Tambocor 50 mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Flecainide acetate

Dostupné s:

Mylan IRE Healthcare Limited

ATC kód:

C01BC; C01BC04

INN (Mezinárodní Name):

Flecainide acetate

Dávkování:

50 milligram(s)

Léková forma:

Tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Antiarrhythmics, class Ic; flecainide

Stav Autorizace:

Marketed

Datum autorizace:

1999-10-01

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMBOCOR 50 MG AND 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.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Tambocor tablets are and what it is used for
2.
What you need to know before you use Tambocor tablets
3.
How to use Tambocor tablets
4.
Possible side effects
5.
How to store Tambocor tablets
6.
Contents of the pack and other information
1.
WHAT TAMBOCOR TABLETS ARE AND WHAT IT IS USED FOR
Tambocor tablets contain the active ingredients flecainide, which
belongs to a group of medicines
called anti-arrhythmics, which control the speed and rhythm of the
heart.
Tambocor tablets are used to treat:
-
Arrhythmias (irregular heart beat such as Wolff-Parkinson White
Syndrome)
-
Tachycardia (fast heart beat)
-
Fibrillation (rapid contraction of muscles in the heart)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TAMBOCOR TABLETS
DO NOT TAKE TAMBOCOR TABLETS:
-
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 before taking Tambocor tablets if
you have any of the following
conditions:
-
If you have liver disease
-
If you have a pa

Charakteristika produktu

Health Products Regulatory Authority
25 November 2020
CRN00C1SL
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tambocor 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains flecainide acetate 50 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, circular, biconvex tablets, 6.35 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is recommended that treatment with Tambocor should be initiated in
hospitals.
Tambocor 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 4.3,
Contra-indications).
d)
Wolff-Parkinson White Syndrome and similar conditions with accessory
pathways in the absence of left ventricular
dysfunction (See 4.3, Contra-indications).
e)
Paroxysmal atrial fibrillation and atrial flutter when treatment need
has been established and in the absence of left
ventricular dysfunction (see 4.3, Contra-indications).
Tambocor tablets 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 initially with subsequent
increments of 50 mg daily every 4 days to the level of
optimal response of a maximum dose of 400 mg daily with subsequent
r