SIDAPVIA FIXED DOSE COMBINATION TABLET 10 MG/100 MG [SIN16958P]

Product Info

SIDAPVIA FIXED DOSE COMBINATION TABLET 10 MG/100 MG

[SIN16958P]

4.1 Therapeutic indications

SIDAPVIA is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and sitagliptin is appropriate.

Limitations of use
SIDAPVIA is not indicated for use in patients with type 1 diabetes mellitus.

SIDAPVIA should not be used for the treatment of diabetic ketoacidosis.

SIDAPVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using SIDAPVIA (see Section 4.4 Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

The recommended dose of SIDAPVIA is one dapagliflozin 10 mg/sitagliptin 100 mg tablet taken orally once daily at any time of the day, with or without food.

The tablet is to be swallowed whole.

Special Populations

Renal impairment

SIDAPVIA should not be used in patients with an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² (see Section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal function should be evaluated prior to initiation of SIDAPVIA and periodically thereafter.

Hepatic impairment

SIDAPVIA should not be used in patients with severe hepatic impairment (see Section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric and adolescent patients

Safety and effectiveness of SIDAPVIA in paediatric and adolescent patients have not been established.

Elderly patients

Older patients are more likely to have decreased renal function. The renal function recommendations provided for all patients also apply to elderly patients (see Section 4.4 Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

SIDAPVIA is contraindicated in patients with a history of any hypersensitivity reaction to the active substances or to any of the excipients (see Sections 4.4 Special warnings and special precautions for use and 4.8 Undesirable effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).