VASTAREL COATED TABLET 20MG

Country: Malaysia

Language: English

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

Active ingredient:

TRIMETAZIDINE HYDROCHLORIDE

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

TRIMETAZIDINE HYDROCHLORIDE

Units in package:

60Tablet Tablets

Manufactured by:

LES LABS SERVIER INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VASTAREL 20 MG
_Trimetazidine dihydrochloride (20mg) _
WHAT IS IN THIS LEAFLET
1.
What VASTAREL 20 mg
is used for
2.
How VASTAREL 20 mg
works
3.
Before
you
use
VASTAREL 20 mg
4.
How
to
use
VASTAREL
20 mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
VASTAREL 20 mg
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT
VASTAREL
20
MG
IS
USED FOR
OTHER
CARDIOVASCULAR
ANTIANGINAL DRUG - 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).
HOW
VASTAREL
20
MG
WORKS
Trimetazidine acts by inhibiting
the break down of
fatty acids
which
enhances
glucose
oxidation.
Energy
obtained
during
glucose
oxidation
requires
less
oxygen
consumption thus optimises the
heart’s
energy
producing
function,
protecting
vulnerable
heart muscle tissue from further
oxygen-deprived damage.
BEFORE YOU TAKE VASTAREL
20 MG
_- When you must not use it_
Do not take VASTAREL 20 mg:
•
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 20 mg.
•
This medicinal product is not
a curative treatment for chest
pain, nor an initial treatment
for unstable angina pectoris
(a type of chest pain). It is
not
a
treatment
for
heart
attack.
•
In the event of chest pain,
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
t

Summary of Product characteristics

VASTAREL 20 mg
Film- coated tablet
INN : Trimetazidine
1. NAME OF THE MEDICINAL PRODUCT
VASTAREL 20 mg, film -coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimetazidine dihydrochloride................................................................................................. 20.00 mg
For one film -co ated tablet.
Excipients with known effect: Sunset yellow FCF (E110) and cochineal red A (E124).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
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 Posology and method of administration
Posology
Oral route.
The dose is one tablet of 20 mg 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 po pulations
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 20 mg twice daily, i.e. one in the morning and one in the
evening , during meals .
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 20 mg twice daily, i.e. one in the morning and one in the evening ,
during meals. Dose titration in elderly patients should be exercised with caution (see section 4.4).
Paediatric population
The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No
data are available.
Final _PI_Vastarel 20mg_15.02.2018 1