NATRILIX SRSUSTAINED-RELEASE COATED TABLET

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

INDAPAMIDE

Dostępny od:

SERVIER MALAYSIA SDN BHD

INN (International Nazwa):

INDAPAMIDE

Sztuk w opakowaniu:

30Tablet Tablets

Wyprodukowano przez:

LES LABS SERVIER INDUSTRIE

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
NATRILIX SR 1.5 MG
_Indapamide 1.5mg _
WHAT IS IN THIS LEAFLET
1.
What Natrilix SR 1.5 mg is
used for
2.
How Natrilix SR 1.5 mg works
3.
Before
you
use
Natrilix
SR
1.5mg
4.
How to use Natrilix SR 1.5 mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Natrilix SR 1.5 mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT NATRILIX SR 1.5MG IS USED
FOR
This medicine is intended to reduce
high blood pressure (hypertension).
It is a sustained-release film-coated
tablet
containing
indapamide
as
active ingredient.
HOW NATRILIX SR 1.5MG WORKS
Indapamide
is
a
diuretic.
Most
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.
In
addition,
indapamide
widens
blood vessels so that blood passes
through more easily. This helps to
lower blood pressure.
BEFORE YOU USE NATRILIX SR 1.5MG
-
_When you must not use it _
_ _
DO NOT TAKE NATRILIX SR 1.5 MG
-
if you are allergic to indapamide
or any other sulphonamide or to
any of the other ingredients of this
medicine
(listed
in
section
Product Description),
-
if you have severe kidney disease,
-
if you have severe liver disease or
suffer
from
a
condition
called
hepatic
encephalopathy
(degenerative
disease
of
the
brain),
-
if you have low potassium levels
in your blood.
PREGNANCY AND BREAST-FEEDING
If
you
are
pregnant
or
breast-
feeding, think you may be pregnant
or are planning to have a baby, ask
your doctor or pharmacist for advice
before taking this medicine.
This medicine is not recommended
during
pregnancy.
When
a
pregnancy is planned or confirmed,
the
switch
to
an
alternative
treatment should be initiated as soon
as possible.
Please tell your doctor if you are
pregnant
or
wish
to
become
pregnant.
The active ingredient is excreted in
milk.
Breastfeeding
is
not
recommended if you are taking this
medicine.
-
_Before you start to use

Charakterystyka produktu

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NATRILIX SR 1.5MG, SUSTAINED RELEASE FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Natrilix SR 1.5 mg, sustained-release film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sustained-release film-coated tablet contains 1.5 mg indapamide.
Excipient with known effect: 124.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sustained-release tablet.
White, round, film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrilix SR 1.5 mg is indicated in essential hypertension in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per 24 hours, preferably in the morning, to be swallowed
whole with water and not chewed.
_ _
At higher doses the antihypertensive action of indapamide is not
enhanced but the saluretic effect is
increased.
Special populations
_ _
_Renal impairment (see sections 4.3 and 4.4): _
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal
function is normal or only minimally
impaired.
_ _
_Hepatic impairment (see sections 4.3 and 4.4): _
In severe hepatic impairment, treatment is contraindicated.
_ _
_Elderly (see section 4.4): _
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly
patients can be treated with Natrilix SR 1.5 mg when renal function is
normal or only minimally
impaired.
Paediatric population:
The safety and efficacy of Natrilix SR 1.5 mg in children and
adolescents have not been established.
No data are available.
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Method of administration
Oral use
_ _
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance, to other sulfonamides or to
any of the excipients listed
in section 6.1.
-
Severe renal failure.
-
Hepatic encephalopathy or
_ _
severe impairment of liver function.
-
Hypokalaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Special warnings