APO-FLECAINIDE flecainide acetate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flecainide acetate, Quantity: 100 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

20, 30, 50, 40, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-FLECAINIDE 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 acetate 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, APO-FLECAINIDE should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,APO-FLECAINIDE 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 to off white, circular, biconvex, tablets debossed with F & 2 separated by scoreline on one side and plain on other side with approximate diameter of 8.8 mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-06-19

Patient Information leaflet

APO-FLECAINIDE
_Flecainide acetate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It 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 this medicine
against the benefits they expect it
will 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 need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-FLECAINIDE is used to treat a
heart condition called arrhythmia.
Arrhythmia is an irregular or
abnormal heart beat. The active
ingredient flecainide acetate belongs
to a group of drugs called
antiarrhythmic medicines which slow
down the impulses that cause the
heart to beat in an irregular or
abnormal way.
Your doctor may have prescribed this
medicine for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
APO-FLECAINIDE is available only
with a doctor's prescription.
BEFORE YOU USE/ARE
GIVEN THIS MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
flecainide acetate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT GIVE THIS MEDICINE TO
CHILDREN.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE SEVERE HEART, LIVER OR KIDNEY
DISEASE UNLESS YOUR DOCTOR SAYS IT IS
SUITABLE FOR YOU
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION; APO-FLECAINIDE 50 MG & 100MG TABLETS
(FLECAINIDE ACETATE)
1.
NAME OF THE MEDICINE
Flecainide acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg and 100 mg of APO-FLECAINIDE Tablets contain 50 mg and 100
mg of Flecainide
acetate
respectively.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
50 MG TABLETS:
White to off white, circular, biconvex, tablets debossed with F1 on
one side and plain
on other side with an approximate diameter of 6.5 mm.
100 MG TABLETS:
White to off white, circular, biconvex, tablets debossed with F & 2
separated by
scoreline on one side and plain on other side with an approximate
diameter of 8.8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flecainide acetate 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 acetate 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 acetate should be used with extreme caution, preferably
after other antiarrhythmic drugs
have been tried or considered inappropriate.
Use of flecainide acetate in chronic atrial fibrillation has not been
adequately studied and is not
recommended.
2. Life threatening ventricular arrhythmias not controlled by other
drugs:
Flecainide acetate 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 SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE, OF THIS
PRODUCT INFORMATION.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ADU