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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMEA/H/C/002324

EPAR summary for the public

Pioglitazone Actavis

Pioglitazone

This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis. 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 Actavis.

What is Pioglitazone Actavis?

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

Pioglitazone Actavis is a 'generic medicine'. This means that Pioglitazone Actavis is similar to a 'reference medicine' already authorised in the European Union (EU) called Actos. For more information on generic medicines, see the question-and-answer document here.

What is Pioglitazone Actavis used for?

Pioglitazone Actavis 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 Actavis is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone Actavis 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 Actavis used?

The recommended starting dose of Pioglitazone Actavis 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)

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control is needed. Pioglitazone Actavis should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).

Treatment with Pioglitazone Actavis 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 Actavis 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 Actavis, 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 Actavis been studied?

Because Pioglitazone Actavis 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 is the risk associated with Pioglitazone Actavis?

Because Pioglitazone Actavis 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 been approved?

The CHMP concluded that, in accordance with EU requirements, Pioglitazone Actavis 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 Actavis be given marketing authorisation.

Other information about Pioglitazone Actavis

The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.

The full EPAR for Pioglitazone Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2011.

Pioglitazone Actavis

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