PIOGLITAZONE ACCORD Tablet Ref.[7334] Active ingredients: Pioglitazone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6<sup>a</sup> planta, 08039 Barcelona, Spain

Product name and form

Pioglitazone Accord 15 mg tablets.

Pioglitazone Accord 30 mg tablets.

Pioglitazone Accord 45 mg tablets.

Pharmaceutical Form

Tablet.

Pioglitazone Accord 15 mg tablets: The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P’ on one side and ‘15’ on other side.

Pioglitazone Accord 30 mg tablets: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘30’ on the other side.

Pioglitazone Accord 45 mg tablets: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO’ on one side and ‘45’ on the other side.

Qualitative and quantitative composition

Pioglitazone Accord 15 mg tablets: Each tablet contains 15 mg of pioglitazone (as hydrochloride).

Excipient with known effect: Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).

Pioglitazone Accord 30 mg tablets: Each tablet contains 30 mg of pioglitazone (as hydrochloride).

Excipient with known effect: Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).

Pioglitazone Accord 45 mg tablets: Each tablet contains 45 mg of pioglitazone (as hydrochloride).

Excipient with known effect: Each tablet contains 111.70 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
Hydroxypropyl cellulose
Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, Spain

Marketing authorization dates and numbers

EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)

Date of first authorisation: 21-March-2012
Date of latest renewal: 05 December 2016

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