EMPAZOX 25 EMPAGLIFLOZIN FILM COATED TABLETS 25 MG [SIN17547P]

Product Info

EMPAZOX 25 EMPAGLIFLOZIN FILM COATED TABLETS 25 MG

[SIN17547P]

Indication

THERAPEUTIC INDICATIONS

Type 2 diabetes mellitus
EMPAZAOX is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as:

Monotherapy
When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.

Add-on combination therapy
In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Add-on combination in patients with established cardiovascular disease
EMPAZOX is indicated as an adjunct to diet, exercise and standard care therapy to reduce the incidence of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease who have inadequate glycemic control (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Heart failure (HF)
EMPAZOX is indicated in adult patients with heart failure (NYHA class II-IV), with or without type 2 diabetes mellitus to reduce the risk of cardiovascular death and hospitalisation for heart failure (see clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Chronic kidney disease
EMPAZOX is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalisation in adults with chronic kidney disease at risk of progression.

Dosing

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Type 2 diabetes mellitus

Monotherapy and add-on combination
The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg (see below and section 4.4).

When empagliflozin 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 4.5 and 4.8).

Heart failure (HF)
The recommended dose of EMPAZOX is 10 mg once daily (see clinical trial section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Chronic kidney disease
The recommended dose of EMPAZOX is 10 mg once daily (see clinical trial section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Renal impairment
Due to limited experience, it is not recommended to initiate treatment with EMPAZOX in patients- on dialysis.

Glycaemic efficacy of empagliflozin is dependent on renal function and reduced in patients with an eGFR <45 ml/min/1.73 m² and likely absent in patients with an eGFR<30 ml/min/1.73 m². If eGFR falls below 45 ml/min/1.73 m² the recommended dose of empagliflozin is limited to 10 mg and additional glucose lowering treatment should be considered if needed (see Special warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is required for patients with hepatic impairment. Empagliflozin exposure is increased in patients with severe hepatic impairment. Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly patients
No dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).

Paediatric population

Type 2 diabetes mellitus
The recommended starting dose of EMPAZOX is 10 mg once daily.

In patients tolerating empagliflozin 10 mg once daily and requiring additional glycaemic control, the dose can be increased to 25 mg once daily (see general information above in section 4.2 Dosage and Administration).

No data are available for children with eGFR <60 ml/min/1.73 m² and children below 10 years of age.

Heart failure
Safety and effectiveness of EMPAZOX for the treatment of heart failure in children under 18 years of age have not been established.

Chronic kidney disease
Safety and effectiveness of EMPAZOX for the treatment of CKD in children under 18 years of age have not been established.

Method of administration
The tablets can be taken with or without food, swallowed whole with water. 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.

Contraindications

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.