AMTAS 5MG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
08-05-2023
Ciri produk Ciri produk (SPC)
28-03-2023

Bahan aktif:

AMLODIPINE BESILATE

Boleh didapati daripada:

JETPHARMA SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE

Unit dalam pakej:

140Tablet Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
AMTAS TABLET
Amlodipine Besylate Tablets 5 mg and 10 mg.
_____________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Amtas tablet is used for
2.
How Amtas works
3.
Before you use Amtas.
4.
How to use Amtas
5.
While you are using Amtas
tablet.
6.
Side effects
7.
Storage and disposal of Bical
tablet.
8.
Product description.
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT AMTAS TABLETS IS USED FOR
This medicine is used to treat
patients suffering from:
1. Mild to moderate high blood
pressure.
2. Angina pectoris:
(a) Chest pain due to narrowing
of the coronary arteries of the
heart
muscle
(chronic
stable
angina).
(b) The rarer form of chest pain
caused
by
cramping
of
the
coronary
arteries
of
the
heart
muscle
(vasospastic
angina
/
prinzmetal's or variant angina)
HOW AMTAS WORKS
Amlodipine is designed to work
with your body by relaxing your
body
vessels,
causing
them
to
widen. This allows your blood to
flow more easily, which in turns
lets
your
heart
work
more
efficiently, placing less strain on
your
arteries
and
heart.
By
reducing
your
heart
workload,
Amlodipine helps to keep your
heart healthy.
BEFORE YOU USE AMTAS
_- When you must not use it _
- If you have ever had an allergic
reaction to Amlodipine or other
calcium channel blockers.
- If you are allergic to any of the
ingredients listed at the end of
this leaflet.
_- Before you start to use it _
Tell
your
healthcare
provider
about
all
of
your
medical
conditions, if you:
•
are
pregnant
or
intend
to
become
pregnant
while
taking Amlodipine.
•
are breastfeeding or wish to
breastfeed.
•
are
allergic
to
any
foods,
dyes,
preservatives
or
any
other medicines.
•
have any health problems,
including:
- heart disease such as heart
failure
-liver problems
- any other allergies
_- Taking other medicines _
_ _
Taking other medicines: Some
medicines
may
interact
with
Amlodipine. This means that the
action of both medicines ca
                                
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Ciri produk

                                AMTAS-5/10
Amlodipine Besylate Tablets USP 5 mg and 10 mg
FOR SPECIALIST'S USE ONLY
Active Ingredient:
Amlodipine Besylate
The uncoated tablets contain amlodipine besylate USP equivalent to 5
mg and 10 mg amlodipine
DOSAGE FORM:
Tablet
THERAPEUTIC CLASS:
Anti hypertensive
Anti anginal
DESCRIPTION:
AMTAS 5, 10: White to off white, round, flat, uncoated tablets with
bevelled edges having breakline on one side
and plain on other side.
PHARMACOLOGY
PHARMACODYNAMICS:
MECHANISM OF ACTION
Amlodipine is a dihydropyridine calcium antagonist (calcium ion
antagonist or slow channel blocker) that inhibits
the transmembrane influx of calcium ions into vascular smooth muscle
and cardiac muscle. Experimental data
suggests that Amlodipine binds to both dihydropyridine and
nondihydropyridine binding sites. The contractile
processes of cardiac muscle and vascular smooth muscle are dependent
upon the movement of extracellular
calcium ions into these cells through specific ion channels.
Amlodipine inhibits calcium ion influx across cell
membranes selectively, with a greater effect on vascular smooth muscle
cells than on cardiac muscle cells.
Negative inotropic effects can be detected in vitro but such effects
have not been seen in intact animals at
therapeutic doses. Serum calcium concentration is not affected by
Amlodipine. Within the physiological pH
range, Amlodipine is an ionized compound (pKa = 8.6), and its kinetic
interaction with the calcium channel
receptor is characterised by a gradual rate of association and
dissociation with the receptor binding site, resulting
in a gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts directly on
vascular smooth muscle to cause a reduction
in peripheral vascular resistance and reduction in blood pressure.
The precise mechanisms by which Amlodipine relieves angina have not
been fully delineated, but are thought to
include the following :
Exertional Angina : In patients with exertional angina, Amlodipine
reduces the total peripheral resistance (after
load) aga
                                
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