DAFASGLIT 10 FILM-COATED TABLETS 10MG [SIN17469P]
Active ingredients: DAFASGLIT 10 FILM-COATED TABLETS 10MG
Last updated 24 April 2026
Product Info
DAFASGLIT 10 FILM-COATED TABLETS 10MG
[SIN17469P]
Product information
Active Ingredient and Strength | DAPAGLIFLOZIN - 10 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | APL HEALTHCARE LIMITED - INDIA |
Registration Number | SIN17469P |
Licence Holder | APOTHECA MARKETING PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A10BK01 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Type 2 diabetes mellitus
Dapagliflozin is indicated in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. Dapagliflozin can be given as monotherapy or in combination with other medicinal products indicated for the treatment of type 2 diabetes mellitus.
For study results with respect to combination of therapies, effects on glycemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Dapagliflozin is not indicated for use in patients with type 1 diabetes.
Dapagliflozin should not be used for the treatment of diabetic ketoacidosis.
Dosing
4.2 Posology and method of administration
Posology
Type 2 diabetes mellitus
The recommended dose of dapagliflozin is 10 mg taken orally once daily at any time of the day regardless of meals.
Special populations
Renal impairment
No dose adjustment is required based on renal function.
Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, end-stage kidney disease and CV death.
In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when eGFR is < 45mL/min/1.73m2. Therefore, if eGFR falls below 45mL/min/1.73m2, additional glucose lowering treatment should be considered in patients with type 2 diabetes mellitus (see sections 4.4, 4.8, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment
No dose adjustment is necessary for patients with mild or moderate hepatic impairment. Dapagliflozin should not be used in patients with severe hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric and Adolescent population
Safety and effectiveness of dapagliflozin in paediatric and adolescent patients have not been established.
Geriatric patients
No dosage adjustment for dapagliflozin is required based on age (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Older patients are more likely to have impaired renal function. The renal function recommendations provided for all patients also apply to elderly patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Method of administration
Dapagliflozin can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance 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.