What is Pioglitazone Accord?
Pioglitazone Accord is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).
Pioglitazone Accord is a "generic medicine". This means that Pioglitazone Accord is similar to a "reference medicine" already authorized in the European Union (EU) called Actos.
What is Pioglitazone Accord used for?
Pioglitazone Accord is indicated for the treatment of type 2 diabetes in adults (aged 18 years or older), particularly those who are overweight. It is used in association with diet and exercise.
Pioglitazone Accord is used on its own in patients for whom metformin (another antidiabetes medicine) is not adequate.
The medicine can only be obtained with a prescription.
How is Pioglitazone Accord used?
The recommended starting dose of Pioglitazone Accord is 15 or 30 mg once a day. This dose can be increased after one or two weeks up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Accord should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.
Treatment with Pioglitazone Accord should be reviewed after three to six months and discontinued in patients who do not benefit sufficiently. In subsequent analyzes, the doctors who prescribe it must confirm the maintenance of the benefits for the patients.
How does Pioglitazone 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. The active substance in Pioglitazone Accord, pioglitazone, makes the cells (fat, muscle and liver) more sensitive to insulin, which allows the body to make better use of the insulin it produces. As a result, blood glucose levels are reduced and this helps to control type 2 diabetes.
How has Pioglitazone Accord been studied?
Because Pioglitazone Accord is a generic medicine, studies in patients have been limited to tests to demonstrate its bioequivalence to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Pioglitazone Accord?
Because Pioglitazone Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Pioglitazone Accord been approved?
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent / comparable to Actos. Therefore, the CHMP considered that, as in the case of Actos, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Pioglitazone Accord.
More information on Pioglitazone Accord
On March 21, 2012, the European Commission issued a marketing authorization for Pioglitazone Accord, valid throughout the European Union.
For more information about treatment with Pioglitazone Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2011.
