JARDIANCE DUO FILM COATED TABLET 12.5MG/500MG [SIN15063P]

Product Info

JARDIANCE DUO FILM COATED TABLET 12.5MG/500MG

[SIN15063P]

Indication

4.1 Therapeutic indications

Glycaemic control:

Adults
JARDIANCE DUO is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus.

• inadequately controlled with metformin

• inadequately controlled with metformin in combination with other glucose lowering products including insulin (see section Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• already treated with empagliflozin and metformin co-administered as separate tablets

Paediatric population
JARDIANCE DUO is indicated as an adjunct to diet and exercise to improve glycaemic control in children aged 10 years and above with type 2 diabetes mellitus.

• when treatment with both empagliflozin and metformin is appropriate

• inadequately controlled with metformin alone or in combination with insulin (see section Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• already treated with empagliflozin and metformin co-administered as separate tablets

Prevention of cardiovascular events:

JARDIANCE DUO is indicated in adult patients with type 2 diabetes mellitus and established cardiovascular disease when treatment with empagliflozin and metformin is appropriate and empagliflozin is needed to reduce the incidence of cardiovascular death (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

4.2 Posology and method of administration

Adults with normal renal function (GFR ≥ 90ml/min)

The recommended dose is one tablet twice daily. The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability. The maximum recommended daily dose of JARDIANCE DUO is 25 mg of empagliflozin and 2000 mg of metformin (see table 1 for additional dosing information).

• In patients not adequately controlled on metformin twice daily alone or in combination with other products, including insulin, the recommended starting dose of JARDIANCE DUO should provide empagliflozin 5 mg twice daily (10 mg total daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of empagliflozin 10 mg and who need a tighter glycemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg.

• Patients switching from separate tablets of empagliflozin (10 mg or 25 mg total daily dose) and metformin (dose taken twice-daily) to JARDIANCE DUO should receive the same daily dose of empagliflozin and metformin.

When JARDIANCE DUO is used in combination with a sulphonylurea and/or insulin, a lower dose of sulphonylurea and/or insulin may be required to reduce the risk of hypoglycaemia (see sections 4.5 Interactions and 4.8 Undesirable Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For the different doses of metformin, JARDIANCE DUO is available in strengths of 5 mg empagliflozin plus 500 mg, 850 mg or 1000 mg metformin hydrochloride or 12.5 mg empagliflozin plus 500 mg, 850 mg or 1000 mg metformin hydrochloride. Not all strength presentation may be available locally.

JARDIANCE DUO should be given with meals to reduce the gastrointestinal undesirable effects associated with metformin.

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers. However, a double dose should not be taken at the same time. In that case, the missed dose should be skipped.

Special Populations

Patients with renal impairment
The 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 further glycaemic control is needed, the addition of other anti-hyperglycaemic agents should be considered. For dose adjustment recommendations according to eGFR refer to Table 1.

For dosing recommendations in the paediatric population see subsection paediatric patients below.

Paediatric population
The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability. The recommended dose is one tablet twice daily.
The maximum recommended daily dose of JARDIANCE DUO is 25 mg of empagliflozin and 2000 mg of metformin. (See general information above in section 4.2 Posology and method of administration)
No data are available for children with eGFR <60 ml/min/1.73 m² and children below 10 years of age.

Elderly patients
In patients 75 years and older, an increased risk for volume depletion should be taken into account.

Contraindications

4.3 Contraindications

• Hypersensitivity to active ingredients empagliflozin and/or metformin or to any of the excipients (see section 2 Composition – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)

• Diabetic pre-coma

• Severe renal failure (CrCl <30 ml/min or eGFR <30 ml/min/1.73m²), due to its metformin component.

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4 Special warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock

• Hepatic insufficiency, acute alcohol intoxication, alcoholism (see section 4.5 Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)