NATRILIX SR TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Servier Laboratories South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS INDAPAMIDE 1,5 mg

Authorization status:

Registered

Authorization date:

1997-02-05

Patient Information leaflet

Page 1 of 10
APPROVED PIL
Applicant:
Servier SA (Pty) Ltd
Product:
Natrilix SR sustained release tablets
Date of submission:
24 December 2020
PATIENT INFORMATION LEAFLET
NATRILIX SR SUSTAINED RELEASE FILM-COATED TABLETS
Indapamide
Contains sugar (lactose)
NATRILIX SR contains 124,5 mg lactose monohydrate
SCHEDULING STATUS
READ OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING NATRILIX SR.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist, nurse or other
-
healthcare provider.
- NATRILIX SR has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What NATRILIX SR is and what it is used for
2.
What you need to know before you take NATRILIX SR
3.
How to take NATRILIX SR
4.
Possible side effects
5.
How to store NATRILIX SR
6.
Contents of the pack and other information
1.
WHAT NATRILIX SR IS AND WHAT IT IS USED FOR
Natrilix
SR
is
a
sustained
release
film-coated
tablet
containing
indapamide
as
active
ingredient.
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3
Page 2 of 10
APPROVED PIL
Applicant:
Servier SA (Pty) Ltd
Product:
Natrilix SR sustained release tablets
Date of submission:
24 December 2020
NATRILIX SR is intended to reduce high blood pressure (hypertension)
in adults.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX SR
DO NOT TAKE NATRILIX SR
-
if you are allergic to indapamide or any other sulphonamide or to any
of the other
ingredients of NATRILIX SR (listed in section 6),
-
if you have severe kidney disease,
-
if
you
have
severe
liver
disease
or
suffer
from
a
condition
called
hepatic
encephalopathy (degenerat

Summary of Product characteristics

Page 1 of 17
APPROVED PI
Applicant:
Servier SA (Pty) Ltd
Product:
Natrilix SR sustained release tablets
Date of submission:
24 December 2020
NATRILIX SR
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
NATRILIX SR, sustained release film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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 indapamide) is indicated in the management of mild
to moderate
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One tablet daily preferably in the morning, to be swallowed whole with
water and not
chewed.
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3
Page 2 of 17
APPROVED PI
Applicant:
Servier SA (Pty) Ltd
Product:
Natrilix SR sustained release tablets
Date of submission:
24 December 2020
In more severe cases NATRILIX SR (1,5 mg indapamide) can be combined
with other
categories of antihypertensive agents.
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 when renal function
is normal or only minimally
impaired.
PAEDIATRIC POPULATION
The safety and efficacy of NATRILIX SR in children and adolescents
below 18 years of age have
not been established. No data are available.
METHOD OF ADMINISTRATION
Oral use.
Page 3 of 17
APPROVED PI