Posology : מינונים

4.2 Posology and method of administration
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 EUC API SEP22 V3                                                          EU SmPC 07.2022 recommended daily dose of 100 mg vildagliptin. Based on the patient’s current dose of metformin, Eucreas may be initiated at either 50 mg /500 mg or 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.


EUC API SEP22 V3                                                             EU SmPC 07.2022 GFR ml/min        Metformin                                    Vildagliptin 
60-89             Maximum daily dose is 3000 mg.               No dose adjustment.

Dose reduction may be considered in relation to declining renal function.
45-59             Maximum daily dose is 2000 mg.               Maximal daily dose is 50 mg.

The starting dose is at most half of the maximum dose.

30-44             Maximum daily dose is 1000 mg.
The starting dose is at most half of the maximum dose.

<30               Metformin is contraindicated.

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).