VASTAREL XR 80mg prolonged-release hard capsule

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:

30 Capsules; 10 Capsules

Manufactured by:

Egis Pharmaceuticals PLC

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
VASTAREL
® XR 80MG_ _
_Trimetazidine dihydrochloride 80mg, prolonged-release hard capsule _
WHAT IS IN THIS LEAFLET
1.
What
VASTAREL
XR
is
used for
2.
How VASTAREL XR works
3.
Before you use VASTAREL
XR
4.
How to use VASTAREL XR
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
VASTAREL XR
8.
Product description
9.
Manufacturer
and
Product
registration holder
10. Date of revision
WHAT VASTAREL XR IS USED
FOR
VASTAREL XR is intended for
use in adults, in combination with
other
medicines
to
treat
angina
pectoris
(chest
pain
caused
by
coronary disease).
HOW VASTAREL XR WORKS
VASTAREL
XR
contains
an
active
ingredient,
trimetazidine
dihydrochloride.
It
acts
by
inhibiting the breakdown of fatty
acids
which
enhances
glucose
oxidation.
Glucose
oxidation
requires less oxygen consumption
thus, optimises the heart's energy
producing
function,
protecting
vulnerable
heart
muscle
tissues
from
further
oxygen-deprived
damage.
BEFORE
YOU
USE
VASTAREL
XR
_When you must not use it_
_DO NOT TAKE VASTAREL XR IF _
_YOU: _
•
are allergic to trimetazidine or
any of the other ingredients of
this
medicine
(listed
in
ingredients section),
•
have
a
Parkinson
disease:
disease of the brain affecting
movement
(trembling,
rigid
posture, slow movements and
a shuffling, unbalanced walk),
•
have severe kidney problems.
_Before you start to use it _
_WARNINGS AND PRECAUTIONS _
Talk to your doctor or pharmacist
before taking VASTAREL XR.
This
drug
is
not
a
curative
treatment for angina attacks, nor
an initial treatment for unstable
angina
or
heart
attack
(myocardial infarction).
In the event of an angina attack,
inform your doctor. Tests may be
required and your treatment may
possibly be modified.
This
medicine
can
cause
or
worsen
symptoms
Parkinsonian
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.
Falls ma

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Vastarel
®
XR 80 mg, prolonged-release hard capsule.
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One prolonged-release hard capsule contains 80 mg of trimetazidine
dihydrochloride
_ _
_ _
Excipient with known effect:
Sucrose 33.75mg per capsule
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release hard capsules.
Hard capsule with a white body and an orange red cap with a printed
white Servier logo
and “80”
on it.
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
The dose is one capsule of 80mg of trimetazidine once daily during
breakfast.
This dosage regimen with Vastarel 80mg is equivalent to the following
regimen with Vastarel 20mg or
Vastarel 35mg.
Vastarel 20mg: one tablet of 20 mg of trimetazidine three times a day
during meals.
Vastarel 35mg: one tablet of 35mg of trimetazidine 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 reduced by half
_ie_
, 1 tablet of 20mg twice daily, one in the morning and
one in the evening during meals or 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 reduced by half
_ie_
, 1 tablet of 20mg twice daily, one in the morning
and one