Flecainide BNM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flecainide acetate 50mg;  

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Flecainide acetate 50 mg

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Flecainide acetate 50mg   Excipient: Croscarmellose sodium Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch

Prescription type:

Prescription

Manufactured by:

Unimark Remedies Limited

Therapeutic indications:

In patients without structural heart disease and without myocardial infarction, Flecainide BNM tablets are indicated for the prevention of: Supraventricular arrhythmias · paroxysmal supraventricular tachycardias (PSVT) including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms; · paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Ventricular arrhythmias · documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (VT) if they are considered life-threatening in the judgement of the attending physician. Not indicated for less severe ventricular arrhythmias even if symptomatic. Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 60 tablets - 3 years from date of manufacture stored at or below 25°C

Authorization date:

2013-07-26

Patient Information leaflet

1
FLECAINIDE BNM
Consumer Medicine Information
FLECAINIDE BNM
_FLECAINIDE ACETATE 50 MG & 100 MG TABLETS _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Flecainide
BNM.
This leaflet answers some common questions about Flecainide BNM. It
does not contain
all the available information. The most up-to-date Consumer Medicine
Information can be
downloaded from www.medsafe.govt.nz.
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 BNM 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 BNM IS USED FOR
Flecainide BNM is used to treat a heart condition called arrhythmia,
which is an irregular
or abnormal heart beat. The active ingredient, flecainide acetate,
belongs to a group of
medicines called anti-arrhythmics, 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 reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Flecainide BNM is only available with a doctor's prescription.
Flecainide BNM is not addictive.
2
FLECAINIDE BNM
BEFORE YOU TAKE FLECAINIDE BNM
_ _
Flecainide BNM is not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE FLECAINIDE BNM IF YOU ARE ALLERGIC TO ANY MEDICINE
CONTAINING FLECAINIDE
OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
DO NOT TAKE FLECAINIDE BNM IF YOU:
▪
suffer from certain other heart conditions, different from the heart
condition for which
you are taking this medicine
▪
are taking certain other medicines for arrhythmia (irregular or
abnormal heart beat)
▪
have severe liver or kidney disease unless your doctor says it is
suitable for you.
DO NOT TAKE IT AFTER THE EXPIRY DA

Summary of Product characteristics

1
FLECAINIDE BNM
FLECAINIDE ACETATE TABLETS 50 MG AND 100 MG
NEW ZEALAND DATA SHEET
1
FLECAINIDE BNM
FLECAINIDE BNM
50 mg and 100 mg tablet.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flecainide acetate 50 mg
Each tablet contains flecainide acetate 50 mg.
Flecainide acetate 100 mg
Each tablet contains flecainide acetate 100 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Flecainide 50 mg tablets: White, circular, biconvex, uncoated tablets
embossed “C” on
one face and the identifying letters “FI” on the reverse.
Flecainide 100 mg tablets: White, circular, biconvex, uncoated tablets
embossed with a
break line on one face with the identifying letters “C” above the
line and “FJ” below, the
reverse with a break line.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In
patients
without
structural
heart
disease
and
without
myocardial
infarction,
Flecainide BNM tablets are indicated for the prevention of:
SUPRAVENTRICULAR ARRHYTHMIAS
•
paroxysmal supraventricular tachycardias (PSVT) including
atrioventricular nodal
reentrant tachycardia, atrioventricular reentrant tachycardia and
other supraventricular
tachycardias of unspecified mechanism associated with disabling
symptoms;
•
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling
symptoms.
2
FLECAINIDE BNM
FLECAINIDE ACETATE TABLETS 50 MG AND 100 MG
VENTRICULAR ARRHYTHMIAS
•
documented life-threatening ventricular arrhythmias such as sustained
ventricular
tachycardia (VT) if they are considered life-threatening in the
judgement of the
attending physician. Not indicated for less severe ventricular
arrhythmias even if
symptomatic.
Use of flecainide in chronic atrial fibrillation has not been
adequately studied and is not
recommended.
4.2
DOSE AND METHOD OF ADMINISTRATION
The following regimen is suggested as a guideline. However, dosage may
need to be
modified as dictated by the weight, age or clinical status of the
patient.
GENERAL CONSIDERATIONS
•
Prior to