Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Incresync 12.5 mg/30 mg film-coated tablets.
Incresync 25 mg/30 mg film-coated tablets.
Incresync 25 mg/45 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet (tablet). Incresync 12.5 mg/30 mg film-coated tablets: Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side. Incresync 25 mg/30 mg film-coated tablets: Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side. Incresync 25 mg/45 mg film-coated tablets: Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side. |
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Excipient(s) with known effect: Each tablet contains 121 mg of lactose (as monohydrate).
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Excipient(s) with known effect: Each tablet contains 121 mg of lactose (as monohydrate).
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Excipient(s) with known effect: Each tablet contains 105 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alogliptin |
Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9. Alogliptin improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high. |
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| Pioglitazone |
Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance. |
|
| Pioglitazone and Alogliptin |
Combination of two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and pioglitazone, a member of the thiazolidinedione class. |
| List of Excipients | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Tablet core: Mannitol Film-coating:
Printing ink:
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Nylon/aluminium/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
EU/1/13/842/001
EU/1/13/842/002
EU/1/13/842/003
EU/1/13/842/004
EU/1/13/842/005
EU/1/13/842/006
EU/1/13/842/007
EU/1/13/842/008
EU/1/13/842/009
EU/1/13/842/019
EU/1/13/842/020
EU/1/13/842/021
EU/1/13/842/022
EU/1/13/842/023
EU/1/13/842/024
EU/1/13/842/025
EU/1/13/842/026
EU/1/13/842/027
EU/1/13/842/028
EU/1/13/842/029
EU/1/13/842/030
EU/1/13/842/031
EU/1/13/842/032
EU/1/13/842/033
EU/1/13/842/034
EU/1/13/842/035
EU/1/13/842/036
Date of first authorisation: 19 September 2013
Date of latest renewal: 24 May 2018
| Drug | Countries | |
|---|---|---|
| INCRESYNC | Austria, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Poland |
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