What is Pioglitazone Actavis Group?
Pioglitazone Actavis Group is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).
Pioglitazone Actavis Group is a "generic medicine". This means that Pioglitazone Actavis Group is similar to a "reference medicine" already authorized in the European Union (EU) called Actos.
What is Pioglitazone Actavis used for?
Pioglitazone Actavis Group 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 Actavis Group is used on its own in patients for whom metformin (another type of diabetes medicine) is not adequate.
Pioglitazone Actavis Group can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetic medicine) when metformin is not adequate ("dual therapy").
Pioglitazone Actavis Group can also be used in combination with metformin and a sulphonylurea in patients who are not satisfactorily controlled despite a double therapy ("triple therapy") by mouth.
Pioglitazone Actavis Group can also be used in combination with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
The medicine can only be obtained with a prescription.
How is Pioglitazone Actavis used?
The recommended starting dose of Pioglitazone Actavis Group is 15 or 30 mg once a day. After one or two weeks it may be necessary to increase the dose up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Actavis Group should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Treatment with Pioglitazone Actavis Group should be reviewed after a period of between three and six months and discontinued in patients who do not benefit sufficiently. During subsequent checks, prescribers must confirm the continuity of the benefits of the treatment.
How does Pioglitazone Actavis 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 Actavis Group, 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, blood glucose levels are reduced and this helps to control type 2 diabetes.
How has Pioglitazone Actavis Group been studied?
Because Pioglitazone Actavis 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 Actavis Group?
Because Pioglitazone Actavis 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 Actavis been approved?
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis Group has been shown to have comparable quality and to be bioequivalent 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 Actavis Group.
More information on Pioglitazone Actavis Group
On 15 March 2012, the European Commission issued a marketing authorization for Pioglitazone Actavis Group, valid throughout the European Union.
For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
