Flecainide Acetate 100mg Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

FLECAINIDE ACETATE

Saatavilla:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-koodi:

C01BC04

INN (Kansainvälinen yleisnimi):

FLECAINIDE ACETATE 100 mg

Lääkemuoto:

TABLET

Koostumus:

FLECAINIDE ACETATE 100 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

CARDIAC THERAPY

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-03-07

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLECAINIDE ACETATE
50 MG TABLETS
FLECAINIDE ACETATE
100 MG TABLETS
flecainide acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Flecainide Acetate is and what it is used for
2.
What you need to know before you take Flecainide Acetate
3.
How to take Flecainide Acetate
4.
Possible side effects
5.
How to store Flecainide Acetate
6.
Contents of the pack and other information
1. WHAT FLECAINIDE ACETATE IS AND WHAT IT IS USED FOR
Flecainide belongs to the group of medicines that work against cardiac
arrhythmia (known as anti-
arrhythmics). It inhibits stimulus conduction in the heart and extends
the time during which the heart is
at rest, causing the heart to pump normally again.
Flecainide Acetate is used
-
for certain serious cardiac arrhythmias, which are often expressed as
serious palpitations of the
heart or tachycardia.
-
for serious cardiac arrhythmias that did not respond well to treatment
with other medicines, or
when other treatments cannot be tolerated.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLECAINIDE ACETATE
DO NOT TAKE FLECAINIDE ACETATE
•
if you are allergic to flecainide or any of the other ingredients of
this medicine (listed in section
6).
•
If you suffer from another heart condition, different from the heart
condition for which you are
taking this medicine. If you are unsure, or if you would like
additional information, consult your
doctor or pharmacist.
•
you are taking certain other antiarrhythmics (sodium channel

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flecainide Acetate 50 mg tablets
Flecainide Acetate 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains flecainide acetate 50 mg
Each tablet contains flecainide acetate 100 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_ _
_Flecainide Acetate 50mg tablets: _
White to off-white, round [diameter 6.5 mm], biconvex tablets embossed
with ‘CC’ on one side and
‘11’ on the other side.
_Flecainide Acetate 100mg tablets: _
White to off-white, round [diameter 8.5 mm], biconvex, scored tablets
debossed with ‘1’ and ‘2’
separated by deep score line on one side and ‘CC’ on the other
side. The tablet can be divided into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of AV nodal reciprocating tachycardia; arrhythmias
associated with Wolff-Parkinson-
White Syndrome and similar conditions with accessory pathways, when
other treatment has been
ineffective.
•
Treatment of severe symptomatic and life-threatening paroxysmal
ventricular arrhythmia which
has failed to respond to other forms of therapy or where other
treatments have not been tolerated.
•
Treatment of paroxysmal atrial arrhythmias (atrial fibrillation,
atrial flutter and atrial tachycardia)
in patients with disabling symptoms after conversion provided that
there is definite need for
treatment on the basis of severity of clinical symptoms, when other
treatment has been
ineffective. Structural heart disease and/or impaired left ventricular
function should be excluded
because of the increased risk for pro-arrhythmic effects.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initiation of flecainide acetate therapy and dose changes should be
made under medical supervision
and monitoring of ECG and plasma level. Hospitalization could be
necessary during such procedures
for certain patients, especially for patients with life threatening
ventricular arrhythmias.These
decisions sh