Repaglinide Accord

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, please 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 regimes 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 with metformin alone.
The medicine can only be obtained with a prescription.

How is Repaglinide Accord used?

Repaglinide Accord is taken before meals, normally up to 15 minutes before each meal. The dose should be adjusted to achieve the best possible control. The treating physician should regularly measure the patient's blood glucose level to find the lowest effective dose. Repaglinide Accord may also be indicated for type 2 diabetics whose blood glucose level is usually well controlled with a diet, but who are going through a phase of temporary loss of blood glucose control.
The recommended starting dose is 0.5 mg. This dose may 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 below 18 years of age 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 make 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?

Since Repaglinide Accord is a generic medicine, the studies have been limited to tests designed to show that the medicine is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance 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, the benefits and risks of the medicine are assumed to be the same as the reference medicine.

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 CHMP's view that, as in the case of NovoNorm, the benefits outweigh the risks The Committee recommended the granting of a marketing authorization for Repaglinide Accord.

Other information about 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 Repaglinide Accord therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 11-2011.

The information on Repaglinide Accord 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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