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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/684102/2011

EMEA/H/C/002277

EPAR summary for the public

Pioglitazone Accord

pioglitazone

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

What is Pioglitazone Accord?

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

Pioglitazone Accord is a 'generic medicine'. This means that Pioglitazone Accord 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 Accord used for?

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

The medicine can only be obtained with a prescription.

How is Pioglitazone Accord used?

The recommended starting dose of Pioglitazone Accord 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 Accord 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.

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Treatment with Pioglitazone Accord 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 Accord 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 Accord, 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 Accord been studied?

Because Pioglitazone Accord 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 Accord?

Because Pioglitazone Accord 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 Accord been approved?

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

Other information about Pioglitazone Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.

The full EPAR for Pioglitazone Accord 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 Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 08-2011.

Pioglitazone Accord

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