NATRILIX SR TABLET 1.5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

INDAPAMIDE

Available from:

SERVIER (S) PTE LTD

ATC code:

C03BA11

Dosage:

1.5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

INDAPAMIDE 1.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

1996-12-14

Patient Information leaflet

NATRILIX SR_proposed PI_ 08.08.2011 
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NATRILIX SR  
INDAPAMIDE 1.5 MG 

1. 
NAME OF THE MEDICINAL PRODUCT 
NATRILIX SR, sustained-release film-coated tablets. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Indapamide …………………..........................1.50 mg  
For a sustained-release film-coated tablet 
Excipient : 124.5 mg lactose monohydrate 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 
Sustained-release film-coated tablet. 
White, round, film-coated tablet. 

4. CLINICAL 
DATA 

4.1 THERAPEUTIC 
INDICATIONS 
Essential hypertension. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Oral route.  
One tablet per 24 hours, preferably in the morning,  
The tablet should be taken whole with water and should not be
chewed. _ _

Higher doses do not improve the antihypertensive action of indapamide;
rather, they increase the 
salidiuretic effect. 

_Renal failure (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. 
_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. 
_Patients with hepatic impairment (see sections 4.3 and 4.4): _
In severe hepatic impairment, treatment is contraindicated.  
_Children and adolescents: _
NATRILIX SR is not recommended for use in children and adolescents
due to a lack of data on safety 
and efficacy. 

NATRILIX SR_PI_20120926 
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4.3 CONTRAINDICATIONS 
- Hypersensitivity to indapamide, to other sulfonamides or to
any of the excipients. 
- Severe renal failure. 
- Hepatic encephalopathy or_ _severe liver failure. 
- Hypokalaemia. 

4.4 
SPECIAL WARNINGS AND SPECIAL PREC

Summary of Product characteristics

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NATRILIX SR
INDAPAMIDE 1.5 MG
1.
NAME OF THE MEDICINAL PRODUCT
Natrilix SR, 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 film-coated tablet.
White, round, film-coated tablet.
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
Natrilix SR is indicated for 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.
Method of administration
Oral use
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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 liver failure.
-
Hypokalaemia.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Special warnings _
When liver function is impaired, thiazide-related diuretics may cause,
particularly in the event of
electrolyte imbalance