BPA-FLECAINIDE 50 flecainide acetate 50 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flecainide acetate, Quantity: 50 mg

Available from:

AUBEX PHARMA Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; hydrogenated vegetable oil; purified water; croscarmellose sodium

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BPA-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 BPA-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, BPA-Flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,Use of BPA-Flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,BPA-Flecainide tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.,Prescribers should also consult the "Special Warnings and Precautions for Use" section of this Product Information.

Product summary:

Visual Identification: 50mg tablets are white to off-white, round shaped oral tablet with debossed "BPL025" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-04-15

Patient Information leaflet

BPA-FLECAINIDE
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BPA-FLECAINIDE. 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 BPA-FLECAINIDE
against the benefits they expect it can 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 BPA-FLECAINIDE IS USED FOR
BPA-FLECAINIDE is used to treat a heart condition called arrhythmia.
Arrhythmia is an irregular or abnormal heartbeat. The active
ingredient in BPA-FLECAINIDE, 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 BPA-FLECAINIDE for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
BPA-FLECAINIDE is available only with a doctor's prescription.
BEFORE USING OR BEING GIVEN BPA-FLECAINIDE
_WHEN YOU MUST NOT USE OR HAVE BPA-FLECAINIDE _
DO NOT USE OR HAVE BPA-FLECAINIDE 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 BPA-FLECAINIDE TO CHILDREN. DO NOT
TAKE OR HAVE THIS MEDICINE:
•
if you have severe heart, liver or kidney disease unless your doctor
says it is suitable for you
•
after the USE BY date. The USE BY date can be found on the box and
tablet blister.
•
if the packaging is torn or shows signs of tampering
IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING OR BE GIVEN THIS
MEDICINE, TALK TO YOUR DOCTOR.
_BEFORE YOU START

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
BPA-FLECAINIDE (FLECAINIDE ACETATE) TABLETS
1
NAME OF THE MEDICINE
Flecainide Acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BPA-FLECAINIDE 50
contains 50 mg of Flecainide Acetate and
BPA-FLECAINIDE 100
contains 100 mg of Flecainide Acetate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BPA-FLECAINIDE 50
are white to off-white, round shaped oral tablet with debossed
"BPL025" on
one side and plain on the other side.
BPA-FLECAINIDE 100
are white to off-white, round shaped tablets with debossed "BPL026" on
one side and scored on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BPA-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 BPA-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,
BPA-Flecainide
should
be
used
with
extreme
caution,
preferably
after
other
antiarrhythmic drugs have been tried or considered inappropriate.
Use of BPA-Flecainide in chronic atrial fibrillation has not been
adequately studied and is not
recommended.
2.
Life threatening ventricular arrhythmias not controlled by other
drugs.
BPA-Flecainide tablets are used for continuous maintenance of normal
rhythm following initial
oral or intravenous (available in other brands) 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 ADMINISTRATION
ADULTS
The dosage of BPA-Flecainide must be adjusted to the individual needs
of each pat