APROVEL 150MG FILM-COATED TABLETS

국가: 말레이시아

언어: 영어

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

유효 성분:

IRBESARTAN

제공처:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

IRBESARTAN

패키지 단위:

14 Tablet Tablets; 28Tablet Tablets

Manufactured by:

SANOFI WINTHROP INDUSTRIE

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
APROVEL
® FILM-COATED TABLET
_ _
Irbesartan (150 mg & 300 mg)
1
WHAT IS IN THIS LEAFLET:
1. What Aprovel is used for
2. How Aprovel works
3. Before you use Aprovel
4. How to use Aprovel
5. While you are using it
6. Side effects
7. Storage and Disposal of Aprovel
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT APROVEL IS USED FOR
Aprovel 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 APROVEL WORKS
Aprovel
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.
Aprovel
prevents
the
binding
of
angiotensin-II
to
these
receptors, causing the blood vessels
to relax and the blood pressure to
lower.
Aprovel slows the decrease of kidney
function in patients with high blood
pressure and type 2 diabetes.
BEFORE YOU USE APROVEL
_- When you must not use it _
•
if
you
are
ALLERGIC
(hypersensitive) to irbesartan or
any other ingredients of Aprovel
•
if you are
MORE THAN 3 MONTHS
PREGNANT
. (It is also better to
avoid
Aprovel
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
Aprovel
should
not
be
given
to
children and adolescents (under 18
years).
_- Before you start to use it _
APROVEL
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.
APROVEL
CONTAINS
SODIUM.
This
medicine contains less than 1 mmol
sodium (23 mg) per tablet, that is to
say essentially ‘sodium-free’.
_- Taking other medicines _
Please tell your doctor or pharmacist
if you are

제품 특성 요약

MY/APR/0521/SmPC0421
1
APROVEL 150 MG FILM-COATED TABLETS
APROVEL 300 MG FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
APROVEL 150 MG FILM-COATED TABLETS.
Each tablet contains 150 mg of irbesartan.
APROVEL 300 MG FILM-COATED TABLETS.
Each tablet contains 300 mg of irbesartan.
PHARMACEUTICAL FORM
APROVEL 150 MG FILM-COATED TABLETS.
White to off-white, biconvex, oval-shaped film-coated tablet, engraved
with a heart on one side and
the number ‘2872’ on the other side.
APROVEL 300 MG FILM-COATED TABLETS.
White to off-white, biconvex, oval-shaped film-coated tablet, engraved
with a heart on one side and
the number ‘2873’ on the other side.
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,
Aprovel 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
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Aprovel 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 Aprovel 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 with
Aprovel (_see Interaction with _
_other medicinal products and other forms of interaction). _
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 treatmen