AXI-NOVELL 35mg MR Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRIMETAZIDINE DIHYDROCHLORIDE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

TRIMETAZIDINE DIHYDROCHLORIDE

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AXI-NOVELL 35MG MR TABLET
_Trimetazidine dihydrochloride 35mg _
1
WHAT IS IN THE LEAFLET
1.
What AXI-NOVELL 35mg MR Tablet
is used for
2.
How AXI-NOVELL 35mg MR Tablet
works
3.
Before you use AXI-NOVELL 35mg
MR Tablet
4.
How to use AXI-NOVELL 35mg MR
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AXI-NOVELL
35mg MR Tablet
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT AXI-NOVELL 35MG MR TABLET 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).
HOW AXI-NOVELL 35MG MR TABLET
WORKS
Trimetazidine acts by inhibiting the
breakdown 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 AXI-NOVELL 35MG MR
TABLET
- _When you must not use it _
Do not take AXI-NOVELL 35mg MR Tablet
:
• 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 AXI-NOVELL 35mg MR Tablet.
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 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

Ciri produk

AXI-NOVELL 35mg MR Tablet
TRIMETAZIDINE DIHYDROCHLORIDE
Modified Release Film-Coated Tablet
COMPOSITION
Each modified release film-coated tablet contains Trimetazidine
Dihydrochloride 35 mg.
MODE OF ACTION OF THE DRUG
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 ß-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 ß-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.
Pharmacokinetic properties
• 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 AXI-NOVELL are not
influenced by meals.
• The apparent distribution volume is 4.8 l/kg; protein binding is
low: in vitro measurements
give value of 16%.
• Trimetazidine is eliminated primarily in the urine, mainly in the
unchanged form.
INDICATION
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.
POSOLOGY
One tablet in the morning and evening, to be taken at meal times.
WARNING &