VASTAREL MR

Country: Malaysia

Language: English

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

Active ingredient:

TRIMETAZIDINE DIHYDROCHLORIDE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE

Units in package:

60Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
VASTAREL MR_ _
_Trimetazidine dihydrochloride, 35mg _
_ _
WHAT IS IN THIS LEAFLET
1.
What
VASTAREL
MR
is
used for
2.
How
VASTAREL
MR
works
3.
Before you use VASTAREL
MR,
4.
How
to
use
VASTAREL
MR,
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
VASTAREL MR
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
WHAT VASTAREL MR IS USED
FOR
OTHER
CARDIAC
PREPARATIONS
-
ATC
code:
C01EB15
This medicine is intended for use
in adult patients, in combination
with
other
medicines
to
treat
angina pectoris (chest pain caused
by coronary disease).
BEFORE
YOU
USE
VASTAREL
MR
- _When you must not use it_
_DO NOT TAKE VASTAREL MR: _
•
if
you
are
allergic
to
trimetazidine
or
any
of
the
other
ingredients
of
this
medicine (listed in section 8),
•
if
you
have
a
Parkinson
disease: disease of the brain
affecting
movement
(trembling, rigid posture, slow
movements
and
a
shuffling,
unbalanced walk),
•
if
you
have
severe
kidney
problems.
-
_Before you start to use it _
Talk to your doctor or pharmacist
before taking VASTAREL MR.
This medicinal product is not a
curative
treatment
for
angina
attacks, nor an initial treatment
for unstable angina. It is not a
treatment
for
myocardial
infarction.
In
the
event
of
an
chest
pain
angina attack, inform your doctor.
Tests may be required and your
treatment
may
possibly
be
modified.
This
medicine
can
cause
or
worsen
symptoms
such
as
trembling,
rigid
posture,
slow
movements
and
a
shuffling,
unbalanced
walk,
especially
in
elderly patients, which should be
investigated and reported to your
doctor
who
could
reassess
the
treatment.
This
medicinal
product
is
generally
not
recommended
during breastfeeding.
Falls may occur following a drop
in
blood
pressure
or
a
loss
of
balance (see description of side
effects).
ATHLETES
VASTAREL
MR
contains
an
active substance that may give a
positive
result
in
anti-doping
tests.
CHILDREN AND ADOLESCENTS
VASTAREL
MR
is
not
recommended
in
children
aged
below

Summary of Product characteristics

Final PI_Vastarel MR_Gidy_17.05.2022
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VASTAREL MR
INN:
Trimetazidine
1.
NAME OF THE MEDICINAL PRODUCT
VASTAREL MR, MODIFIED RELEASE FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimetazidine
dihydrochloride………………………………………………………….35
mg
_ _
Excipients q.s. for one modified release film-coated tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release film-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
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.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
DOSAGE
Oral route.
The dose is one tablet of trimetazidine 35 mg twice daily, i.e. once
in the morning and once in the
evening, 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
_ _
_Patients with renal impairment _
In patients with moderate renal impairment (creatinine clearance
[30-60] ml/min) (see sections 4.4 and
5.2), the recommended dose is 1 tablet of 35mg in the morning during
breakfast.
_Elderly patients_
Elderly patients may have increased trimetazidine exposure due to
age-related decrease in renal
function (see section 5.2). In patients with moderate renal impairment
(creatinine clearance [30-
60] ml/min), the recommended dose is 1 tablet of 35mg in the morning
during breakfast.
Dose titration in elderly patients should be exercised with caution
(see section 4.4).
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_Paediatric population: _
The safety and efficacy of trimetazidine in children aged below 18
years have not been established. No
data are available.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
Parkinson disease, parkinsonian symptoms, tremors,