COMPETACT Film-coated tablet Ref.[10500] Active ingredients: Metformin Metformin and Pioglitazone Pioglitazone

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Product name and form

Competact 15 mg/850 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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
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.

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.

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

Tablet core:

Microcrystalline cellulose
Povidone (K30)
Croscarmellose sodium
Magnesium stearate

Film coat:

Hypromellose
Macrogol 8000
Talc
Titanium dioxide (E171)

Pack sizes and marketing

Aluminium/aluminium blisters.

Packs of 56, 112.

Not all pack sizes may be marketed.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization dates and numbers

EU/1/06/354/005
EU/1/06/354/010

Drugs

Drug Countries
COMPETACT Austria, Estonia, Spain, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.