Bezartan Tablet 300mg

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

Irbesartan

Dostępny od:

Duopharma Marketing Sdn. Bhd.

INN (International Nazwa):

Irbesartan

Sztuk w opakowaniu:

3 x 10 Tablets

Wyprodukowano przez:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Ulotka dla pacjenta

_ Consumer Medication Information Leaflet (RiMUP)_
1
BEZARTAN TABLET
®
Irbesartan (150 mg, 300 mg)
WHAT IS IN THIS LEAFLET
1.
What Bezartan Tablet is used for
2.
How Bezartan Tablet works
3.
Before you use Bezartan Tablet
4.
How to use Bezartan Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Bezartan
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BEZARTAN TABLET
IS USED FOR
Bezartan Tablet is used
• to treat high blood pressure (essential
hypertension)
• to protect the kidney in patients with
high blood pressure, type 2 diabetes
and
laboratory
evidence
of
impaired
kidney function.
HOW BEZARTAN TABLET
WORKS
_ _
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
results
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 patients
with
high blood
pressure and type 2 diabetes.
BEFORE YOU USE BEZARTAN TABLET
_-When you must not use it _
•
If you are allergic to irbesartan or any
other ingredients of this medicine.
•
If
you
are
more
than
3
months
pregnant. (it is also better to avoid
Bezartan
in
early
pregnancy-
see
pregnancy section)
•
If
you
have
diabetes
or
impaired
kidney function and you are treated
with
a
blood
pressure
lowering
medicine containing aliskiren.
-
_Before you start to use it_
Bezartan contains lactose. If you have
been told by your doctor that you have
an
intolerance
to
some
sugars
(e.g.
lactose),
contact
your
doctor
before
taking this medicine.
_- Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken
any
other
medicines,
including
medicines
obtained
without
a
prescription.
Bezartan
Tablet
does
not
usually
interact with other med

Charakterystyka produktu

BEZARTAN TABLET
IRBESARTAN 150MG, 300MG
DESCRIPTION
Bezartan Tablet 150mg - White to off white,
biconvex, oval-shaped, with marking ‘150’ on
one side and film coated tablet
Bezartan Tablet 300mg - White, oval shape,
with scored on one side and film coated tablet
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Treatment
of
diabetic
nephropathy
with
an
elevated
serum
creatinine
and
proteinuria
(>300 mg/day) in patients with type 2 diabetes
and hypertension. In this population, Bezartan
reduces the rate of progression of nephropathy
as measured by the occurrence of doubling of
serum creatinine or end-stage renal disease
(need for dialysis or renal transplantation).
POSOLOGY AND METHOD OF ADMINISTRATION
The
usual
recommended
initial
and
maintenance dose is 150 mg once daily, with or
without food. Bezartan at a dose of 150 mg once
daily generally provides a better 24 hour blood
pressure control than 75 mg. However, initiation
of therapy with 75 mg could be considered,
particularly in haemodialysed patients and in
the elderly over 75 years.
In patients insufficiently controlled with 150 mg
once
daily,
the
dose
of
Bezartan
can
be
increased to 300 mg, or other antihypertensive
agents can be added. In particular, the addition
of a diuretic such as hydrochlorothiazide has
been shown to have an additive effect.
In hypertensive type 2 diabetic patients, therapy
should be initiated at 150 mg irbesartan once
daily and titrated up to 300 mg once daily as the
preferred maintenance dose for treatment of
renal disease.
Special Populations
_Renal impairment_: no dosage adjustment is
necessary
in
patients
with
impaired
renal
function. A lower starting dose (75 mg) should
be
considered
for
patients
undergoing
haemodialysis.
_Hepatic impairment_: no dosage adjustment is
necessary in patients with mild to moderate
hepatic
impairment.
There
is
no
clinical
experience
in
patients
with
severe
hepatic
impairment.
_Older people_: although consideration should be
given to initiating therapy with 75 mg in