Converium 150mg Tablets

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

IRBESARTAN

Commercializzato da:

KOMEDIC SDN BHD

INN (Nome Internazionale):

IRBESARTAN

Confezione:

14tablet Tablets; 28tablet Tablets; 30tablet Tablets; 60tablet Tablets; 100tablet Tablets

Prodotto da:

MEDOCHEMIE LTD

Foglio illustrativo

_Consumer Medication Information Leaflet (RiMUP) _
CONVERIUM
Irbesartan (150mg, 300mg)
1
WHAT IS IN THIS LEAFLET
1.
What CONVERIUM is used for
2.
How CONVERIUM works
3.
Before you use CONVERIUM
4.
How to use CONVERIUM
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
CONVERIUM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CONVERIUM IS USED FOR
CONVERIUM 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
-
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, Converium 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).
HOW CONVERIUM WORKS
CONVERIUM 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 CONVERIUM
_When you must not use it _
DO NOT TAKE CONVERIUM:
-
If you are allergic (hypersensitive)
to
irbesartan
or
any
other
ingredients of CONVERIUM
-
If
you
are
more
than
3
months
pregnant (it is also better to avoid
CONVERIUM in early pregnancy
– see pregnancy section)
Converium
should
not
be
given
to
children
and
adolescents
(under
18
years)
_Pregnancy and Lactation _
You must tell your doctor if you think
that
you
are
(or
might
become)
pregnant. Your doctor will normally
advise you to stop taking Converium
before yo

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Converium 150mg tablets
Converium 300mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Converium tablets 150mg: each tablet contains 150mg irbesartan
Converium tablets 300mg: each tablet contains 300mg irbesartan
Excipients:
31.0mg of lactose monohydrate per Converium 150mg tablet
62.0mg of lactose monohydrate per Converium 300mg tablet
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Converium tablets 150mg: White, round flat, scored tablets having a
diameter of 10.5mm
Converium tablets 300mg: White, round flat, scored tablets having a
diameter of 12.7mm
Converium 150mg and 300mg tablets can be divided into equal halves
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
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,
Converium 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended initial and maintenance dose is 150mg once
daily, with or without food.
Converium 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 Converium can be increased to
300 mg, or other anti-hypertensive agents can be added. In particular,
the addition of a diuretic such as
hydrochlorothiazide has been shown to have an additive effect with
Converium (see section 4.5).
In hypertensive type 2 diabetic patients therapy should be initiated
at 150mg irbesartan once daily and
titrated up to 300mg once daily as the preferred maintenance dose for
treatm