What is Repaglinide Accord?
Repaglinide Accord is a medicine that contains the active substance repaglinide and is available as round tablets (0.5 mg, 1 mg and 2 mg).
Repaglinide Accord is a "generic medicine". This means that Repaglinide is similar to a 'reference medicine' already authorized in the European Union (EU) called NovoNorm. For more information on generic medicines, see the questions and answers by clicking here.
What is Repaglinide Accord used for?
Repaglinide Accord is used in patients with type 2 diabetes (non-insulin-dependent diabetes). The medicine is given in combination with specific diet and exercise regimens to reduce blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) can no longer be controlled through diet, weight loss and physical exercise. Repaglinide Accord can also be used in combination with metformin (another antidiabetic) in type 2 diabetics whose blood glucose levels are not satisfactorily controlled on metformin alone.
The medicine can only be obtained with a prescription.
How is Repaglinide Accord used?
Repaglinide Accord should be taken before meals, normally up to 15 minutes before each meal. The dose should be adjusted to obtain the best possible control. The treating doctor should regularly measure the patient's blood glucose level to find the lowest effective dose. Repaglinide Accord can also be indicated for type 2 diabetics whose blood glucose level is usually well controlled on a diet, but who are experiencing a temporary loss of blood glucose control.
The recommended starting dose is 0.5 mg. This dose could be increased after one or two weeks.
If patients were using another antidiabetic, the recommended starting dose is 1 mg.
Repaglinide Accord is not recommended in patients under the age of 18, in the absence of information on the safety and efficacy of the product for this age group.
How does Repaglinide Accord work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively. Repaglinide Accord helps the pancreas to produce more insulin during meals and is used to control type 2 diabetes.
How has Repaglinide Accord been studied?
Because Repaglinide Accord is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Repaglinide Accord?
Because Repaglinide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Repaglinide Accord been approved?
The CHMP concluded that, in accordance with EU requirements, Repaglinide Accord has been shown to have comparable quality and to be bioequivalent / comparable to the reference medicine. It is the opinion of the CHMP that, as in the case of NovoNorm, the benefits outweigh the identified risks. The Committee recommended that Repaglinide Accord be given marketing authorization.
Further information on Repaglinide Accord
On 22 December 2011, the European Commission issued a marketing authorization for Repaglinide Accord, valid throughout the European Union.
For more information about treatment with Repaglinide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 11-2011.
