What is Pioglitazone Teva?
Pioglitazone Teva is a medicine that contains the active substance pioglitazone. It is available in tablets (15, 30 and 45 mg).
Pioglitazone Teva is a 'generic medicine'. This means that Pioglitazone Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Actos.
What is Pioglitazone Teva used for?
Pioglitazone Teva is indicated for the treatment of type 2 diabetes in adults (aged 18 years and over), particularly those who are overweight, as an adjunct to diet and exercise.
Pioglitazone Teva is used as monotherapy (alone) in patients for whom treatment with metformin (another antidiabetic medicine) is not suitable.
Pioglitazone Teva 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 diabetes medicine) when metformin is not indicated ("dual therapy").
Pioglitazone Teva can also be used in combination with metformin and a sulphonylurea in patients with insufficient control despite oral dual therapy ("triple therapy").
Pioglitazone Teva is also indicated in combination with insulin in patients who are not sufficiently controlled on insulin alone and who cannot take metformin.
The medicine can only be obtained with a prescription.
How is Pioglitazone Teva used?
The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day. 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 Teva 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 Teva should be re-evaluated after 3-6 months and discontinued in patients who are not benefiting sufficiently. Prescribing physicians must confirm continuity of treatment benefits during subsequent check-ups.
How does Pioglitazone Teva 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 Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, allowing the body to make better use of the insulin it produces. As a result, levels are reduced. blood glucose and this helps control type 2 diabetes.
How has Pioglitazone Teva been studied?
Because Pioglitazone Teva is a generic medicine, studies in patients have been limited to tests to determine 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 Teva?
Because Pioglitazone Teva 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 Teva been approved?
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva 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 marketing authorization for Pioglitazone Teva.
More information about Pioglitazone Teva
On 26 March 2012, the European Commission issued a "Marketing Authorization" for Pioglitazone Teva, valid throughout the European Union.
For more information about Pioglitazone Teva therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
Information on Pioglitazone Teva 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.