Flecaïnideacetaat 100 mg, tabletten

Země: Nizozemsko

Jazyk: nizozemština

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivní složka:

FLECAÏNIDEACETAAT;

Dostupné s:

Stada Arzneimittel AG

ATC kód:

C01BC04

INN (Mezinárodní Name):

FLECAÏNIDEACETAAT;

Léková forma:

Tablet

Podání:

Oraal gebruik

Terapeutické oblasti:

Flecainide

Přehled produktů:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD;

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLECAÏNIDEACETAAT 100 MG, TABLETTEN
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.
IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT 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 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
DO NOT USE FLECAINIDE

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

if you are taking certain other antiarrhythmics (sodium channel
blockers) as well

if have known brugada syndrome (genetic disease that is characte

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Flecaïnideacetaat 100 mg, tabletten
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.
White, circular, biconvex, uncoated tablets embossed with a score line
on one face with the
identifying letters “C” above the line and “FJ” below, the
reverse with a score line.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of
1. AV nodal reciprocating tachycardia; arrhythmias associated with
Wolff-Parkinson-White
Syndrome and similar conditions with accessory pathways, when other
treatment has
been ineffective.
2. Severe symptomatic and life-threatening paroxysmal ventricular
arrhythmia which has
failed to respond to other forms of therapy. Also where other
treatments have not been
tolerated.
3. 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 in hospital under
ECG and plasma level monitoring. The clinical decision to initiate
flecainide treatment should
be made in consultation with a specialist. 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 IC
(especially amiodarone), are
ineffective or not tolerated and when non-pharmacological treatment
(surgery, ablation,
implanted defibrillator) is not indicated. Strict medical monito