Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
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
Documents
Package Inserts
Swilix SR Tablet PI.pdf
Approved: March 30, 2023