FLECAINIDE 100 Milligram Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

FLECAINIDE ACETATE

Disponible depuis:

McDermott Laboratories Ltd t/a Gerard Laboratories

Code ATC:

C01BC04

DCI (Dénomination commune internationale):

FLECAINIDE ACETATE

Dosage:

100 Milligram

forme pharmaceutique:

Tablets

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Antiarrhythmics, class Ic

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-06-13

Notice patient

PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLECAINIDE 50 MG TABLETS
FLECAINIDE 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 antiarrhythmics
which can be used to control the 
rate and rhythm of the heart.
Flecainide tablets are used to treat:

Arrhythmias (irregular heart beat)

Tachycardia (heart beat too fast)

Atrial fibrillation (rapid contractions of muscles in the heart).
It is important for your doctor to treat these conditions quickly and
effectively in order to prevent more 
serious heart problems from developing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLECAINIDE
DO NOT TAKE FLECAINIDE
:
- if you are allergic to flecainide or any of the other ingredients
of this medicine (listed in section 
6).
- if you suffer from heart failure, heart valve disease or missed
heart beats (heart block)
- if you have had a heart attack in the past
- if you have a continuous (long-standing) rapid and irregular
heart beat (atrial fibrillation)
- if you have any other condition that may affect the rhythm of
your heart
- if you have a heart condition called Brugada syndrome, whi

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flecainide 100mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg flecainide acetate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Uncoated white, convex 8.5mm long tablets, with scoreline, debossed “FC” over “100” on one side and “G” on the
other.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is recommended that treatment with Flecainide should be initiated in hospitals.
Flecainide are indicated for:
a) Symptomatic life threatening or disabling sustained ventricular tachycardia.
b) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling
symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.
c) AV nodal reciprocating tachycardia when patients have been unresponsive to beta-blockers or calcium channel
blockers and in the absence of left ventricular dysfunction (see section 4.3).
d) Wolff-Parkinson White Syndrome and similar conditions with accessory pathways in the absence of left
ventricular dysfunction (see section 4.3).
e) Paroxysmal atrial fibrillation and atrial flutter when treatment need has been established and in the absence of
left ventricular dysfunction (see section 4.3).
Flecainide can be used for the maintenance of normal rhythm following conversion by other means.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initiation of therapy should take place in the hospital environment with ECG monitoring.
Supraventricular arrhythmias
Adults: The recommended starting dose is 50mg twice daily and most patients will be controlled at t