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HSA Approval

NATRILIX SR TABLET 1.5 mg

SIN09074P

NATRILIX SR TABLET 1.5 mg

NATRILIX SR TABLET 1.5 mg

December 14, 1996

SERVIER (S) PTE LTD

SERVIER (S) PTE LTD

Regulatory Information

SERVIER (S) PTE LTD

SERVIER (S) PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_): 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_): In severe hepatic impairment, treatment is contraindicated. _Elderly (see section 4.4_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_): 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

ORAL

Medical Information

**4.1 Therapeutic indications** Natrilix SR is indicated for essential hypertension in adults.

**4.3 Contraindications** - Hypersensitivity to the active substance, to other sulfonamides or to any of the excipients listed in section 6.1. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Severe renal failure. - Hepatic encephalopathy or severe liver failure. - Hypokalaemia.

C03BA11

indapamide

Manufacturer Information

SERVIER (S) PTE LTD

LES LABORATOIRES SERVIER INDUSTRIE

Active Ingredients

INDAPAMIDE

1.5 mg

Indapamide

Documents

Package Inserts

Natrilix SR Tablet PI.pdf

Approved: April 8, 2022

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