AMLO-H 5MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

AMLODIPINE BESILATE

Available from:

CAMBER LABORATORIES SDN. BHD.

INN (International Name):

AMLODIPINE BESILATE

Units in package:

10 x 10tablet Tablets; 10 x 10tablet Tablets

Manufactured by:

Hetero Labs Ltd., Unit V

Patient Information leaflet

AMLO-H 5 MG TABLET
AMLO-H 10MG TABLET
AMLODIPINE BESILATE TABLETS 5 AND 10MG
_Consumer Medication Information Leaflet (RiMUP)_
_ _
Page
1
of
2
WHAT IS IN THIS LEAFLET?
1.
What
AMLO-H
is
used for?
2.
How AMLO-H works
3.
Before
you
use
AMLO-H
4.
How to use AMLO-H
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of AMLO-H
8.
Product Description
9.
Manufacturer
10.
Product Registration
11.
Date of revision
WHAT AMLO-H IS USED FOR?
AMLO-H
is one of a group of
medicines
called
calcium
antagonists.
AMLO-H
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 AMLO-H WORKS?
In
patients
with
high
blood
pressure
AMLO-H
works
by
relaxing blood vessels, so that
blood passes through them more
easily.
In patients with angina
AMLO-
H
works
by
improving
blood
supply to the heart muscle which
then receives more oxygen and
as
a
result
chest
pain
is
prevented.
AMLO-H
does not
provide immediate relief of chest
pain from angina.
BEFORE YOU USE AMLO-H
WHEN YOU MUST NOT TAKE IT
Do not use
AMLO-H
if you are
allergic to amlodipine (the active
ingredient in
AMLO-H)
, or to
the inactive ingredients. Your
doctor or pharmacist can give
you a list of these ingredients.
BEFORE YOU START TO TAKE IT
Tell your doctor if you:
•
ever had heart disease
•
ever had liver problems
•
are pregnant, or plan to become
pregnant.
Your
doctor
will
decide if
AMLO-H
is the best
treatment for you.
•
are
breast-feeding.
Do
not
breast-feed while taking
AMLO-
H
. You can stop breastfeeding
or take a different 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,
including
natural
or
herbal
remedies.
TAKING
AMLO-H
WITH
FOOD
AND DRINK
Your
medicine
can
be
used
before or after food. Grapefruit
juice and grapefruit should
not
be consumed by people who are
taking
AMLO-H
.
This
is
because grapefruit and grapefrui

Summary of Product characteristics

AMLO-H 5MG TABLET
AMLO-H 10MG TABLET
DESCRIPTION AND COMPOSITION:
AMLO-H 5:
White to off white round shaped, biconvex tablets debossed with 'J' on
one side and '20' on the other side.
Each uncoated tablet contains: Amlodipine 5mg (equivalent to 6.934mg
of Amlodipine Besilate).
AMLO-H 10:
White to off white round shaped, biconvex tablets debossed with 'J' on
one side and '21' on the other side.
Each uncoated tablet contains: Amlodipine 10mg (equivalent to 13.868
mg of Amlodipine Besilate).
PHARMACODYNAMICS:
Amlodipine is a dihydropyridine calcium antagonist (calcium ion
antagonist or slow-channel blocker)
that inhibits the transmembrane influx of calcium ions intovascular
smooth muscle and cardiac muscle.
Experimental data suggest that Amlodipine binds to both
dihydropyridine and nondihydropyridine
binding sites. The contractile processes of cardiac 2 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. Amlodipineis 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 peripheralresistance
(afterload) against which the heart works and reduces the rate
pressure product, and thus myocardial
oxygen demand, at any given level of exercise.
Vasospastic Angina: Amlodipine has been demonstrated to block
constriction and restore blood flow in
coronary arteries and arterioles in response to calcium, potassium
epinephrine, serotoni