NATRILIX SR

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Principio attivo:

INDAPAMIDE

Commercializzato da:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (Nome Internazionale):

INDAPAMIDE

Dosaggio:

1,5 MG

Forma farmaceutica:

TABLET SALUT SELAPUT PELEPASAN LAMBAT

Confezione:

DUS, 3 STRIP @ 10 TABLET SALUT LEPAS LAMBAT

Prodotto da:

DARYA-VARIA LABORATORIA TBK - Indonesia

Data dell'autorizzazione:

2018-03-29

Scheda tecnica

_ NATRILIX_
_®_
_ _ INDAPAMIDE 1.5 MG
_ _
COMPOSITION
Each sustained release coated tablet contains:
Indapamide
………………………………………………………………………
1.5 mg
INDICATION
Natrilix SR is indicated in essential hypertension in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One sustained release 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.
_In case one or several doses have been missed: do not take a double
dose the day after the omitted doses_.
Special populations
_Renal impairment (see sections “Contraindications” and “Special
warnings and precautions for use”): _
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 “Contraindications” and
“Special warnings and precautions for use”): _
In severe hepatic impairment, treatment is contraindicated.
_ _
_Elderly (see section “Special warnings and precautions for use”):
_
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
have not been established. No data are
available.
Method of administration
Oral use
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, or to other sulfonamides.
•
Severe renal failure.
•
Hepatic encephalopathy or severe impairment of liver function.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_ _
_Special warnings _
_SR_
•
Hypokalemia.
•
Recent cerebrovascular accident
DISETUJUI OLEH BPOM : 08/03/2022
EREG10008712100126
When liver function is impaired, thiazide-related diureti