Content: Empagliflozin
Description:
Each tablet contains 10 mg or 25 mg empagliflozin.
Excipient with known effect: Each tablet contains lactose monohydrate equivalent to 154.3 mg (10 mg Empagliflozin) or 107.4 mg (25 mg Empagliflozin) lactose anhydrous.
Excipients/Inactive Ingredients: Tablet core: Lactose monohydrate, Cellulose microcrystalline, Hydroxypropylcellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate.
Film coating (Opadry Yellow 02B38190): Hypromellose 2910, Titanium dioxide, Talc, Macrogol 400, Iron oxide yellow.
Indication:
Type 2 diabetes mellitus: Glycaemic control: Jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults 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 Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions for available data on different combinations).
Prevention of cardiovascular death: Jardiance is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions).
To prevent cardiovascular deaths, Jardiance should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.
Heart failure: Jardiance is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV).
Dosage:
Posology: Type 2 diabetes mellitus: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products. 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 as follows and Precautions).
Heart failure: The recommended dose is 10 mg empagliflozin once daily.
All indications: 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 Interactions and Adverse Reactions).
If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Special populations: Patients with renal impairment: Renal function must be assessed prior to initiation of empagliflozin therapy and periodically thereafter.
Type 2 diabetes mellitus: The glucose lowering efficacy of empagliflozin declines with decreasing renal function (see Table 8 under Pharmacology: Pharmacodynamics under Actions). Empagliflozin is contraindicated in patient with severe renal impairment (eGFR < 30 ml/min/1.73 m2), end-stage renal disease or patients on dialysis (see Contraindications). No dosage adjustment for empagliflozin is necessary in patient with mild to moderate renal impairment.
More intensive monitoring of glycaemic and renal biomarker and signs and symptoms of renal dysfunction is recommended if empagliflozin is used in patients with an eGFR < 60 ml/min/1.73 m2, especially if the eGFR is < 45 ml/min/1.73 m2.
Jardiance should be discontinued if the eGFR fall to a level < 30 ml/min/1.73 m2 (see Contraindications, Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Heart failure: For treatment of heart failure in patients with or without type 2 diabetes mellitus, empagliflozin 10 mg is not recommended for use in patients with eGFR < 20 ml/min/1.73 m2 (see Precautions). There are insufficient data to support use in these patients.
Patients with 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 Pharmacology: Pharmacokinetics under Actions).
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 Precautions and Adverse Reactions).
Paediatric population: The safety and efficacy of empagliflozin in children and adolescents has not yet been established. No data are available.
Method of administration: The tablets can be taken with or without food, swallowed whole with water.
