NATRILIX SR Indapamide hemihydrate 1.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

indapamide hemihydrate, Quantity: 1.5 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: lactose monohydrate; macrogol 6000; hypromellose; magnesium stearate; titanium dioxide; colloidal anhydrous silica; glycerol; povidone

Administration route:

Oral

Units in package:

30 tablets, 90 tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Management of essential hypertension. It may be tried as a sole therapeutic agent in the treatment of mild to moderate hypertension. Normally, Natrilix SR is used as the initial agent in multiple drug regimes.

Product summary:

Visual Identification: White film-coated lenticular tablet.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-12-07

Patient Information leaflet

NATRILIX SR
_Sustained Release tablets containing indapamide (pronounced
in-dap-a-mide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NATRILIX SR. It
does not contain all the available
information about this medicine.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NATRILIX
SR against the expected benefits for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NATRILIX SR IS
The name of your medicine is
NATRILIX SR. The medicine
releases the active ingredient
indapamide progressively over 24
hours. Indapamide belongs to a group
of medicines called chlorosulfamoyl
diuretics (a type of "fluid" or "water"
tablet).
WHAT NATRILIX SR IS
USED FOR
YOU HAVE BEEN PRESCRIBED
NATRILIX SR FOR HIGH BLOOD
PRESSURE.
NATRILIX SR is available only with
a doctor's prescription.
There is no evidence that NATRILIX
SR is addictive.
_WHY NATRILIX SR IS USED_
_FOR HIGH BLOOD PRESSURE_
Everyone has blood pressure. This
pressure helps to circulate blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or stressed you are.
You have high blood pressure (also
known as hypertension) which is
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
If high blood pressure is not treated it
can lead to serious health problems.
You may feel fine and have no
symptoms, but eventually it can
cause stroke, heart disease and
kidney failure.
NATRILIX SR helps to lower your
blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NATRILIX
SR HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
NATRILIX SR
There are some people who should
not take NATRILIX SR. Please read
the lists below. If you think any of
these situations apply to you, or you
have any questions, plea

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – NATRILIX
® SR (INDAPAMIDE HEMIHYDRATE)
Version 13
1/14
AUSTRALIAN PRODUCT INFORMATION
NATRILIX SR (INDAPAMIDE HEMIHYDRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Indapamide hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NATRILIX SR tablet contains 1.5 mg of sustained release
indapamide hemihydrate.
Excipient with known effect: lactose monohydrate. For the full list of
excipients, see _section 6.1_ - List of
excipients.
3
PHARMACEUTICAL FORM
Each NATRILIX SR tablet is a white, film-coated biconvex tablet
containing sustained release indapamide
hemihydrate 1.5 mg.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. It may be tried as a sole therapeutic agent
in the treatment of hypertension.
Normally, NATRILIX SR is used as the initial agent in multiple drug
regimes.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS. One NATRILIX SR tablet daily to be taken, by oral route, in
the morning. The tablet should be
swallowed whole and must not be chewed or crushed. The action of
NATRILIX SR is progressive and whilst
the optimum reduction in blood pressure is usually seen after four
weeks, a further small but useful
reduction in blood pressure may be observed over the following four to
six weeks. A larger dose than one
tablet of NATRILIX SR daily is not recommended as there is little
additional antihypertensive effect, whilst
the diuretic effect becomes more pronounced.
A single daily tablet of NATRILIX SR may effectively be combined with
the following antihypertensive
medicines: beta-blockers, methyldopa sesquihydrate, clonidine,
prazosin and ACE inhibitors.
Combination with a diuretic is not recommended as significant
electrolyte disturbances may occur.
Indapamide has a slight but significant carry-over hypotensive effect
lasting up to one or two weeks after
treatment is stopped.
4.3
C
ONTRAINDICATIONS
NATRILIX SR is contraindicated in:
•
Severe renal failure, anuria, progressive and severe oliguria.
•
Hepatic coma, hepatic encephalopathy or