Pioglitazone Teva Pharma
What is Pioglitazone Teva Pharma?
Pioglitazone Teva Pharma is a medicine that contains the active substance pioglitazone. It is available in 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 years and over), particularly those who are overweight, as an adjunct to diet and exercise.
Pioglitazone Teva Pharma is used as monotherapy (alone) in patients for whom treatment with metformin (another antidiabetic medicine) is not suitable.
Pioglitazone Teva Pharma 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 Pharma used?
The recommended starting dose of Pioglitazone Teva Pharma 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 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 are not benefiting sufficiently. Prescribing physicians must confirm continuity of treatment benefits during subsequent check-ups.
How does Pioglitazone Teva Pharma 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 Pharma, 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, the insulin it produces is reduced. blood glucose levels and this helps control type 2 diabetes.
How has Pioglitazone Teva Pharma been studied?
Since 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 the active substance 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 taken as being the same as the reference medicine's.
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 marketing authorization for Pioglitazone Teva Pharma.
More information about Pioglitazone Teva Pharma
On March 26, 2012, the European Commission issued a "Marketing Authorization" for Pioglitazone Teva Pharma, valid throughout the European Union.
For more information about Pioglitazone Teva Pharma 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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