Actos

pioglitazone

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

What is Actos?

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

What is Actos used for?

Actos 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.

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

Actos can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy’).

Actos can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).

Actos 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 Actos used?

The recommended starting dose of Actos 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. The tablets should be swallowed with water.

Treatment with Actos 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 Actos 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 Actos, 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 Actos been studied?

Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies. Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea. Further studies also looked at long-term use of Actos. Almost 7,000 patients received Actos in all of the studies combined. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefit has Actos shown during the studies?

Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide. Actos also improved the glucose control obtained in type-2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.

What is the risk associated with Actos?

The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper-respiratory-tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight. If Actos is used in combination with other antidiabetes medicines, other side effects may occur. For the full list of all side effects reported with Actos, see the package leaflet.

Actos must not be used in people who are hypersensitive (allergic) to pioglitazone or any of the other ingredients. It must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes). 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.

The doses of Actos may need to be adjusted when given with some other medicines such as gemfibrozil (used to lower cholesterol) or rifampicin (an antibiotic used to treat tuberculosis).

Why has Actos been approved?

The CHMP decided that Actos’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Actos

The European Commission granted a marketing authorisation valid throughout the European Union, for Actos on 13 October 2000.

For more information about treatment with Actos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Actos : EPAR - Summary for the public BG = bălgarski 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public ES = español 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public CS = čeština 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public DA = dansk 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public DE = Deutsch 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public ET = eesti keel 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public EL = elliniká 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public EN = English 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public FR = français 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public IT = italiano 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public LV = latviešu valoda 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public LT = lietuvių kalba 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public HU = magyar 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public MT = Malti 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public NL = Nederlands 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public PL = polski 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public PT = português 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public RO = română 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public SK = slovenčina 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public SL = slovenščina 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public FI = suomi 11/06/2007 26/04/2012
Actos : EPAR - Summary for the public SV = svenska 11/06/2007 26/04/2012

This EPAR was last updated on 26/05/2016 .

Authorisation details

Product details

Product details for Actos
NameActos
Agency product numberEMEA/H/C/000285
Active substance

pioglitazone hydrochloride

International non-proprietary name (INN) or common name

pioglitazone

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BG03

Publication details

Publication details for Actos
Marketing-authorisation holder

Takeda Pharma A/S

Revision23
Date of issue of marketing authorisation valid throughout the European Union13/10/2000

Contact address:

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

Product information

28/04/2016  Actos -EMEA/H/C/000285 -WS/0848

Name Language First published Last updated
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016
Actos : EPAR - Product Information SV = svenska 05/10/2009 26/05/2016

Contents

  • 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.


Name Language First published Last updated
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010
Actos : EPAR - All Authorised presentations SV = svenska 06/09/2006 02/07/2010

Name Language First published Last updated
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Actos : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:

  • as monotherapy:
    • in 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 patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
    • a sulphonylurea, only in 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 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 patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Actos : EPAR - Procedural steps taken before authorisation SV = svenska 03/04/2006  
Actos : EPAR - Scientific Discussion SV = svenska 03/04/2006