NATRIXAM 1.5mg10mg modified-release tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMLODIPINE BESILATE; INDAPAMIDE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

AMLODIPINE BESILATE; INDAPAMIDE

Unit dalam pakej:

30tablet Tablets; 10tablet Tablets

Dikeluarkan oleh:

LES LABORATOIRES SERVIER INDUSTRIE

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
___________________________________________________________________________________________
1
NATRIXAM_ _MODIFIED-RELEASE TABLETS_ _
_Indapamide /amlodipine (1.5 mg/5 mg & 1.5 mg/10 mg) _
WHAT IS IN THIS LEAFLET
1.
What Natrixam is used for
2.
How Natrixam works
3.
Before you use Natrixam
4.
How to use Natrixam
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Natrixam
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT NATRIXAM IS USED FOR
Natrixam
is
prescribed
as
substitution treatment of high
blood
pressure (hypertension) in
patients
already
taking
i
ndapamide
and
amlodipine from
separate tablets in
the same
strength.
HOW NATRIXAM WORKS
Natrixam is a combination of
two
active ingredients,
indapamide and
amlodipine.
Indapamide is a diuretic
.
Diuretics
increase
the
amount
of
urine
produced by the kidneys.
However,
indapamide is different
from other
diuretics, as it only
causes a slight
increase
in
the
amount
of
urine
produced.
Amlodipine
is
a
calcium
antagonist (which belongs
to
a
class
of
medicines
called
dihydropyridines) and it works by
relaxing blood vessels, so that
blood
passes
through
them
more
easily.
Each
of
the
active
ingredients
reduces blood pressure.
BEFORE YOU USE NATRIXAM
-
_When you must not use it_
DO NOT TAKE NATRIXAM
-
if you are allergic to indapamide
or any other
sulfonamide (class
of
medicinal
product
for
the
treatment of hypertension), or
to
amlodipine
or
any
other
calcium
antagonist
(class
of
medicinal
product
for
the
treatment of hypertension) or
to
any of the other ingredients
of
this medicine (listed in
section
Product Description). This may
be
itching, reddening of the skin
or difficulty in breathing,
-
if you have severe low blood
pressure (hypotension),
-
if
you have narrowing of the
aortic
heart
valve
(aortic
stenosis) or cardiogenic shock
(a
condition where your heart
is
unable
to
supply
enough
blood to the body),
-
if you suffer from heart failure
after a heart att

Ciri produk

_ _
_Final PI_Natrixam_02.12.2022 _
_ _
_ _
1
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Natrixam 1.5 mg / 5 mg modified-release tablets
Natrixam 1.5 mg / 10 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate
equivalent to 5 mg
amlodipine.
One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate
equivalent to 10 mg
amlodipine.
Excipient with known effect: 104.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
1.5 mg / 5 mg : White, round, film-coated, bilayered, modified-release
tablet of 9 mm diameter
engraved with
on one face.
1.5 mg / 10 mg : Pink, round, film-coated, bilayered, modified-release
tablet of 9 mm diameter
engraved with
on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrixam is indicated as substitution therapy for treatment of
essential hypertension in patients already
controlled with indapamide and amlodipine given concurrently at the
same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per day as single dose, preferably to be taken in the
morning, to be swallowed whole with
water and not chewed.
The fixed dose combination is not suitable for initiation therapy.
If a change of the posology is required, titration should be done with
the individual components.
Special populations
_Paediatric population _
The safety and efficacy of Natrixam in children and adolescents have
not been established.
No data are available.
_Patients with renal impairment (see sections 4.3 and 4.4): _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with mild to moderate renal impairment, no dose adjustment
is needed.
_Older people (see section 4.4 and 5.2): _
Older people can be treated with Natrixam according to renal function.
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_Final PI_Natrixam_02.12.2022 _
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_Patients with hepatic impairment (see sections 4.3 and 4.4): _
In severe