FORXIGA Film-coated tablet Ref.[6755] Active ingredients: Dapagliflozin

Posology

Type 2 diabetes mellitus

The recommended dose is 10 mg dapagliflozin once daily.

When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).

Heart failure

The recommended dose is 10 mg dapagliflozin once daily.

Chronic kidney disease

The recommended dose is 10 mg dapagliflozin once daily.

Special populations

Renal impairment

No dose adjustment is required based on renal function.

Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR <25 mL/min.

In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when the glomerular filtration rate (GFR) is <45 mL/min and is likely absent in patients with severe renal impairment. Therefore, if GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with type 2 diabetes mellitus if further glycaemic control is needed (see sections 4.4, 4.8, 5.1 and 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg (see sections 4.4 and 5.2).

Elderly (≥65 years)

No dose adjustment is recommended based on age.

Paediatric population

No dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and above (see sections 5.1 and 5.2). No data are available for children below 10 years of age.

The safety and efficacy of dapagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children <18 years have not yet been established. No data are available.

Method of administration

Forxiga can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.

Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose). These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval. The incidence of hypoglycaemia was similar to placebo. In clinical studies where once-daily doses of up to 100 mg (10 times the maximum recommended human dose) were administered for 2 weeks in healthy subjects and type 2 diabetes subjects, the incidence of hypoglycaemia was slightly higher than placebo and was not dose-related. Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function.

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

3 years.

This medicinal product does not require any special storage conditions.

Alu/Alu blister

Forxiga 5 mg film-coated tablets:

Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters.

Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.

Forxiga 10 mg film-coated tablets:

Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters.

Pack sizes of 10x1, 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

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