SYNJARDY Film-coated tablet Ref.[51286] Active ingredients: Empagliflozin Metformin Metformin and Empagliflozin

Posology

Adults with normal renal function (eGFR ≥90 ml/min/1.73 m²)

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 using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding the maximum recommended daily dose of metformin.

For patients insufficiently controlled on metformin (either alone or in combination with other medicinal products for the treatment of diabetes)

In patients insufficiently controlled on metformin alone or in combination with other medicinal products for the treatment of diabetes, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg 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 tighter glycaemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg. When Synjardy 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 hypoglycemia (see sections 4.5 and 4.8).

For patients switching from separate tablets of empagliflozin and metformin

Patients switching from separate tablets of empagliflozin (10 mg or 25 mg total daily dose) and metformin to Synjardy should receive the same daily dose of empagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin (for available strengths see section 2).

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 on the same time. In that case, the missed dose should be skipped.

Special populations

Renal impairment

The glycaemic efficacy of empagliflozin is dependent on renal function. For cardiovascular risk reduction as add on to standard of care, a dose of 10 mg empagliflozin daily should be used in patients with an eGFR below 60 ml/min/1.73 m² (see Table 1). Because the glycaemic lowering efficacy of empagliflozin is reduced in patients with moderate renal impairment and likely absent in patients with severe renal impairment, if further glycaemic control is needed, the addition of other antihyperglycaemic agents should be considered. For dose adjustment recommendations according to eGFR or CrCL refer to Table 1.

A eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.

Table 1. Posology for renally impaired patients^a:

^a See sections 4.4, 4.8, 5.1 and 5.2
^b patients with type 2 diabetes mellitus and established cardiovascular disease

Hepatic impairment

This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).

Elderly

Due to the mechanism of action, decreased renal function will result in reduced glycaemic efficacy of empagliflozin. Because metformin is excreted by the kidney and elderly patients are more likely to have decreased renal function, Synjardy should be used with caution in these patients. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4). 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 Synjardy in children and adolescents aged 0 to 18 years has not been established. No data are available.

Method of administration

Synjardy should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. The tablets should be swallowed whole with water. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy restricted diet.

Symptoms

Empagliflozin

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.

Metformin

Hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital (see sections 4.4 and 4.5).

Therapy

In the event of an overdose, treatment should be initiated as appropriate to the patient’s clinical status. The most effective method to remove lactate and metformin is haemodialysis. The removal of empagliflozin by haemodialysis has not been studied.

3 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC/aluminium perforated unit dose blisters.

Pack sizes of 10 × 1, 14 × 1, 30 × 1, 56 × 1, 60 × 1, 90 × 1 and 100 × 1 film-coated tablets and multipacks containing 120 (2 packs of 60 × 1), 180 (2 packs of 90 × 1) and 200 (2 packs of 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.