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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/219822/2016

EMEA/H/C/000655

EPAR summary for the public

Competact

Pioglitazone / metformin hydrochloride

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

What is Competact?

Competact is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).

What is Competact used for?

Competact is used in adults (particularly those who are overweight) who have type 2 diabetes. Competact is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.

The medicine can only be obtained with a prescription.

How is Competact used?

The usual dose of Competact is one tablet taken twice a day. Patients changing from metformin only to Competact may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached. It is possible to change to Competact directly from metformin if appropriate. Taking Competact with or just after food may reduce any stomach problems caused by metformin. Elderly patients should have their kidney function monitored regularly.

Treatment with Competact 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.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How does Competact 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. Competact contains two active substances which each have a different mode of action. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.

How has Competact been studied?

Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication. The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination. They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefit has Competact shown during the studies?

In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.

What is the risk associated with Competact?

At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur. These side effects are very common but disappear on their own in most cases. Lactic acidosis (a build-up of lactic acid in the body) is a side effect which may occur in less than 1 in 10,000 patients. Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients. For the full list of side effects reported with Competact, see the package leaflet.

Competact must not be used in patients who have heart failure, or problems with their liver or their kidneys. Competact must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock. Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding. It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated. For the full list of restrictions, see the package leaflet.

Why has Competact been approved?

The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required. The Committee decided that Competact's benefits are greater than its risks and recommended that it be given marketing authorisation.

Competact

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What measures are being taken to ensure the safe and effective use of Competact?

A risk management plan has been developed to ensure that Competact is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Competact will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.

Other information about Competact

The European Commission granted a marketing authorisation valid throughout the European Union for Competact on 28 July 2006.

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

This summary was last updated in 04-2016.

Competact

EMA/219822/2016