JARDIANCE Film-coated tablet Ref.[7237] Active ingredients: Empagliflozin

Posology

Type 2 diabetes mellitus

The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60 ml/min/1.73 m² 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).

Heart failure

The recommended dose is 10 mg empagliflozin once daily.

Chronic kidney disease

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 sections 4.5 and 4.8).

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

Renal impairment

Due to limited experience, it is not recommended to initiate treatment with empagliflozin in patients with an eGFR <20 ml/min/1.73 m².

In patients with an eGFR <60 ml/min/1.73 m² the daily dose of empagliflozin is 10 mg.

In patients with type 2 diabetes mellitus, the glucose lowering efficacy of empagliflozin is 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. Therefore, if eGFR falls below 45 ml/min/1.73 m², additional glucose lowering treatment should be considered if needed (see sections 4.4, 4.8, 5.1 and 5.2).

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).

Elderly

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

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.

Symptoms

In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Empagliflozin increased urine glucose excretion leading to an increase in urine volume. The observed increase in urine volume was not dose-dependent and is not clinically meaningful. There is no experience with doses above 800 mg in humans.

Therapy

In the event of an overdose, treatment should be initiated as appropriate to the patient’s clinical status. The removal of empagliflozin by haemodialysis has not been studied.

3 years.

This medicinal product does not require any special storage conditions.

PVC/aluminium perforated unit dose blisters.

Pack sizes of 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1, and 100 × 1 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.