IRBESARTAN RBX irbesartan 150 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Irbesartan

Beschikbaar vanaf:

Sun Pharma ANZ Pty Ltd

INN (Algemene Internationale Benaming):

Irbesartan

Bijsluiter

IRBESARTAN RBX CMI v1.4
Page 1 of 7
_IRBESARTAN RBX _
_IRBESARTAN 75/150/300 MG TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before taking IRBESARTAN RBX. This leaflet
answers some common questions about IRBESARTAN RBX. It does not
contain all
the available information. It does not take the place of talking to
your
doctor or pharmacist. Do not throw this leaflet away. You may need to
refer
to it again later.
This leaflet was last updated on the date at the end of this leaflet.
More
recent information may be available. The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may contain
important information about the medicine and its use of which you
should be
aware.
ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR AND PHARMACIST GIVE
YOU
ABOUT IRBESARTAN RBX. IF YOU HAVE ANY CONCERNS ABOUT TAKING IRBESARTAN
RBX,
ASK YOUR DOCTOR OR PHARMACIST.
WHAT IRBESARTAN RBX_ _TABLET IS USED FOR
IRBESARTAN RBX lowers high blood pressure, which doctors call
hypertension.
Your doctor measured your blood pressure and found it to be too high.
Everyone has blood pressure. This pressure helps get your blood all
around
your body. Your blood pressure may be different at different times of
the
day, depending on how busy or worried you are. You have hypertension
(high
blood pressure) which means your blood pressure stays high, even when
you
are calm and relaxed.
There are usually no symptoms of high blood pressure. The only way of
knowing that you have hypertension is to have your blood pressure
checked
on a regular basis. High blood pressure, if not treated, can damage
blood
vessels in several organs such as the heart, the kidneys, the brain
and the
eyes. This may lead to heart attacks, heart or kidney failure,
strokes, or
blindness. There are usually no symptoms of high blood pressure before
damage occurs, so your doctor needs to measure your blood pressure to
see
if it is too high.
High blood pressure can be treated and controlled with medicines such
as

Productkenmerken

IRBESARTAN RBX PI V5 Jan 2014
Page 1 of 16
PRODUCT INFORMATION
IRBESARTAN RBX
Irbesartan 75/150/300 mg Tablets
NAME OF THE MEDICINE
Irbesartan
STRUCTURAL FORMULA:
IRBESARTAN
MOLECULAR FORMULA: C
25
H
28
N
6
O
CHEMICAL NAME:
2-Butyl-3-[[2’-(1_H_-tetrazol-5-yl)biphenyl-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
MOLECULAR WEIGHT: 428.5
CAS NUMBER: 138402-11-6
DESCRIPTION
The active ingredient in IRBESARTAN RBX tablets is irbesartan.
Irbesartan is a white or almost white
crystalline powder, practically insoluble in water, sparingly soluble
in methanol, slightly soluble in methylene
chloride.
IRBESARTAN RBX is available as 75, 150 or 300 mg strength tablets
which include the following
excipients: lactose, microcrystalline cellulose, croscarmellose
sodium, hypromellose, colloidal anhydrous
IRBESARTAN RBX PI V5 Jan 2014
Page 2 of 16
silica, magnesium stearate and Opadry II OY-LS-28900 White (lactose,
hypromellose, titanium dioxide and
macrogol 4000; Proprietary Ingredient No.107728).
PHARMACOLOGY
PHARMACODYNAMICS
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype). Angiotensin II is an important
component of the renin-angiotensin system and is involved in the
pathophysiology of hypertension and in
sodium homeostasis. Irbesartan does not require metabolic activation
for its activity.
Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting
effects of angiotensin II by selective
antagonism of the angiotensin II (AT
1
subtype) receptors localised on vascular smooth muscle cells and in
the adrenal cortex. It has no agonist activity at the AT
1
receptor and a much greater affinity (more than
8500-fold) for the AT
1
receptor than for the AT
2
receptor (a receptor that has not been shown to be
associated with cardiovascular homeostasis).
Irbesartan does not inhibit enzymes involved in the renin-angiotensin
system (i.e., renin, angiotensin
converting enzyme [ACE]) or affect other hormone receptors or ion
channels involved in the cardiovascular
regulation of blood pressure and sodiu