SEGLUROMET Film-coated tablet Ref.[51301] Active ingredients: Ertugliflozin Metformin Metformin and Ertugliflozin

Posology

Adults with normal renal function (glomerular filtration rate [GFR] ≥90 mL/min)

The recommended dose is one tablet twice daily. The dose should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability using the recommended daily dose of 5 mg or 15 mg of ertugliflozin, while not exceeding the maximum recommended daily dose of metformin.

In patients with volume depletion, correcting this condition prior to initiation of Segluromet is recommended (see section 4.4).

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

The recommended starting dose of Segluromet should provide ertugliflozin 2.5 mg twice daily (5 mg daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of ertugliflozin 5 mg, the dose can be increased to a total daily dose of ertugliflozin 15 mg if additional glycaemic control is needed.

For patients switching from separate tablets of ertugliflozin and metformin

Patients switching from separate tablets of ertugliflozin (5 mg or 15 mg total daily dose) and metformin to Segluromet should receive the same daily dose of ertugliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.

When Segluromet is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see sections 4.4, 4.5, and 4.8).

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers. Patients should not take two doses of Segluromet at the same time.

Special populations

Renal impairment

A GFR 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 (see section 4.4).

Initiation of this medicinal product is not recommended in patients with a GFR less than 45 mL/min (see section 4.4).

Because the glycaemic lowering efficacy of ertugliflozin 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 anti-hyperglycaemic agents should be considered (see section 4.4).

The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR <60 mL/min.

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

Hepatic impairment

Segluromet is contraindicated in patients with hepatic impairment (see sections 4.3 and 4.4).

Elderly

Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, Segluromet should be used with caution in the elderly. Regular assessment of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see section 4.4). Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8).

Paediatric population

The safety and efficacy of Segluromet in children under 18 years of age have not been established. No data are available.

Method of administration

Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.

In the event of an overdose with Segluromet, employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status.

Ertugliflozin

Ertugliflozin did not show any toxicity in healthy subjects at single oral doses up to 300 mg and multiple doses up to 100 mg daily for 2 weeks. No potential acute symptoms and signs of overdose were identified. Removal of ertugliflozin by haemodialysis has not been studied.

Metformin

Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 g. Hypoglycaemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see section 4.4). Lactic acidosis is a medical emergency and must be treated in a hospital. Metformin is dialysable with a clearance of up to 170 mL/min under good haemodynamic conditions. Therefore, haemodialysis may be useful for removal of accumulated metformin from patients in whom metformin overdose is suspected.

2 years.

This medicinal product does not require any special storage conditions.

Alu/PVC/PA/Alu blisters.

Packs of 14, 28, 56, 60, 168, 180, and 196 film-coated tablets in non-perforated blisters.

Packs of 30x1 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.