IRBEVELL 300 mg Film-Coated Tablet

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

IRBESARTAN

Beszerezhető a:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (nemzetközi neve):

IRBESARTAN

db csomag:

20tablet Tablets; 100 Tablets; 30 Tablets

Gyártó:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IRBEVELL 300MG FILM-COATED TABLET
Irbesartan (300mg)
IRBEVELL 150MG FILM-COATED TABLET
Irbesartan (150mg)
WHAT IS IN THIS LEAFLET
1. What Irbevell is used for
2. How Irbevell works
3. Before you use Irbevell
4. How to use Irbevell
5. While you are using it
6. Side effects
7. Storage and Disposal of Irbevell
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT IRBEVELL IS USED FOR
Irbevell 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 IRBEVELL WORKS
Irbevell
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.
Irbevell
prevents
the
binding
of
angiotensin-II
to
these
receptors, causing the blood vessels
to relax and the blood pressure to
lower. Irbevell slows the decrease
of kidney function in patients with
high
blood
pressure
and
type
2
diabetes.
BEFORE YOU USE IRBEVELL
_- When you must not use it _
Do not take Irbevell if:
• You are allergic to Irbesartan or
any ingredients of Irbevell
• 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
Irbevell
during
the
first
trimester
and do not take Irbevell during the
second and third trimester.
Do
not
take
Irbevell
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
d

Termékjellemzők

IRBEVELL FILM-COATED TABLETS
IRBESARTAN
PRODUCT NAME
IRBEVELL 300 mg Film-Coated Tablet
IRBEVELL 150 mg Film-Coated Tablet
DESCRIPTION
_IRBEVELL 300 mg Film-Coated Tablet: _
White color, round film-coated tablet, convex, plain on both sides,
diameter: 11.8 – 12.2 mm, thickness: 5.8 – 6.8 mm
_IRBEVELL 150 mg Film-Coated Tablet: _
White color, round film-coated tablet, convex, plain on both sides,
diameter: 9.8 – 10.3 mm, thickness: 4.1 – 5.1 mm
COMPOSITION
_IRBEVELL 300 mg Film-Coated Tablet: _
Each film-coated tablet contains Irbesartan 300 mg
_IRBEVELL 150 mg Film-Coated Tablet: _
Each film-coated tablet contains Irbesartan 150 mg
_ _
PHARMACODYNAMICS
Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
ATC code: C09C A04.
MECHANISM OF ACTION
: Irbesartan is a potent, orally active, selective angiotensin-II
receptor (type AT
1
) antagonist. It is expected
to block all actions of angiotensin-II mediated by the AT
1
receptor, regardless of the source or route of synthesis of
angiotensin-
II. The selective antagonism of the angiotensin-II (AT
1
) receptors results in increases in plasma renin levels and
angiotensin-II
levels, and a decrease in plasma aldosterone concentration. Serum
potassium levels are not significantly affected by Irbesartan
alone at the recommended doses. Irbesartan does not inhibit ACE
(kininase-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:
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 r