AXINOL TABLET 20MG

Country: Malaysia

Language: English

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

Active ingredient:

TRIMETAZIDINE DIHYDROCHLORIDE

Available from:

IDAMAN PHARMA SDN. BHD.

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE

Units in package:

500Tablet Tablets; 100Tablet Tablets; 90 Tablet Tablets

Manufactured by:

T.O. CHEMICALS (1979) LTD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AXINOL
® 20MG TABLET
Trimetazidine dihydrochloride (20mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Axinol is used for
2.
How Axinol works
3.
Before you use Axinol
4.
How to use Axinol
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Axinol
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT AXINOL
IS USED FOR
Axinol contains the active ingredient
trimetazidine dihydrochloride.
This medicine is intended for use in adult
patients in combination with other medicines
to treat angina pectoris (chest pain caused by
coronary disease).
HOW AXINOL
WORKS
Axinol protects the heart cell from the effects
of reduced oxygen supply (ischemia) during
an episode of angina (chest pain).
BEFORE YOU USE AXINOL_ _
-
_When you must not use it_
• Have ever had allergic reaction to
trimetazidine dihydrochloride, the active
ingredient, or to any other ingredients in
Axinol.
• With Parkinson disease and/or parkinsonian
symptoms that affecting movements
(shaking, slowed movement and unbalanced
walk
• Have severe kidney problems
If you are not sure whether you should start
taking this medicine, consult your doctor.
-
_Before you start to use it _
Tell your doctor if you have allergies to any
other medicines, foods, preservatives or
dyes.
Tell your doctor if you:
• Suffer from kidney or liver disease
• Suffer from high blood pressure
• With Parkinson disease
• Suffer from movement disorders
• An elderly patient older than 75 years old
-
_Taking other medicines _
Tell your doctor if you are taking any other
medicine, including any that you buy without
a prescription. You may need to use different
amounts of these medicines, or you may
need to take different medicines. Your doctor
will advise you.
Axinol should not be taken together with
medicines from the group of Mono-amine
Oxidase (MAO) inhibitor.
-
_Pregnancy and lactation _
Safety of use of Axinol in pregnant and
nursing mothers has not been established. As
a prec

Summary of Product characteristics

AXINOL® 20 MG TABLET
COMPOSITION
Red film-coated round bi-convex tablets, embossed with ‘T’ on one
side.
Each tablet contains trimetazidine dihydrochloride 20 mg.
PROPERTIES
Trimetazidine is an antianginal and ant ischaemic agent which differs
chemically and
pharmacologically from beta-blocking agents, nitrates, and calcium
antagonists. Animal and
human studies have suggested cardio protective effects of
trimetazidine during ischaemic
states.
Trimetazidine maintains the level of energy of the cells during
systemic hypoxemia or local
ischaemia. It prevents electrophysiological manifestations of
ischaemia. It diminishes the rise
in the ST segment in ECG of dogs with experimental myocardial
infarction.
Studies in animals under severe hypoxia show that trimetazidine
prevents the collapse in the
levels of energy supplying ATP and cyclic AMP stores in the cerebral
cells. Trimetazidine
maintains functional activity of mitochondrial enzymes, the site of
cellular energy production
in the liver cell. The drug has been shown to protect tissues against
oxygen-free radicals
induced by chemicals or during ischaemic reperfusion.
Controlled double-blind trials in angina have demonstrated that
trimetazidine leads to
increased exercise tolerance beginning on the 15th day of treatment,
rise in total work
capacity in the exercise tolerance test, decreased the frequency and
intensity of anginal
episodes, and decreased trinitrate consumption.
Trimetazidine is rapidly absorbed following oral administration, with
a plasma peak level of
90 - 130 ng/ml attained 2 - 3 hours after administration of 40mg
doses.
The apparent volume of distribution is 4.8 L/kg; protein binding
approximately 21%.
Elimination of trimetazidine is primarily urinary; the mean half-life
is 5.5 hours.
INDICATIONS
_AXINOL _is indicated in adults as add-on therapy for the symptomatic
treatment of patients with
stable angina pectoris who are inadequately controlled by or
intolerant to first-line antianginal
therapies.
CONTRAINDICATIONS
_AXINOL _is contraindicated i