Trime MR (Trimetazidine Dihydrochloride MR Tablets 35mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRIMETAZIDINE DIHYDROCHLORIDE

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

TRIMETAZIDINE DIHYDROCHLORIDE

Unit dalam pakej:

10 X 10 Tablets

Dikeluarkan oleh:

Medreich Limited (Unit 3)

Risalah maklumat

TRIME MR
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRIMETAZIDINE DIHYDROCHLORIDE MR TABLETS 35MG
1
WHAT IS IN THIS LEAFLET
1.
What TRIME MR is used for
2.
How TRIME MR works
3.
Before you use TRIME MR
4.
How to use TRIME MR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TRIME
MR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS TRIME MR USED FOR
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 TRIME MR 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 USE TRIME MR
_-When you must not use it _
DO NOT TAKE TRIME MR:
•
if you are allergic to
trimetazidine or any of the other
ingredients of this medicine.
•
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 TRIME MR.
This medicinal product is generally
not recommended
during breastfeeding.
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.
CHILDREN AND ADOLESCENT
TRIME MR is not
recommende

Ciri produk

TRIME MR
ACTIVE INGREDIENT:
Trimetazidine Dihydrochloride MR Tablets 35mg
EXCIPIENTS:
Anhydrous Calcium Hydrogen Phosphate, Colloidal
Anhydrous Silica, Polyethylene Oxide, Povidone K-90, Xanthan Gum,
Magnesium Stearate (synthetic), Opdary II Brown, Glycerol and
Purified Water
PRODUCT DESCRIPTION
A pinkish brown coloured round biconvex film coated with “TZN 35”
embossed on one side and plain on the other side.
PHARMACODYNAMICS
ATC Code: C01EB15
Mechanism of Action
By preserving energy metabolism in cells exposed to hypoxia or
ischaemia,
trimetazidine prevents a decrease in intracellular ATP levels, thereby
ensuring the proper functioning of ionic pumps and transmembrane
sodium-potassium flow whilst maintaining cellular homeostasis.
Trimetazidine inhibits β-oxidation of fatty acids by blocking
long-chain
3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an
ischaemic 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 ischaemia.
Pharmacodynamic effects
In patients with ischaemic heart disease, trimetazidine acts as a
metabolic agent, preserving the myocardial high-energy phosphate
intracellular levels. Anti-ischemic effects are achieved without
concomitant haemodynamic effects.
PHARMACOKINETICS
After oral administration, maximum concentration is found, on average,
5 hours after taking the tablet. Over 24 hours the plasma
concentration
remains at levels above or equal to 75% of the maximum concentration
for 11 hours.
Steady state is reached by the 60th hour, at the latest.
The pharmacokinetic characteristics of trimetazidine 35mg are not
influenced by meals.
The apparent distribution volume is 4.8 l/kg; protein binding is low.
Trimetazidine is eliminated primarily in the urine, mainly in the
unchanged form.
The elimination half-life of trimetazidine 35mg is an average of 7
hours, and 12 hours in those aged more than 65