Metazine Tablet 20mg

Country: Malaysia

Language: English

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

Active ingredient:

TRIMETAZIDINE DIHYDROCHLORIDE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE

Units in package:

500 Tablets; 100 Tablets; 500 Tablets; 100 Tablets; 100 Tablets; 500 Tablets

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
METAZINE TABLET
Trimetazidine dihydrochloride (20mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
METAZINE
TABLET is used for
2.
How
METAZINE
TABLET works
3.
Before you use METAZINE
TABLET
4.
How
to
use
METAZINE
TABLET
5.
While
you
are
using
METAZINE TABLET
6.
Side effects
7.
Storage
and
disposal
of
METAZINE TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT METAZINE TABLET
IS USED FOR
METAZINE TABLET is used
in adults as add-on therapy for
the symptomatic treatment of
individuals with stable angina
pectoris
(chest
pain
due
to
coronary heart disease) who are
inadequately controlled by or
intolerant
to
first-line
antianginal therapies.
HOW
METAZINE
TABLET
WORKS
METAZINE TABLET contains
trimetazidine which restores the
energetic
activity
and
the
operation of the ionic pump in
the membrane of the ischemic
cell,
especially
at
the
myocardial level.
For
treatment
in
angina
pectoris,
METAZINE
TABLET
increases
coronary
reserve, prevents sudden rises
in blood pressure and reduces
the frequency of attacks.
BEFORE YOU USE METAZINE
TABLET
_-_
_ _
_When you must not use it _
Do
not
use
METAZINE
TABLET if you are allergic to
Trimetazidine Hydrochloride or
any
of
the
other
ingredients
listed at the end of the leaflet.
_-_
_ _
_Before you start to use it _
Before
taking
METAZINE
TABLET, you must tell your
doctor
or
pharmacist
if
you
have, or have had, any of the
following conditions:

Parkinson
disease,
parkinsonian
symptoms,
tremors,
restless
leg
syndrome and other related
movement disorders.

Severe
renal
impairment
(creatinine
clearance
<30ml/min).
If you are not sure if you have,
or
have
had,
any
of
these
conditions,
you
should
raise
those concerns with your doctor
or pharmacist.
_Pregnancy _
Ask for your doctor’s advice if
you are pregnant, or likely to
become pregnant during your
course of medication.
_Breastfeeding _
Ask for your doctor’s advice if
you are breastfeeding, or likely
to
breastfeed
during
your
course

Summary of Product characteristics

Page 1 of 1
[REVISION DATE:11.04.2023]
[DUOPHARMA (M) SDN BHD]
METAZINE TABLET 20MG
DESCRIPTION:
A round tablet, scored on one side and with marking ‘DUO 3’ on the
scored side and ‘DUO 4’ on the other side.
COMPOSITION:
Each tablet contains Trimetazidine Dihydrochloride 20 mg.
PHARMACODYNAMICS:
Trimetazidine restores the energetic activity and the operation of the
ionic pump in the membrane of the ischaemic cell, especially at the
myocardial level. In patients suffering from angina pectoris, Metazine
increases coronary reserve, prevents sudden rises in blood pressure
and reduces the frequency of attacks.
PHARMACOKINETICS:
_ABSORPTION _
Following oral administration blood levels reach a peak in 2 - 3 hours
and then decrease gradually with terminal half-life of about 6 hours.
The bioavailability of orally administered trimetazidine is
approximately 90%. Food intake does not modify absorption.
_METABOLISM _
The major route of elimination is urinary, with about 60% of the
administered dose being eliminated in the unchanged form. The rest is
metabolized. Little is known of the properties of the metabolites,
which are however only present in weak concentrations.
_PLASMA PROTEIN BINDING _
Approximately 16% is bound to plasma proteins, chiefly albumin.
INDICATION:
Trimetazidine 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.
RECOMMENDED DOSAGE:
The dose is one tablet of 20mg of trimetazidine three times a day
during meals.
The benefit of the treatment should be assessed after three months and
trimetazidine should be discontinued if there is no treatment
response.
Special populations
Patient with renal impairment:
In patients with moderate renal impairment (creatinine clearance
[30-60] ml/min), the recommended dose is 1 tablet of 20mg twice daily
i.e., one in the morning and one in the evening during meals.
Elderly patient:
Elderly patient may have increased trimetazi