Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Actos 15 mg tablets.
Actos 30 mg tablets.
Actos 45 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Actos 15 mg tablets: The tablets are white to off-white, round, convex and marked ‘15’ on one face and ‘ACTOS’ on the other face. Actos 30 mg tablets: The tablets are white to off-white, round, flat and marked ‘30’ on one face and ‘ACTOS’ on the other face. Actos 45 mg tablets: The tablets are white to off-white, round, flat and marked ‘45’ on one face and ‘ACTOS’ on the other face. |
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Excipient with known effect: Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Excipient with known effect: Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Excipient with known effect: Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Carmellose calcium |
Aluminium/aluminium blisters, packs of 28, 56, 98 and 112 tablets.
Not all pack sizes may be marketed.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
EU/1/00/150/001
EU/1/00/150/003
EU/1/00/150/004
EU/1/00/150/006
EU/1/00/150/009
EU/1/00/150/010
EU/1/00/150/012
EU/1/00/150/015
EU/1/00/150/025
EU/1/00/150/027
EU/1/00/150/029
Date of first authorisation: 13/10/2000
Date of latest renewal: 31/08/2010
| Drug | Countries | |
|---|---|---|
| ACTOS | Austria, Australia, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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