Eurythmic Tablet 200mg

Valsts: Malaizija

Valoda: angļu

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

Nopērc to tagad

Lietošanas instrukcija Lietošanas instrukcija (PIL)
08-04-2022
Produkta apraksts Produkta apraksts (SPC)
31-05-2022

Aktīvā sastāvdaļa:

AMIODARONE HYDROCHLORIDE

Pieejams no:

UNIMED SDN BHD

SNN (starptautisko nepatentēto nosaukumu):

AMIODARONE HYDROCHLORIDE

Vienības iepakojumā:

100Tablet Tablets

Ražojis:

Troikaa Pharmaceuticals Ltd

Lietošanas instrukcija

                                EURYTHMIC TABLETS 200MG
Amiodarone Hydrochloride 200mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What EURYTHMIC Tablet is used
for
2.
How EURYTHMIC Tablet works
3.
Before you use EURYTHMIC
Tablet
4.
How to use EURYTHMIC Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
EURYTHMIC Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT EURYTHMIC TABLET IS USED FOR
EURYTHMIC tablet is indicated only
for the treatment of severe heart rhythm
disorders, not responding to other
therapy or when other treatment cannot
be used:
•
Treat uneven heartbeats
•
Treat other types of fast or uneven
heartbeats known as ‘ atrial
flutter’ or ‘atrial fibrillation’
•
Treat fast heartbeats which may
happen suddenly and may be
uneven.
•
Treat an illness called Wolff-
Parkinson-White Syndrome. This
is where your heart beats
unusually fast.
HOW EURYTHMIC TABLET WORKS
EURYTHMIC tablet contains the active
ingredient
Amiodarone
Hydrochloride
which belongs to the group of medicines
called anti-arrhythmics. Eurythmic works
by controlling the uneven beating of your
heart (called ‘arrhythmias’). Taking the
tablet helps your heartbeat to return to
normal.
BEFORE YOU USE EURYTHMIC TABLET_ _
_When you must not use it _
Do not take EURYTHMIC tablet if:
•
You are allergic (hypersensitive) to
iodine, amiodarone or any of the
other ingredients of this medicine.
•
Signs of allergic reaction include: a
rash, swallowing or breathing
problem, swelling of your lips, face,
throat or tongue
•
You have a slower than usual
heartbeat (called ‘sino-atrial’ heart
block.
•
You have any other problem with
your heartbeat and do not have a
pacemaker fitted.
•
You have ever had thyroid problem.
Your doctor should test your thyroid
before giving you this medicine.
•
If you’re pregnant or breast-feeding.
•
You are taking any other medicines
that may include heart rhythm
disturbances
Do not use this medicin
                                
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Produkta apraksts

                                FRONT
AMIODARONE HYDROCHLORIDE BP 200 mg.
Pharmacodynamics: There is no well-established relationship of
plasma concentration to effectiveness, but it does appear that
concentrations much below 1 mg/L are often ineffective and that
levels above 2.5 mg/L are generally not needed. Some
observations have suggested a plasma concentration, dose, or
dose/duration relationship for side effects such as pulmonary
fibrosis, liver-enzyme elevations, corneal deposits and facial
pigmentation, peripheral neuropathy, gastrointestinal and central
nervous system effects.
White to off white colored, round, flat, uncoated beveled edge and
having break line on one side of tablet.
Pharmacodynamics
Electrophysiology / Mechanism of Action: The antiarrhythmic
effect of amiodarone may be due to at least two major properties:
DESCRIPTION:
2.
Noncompetitive
α
- and
β
-adrenergic inhibition.
Amiodarone prolongs the duration of the action potential of all
cardiac fibers while causing minimal reduction of dV/dt (maximal
upstroke velocity of the action potential). The refractory period is
prolonged in all cardiac tissues without influencing
resting
membrane potential, except in automatic cells where the slope of
the prepotential is reduced, generally reducing automaticity.
These electrophysiologic effects are reflected in a decreased
sinus rate of 15 to 20%, increased PR and QT intervals of about
10%, the development of U-waves, and changes in T-wave
contour. These changes should not require discontinuation of
amiodarone as they are evidence of its pharmacological action,
although amiodarone can cause marked sinus bradycardia or
sinus arrest and heart block. On rare occasions, QT prolongation
has been associated with worsening of arrhythmia.
Hemodynamics: After intravenous administration, amiodarone
relaxes vascular smooth muscle, reduces peripheral vascular
resistance (afterload), and slightly increases cardiac index. After
oral dosing, amiodarone produces no significant change in left
ventricular ejection fraction (LVEF), even in patients 
                                
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