Glustin

pioglitazone

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

What is Glustin?

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

What is Glustin used for?

Glustin 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.

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

Glustin 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’).

Glustin 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’).

Glustin 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 Glustin used?

The recommended starting dose of Glustin 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 Glustin 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 Glustin 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 Glustin, 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 Glustin been studied?

Glustin has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies. Some studies also looked at combining Glustin with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea. Further studies also looked at long-term use of Glustin. Almost 7,000 patients received Glustin 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 Glustin shown during the studies?

Glustin 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. Glustin on its own was shown to be as effective as metformin and gliclazide. Glustin 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 Glustin?

The most common side effects with Glustin (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 Glustin is used in combination with other antidiabetes medicines, other side effects may occur. For the full list of all side effects reported with Glustin, see the package leaflet.

Glustin should not be used in people who may be 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 Glustin 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 Glustin been approved?

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

Other information about Glustin

The European Commission granted a marketing authorisation valid throughout the European Union, for Glustin on 11 October 2000.

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

Name Language First published Last updated
Glustin : EPAR - Summary for the public BG = bălgarski 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public ES = español 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public CS = čeština 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public DA = dansk 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public DE = Deutsch 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public ET = eesti keel 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public EL = elliniká 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public EN = English 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public FR = français 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public IT = italiano 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public LV = latviešu valoda 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public LT = lietuvių kalba 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public HU = magyar 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public MT = Malti 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public NL = Nederlands 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public PL = polski 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public PT = português 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public RO = română 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public SK = slovenčina 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public SL = slovenščina 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public FI = suomi 16/09/2008 07/05/2012
Glustin : EPAR - Summary for the public SV = svenska 16/09/2008 07/05/2012

This EPAR was last updated on 18/12/2013 .

Authorisation details

Product details

Product details for Glustin
NameGlustin
Agency product numberEMEA/H/C/000286
Active substance

pioglitazone

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 Glustin
Marketing-authorisation holder

Takeda Pharma A/S

Revision21
Date of issue of marketing authorisation valid throughout the European Union11/10/2000

Contact address:

Takeda Pharma A/S
Langebjerg 1
DK-4000 Roskilde
Denmark

Product information

Product information

13/11/2013  Glustin -EMEA/H/C/000286 -PSUV/0056

Name Language First published Last updated
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013
Glustin : EPAR - Product Information SV = svenska 05/10/2009 18/12/2013

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
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  
Glustin : EPAR - All Authorised presentations SV = svenska 12/02/2008  

Name Language First published Last updated
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 06/07/2012  
Glustin : 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 as second or third line treatment of type-2 diabetes mellitus as described below:

  • as monotherapy:
    • 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 three to six 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).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Glustin : EPAR - Procedural steps taken before authorisation SV = svenska 06/09/2006  
Glustin : EPAR - Scientific Discussion SV = svenska 06/09/2006