Tambocor 100mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

flecainide acetate 100 mg

Available from:

Meda Pharmaceuticals Limited

ATC code:

C01BC04

INN (International Name):

flecainide acetate

Pharmaceutical form:

tablet

Authorization status:

Authorised

Authorization date:

2006-03-29

Patient Information leaflet

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.
•   This medicine has been prescribed for you. Do not pass 
it on to others. It may harm them, even if their symptoms 
are the same as yours.
WHAT IS IN THIS LEAFLET:
1. What Tambocor is and what it is used for
2.  What you need to know before you take  Tambocor  
tablets
3. How to take Tambocor tablets
4. Possible side effects
5. How to store Tambocor tablets
6. Contents of the pack and other information.
1. WHAT TAMBOCOR IS AND WHAT IT IS USED FOR
Tambocor tablets belong to a group of medicines called 
 anti-arrhythmics. Anti-arrhythmics work by controlling the 
rate and rhythm of the heart.
Tambocor tablets are used to treat:
•  Arrhythmias (irregular heart beat)
•  Tachycardia (heart beat too fast)
•   Atrial fibrillation (rapid contractions of muscles in the 
heart).
It is important for your doctor to treat these conditions 
 quickly and effectively in order to prevent more serious 
heart problems from developing.
There are two strengths of tablet available, 50 mg and  
100 mg.
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE  
TAMBOCOR TABLETS
DO NOT TAKE TAMBOCOR TABLETS IF:
•   You are allergic to flecainide acetate or any of the other 
ingredients of Tambocor tablets (see Section 6)
•   You have heart failure
•    You have cardiogenic shock (your heart is unable to 
pump as much blood as your body needs)
•   You have heart block (your heart misses beats)
•   You have long-standing atrial fibrillation  
(rapid contractions of muscles in the heart)
•   You have or have ever had any heart problems including 
problems with the valves in your heart or conduction 
 problems
•   You have sinus node dysfunction (a specific  condition 
where your heart beats abnormally)
•  You h

Summary of Product characteristics

1.  NAME OF THE MEDICINAL PRODUCT 
Tambocor™100 mg tablets 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 100 mg of flecainide acetate 
For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 
Tablet 

4.  CLINICAL PARTICULARS 
Tambocor is a potent sodium channel blocking agent for the treatment of theconditions listed 
below: 

The effect on the JT interval is insignificant at
therapeutic levels. 

4.1 THERAPEUTIC INDICATIONS 
Tambocor tablets are indicated for: 
a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White 
Syndrome and similar conditions with accessory pathways. 

b) Paroxysmal atrial
fibrillation in patients with disabling symptoms when treatment need
has 
been established and in
the absence of left ventricular dysfunction
(see 4.4, Special warnings 
and special precautions for use). Arrhythmias of recent onset
will respond more readily. 

c) Symptomatic sustained ventricular tachycardia. 

d) 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. 

Tambocor tablets can be used
for the maintenance of normal rhythm following conversion by 
other means. 

Tambocor tablets are for oral administration. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Adults: Supraventricular arrhythmias:
The recommended starting dosage is 50mgtwice 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: The recommended starting dosage is 100mg twice daily. 
The maximum daily dose is 400mg and
this is normally reserved for patients of large build or 
where rapid c