Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Competact 15 mg/850 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). The tablets are white to off-white, oblong, film-coated, embossed ‘15 / 850’ on one face and ‘4833M’ on the other. |
Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
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Metformin and Pioglitazone |
Combination of two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class. Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production. |
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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. |
List of Excipients |
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Tablet core: Microcrystalline cellulose Film coat: Hypromellose |
Aluminium/aluminium blisters.
Packs of 56, 112.
Not all pack sizes may be marketed.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
EU/1/06/354/005
EU/1/06/354/010
Drug | Countries | |
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COMPETACT | Austria, Estonia, Spain, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, United Kingdom |
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