IRBEMAC 300MG TABLET (IRBESARTAN)

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Irbesartan

Verfügbar ab:

SYNERRV SDN BHD

INN (Internationale Bezeichnung):

Irbesartan

Einheiten im Paket:

28 Tablets

Hergestellt von:

Macleods Pharmaceuticals Ltd

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP) _ IRBEMAC 150MG TABLET (IRBESARTAN) IRBEMAC 300MG TABLET (IRBESARTAN)
Irbesartan 150mg and 300 mg Tablet
1
WHAT IS IN THIS LEAFLET
1.
What Irbemac is used for
2.
How Irbemac works
3.
Before you use Irbemac
4.
How to use Irbemac
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Irbemac
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IRBEMAC IS USED FOR
Irbemac is used to treat high blood
pressure and to protect the kidney in
patients with high blood pressure, type 2
diabetes and impaired kidney function.
HOW IRBEMAC WORKS
Irbemac 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 results in an increased in
blood
pressure.
Irbemac
prevents
the
binding
of
angiotensin-II
to
these
receptors, causing the blood vessels to
relax and the blood pressure to lower.
Irbemac
slows
the
decrease
of
kidney
function
in
patients
with
high
blood
pressure and type 2 diabetes.
BEFORE YOU USE IRBEMAC
-
_When you must not use it _
Do not take Irbemac if:
•
You are allergic to Irbesartan or any
ingredients of Irbemac
•
You are pregnant more than 3 months
•
if
you
have
diabetes
or
impaired
kidney function and you are treated
with
a
blood
pressure
lowering
medicine containing aliskiren (anti-
hypertensive medicine)
_Pregnancy and lactation _
It is not recommended to take Irbemac
during the first trimester and do not take
Irbemac
during
the
second
and
third
trimester. Do not take Irbemac if you are
breast-
feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
Talk
to
your
doctor
before
taking
irbesartan and if any of the following
apply to you:
•
if you get excessive vomiting or
diarrhoea
•
if
you
suffer
from
kidney
problems
•
if you suffer from heart problems
•
if
you
receive
irbesartan
for
diabetic kidney disea

Fachinformation

_ _
IRBEMAC 300MG TABLET
(Irbesartan Tablets 300 mg) MACLEODS PHARMACEUTICALS LTD.
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
IRBEMAC 150MG TABLET (IRBESARTAN)
IRBEMAC 300MG TABLET (IRBESARTAN)
COMPOSITION:
IRBEMAC 150MG TABLET
Each tablet contains Irbesartan Ph.Eur 150mg
IRBEMAC 300MG TABLET
Each tablet contains Irbesartan Ph.Eur 300mg
LIST OF EXCIPIENTS:
Carboxymethylcellulose Calcium
Colloidal silicon dioxide (Aerosil 200)
Povidone (PVP K29/32)
Sodium Starch Glycolate Type A (Glycolys)
Talc
Magnesium stearate
Opadry II white 32F58900
DOSAGE FORM :
Film coated tablet
DESCRIPTION:
IRBEMAC 150MG TABLET :
White to off white oval film coated tablets debossed with
“ML 95” on one side and plain on other side.
IRBEMAC 300MG TABLET :
White to off white oval film coated tablets debossed with
“ML 96” on one side and plain on other side.
PHARMACOLOGICAL CLASSIFICATION
Angiotensin II Receptor Antagonist
_ _
IRBEMAC 300MG TABLET
(Irbesartan Tablets 300 mg) MACLEODS PHARMACEUTICALS LTD.
PHARMACOLOGICAL ACTION:
PHARMACOKINETICS
Absorption
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.
Distribution
Plasma protein binding is approximately 96%, with negligible binding
to cellular blood
components. The volume of distribution is 53 - 93 litres.
Biotransformation
Following oral or intravenous administration of 14C irbesartan, 80-85%
of the circulating
plasma radioactivity is attributable to unchanged irbesartan.
Irbesartan is metabolised by the
liver via glucuronide conjugation and oxidation. The major circulating
metabolite is
irbesartan glucuronide (approximately 6%). In vitro studies indicate
that irbesartan is
primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme
CYP3A4 has
negligible effect.
Linearity/non-linearity
Irbesartan exhibits linear and dose proportional pharmacokinetics over
the dose r