Flecainide Sandoz flecainide acetate 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flecainide acetate, Quantity: 100 mg

Available from:

Boucher & Muir Pty Ltd

INN (International Name):

Flecainide acetate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; maize starch

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White circular biconvex tablets, embossed with a breakline and the identifying letters "C" above the line and "FJ" below, breakline on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-11-20

Patient Information leaflet

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

Summary of Product characteristics

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