KARDAM 10 (Amlodipine Besilate Tablets 10 mg)

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

AMLODIPINE BESILATE

Dostopno od:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (mednarodno ime):

AMLODIPINE BESILATE

Enote v paketu:

30tablet Tablets

Izdeluje:

M/s Aurobindo Pharma Limited (Unit XV)

Navodilo za uporabo

KARDAM 5 & 10
_Consumer Medication Information Leaflet (RiMUP)_
Amlodipine Besilate Tablets 5 mg & 10 mg
1
WHAT IS IN THIS LEAFLET
1.
What Kardam is used for
2.
How Kardam works
3.
Before you use Kardam
4.
How to use Kardam
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Kardam
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS KARDAM USED FOR
Kardam
helps
to
keep
your
blood
pressure
under
control.
Kardam
relaxes your blood vessels and this
helps to lower your blood pressure. It
may be used on its own or together
with other medicines.
Kardam may also be used to treat
other conditions, for example, chest
pain.
HOW KARDAM WORKS
If
you
suffer
from
high
blood
pressure, Kardam works by relaxing
blood vessels, so that blood passes
through them more easily.
If you suffer from chest pain (angina),
Kardam works by improving blood
supply to the heart muscle which then
receives more oxygen and as a result
chest pain is prevented. Kardam does
not provide immediate relief of chest
pain from angina.
BEFORE YOU USE KARDAM
_-When you must not use it _
Kardam is contraindicated in patients
with
a
known
sensitivity
to
dihydropyridines.
_-Before you start to use it _
Tell
your
doctor
before
you
start
treatment:
- if you have Kidney failure
- if you have impaired Liver function
_ _
_-Taking other medications _
Inform your doctor and pharmacist if
you are taking any other medicines,
especially those listed here:
- any other medicines for high blood
pressure or heart disease
- antiviral medicines such as ritonavir
-
antifungal
medicines
such
as
itraconazole, ketoconazole
Always
inform
your
doctor
and
pharmacist if you are taking any other
medicines,
including
herbal
tonics,
supplements and medicines that you
buy without a prescription.
PREGNANCY AND BREAST FEEDING
Kardam should not be administered
during pregnancy or lactation or to
women
of
childbearing
potential
unless effective contraception is used.
HOW TO USE KARDAM
_-How much to use _
_In _
_

Lastnosti izdelka

PACKAGE INSERT
_Rx Only_
KARDAM
Amlodipine Besilate
Tablets 5 mg and 10 mg
PHARMACODYNAMIC PROPERTIES
Amlodipine besilate is a calcium ion influx inhibitor of
the dihydropyridine group (slow channel-blocker or
calcium
ion
antagonist)
and
inhibits
the
transmembrane influx of calcium ions into the cardiac
and vascular smooth muscle.
The mechanism of the antihypertensive action of
Amlodipine besilate is due to a direct relaxant effect on
vascular smooth muscle. Amlodipine besilate reduces
total ischemic burden by the following two actions:
1)
Amlodipine
besilate
dilates
peripheral
arterioles and thus, reduces the total peripheral
resistance (after load) against which the heart
works. Since the heart rate remains stable, this
unloading of the heart reduces myocardial energy
consumption and oxygen requirements.
STRENGTH:
5 mg and 10 mg.
PHARMACEUTICAL DOSAGE FORM:Tablet.
ROUTE OF ADMINISTRATION: Oral
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
2)
The
mechanism
of
action
of
Amlodipine
besilate also probably involves dilatation of the
main coronary arteries and coronary arterioles,
both
in
normal
and
ischaemic
regions.
This
dilatation increases myocardial oxygen delivery
in
patients
with
coronary
artery
spasm
(Prinzmetal's or variant angina).
In
patients
with
hypertension,
once
daily
dosing
provides
clinically
significant
reductions
of
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
Amlodipine besilate administration.
In patients with angina, once daily administration of
Amlodipine besilate increases total exercise time, time
to angina onset and time to 1 mm ST segment
depression
and
decreases
both
angina
attack
frequency and glyceryl trinitrate tablet consumption.
PHARMACEUTICAL FORM:
_Amlodipine Besilate Tablets 5 mg: _White to off white,
flat, bevel edged, barrel shaped, uncoated tablets
debossed with 'C' on one side and '58' on the other
side.
_Amlodipine Besilate Tablets 10 mg:_ White to off white,
flat,