandoz is indicated for: 1. Supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong- Levine syndromes. b) due to dual AV nodal pathways in patients with debilitating symptoms. c) 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 should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. FLECAINIDE SANDOZ 2 Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended. 2. Life threatening ventricular arrhythmias not controlled by other drugs. Flecainide Sandoz are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means. PRESCRIBERS SHOULD ALSO CONSULT THE "SPECIAL WARNINGS AND PRECAUTIONS FOR USE" SECTION OF THIS PRODUCT INFORMATION. 4.2 DOSE AND METHOD OF ADMI Read the complete document