Flecainideacetaat 50 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FLECAÏNIDEACETAAT

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

C01BC04

INN (Algemene Internationale Benaming):

FLECAÏNIDEACETAAT

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Flecainide

Product samenvatting:

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

Autorisatie datum:

2006-02-10

Bijsluiter

Hexal AG.
Page 1/6
Flecaïnideacetaat 50 en 100 mg, tabletten
RVG 33523-4
1313-v7
1.3.1.3 Bijsluiter
Juli 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLECAÏNIDEACETAAT 50 MG, TABLETTEN
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.
WHAT IS IN THIS LEAFLET:
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] belongs to the group of medicines that
work against cardiac arrhythmia
(known as antiarrhythmics). 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.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT USE [NATIONALLY COMPLETED NAME]
-
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

Productkenmerken

HEXAL AG
Page 1/10
Flecaïnideacetaat 50 mg en 100 mg, tabletten
RVG 33523-4
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
Juli 2019
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flecaïnideacetaat 50 mg, tabletten
Flecaïnideacetaat 100 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of flecainide acetate.
Each tablet contains 100 mg of flecainide acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_50 mg tablets: _
White, circular, biconvex, uncoated tablets embossed “C” on one
face and the identifying letters “FI” on the
reverse.
_100 mg tablets: _
White, circular, biconvex, uncoated tablets embossed with a breakline
on one face with the identifying letters
“C” above the line and “FJ” below, the reverse with a
breakline.
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
HEXAL AG
Page 2/10
Flecaïnideacetaat 50 mg en 100 mg, tabletten
RVG 33523-4
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
Juli 2019
2
Initiation of flecainide acetate therapy and dose changes should be
made under medic