MedPath
HSA Approval

SWILIX SR TABLET 1.5MG

SIN16750P

SWILIX SR TABLET 1.5MG

SWILIX SR TABLET 1.5MG

March 30, 2023

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED, EXTENDED RELEASE

**DOSAGE & 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:**_ 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:**_ In severe hepatic impairment, treatment is contraindicated. _**Elderly:**_ In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Indapamide Sustained Release Tablets when renal function is normal or only minimally impaired. _**Paediatric population:**_ The safety and efficacy of Indapamide Sustained Release Tablets in children and adolescents have not been established. No data are available. **Method of administration** Oral use

ORAL

Medical Information

**INDICATIONS & USAGE:** Indapamide Sustained Release Tablets is indicated in essential hypertension in adults.

**CONTRAINDICATION:** - Hypersensitivity to the active substance, to other sulfonamides or to any of the excipients. - Severe renal failure. - Hepatic encephalopathy or severe impairment of liver function. - Hypokalaemia

C03BA11

indapamide

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Ind-Swift Limited

Active Ingredients

Indapamide

1.50mg

Indapamide

Documents

Package Inserts

Swilix SR Tablet PI.pdf

Approved: March 30, 2023

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