Pioglitazone Teva

pioglitazone

This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva.

What is Pioglitazone Teva?

Pioglitazone Teva is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30 and 45 mg).

Pioglitazone Teva is a ‘generic medicine’. This means that Pioglitazone Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Actos.

What is Pioglitazone Teva used for?

Pioglitazone Teva is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise.

Pioglitazone Teva is used on its own in patients for whom metformin (another antidiabetes 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 antidiabetes medicine) when metformin is not suitable (‘dual therapy’).

Pioglitazone Teva can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).

Pioglitazone Teva can also be used together 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 Teva used?

The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up 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 reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

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 when 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, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to 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 that it is bioequivalent 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’s view was that, as for Actos, the benefit outweighs the identified risk. The Committee recommended that Pioglitazone Teva be given marketing authorisation.

Other information about Pioglitazone Teva

The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva on 26 March 2012.

For more information about treatment with Pioglitazone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 10/04/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

26/03/2012  Pioglitazone Teva -EMEA/H/C/002297

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Alimentary tract and metabolism

Therapeutic indication

Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:

• as monotherapy
  - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
• as dual oral therapy in combination with
  - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
  - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea
• as triple oral therapy in combination with
  - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.

Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents