Cruzor Tablet 300mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Irbesartan

Beschikbaar vanaf:

PHARMANIAGA MANUFACTURING BERHAD

INN (Algemene Internationale Benaming):

Irbesartan

Eenheden in pakket:

30 Tablets; 30 Tablets

Geproduceerd door:

PHARMANIAGA MANUFACTURING BERHAD

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CRUZOR TABLET
Irbesartan (150mg, 300mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Cruzor Tablet is used for
2.
How Cruzor Tablet works
3.
Before you use Cruzor Tablet
4.
How to use Cruzor Tablet
5.
While
you
are
using
Cruzor
Tablet
6.
Side effects
7.
Storage and disposal of Cruzor
Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CRUZOR TABLET IS USED FOR
Cruzor tablet is used to treat high
blood
pressure
(essential
hypertension)
and
to
protect
the
kidney in patients with high blood
pressure,
type
2
diabetes
with
laboratory
evidence
of
impaired
kidney function.
HOW CRUZOR TABLET WORKS
Cruzor tablet
_ _
contains Irbesartan as
the active ingredient.
Irbesartan belongs to a group of
medicines known as angiotensin-II
receptor antagonists. Angiotensin-
II is a substance produced in the
body which binds to receptors in
blood
vessels
causing
them
to
tighten.
This
resulting
in
an
increase
in
blood
pressure.
Irbesartan prevents the binding of
angiotensin-II
to
these
receptors,
causing the blood vessels to relax
and the blood pressure to lower.
Irbesartan
slows the
decrease
of
kidney
function
in
high
blood
pressure
patients
with
type
2
diabetes.
BEFORE YOU USE CRUZOR TABLET
_-When you must not use it_
Do not take Cruzor tablet if you: -
•
have an allergy to Irbesartan or
any of the ingredients listed at
the end of this leaflet.
•
are
more
than
3
months
pregnant. (It is also better to
avoid taking Irbesartan in early
pregnancy)
•
are breast-feeding.
If you are not sure whether you
should start taking this medicine,
do consult your doctor.
_-Before you start to use it_
Cruzor Tablet contains lactose. If
you have been told by your doctor
that you have lactose intolerance,
consult your doctor before taking
this medicine.
_-Taking other medicines _
Tell your doctor if you are taking
any other medicines, including any
that you buy without a prescription
from a pharmacy, supermarket or
health food shop.
Some medicines and Cr

Productkenmerken

CRUZOR
I R B E S A R T A N
CRUZORTABLET 300 MG
CRUZOR TABLET 150 MG
COMPOSITION
CRUZOR TABLET 150MG
Each film coated tablet contains 150mg of Irbesartan
CRUZOR TABLET 300MG
Each film coated tablet contains 300mg of Irbesartan
DESCRIPTION
CRUZOR TABLET 150MG
12.5 mm length, white to off-white, oval-shaped film-coated
tablet with Pharmaniaga icon on one side and plain on the other
side.
CRUZOR TABLET 300MG
15.5 mm length, white to off-white, oval-shaped film-coated
tablet with Pharmaniaga icon on one side and plain on the other
side.
PHARMACODYNAMICS
Irbesartan is a potent, orally active, selective angiotensin II
receptor
(type AT
1)
antagonist
that
blocks
the
binding
of
angiotensin II to the AT 1 receptor. In the renin-angiotensin
system, angiotensin I is converted by angiotensin-converting
enzyme (ACE) to form angiotensin II. Angiotensin II stimulates
the adrenal cortex to synthesize and secrete aldosterone, which
decreases the excretion of sodium and increases the excretion
of potassium. Angiotensin II also acts as a vasoconstrictor in
vascular smooth muscle. Irbesartan, by blocking the binding of
angiotensin II to the AT 1 receptor, promotes vasodilation and
decreases the effects of aldosterone. The negative feedback
regulation of angiotensin II on renin secretion also is inhibited,
but
the
resulting
rise
in
plasma
renin
concentrations
and
consequent rise in angiotensin II plasma concentrations do not
counteract
the
blood
pressure–lowering
effect
that
occurs.
Irbesartan does not inhibit ACE (kinase II), an enzyme which
generates angiotensin II and also degrades bradykinin into
inactive
metabolites.
Irbesartan
does
not
require
metabolic
activation for its activity.
PHARMACOKINETICS
ABSORPTION AND DISTRIBUTION
After oral administration, irbesartan is well absorbed: studies of
absolute bioavailability gave values of approximately 60-80%.
Concomitant food intake does not significantly influence the
bioavailability
of
irbesartan.
Plasma
protein
binding
is
approximately 96%, with negligible binding to cellular bloo