VAMLO TABLETS 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMLODIPINE BESILATE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE

Unit dalam pakej:

10x10 Tablets; 3X10 Tablets

Dikeluarkan oleh:

RANBAXY (MALAYSIA) SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
VAMLO TABLETS
_Amlodipine Besilate (5 and 10 mg) _
WHAT IS IN THIS LEAFLET
1.
What
VAMLO TABLETS
are used
for
2.
How
VAMLO TABLETS
works
3.
Before you use
VAMLO
TABLETS
4.
How to use
VAMLO TABLETS
5.
While you are using
VAMLO
TABLETS
6.
Side effects
7.
Storage and Disposal of
VAMLO
TABLETS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT VAMLO TABLETS ARE USED
FOR
VAMLO TABLETS
are 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 VAMLO TABLETS WORKS
VAMLO TABLETS
contain the
active substance amlodipine which
belongs to a group of medicines called
calcium antagonists.
In patients with high blood pressure
this medicine works by relaxing blood
vessels, so that blood passes through
them more easily. In patients with
angina amlodipine works by improving
blood supply to the heart muscle which
then receives more oxygen and as a
result chest pain is prevented. This
medicine does not provide immediate
relief of chest pain from angina.
Your
doctor
however,
may
have
prescribed
this
medicine
for
another
purpose. Ask your doctor if you have
any
questions
why
it
has
been
prescribed for you.
BEFORE YOU USE VAMLO TABLETS
-
_When you must not use it _
If you are allergic (hypersensitive) to
amlodipine, or any other medicine of
same class (dihydropyridines e.g.
nifedipine, felodipine) or any of the
other ingredients of this medicine (see
PRODUCT DESCRIPTION
at the end of this
leaflet). Some of the symptoms of an
allergic reaction may include: skin
rash, itching, swelling of the face, lips,
tongue and throat or difficulty in
breathing.
-
_Before you start to use it _
YOU MUST TELL YOUR DOCTOR IF YOU:

have or have had heart failure

have liver problems
PREGNANCY AND LACTATION
The safety of amlodipine in human
pregnancy has not been established.
IF
YOU ARE PREGNANT, THINK YOU MIGHT
BE OR YOU ARE PLANNING TO GET
PREGNANT,

Ciri produk

_For the use only of a Registered Medical Practitioner _
PRESCRIBING INFORMATION
VAMLO TABLETS
(Amlodipine Besilate Tablets)
COMPOSITION
VAMLO 5
Each tablet contains:
Amlodipine Besilate BP equivalent to Amlodipine
…………………..…………5 mg
VAMLO 10
Each tablet contains:
Amlodipine Besilate BP equivalent to Amlodipine
…………………..…………10 mg
PRODUCT DESCRIPTION
5 MG White to off-white, flat, beveled edge, round, uncoated tablets
with a score-line on one side.
Diameter : 8.0 mm
10 MG: White to off-white, flat, beveled edge, round, uncoated tablets
with a score-line on one side.
Diameter : 10.5 mm
DESCRIPTION
VAMLO TABLETS contain besilate salt of amlodipine, which is a
long-acting calcium channel blocker.
Amlodipine
besilate
is
chemically
described
as
3-ethyl-5-methyl
(±)-2-[(2-aminoethoxy)methyl]4-(2-
chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate,
monobenzenesulphonate.
Its
empirical
formula is C
20
H
25
CLN
2
O
5
•C
6
H
6
O
3
S and the structural formula is:
AMLODIPINE BESILATE
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Amlodipine besilate 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 to 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 increas