Flecainide 100mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Flecainide acetate

Tilgjengelig fra:

Accord-UK Ltd

ATC-kode:

C01BC04

INN (International Name):

Flecainide acetate

Dosering :

100mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02030200; GTIN: 5012617005380

Informasjon til brukeren

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 blockers) as well;
•
If you know that you have a genetic disease
[Brugada syndrome] characterized by
abnormal electrocardiogram (ECG)
WARN

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flecainide Acetate Tablets 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg Flecainide Acetate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex, uncoated tablets one side embossed with a
breakline
and the identifying letters “C” above the line and “FJ” below,
the reverse side
embossed with a breakline.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide 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
Adults:
Supraventricular arrhythmias: The recommended starting dose is 50mg
twice daily
and most patients will be controlled at this dose. If required the
dose may be
increased to a maximum of 300mg daily.
Ventricular arrhythmias: The recommended starting dose is 100mg twice
daily. The
maximum daily dose is 400mg and this is normally reserved for patients
of large
build or where rapid control of the arrhythmia is required. After 3-5
days it is
recommended that the dosage be progressively adjusted to the lowest
level which
maintains cont