CARVIDON-MR (Trimetazidine Dihydrochloride Modified-Release Tablets 35 mg)

Country: Malaysia

Language: English

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

Active ingredient:

TRIMETAZIDINE DIHYDROCHLORIDE

Available from:

Gopharma Sdn. Bhd.

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE

Units in package:

20tablet Tablets; 60tablet Tablets; 100tablet Tablets

Manufactured by:

MICRO LABS LTD

Patient Information leaflet

CARVIDON-MR
Trimetazidine Dihydrochloride Modified Release Tablets 35 mg
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Carvidon-MR is used for
2.
How Carvidon-MR works
3.
Before you use Carvidon-MR
4.
How to use Carvidon-MR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Carvidon-
MR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What Carvidon-MR is used for
This
medicine
is
intended
for
use
in
combination with other medicine to treat
angina
pectoris
(chest
pain
caused
by
coronary disease).
How Carvidon-MR works
Trimetazidine
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 Carvidon-MR
- When you must not use it
Do not take Carvidon-MR
-
If you are allergic to Trimetazidine
or to any other ingredients of this
medicine.
-
If you have a Parkinson disease:
disease of the brain affecting
movement (trembling, rigid posture,
show movements and a shuffling,
unbalanced walk.
-
If you have severe kidney problems.
Pregnancy and lactation
Safety of use of Carvidon-MR in
pregnant and nursing mothers has not
been established.
As a precaution, Carvidon-MR is not to
be taken during pregnancy or
breastfeeding.
Tell your doctor if you are pregnant,
think you are pregnant or planned to get
pregnant
- Before you start use it
- Talk
to
your
doctor
or
pharmacist
before taking Carvidon-MR
- Taking other medicines
You
must
inform
your
doctor
or
pharmacist if you are taking, or have
recently
taken
any
other
medicines,
even if it is a medicine that you can
buy without a prescription.
How to use Carvidon-MR
- How much to use
-
Always take this medicine exactly as
your
doctor
has
told
you.
Check
with
your
doctor or
pharmacist
if
you are not sure.
-
The recommended dose is Carvidon-
MR tablet is one tablet to be

Summary of Product characteristics

1
CARVIDON-MR (TRIMETAZIDINE DIHYDROCHLORIDE MODIFIED RELEASE TABLETS 35
MG)
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Trimetazidine Dihydrochloride ….. 35 mg.
PRODUCT DESCRIPTION:
Light pink colored, circular, biconvex, film coated tablets, plain on
both the faces.
PHARMACOLOGY:
_PHARMACODYNAMICS:_
_Mechanism of action_
Trimetazidine inhibits β-oxidation of fatty acids by blocking
long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation.
In an
ischemic cell, energy obtained during glucose oxidation requires less
oxygen consumption than in the β-oxidation process. Potentiation of
glucose oxidation optimizes cellular energy processes, thereby
maintaining proper energy metabolism during ischemia.
Pharmacodynamic effects
In patients with ischemic heart disease, Trimetazidine acts as a
metabolic agent, preserving the myocardial
high-energy phosphate
intracellular levels. Ant ischemic effects are achieved without
concomitant hemodynamic effects.
_PHARMACOKINETICS:_
Orally, the maximum concentration is on average five hours after
taking the tablet. About 24 hours, the plasma concentration is
maintained at
concentrations greater than or equal to 75% of the maximum
concentration for 11 hours.
The steady state is reached, no later than the 60th hour.
The pharmacokinetic characteristics of trimetazidine are not
influenced by meal.
The apparent volume of distribution is 4.8 l/Kg, the determination of
trimetazidine protein is weak: the value measured in vitro is 16%.
The elimination of trimetazidine is mainly via the kidneys, mainly in
the form of the unchanged product.
The half-life of trimetazidine is an average of 7 hours in healthy
young volunteers, and 12 hours in the elderly over 65 years.
The total clearance of trimetazidine is the one that results from
renal clearance majority directly related to creatinine clearance and
to a lesser
value, a hepatic clearance that decreases with age.
A specific clinical study, conducted in an elderly population, with a
dose of 2 tablets per day in two doses, as measured