Incresync

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alogliptin / pioglitazone

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

Overview

Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone. It is used as an addition to diet and exercise in adults with type 2 diabetes to improve the control of glucose (sugar) levels in the blood:

  • in patients who are not satisfactorily controlled with pioglitazone alone, and who cannot be treated with metformin (another diabetes medicine); 
  • together with metformin in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.

Incresync can also be used to replace separate alogliptin and pioglitazone tablets in adults who are already being treated with this combination.

This EPAR was last updated on 09/09/2022

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
13
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address

Delta Park 45
2665 Vallensbaek Strand
Denmark

Product information

07/09/2022 Incresync - EMEA/H/C/002178 - N/0043

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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