Alpharme Amlodipine 5mg tablet

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
10-03-2022
Ciri produk Ciri produk (SPC)
07-07-2022

Bahan aktif:

AMLODIPINE BESILATE

Boleh didapati daripada:

Alpharme Plc Sdn. Bhd.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE

Unit dalam pakej:

30 Tablets Tablets; 60 Tablets; 90 Tablets

Dikeluarkan oleh:

Bluepharma - Industria Farmaceutica, S.A.

Risalah maklumat

                                _Consumer Medication Information Leaflet (RiMUP) _
ALPHARME AMLODIPINE 5MG TABLET
Amlodipine Besilate 6.944mg equivalent to amlodipine 5mg
ALPHARME AMLODIPINE 10MG TABLET
Amlodipine Besilate 13.888mg equivalent to amlodipine 10mg
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Alpharme Amlodipine is
used for
2.
How Alpharme Amlodipine
works
3.
Before you use Alpharme
Amlodipine
4.
How to use Alpharme
Amlodipine
5.
While you are using Alpharme
Amlodipine
6.
Side effects
7.
Storage and disposal of
Alpharme Amlodipine
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ALPHARME AMLODIPINE IS
USED FOR
Alpharme Amlodipine is used to
treat
high
blood
pressure
(hypertension) or a certain type of
chest pain called angina, a rare
form of which is Prinzmetal’s or
variant angina.
HOW
ALPHARME
AMLODIPINE
WORKS
Alpharme Amlodipine is one of a
group of medicines called calcium
antagonists.
In
patients
with
high
blood
pressure,
Alpharme
Amlodipine
works by relaxing blood vessels,
so that blood passes through them
more easily.
In patient with angina, Alpharme
Amlodipine works by improving
blood supply to the heart muscle
which then receives more oxygen
and
as
a
result
chest
pain
is
prevented.
It
does
not
provide
immediate relief of chest pain from
angina.
BEFORE
YOU
USE
ALPHARME
AMLODIPINE
_When you must not use it _
Do not use Alpharme Amlodipine
if
you
have
hypersensitivity
to
dihydropyridines and amlodipine
or any of the inactive ingredients.
_Before you start to use it _
Tell your doctor if you:
-
Ever had heart disease
-
Ever had liver problems
-
Are pregnant, or plan to become
pregnant.
-
Amlodipine has been shown to
pass into breast milk in small
amount.
Ask
your
doctor
or
pharmacist
for
advice
before
taking any medicine.
_Taking other medicines _
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines,
including
medicines
obtained
without
a
prescription
because
they
may
interact
with
each other.
Please
tell
your
doctor
or
ph
                                
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Ciri produk

                                ALPHARME AMLODIPINE 5MG TABLET
ALPHARME AMLODIPINE 10MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Alpharme Amlodipine 5mg Tablet
Each tablet contains Amlodipine besilate 6.944mg equivalent to
amlodipine 5mg.
Alpharme Amlodipine 10mg Tablet
Each tablet contains Amlodipine besilate 13.888mg equivalent to
amlodipine 10mg.
PRODUCT DESCRIPTION
Alpharme Amlodipine 5mg Tablet is white to almost white tablet of
oblong shape, 10.1mm ±0.3mm (length) and 4.1mm ±
0.3mm (diameter), with a score on one side of the tablet.
Alpharme Amlodipine 10mg Tablet is white to almost white tablet of
oblong shape, 12mm ± 0.3mm (length) and 6mm ±
0.3mm (diameter), with a score on one side of the tablet.
PHARMACODYNAMICS
Amlodipine is a calcium ion influx inhibitor (slow channel blocker or
calcium ion antagonist) and inhibits the transmembrane
influx of calcium ions into cardiac and vascular smooth muscle. The
mechanism of the antihypertensive action of amlodipine
is due t o a direct relaxant effect on vascular smooth muscle. The
precise mechanism by which amlodipine relieves angina
has not been fully determined but amlodipine reduces total ischemic
burden by the following two actions:
1)
Amlodipine dilates peripheral arterioles and thus reduces the total
peripheral resistance (afterload) against which the heart
works. Since the heart rate remains stable, this unloading of the
heart reduces myocardial energy consumption and
oxygen requirements.
2)
The mechanism of action of amlodipine also probably involves
dilatation of the main coronary arteries and coronary
arterioles, both in normal and ischemic regions. This dilatation
increases myocardial oxygen delivery in patients with
coronary artery spasm (Prinzmetal's or variant angina) and blunts
smoking induced coronary vasoconstriction.
In patients with hypertension, once-daily dosing provides clinically
significant reductions in blood pressure in both the supine
and standing positions throughout the 24-hour interval. Due to the
slow onset of action, acute hypotension is not a feature
of
                                
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