Tambocor

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Flecainide acetate

זמין מ:

iNova Pharmaceuticals Australia Pty Ltd

סיווג:

Medicine Registered

עלון מידע

TAMBOCOR(TM)
1
TAMBOCOR(TM)
(tam-bo-core)
_Flecainide acetate (fleck-ain-ide ass-e-tate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tambocor tablets
and injection.  It does not contain all
the available information.  It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits.  Your doctor has weighed
the risk of you taking or being given
Tambocor against the benefits it can
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING OR HAVING THIS MEDICINE
PLEASE SPEAK TO YOUR DOCTOR, NURSE
OR PHARMACIST.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT TAMBOCOR IS
USED FOR
Tambocor is used to treat a heart
condition called arrhythmia.
Arrhythmia is an irregular or
abnormal heart beat. The active
ingredient in Tambocor, flecainide
acetate, belongs to a group of drugs
called antiarrhythmic medicines
which slow down the impulses that
cause the heart to beat in an irregular
or abnormal way.
Your doctor may have prescribed
Tambocor for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE USING OR BEING
GIVEN TAMBOCOR
_WHEN YOU MUST NOT USE OR_
_HAVE TAMBOCOR_
DO NOT USE OR HAVE TAMBOCOR IF
YOU HAVE AN ALLERGY TO:
*
flecainide acetate
*
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
*
shortness of breath
*
wheezing or difficulty breathing
*
swelling of the face, lips, tongue
or other parts of the body
*
rash, itching or hives on the skin
DO NOT GIVE TAMBOCOR TO CHILDREN.
DO NOT TAKE OR HAVE THIS MEDICINE:
*
if you have severe heart, liver or
kidney disease unless your doctor
says it is suitable for you
*
after the 'USE BY' date.  The
'USE BY' date can be found on
the box and tablet blister. For the
injection this can be found on the
box and vial label
*
if

מאפייני מוצר

iaptambo10808.doc - 
1 - 

PRODUCT INFORMATION 

TAMBOCOR
™ 

TABLETS 50MG, 100MG & INJECTION 150MG 

NAME OF THE MEDICINE 

NON-PROPRIETARY NAME: 
Flecainide Acetate 

CHEMICAL STRUCTURE: 

DESCRIPTION:   

Flecainide acetate; N-(2-piperidinylmethyl)-2, 5-bis
(2,2,2-trifluoroethoxy) benzamide acetate, belongs to the 
benzamide class of antiarrhythmic drugs
and is structurally related to lignocaine and procainamide.
 It is 
chemically distinguished from these agents by the
presence of trifluoroethoxy- substituents in the aromatic 
portion of the molecule and a piperidine ring in the amide side
chain instead of the diethylaminoethyl group of 
the procainamide side chain.  The compound is a racemic mixture.
 It is soluble in water, dilute acetic acid, 
methanol and ethanol and practically insoluble
in dilute hydrochloric acid. It has a molecular formula of 
C17H20F6N2O3.C2H4O2 and a molecular weight of 474.4; CAS
No: 54143-56-5. 

EXCIPIENTS: 
Tablets 
Pregelatinised Maize Starch;
Croscarmellose Sodium; Microcrystalline Cellulose; Hydrogenated
Vegetable Oil; 
Magnesium Stearate. 

Injection 
Sodium Acetate; Glacial Acetic Acid. 

PHARMACOLOGY 

PHARMACOLOGY:  TAMBOCOR belongs generally to the membrane
stabilising (Class 1) group of antiarrhythmic 
agents, however, it has its own characteristic electrophysiological
effects.  Its predominant effect on the 
transmembrane action potential in single cell
preparations from canine Purkinje fibres is to decrease the rate
of 
rise (V max, Phase 0) of the action potential without greatly
affecting duration.  In these same preparations, the 
duration of the effective refractory period was lengthened and
little, if any, change was observed in the slope of 
Phase 4 depolarization.  In ventricular muscle,
some lengthening of the action potential duration has been 
observed.  These results