What is Eucreas?
Eucreas is a medicine containing the active substances vildagliptin and metformin hydrochloride. It is available as oval tablets (dark yellow: 50 mg / 850 mg; light yellow: 50 mg / 1 000 mg).
What is Eucreas used for?
Eucreas is used to treat type 2 diabetes (non-insulin-dependent diabetes). It is used in patients whose disease is insufficiently controlled on the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin given as separate tablets.
The medicine can only be obtained with a prescription.
How is Eucreas used?
The recommended dose of Eucreas is one tablet twice a day, one tablet in the morning and one in the evening. The choice of starting dose depends on the dose of metformin currently taken by the patient, but the recommended dose is 50 mg of vildagliptin and 1 000 mg of metformin twice daily. Patients already taking vildagliptin and metformin should be switched to Eucreas tablets containing the same doses of each active substance. Doses greater than 100 mg of vildagliptin are not recommended.Taking Eucreas with or shortly after meals can reduce stomach problems caused by metformin.
Eucreas must not be used by patients with moderate to severe renal insufficiency or liver problems. In older patients taking Eucreas, kidney function should be monitored regularly. Eucreas is not recommended for patients over 75 years of age.
How does Eucreas work?
Type 2 diabetes is a disease where the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. Eucreas contains two active ingredients that each have a different action. Vildagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by inhibiting the breakdown of "incretin" hormones in the body. Incretins, which are released into the blood after a meal, stimulate the pancreas to produce insulin. By increasing the level of incretins in the blood, vildagliptin stimulates the pancreas to produce more insulin when the blood sugar level is high, while it is ineffective when the blood glucose concentration is low. Vildagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon. Metformin basically inhibits glucose production and reduces
its absorption in the intestine. The result of the combined action of the two active ingredients is a reduction of the glucose present in the blood, which helps to control type 2 diabetes.
How has Eucreas been studied?
In September 2007, Vildagliptin alone was approved by the European Union (EU) under the name Galvus, while metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in patients with type 2 diabetes, whose disease is not sufficiently controlled with metformin alone. The studies carried out on Galvus were integrated with those on metformin to support the use of Eucreas for the same indication. In these studies, the level of a substance called glycosylated hemoglobin (HbA1c) was measured in the blood, which gives an indication of the "effectiveness of blood glucose control.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas are absorbed by the body in the same way as when taken as separate tablets.
What benefit has Eucreas shown during the studies?
Vildagliptin was more effective than placebo (phytite treatment) in reducing HbA1c levels when added to metformin. Patients who added vildagliptin experienced a decrease in HbA1c levels of 0.88% after 24 weeks, with an initial level of 8.38%. HbA1c, with an increase of 0.23%, starting from an initial level of 8.30%.
What is the risk associated with Eucreas?
The most common side effects recorded with Eucreas (seen in more than 1 in 10 patients) are nausea, vomiting, diarrhea, abdominal pain and loss of appetite. For the full list of side effects reported with Eucreas, see the Package Leaflet. .
Eucreas must not be used by people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients (components). It must not be used in patients with diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, kidney or liver problems, conditions that can affect the kidneys or a disease that causes reduced oxygen supply to the tissues such as heart or lung failure or a recent heart attack. Also, it should not be used in patients with alcoholic intoxication (excessive alcohol consumption) or alcoholism, who are breastfeeding. For the full list of restrictions, see the Package Leaflet.
Why has Eucreas been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and that combining the two active substances in one tablet can help patients stick to their treatment.
The Committee therefore decided that Eucreas's benefits are greater than its risks in the treatment of patients with type 2 diabetes mellitus who are unable to achieve sufficient glycemic control at their maximum tolerated dose of oral metformin or who are already being treated. with the combination of vildagliptin and metformin in separate capsules. The committee recommended the granting of a marketing authorization for Eucreas.
More information about Eucreas
On November 14, 2007, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Eucreas valid throughout the European Union.
The full version of the EPAR for Eucreas can be found here.
Last update of this summary: 10-2007.
The information on Eucreas - vildagliptin and metformin hydrochloride published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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