Flecainide 100mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Flecainide acetate

Saatavilla:

Viatris UK Healthcare Ltd

ATC-koodi:

C01BC04

INN (Kansainvälinen yleisnimi):

Flecainide acetate

Annos:

100mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02030200; GTIN: 5016695320199

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
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 is and what it is used for
2. What you need to know before you take
Flecainide
3. How to take Flecainide
4. Possible side effects
5. How to store Flecainide
6. Contents of the pack and other
information
1. WHAT FLECAINIDE IS AND WHAT IT IS
USED FOR
Flecainide belongs to a group of medicines
called antiarrhythmic agents. Flecainide is
used to treat an irregularity in the heartbeat
(known as an arrhythmia). It works by
correcting irregular heartbeats to a normal
rhythm.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLECAINIDE
DO NOT TAKE FLECAINIDE:
•
if you are allergic to flecainide acetate
or any of the other ingredients of this
medicine (listed in section 6).
•
if you suffer from heart failure or some
types of heart rhythm disorders
•
if you suffer from heart valve disease
•
if you have a history of heart attacks
•
if you have low blood pressure or a slow
beating heart
•
if you have a serious heart condition
called cardiogenic shock which causes
rapid breathing, weakness, looking
pale, confusion and can lead to a loss of
consciousness
•
if you have a heart condition called
Brugada Syndrome, which causes you to
have a potentially life-threatening heart
rhythm disorder
•
if you are already taking Disopyramide to
regulate your heartbeat
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
Flecainide acetate 100 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 87.34mg of flecainide as flecainide acetate
100mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
100mg: Uncoated, white, convex 8.5mm round tablet, with breakline,
debossed “FC” over “100” on one side
and “G” on the other. The 100 mg tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flecainide acetate is indicated for use in patients with the following
arrhythmias:
Severe symptomatic supraventricular arrhythmia
AV nodal reciprocating tachycardia.
Arrhythmias associated with the Wolff-Parkinson-White syndrome and
similar conditions associated with
the presence of accessory pathways.
Paroxysmal atrial fibrillation in patients with disabling symptoms
after cardioversion.
Patients with structural heart disease and/or impaired left
ventricular function should be excluded because of
the increased risk of pro-arrhythmic effects. Arrhythmias of recent
onset will respond more readily.
Symptomatic sustained ventricular tachycardia.
Premature ventricular contractions and/or non-sustained ventricular
tachycardia which are causing disabling
symptoms which have failed to respond to other forms of therapy or in
which other treatments have not been
tolerated.
Flecainide tablets can be used for the maintenance of normal rhythm
following conversion by other means.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The clinical decision to initiate flecainide treatment should be made
in consultation with a specialist and
should be initiated in hospital. In patients with an underlying
organic cardiopathy and especially those with
a history of myocardial infarction, flecainide treatment should only
be started when other arrhythmic agents,
other than class 1C (especially amiodarone), are ineffective or not
tolerated and when non pharmacological
treatment (surgery, ablation, implanted defibrillator) is not
indicated.