GLYXAMBI FILM-COATED TABLETS 10 MG/5 MG [SIN15273P]

Product Info

GLYXAMBI FILM-COATED TABLETS 10 MG/5 MG

[SIN15273P]

4.1 Therapeutic indications

GLYXAMBI tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. (See Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Limitations of Use
GLYXAMBI is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

GLYXAMBI has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI.

4.2 Posology and method of administration

Recommended Dosage
The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended.

No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

Patients with Renal Impairment
Assessment of renal function is recommended prior to initiation of GLYXAMBI and periodically thereafter.

GLYXAMBI should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m².

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m².

GLYXAMBI should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m².

Patients with hepatic impairment
No dose adjustment is required in patients with mild to moderate hepatic impairment.
Empagliflozin exposure is increased in patients with severe hepatic impairment and therapeutic experience in such patients is limited. Therefore, GLYXAMBI is not recommended for use in this population.

Elderly Patients
No dosage adjustment is recommended based on age. Glyxambi should be prescribed with caution in patients aged 75 years and older (see Special Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and effectiveness of GLYXAMBI in children below 18 years of age have not been established. GLYXAMBI is not recommended for use in patients under 18 years of age.

Combination therapy
When GLYXAMBI is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. (see sections Interactions and Side effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Missed dose
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

4.3 Contraindications

Hypersensitivity to empagliflozin or linagliptin or any of the excipients.