Pioglitazone Actavis Group
What is Pioglitazone Actavis Group?
Pioglitazone Actavis Group is a medicine that contains the active substance pioglitazone. It is available in 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 Group used for?
Pioglitazone Actavis Group is indicated for the treatment of type 2 diabetes in adults (aged 18 years and over), particularly in those who are overweight. It is used in conjunction with diet and exercise.
Pioglitazone Actavis Group is used on its own in patients for whom metformin (another type of diabetes medicine) is not suitable.
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 dual therapy ("triple therapy") by mouth.
Pioglitazone Actavis Group can also be used in combination with insulin in patients who are not satisfactorily controlled on insulin alone and cannot take metformin.
The medicine can only be obtained with a prescription.
How is Pioglitazone Actavis Group used?
The recommended starting dose of Pioglitazone Actavis Group is 15 or 30 mg once daily. After one or two weeks the dose may need to be increased 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. Prescribing physicians must confirm continuity of treatment benefits at subsequent check-ups.
How does Pioglitazone Actavis Group 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 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, they are reduced blood glucose levels and this helps control type 2 diabetes.
How has Pioglitazone Actavis Group been studied?
Since Pioglitazone Actavis Group is a generic medicine, the patient studies 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 the active substance in the body.
What are the benefits and risks of Pioglitazone Actavis Group?
Because Pioglitazone Actavis Group 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 Actavis Group 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 a marketing authorization for Pioglitazone Actavis Group.
More information about Pioglitazone Actavis Group
On March 15, 2012, the European Commission issued a "marketing authorization" for Pioglitazone Actavis Group, valid throughout the European Union.
For more information about Pioglitazone Actavis Group therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
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