TAMBOCOR 100 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLECAINIDE ACETATE

Available from:

Meda Health Sales Ireland Limited

ATC code:

C01BC04

INN (International Name):

FLECAINIDE ACETATE

Dosage:

100 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiarrhythmics, class Ic

Authorization status:

Authorised

Authorization date:

2007-07-06

Patient Information leaflet

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 bee

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tambocor 100 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Flecainide Acetate 100 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex tablets, marked ‘3M’ on one side and
‘TR 100’ with a breakline on the other.
The tablet can be divided into equal halves.
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 contraction 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, Contraindications).
d)
Wolff-Parkinson-White Syndrome and similar conditions with accessory
pathways in the absence of left
ventricular dysfunction (See section 4.3, Contraindications).
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, Contraindications).
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 50mg twice daily and most
patients will be controlled at this dose. If
required the dose may be increased to a maximum of 300mg daily.
Ventricular arrhythmias:
Adults Only: The usual dose is 100mg twice daily initially with
subsequent increments of 50mg every 4 days daily to
the level of optimal response