This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis. 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 Actavis.
For practical information about using Pioglitazone Actavis, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Pioglitazone Actavis and what is it 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 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 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.
Pioglitazone Actavis contains the active substance pioglitazone.
- How is Pioglitazone Actavis used?
Pioglitazone Actavis 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 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 are the benefits and risks of 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 is Pioglitazone Actavis approved?
The Agency’s Committee for Medicinal Products for Human Use (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 approved for use in the EU.
- What measures are being taken to ensure the safe and effective use of Pioglitazone Actavis?
The company that markets Pioglitazone Actavis 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 Actavis have also been included in the summary of product characteristics and the package leaflet.
- Other information about Pioglitazone Actavis
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.
For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 31/01/2017 .
14/11/2016 Pioglitazone Actavis -EMEA/H/C/002324 -IB/0010
- 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.
Drugs used in diabetes
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
- 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 (see section 4.4).
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 (see section 4.4).
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Pioglitazone Actavis : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||2014-02-18||2017-01-31|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Pioglitazone Actavis : EPAR - Public assessment report||HR = Hrvatski||2012-04-26|
|CHMP summary of positive opinion for Pioglitazone Actavis||HR = Hrvatski||2011-09-23||2012-01-20|