What is Repaglinide Krka?
Repaglinide Krka is a medicine containing the active substance repaglinide, available as tablets (white: 0.5 mg; yellow: 1 mg; pink: 2 mg).
Repaglinide Krka is a "generic medicine". This means that it 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 Krka used for?
Repaglinide Krka is used in patients with type 2 diabetes (non-insulin-dependent diabetes). It is used in combination with specific diet and exercise regimens to reduce blood glucose (sugar) levels in patients whose hyperglycemia (high blood glucose levels) can no longer be controlled through diet, weight loss and exercise .
The medicine can only be obtained with a prescription.
How is Repaglinide Krka used?
Repaglinide Krka should be taken before meals, normally up to 15 minutes before each meal. The dose must be adjusted so as 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 Krka can also be indicated for type 2 diabetics who are usually well controlled on a diet, but who go through a passing phase in which the body cannot regulate the level of glucose in the blood.
The recommended starting dose is 0.5 mg. This dose could be increased after one or two weeks.
If patients switch to Repaglinide Krka while they are already using another antidiabetic, the recommended starting dose is 1 mg.
The use of Repaglinide Krka 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 Krka 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 Krka helps the pancreas to produce more insulin during meals and is used to control type 2 diabetes.
How has Repaglinide Krka been studied?
Because Repaglinide Krka is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, NovoNorm. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits associated with Repaglinide Krka?
Because Repaglinide Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.
Why has Repaglinide Krka been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Repaglinide Krka has been shown to have comparable quality and to be bioequivalent to NovoNorm. 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 Krka be given marketing authorization.
More information on Repaglinide Krka:
On 4 November 2009, the European Commission granted Krka, dd, Novo mesto a marketing authorization for Repaglinide Krka, valid throughout the European Union.
For the full EPAR for Repaglinide Krka, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 11-2009.
