TAMBOCOR TABLET 100MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FLECAINIDE ACETATE

Boleh didapati daripada:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (Nama Antarabangsa):

FLECAINIDE ACETATE

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

3M HEALTH CARE LTD

Risalah maklumat

1
_Consumer Medication Information Leaflet (RiMUP) _
TAMBOCOR TABLET 100MG
Flecainide acetate 100mg
WHAT IS IN THIS LEAFLET
1.
What Tambocor Tablet 100mg is
used for
2.
How Tambocor Tablet 100mg
works
3.
Before you use Tambocor Tablet
100mg
4.
How to use Tambocor Tablet
100mg
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Tambocor
Tablet 100mg
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT TAMBOCOR TABLET 100MG IS
USED FOR
Tambocor Tablet 100mg is used to
treat a heart condition called
arrhythmia. Arrhythmia is an irregular
or abnormal heart beat.
HOW TAMBOCOR TABLET 100MG WORKS
Tambocor Tablet 100mg contains the
active ingredient Flecainide acetate
100mg. It belongs to a group of
medicines called anti-arrthymic
medicine.
Tambocor Tablet 100mg works by
slowing down the impulses that cause
the heart to beat irregularly or
abnormally.
Ask your pharmacist or doctor if you
have any questions about this
medicine.
BEFORE YOU USE TAMBOCOR TABLET
100MG
_ When you must not use it _
Do not take Tambocor Tablet 100mg if
you have
any of the following:
•
You are allergic to Flecainide
acetate or any other
ingredients of Tambocor
Tablet 100mg tablets.
•
You have a heart failure
•
You have had a myocardiac
infraction (heart attack)
•
You have a long standing
atrial fibrillation (rapid
contractions of muscles in the
heart)
•
You have had problems with
the valves in your heart
•
You have sinus node
dysfunction (a specific
condition where your heart
beats abnormally)
•
You have heart block (your
heart misses beats)
Do not take Tambocor Tablet 100mg:
•
after the expiry date on the
pack;
•
if the packaging shows signs
of tampering.
•
unless advised by your doctor
_Before you start to use it _
Tell your doctor or pharmacist if
•
you have allergies to any
other medicines
•
you have any heart problems;
•
you have any liver or kidney
problems;
Tell your doctor if you are pregnant or
breast feeding or intend to become
pregnant or breastfeed.

Ciri produk

Presentation
Tambocor Tablets:  White, circular, biconvex tablets, 8.5mm in diameter marked “3M” on one side and “TR100” with a break-line 
on the other. Each tablet contains ecainide acetate 100mg.
Uses
Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below. It is recommended that 
treatment with Tambocor should be initiated in hospitals. Tambocor slows conduction through the heart, its actions may be 
reected in the ECG by prolongation of the PR interval and widening of the QRS complex. 
The eect on the JT interval is insignicant at therapeutic levels.
Pharmacodynamics
Tambocor is a class 1 anti-arrhythmic (Local anaesthetic) agents.
Tambocor slows conduction through the heart, having its greatest eect on His Bundle conduction. It also acts selectively to 
increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reected in the ECG by 
prolongation of the PR interval and widening of the QRS complex. The eect on the JT interval is insignicant.
Pharmacokinetics
Oral administration of ecainide results in extensive absorption, with bioavailability approaching 90 to 95%. Flecainide does not 
appear to undergo signicant hepatic rst-pass metabolism. In patients, 200 to 500mg ecainide daily produced plasma 
concentrations within the therapeutic range of 200-1000μg/l. Protein binding of ecainide is within the range of 32 to 58%.
Recovery of unchanged ecainide in urine of healthy subjects was approximately 42% of a 200mg oral dose, whilst the two major 
metabolites (Meta-O-Dealkylated lactam Metabolites) accounted for a further 14% each. The elimination half-life was 
12 to 27 hours.
Indications
Tambocor tablets are indicated for:
a) AV nodal reciprocating tachycar