What is Pioglitazone Teva Pharma?
Pioglitazone Teva Pharma is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).
Pioglitazone Teva Pharma is a "generic medicine". This means that Pioglitazone Teva Pharma is similar to a "reference medicine" already authorized in the European Union (EU) called Actos.
What is Pioglitazone Teva Pharma used for?
Pioglitazone Teva Pharma is indicated for the treatment of type 2 diabetes in adults (aged 18 or over), particularly those who are overweight, in addition to diet and exercise.
Pioglitazone Teva Pharma is used on its own (monotherapy) in patients for whom treatment with metformin (another antidiabetes medicine) is not adequate.
Pioglitazone Teva Pharma is also indicated in combination with insulin in patients who are insufficiently controlled with insulin alone and cannot take metformin.
The medicine can only be obtained with a prescription.
How is Pioglitazone Teva Pharma used?
The recommended starting dose of Pioglitazone Teva Pharma 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 Teva Pharma 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 Pharma should be re-evaluated after 3-6 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 Teva Pharma 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 Teva Pharma, pioglitazone, makes the cells (fat, muscle and liver) more sensitive to insulin, allowing the body to better use the insulin it produces. As a result, blood glucose levels are reduced and this helps to control type 2 diabetes.
How has Pioglitazone Teva Pharma been studied?
Because Pioglitazone Teva Pharma 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 active ingredient in the body.
What are the benefits and risks of Pioglitazone Teva Pharma?
Because Pioglitazone Teva Pharma 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 Teva Pharma been approved?
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Pharma 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 Teva Pharma.
More information on Pioglitazone Teva Pharma
On 26 March 2012, the European Commission granted a marketing authorization valid throughout the European Union for Pioglitazone Teva Pharma.
For more information about treatment with Pioglitazone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
