GLUSTIN Tablet Ref.[49915] Active ingredients: Pioglitazone

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark

Product name and form

Glustin 15 mg tablets.

Glustin 30 mg tablets.

Glustin 45 mg tablets.

Pharmaceutical Form

Tablet.

Glustin 15 mg tablets: The tablets are white to off-white, round, convex and marked ‘15’ on one face, ‘AD4’ on the other.

Glustin 30 mg tablets: The tablets are white to off-white, round, flat and marked ‘30’ on one face, ‘AD4’ on the other.

Glustin 45 mg tablets: The tablets are white to off-white, round, flat and marked ‘45’ on one face, ‘AD4’ on the other.

Qualitative and quantitative composition

Glustin 15 mg tablets

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).

Glustin 30 mg tablets

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).

Glustin 45 mg tablets

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
Hyprolose
Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark

Marketing authorization dates and numbers

EU/1/00/151/001
EU/1/00/151/002
EU/1/00/151/003
EU/1/00/151/004
EU/1/00/151/005
EU/1/00/151/006
EU/1/00/151/007
EU/1/00/151/008
EU/1/00/151/009
EU/1/00/151/010
EU/1/00/151/011
EU/1/00/151/012
EU/1/00/151/013
EU/1/00/151/014
EU/1/00/151/015
EU/1/00/151/016
EU/1/00/151/017
EU/1/00/151/018
EU/1/00/151/019
EU/1/00/151/020
EU/1/00/151/021
EU/1/00/151/022
EU/1/00/151/023
EU/1/00/151/024

Date of first authorisation: 11/10/2000
Date of latest renewal: 31/08/2010

Drugs

Drug Countries
GLUSTIN Austria, Estonia, Ireland, Italy, Lithuania, Poland

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