Pioglitazone Accord
Authorised
This medicine is authorised for use in the European Union
pioglitazone
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pioglitazone Accord.
For practical information about using Pioglitazone Accord, patients should read the package leaflet or contact their doctor or pharmacist.
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 as follows:
- on its own in patients for whom metformin (another diabetes medicine) is not suitable.
- in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
- together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
- together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
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.
Pioglitazone Accord contains the active substance pioglitazone.
Pioglitazone Accord can only be obtained with a prescription.
The medicine is available as tablets (15, 30 and 45 mg) and the recommended starting dose 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.
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.
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.
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.
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.
The Agency’s Committee for Medicinal Products for Human Use (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 approved for use in the EU.
The company that markets Pioglitazone Accord will produce educational material 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.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Accord have also been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.
For more information about treatment with Pioglitazone Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:EMA/VR/0000225173
19/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Pioglitazone Accord
- Active substance
- pioglitazone hydrochloride
- International non-proprietary name (INN) or common name
- pioglitazone
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BG03
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic 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.
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.
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