What is Pioglitazone Accord?
Pioglitazone Accord is a medicine that contains the active substance pioglitazone. It is available in 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 and over), particularly those who are overweight. It is used in conjunction with diet and exercise.
Pioglitazone Accord is used on its own in patients for whom metformin (another diabetes medicine) is not suitable.
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 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 a period of between three and six months and discontinued in patients who are not benefiting sufficiently. Prescribing physicians should confirm the continued benefit for patients at subsequent analyzes.
How does Pioglitazone 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. The active substance in Pioglitazone Accord, pioglitazone, makes 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, they are reduced. blood glucose levels and this helps control type 2 diabetes.
How has Pioglitazone Accord been studied?
Since Pioglitazone Accord is a generic medicine, the patient studies have been limited to tests to show that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance 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 taken as being the same as the reference medicine's.
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 risks. identified and recommended the granting of marketing authorization for Pioglitazone Accord.
Other information about Pioglitazone Accord
On 21 March 2012, the European Commission issued a "Marketing Authorization" for Pioglitazone Accord, valid throughout the European Union.
For more information about Pioglitazone Accord therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08-2011.
The information on Pioglitazone 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.