TAMBOCOR 10 Mg/Ml Solution for Inj/Inf

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

FLECAINIDE ACETATE

Dostępny od:

Meda Health Sales Ireland Limited

Kod ATC:

C01BC04

INN (International Nazwa):

FLECAINIDE ACETATE

Dawkowanie:

10 Mg/Ml

Forma farmaceutyczna:

Solution for Inj/Inf

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Antiarrhythmics, class Ic

Status autoryzacji:

Authorised

Data autoryzacji:

2007-07-06

Ulotka dla pacjenta

PACKAGE LEAFLET: 
INFORMATION FOR THE USER  
TAMBOCOR  
10MG/ML SOLUTION FOR THE INJECTION OR INFUSION 
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 nurse. 
- 
If you get any side effects, talk to your doctor or
nurse. This includes any possible side 
effects not listed in this leaflet. 
The name of your medicine is Tambocor 10mg/ml Solution for
injection, which will be called 
Tambocor throughout this leaflet. 

WHAT IS IN THIS LEAFLET: 
1.  What Tambocor is and what it is used for 
2.  What you need to know before you use Tambocor 
3.  How to use Tambocor 
4.  Possible side effects 
5.  How to store Tambocor 
6.  Contents of the pack and other information 

1.  WHAT TAMBOCOR IS AND WHAT IT IS USED FOR 
Tambocor contains the active ingredient flecainide, which belongs
to a group of medicines called 
anti-arrhytmics, which control the speed and rhythm of
the heart. 

Tambocor is used to treat: 
- 
Arrhythmias (irregular heart beat)  
- 
Tachycardia ( too fast heart beat) 
- 
Wolff-Parkinson-White Syndrome ( a special kind of
heart beat irregularity with a 
disorder of conduction) 
- 
Atrial fibrillation and atrial flutter ( rapid contraction of
muscles in the heart) 

2.  WHAT YOU NEED TO KNOW BEFORE YOU USE TAMBOCOR 
DO NOT USE TAMBOCOR: 
- 
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 taking a similar anti-arrhythmic drug (other class
1 anti-arrhythmics, e.g.

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tambocor 10 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg Flecainide acetate.
Each 15ml ampoule contains 150mg Flecainide acetate.
Excipients: contains 1.6mmol (37.7mg) of sodium per ampoule.
_For a full list of excipients, see 6.1._
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is recommended that treatment with Tambocor should be initiated in
hospitals.
‘Tambocor’ injection is indicated when rapid control of the
following arrhythmias is the main clinical
requirement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Initiation of therapy should take place in the hospital environment
with ECG monitoring. ECG monitoring should be
maintained during intravenous infusion.
Adults Only:
a)
Bolus injection: Tambocor can be given in an emergency or for rapid
effect by a slow injection of 2mg/kg over
not less than ten minutes, or in divided doses. If preferred, the dose
may be diluted with 5% dextrose and given as
a mini-infusion. Continuous ECG monitoring is recommended in all
patients receiving the bolus dose. The
injection should be stopped when there is control of the arrhythmia.
It is recommended that Tambocor should be administered more slowly to
patients in sustained ventricular tachycardia,
with careful monitoring of the electrocardiogram. Similar caution
should apply to patients with a history of cardiac
failure, who may become decompensated during the administration. For
such patients it is recommended that the initial
dose is given over 30 minutes.
a)
Ventricular tachyarrhythmias.
b)
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).
c)
Wolff-Parkinson-White Syndrome and similar conditions with accessory
pathways in the absence of left-
ventricular dys