EUCREAS Film-coated tablet Ref.[10491] Active ingredients: Metformin Metformin and Vildagliptin Vildagliptin

Posology

Adults with normal renal function (GFR ≥90 ml/min)

The dose of antihyperglycaemic therapy with Eucreas should be individualised on the basis of the patient’s current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. Eucreas may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.

• For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
• For patients switching from co-administration of vildagliptin and metformin as separate tablets: Eucreas should be initiated at the dose of vildagliptin and metformin already being taken.
• For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Eucreas is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
• For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Eucreas should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.

Special populations

Elderly (≥65 years)

As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see sections 4.4 and 5.2).

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.

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 Eucreas is available, individual monocomponents should be used instead of the fixed dose combination.

Hepatic impairment

Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).

Paediatric population

Eucreas is not recommended for use in children and adolescents (<18 years). The safety and efficacy of Eucreas in children and adolescents (<18 years) have not been established. No data are available.

Method of administration

Oral use.

Taking Eucreas with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).

No data are available with regard to overdose of Eucreas.

Vildagliptin

Information regarding overdose with vildagliptin is limited.

Symptoms

Information on the likely symptoms of overdose with vildagliptin was taken from a rising dose tolerability study in healthy subjects given vildagliptin for 10 days. At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels. At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels. Three other subjects experienced oedema of the feet, with paraesthesia in two cases. All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.

Metformin

A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital.

Management

The most effective method of removing metformin is haemodialysis. However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can. Supportive management is recommended.

PA/alu/PVC/alu: 2 years.

PCTFE/PVC/alu: 18 months.

PVC/PE/PVDC/alu: 18 months.

Do not store above 30°C.

Store in the original package (blister) in order to protect from moisture.

Aluminium/Aluminium (PA/alu/PVC/alu) blister: Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.

Polychlorotrifluoroethylene (PCTFE/PVC/alu) blister: Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.

Polyvinylchloride/Polyethylene/Polyvinylidene chloride/Aluminium (PVC/PE/PVDC/alu) blister: Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.

Not all pack sizes and tablet strengths may be marketed.

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