TAMBOCOR TABLET 100MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
02-07-2021
Ciri produk Ciri produk (SPC)
03-11-2021

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:

60 Tablets

Dikeluarkan oleh:

UNIQUE PHARMACEUTICAL LABORATORIES

Risalah maklumat

                                1
TAMBOCOR TABLET
FLECAINIDE ACETATE 100MG _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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 and Product
Registration Holder
10.
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
•
You have a heart failure
•
You have had a myocardiac
infarction (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 beat)
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.
_Taking other
                                
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Ciri produk

                                PRODUCT DESCRIPTION
White, circular, biconvex tablets coded “TR100”
TAMBOCOR
®
Tablet 100mg
Black
Guide
A3038
8.22 mm
3.966 mm
2.201 mm
2.159 mm
2.159 mm
6.17 mm
1.955 mm
®
ARTWORK
COLOUR
100%
JOB NO. : JB-02153
UIC
: A3038
SKU
: 104141
A3038_TAMBOCOR 100MG TABLET 60
COMPONENT : LEAFLET
COUNTRY : MY
DIELINE REF: PP-1098
EMO: UNIQUE
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V2
G247 FILE NAME:
89154_A3038_TAMBOCOR
100MG TABLET 60_MY_LT_V2
08.11.19 - V0 - Artwork build - Sunny
24.02.21 - V1 - Amends - Sunny
28.10.21 - V2 - Amends - Soravit
THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK
SUPPLIER INFORMATION MAY BE PRESENT ON THE
PACKAGING
EMO/PRINTING VENDOR:
PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR
CHECKS ON:
• COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS
• TEXT - LINE THICKNESS, FONT SIZE
• DIELINE - SIZE, EYEMARK, PRINT DIRECTION
• CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR
MOVING FORWARD WHEN POSSIBLE ANY ADDITONAL
INFORMATION AND TECHNICAL CHECK REQUIRED BY EMO
ON THE ARTWORK BEFORE APPROVING.
Helvetica Neue LT W1G
77 Bold Condensed 31.4 pt
Helvetica Neue LT W1G
77 Bold Condensed 8.4 pt
Helvetica Neue LT W1G
57 Condensed 8.4 pt
Helvetica Neue LT W1G
57 Condensed 8.4 pt
PRODUCT DESCRIPTION
White, circular, biconvex tablets coded “TR100” on one face with a
break-line and plain on the other face.
Each tablet contains Flecainide Acetate 100mg.
COMPOSITION
Each tablet contains
Flecainide Acetate 100mg
PHARMACODYNAMICS
Flecainide is a Class 1 anti-arrhythmic (local anaesthetic) agents.
Flecainide slows conduction through the heart, having its greatest
effect on His bundle
conduction. It also acts selectively to increase anterograde and
particularly retrograde accessory pathway refractoriness.
Its actions may be reflected in the ECG by prolongation of the PR
interval and widening of the QRS complex. The effect on the JT
interval is insignificant.
PHARMACOKINETICS
Oral administration of Flecainide results in extensive absorption,
with bioavailability approaching 90 to 95%. Flecainide does no
                                
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