Flecainide 100mg Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Flecainide acetate

Доступна з:

Teva B.V.

Код атс:

C01BC; C01BC04

ІПН (Міжнародна Ім'я):

Flecainide acetate

Дозування:

100 milligram(s)

Фармацевтична форма:

Tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Antiarrhythmics, class Ic; flecainide

Статус Авторизація:

Marketed

Дата Авторизація:

2006-06-13

інформаційний буклет

PAGE 1 OF 5
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 such as Wolff-Parkinson White
Syndrome)

Tachycardia (fast heart beat)

Fibrillation (rapid contractions of muscles in the heart).
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). An allergic reaction may include rash, itching, difficulty
breathing or swelling of the face,
lips, throat or tongue.
- if you are using class 1 anti-arrhythmics (e.g., quinidine,
procainamide)
- if you have had heart problems such as heart failure, heart attack,
heart valve or conduction
problems - your doctor will study your medical history
- if you have been told you have an electrolyte imbalance (altered
blood salts)
- if you have cardiogenic shock
- if you suffer from known Brugada syndrome
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST

Характеристики продукта

Health Products Regulatory Authority
04 November 2021
CRN00CKSS
Page 1 of 8
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 Tablets 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
Initiation of therapy should take place in the hospital environment
with ECG monitoring.
SUPRAVENTRICULAR ARRHYTHMIAS:
Adults: the recommended starting dose is 50 mg twice daily and most
patients will be controlled at this dose. If required, the
dose may be increased to a maximum of 300 mg daily.
VENTRICULAR ARRHYTHMIAS:
Adults: the usual dose is 100 mg twice daily init