Incresync

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alogliptin / pioglitazone

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Incresync. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Incresync.

For practical information about using Incresync, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Name
Incresync
Agency product number
EMEA/H/C/002178
Active substance
  • alogliptin
  • pioglitazone
International non-proprietary name (INN) or common name
alogliptin / pioglitazone
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD09
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

25/05/2018 Incresync - EMEA/H/C/002178 - R/0023

Contents

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.

Pharmacotherapeutic group

  • Drugs used in diabetes

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus:

  • as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;
  • in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.

In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination.

After initiation of therapy with Incresync, 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, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).

Assessment history

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