Vildagliptin / metformin hydrochloride
This is a summary of the European public assessment report (EPAR) for Eucreas. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eucreas.
What is Eucreas?
Eucreas is a medicine that contains the active substances vildagliptin and metformin hydrochloride. It is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).
What is Eucreas used for?
Eucreas is used to treat adults with type 2 diabetes. It is used in the following ways:
•in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone;
- Zomarist - vildagliptin / metformin hydrochloride
Prescription drugs listed. Substance: "Vildagliptin / metformin hydrochloride"
•in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
•in combination with a sulphonylurea (another type of
•in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
The medicine can only be obtained with a prescription.
© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
How is Eucreas used?
The recommended dose of Eucreas is one tablet twice a day, with one tablet taken in the morning and one in the evening. The choice of tablet strength to start with depends on the patient’s current treatment and the expected effects of Eucreas, but it is recommended to provide a dose of metformin similar to the dose already being taken. Patients already taking vildagliptin and metformin should switch to Eucreas containing the same amounts of each active substance. Doses of vildagliptin above 100 mg are not recommended. Taking Eucreas with or just after food may reduce any stomach problems caused by metformin.
Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver. Elderly patients taking Eucreas should have their kidney function monitored regularly.
How does Eucreas work?
Type 2 diabetes is a disease in which the pancreas does not make 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 substances, which each have a different mode of action. Vildagliptin, which is a dipeptidyl peptidase 4
How has Eucreas been studied?
Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959. Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. The studies with Galvus as an
The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas were absorbed in the body in the same way as when they were taken as separate tablets.
What benefit has Eucreas shown during the studies?
Vildagliptin has been shown to be more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin. Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%. In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23 percentage points from a starting level of 8.3%. In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
What is the risk associated with Eucreas?
- Zomarist - A10BD08
Prescription drugs listed. ATC Code: "A10BD08"
The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite. For the full list of all side effects reported with Eucreas, see the package leaflet.
Eucreas should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients. It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic
Why has Eucreas been approved?
The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment. The CHMP also noted that the combination of vildagliptin and metformin was effective as an
Other information about Eucreas
The European Commission granted a marketing authorisation valid throughout the EU for Eucreas on 14 November 2007.
The full EPAR for Eucreas can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Eucreas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in