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PIOGLITAZONE ACCORD Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pioglitazone Accord 15 mg tablets. Pioglitazone Accord 30 mg tablets. Pioglitazone Accord 45 mg tablets.

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 ...

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 ...

Therapeutic indications

Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy: in adult patients (particularly overweight patients) inadequately controlled ...

Posology and method of administration

Posology Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily. In combination with insulin, the current insulin dose can ...

Contraindications

Pioglitazone is contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients listed in 6.1 cardiac failure or history of cardiac failure (NYHA stages I to IV) ...

Special warnings and precautions for use

Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. When treating patients who have at least one risk factor for development of ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Co-administration of pioglitazone ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate human data to determine the safety of pioglitazone during pregnancy. Foetal growth restriction was apparent in animal studies with pioglitazone. This was attributable to ...

Effects on ability to drive and use machines

Pioglitazone Accord has no or negligible influence on the ability to drive and use machines. However patients who experience visual disturbance should be cautious when driving or using machines.

Undesirable effects

Tabulated list of adverse reactions Adverse reactions reported in excess (>0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below ...

Overdose

In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins ATC code: A10BG03 Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone ...

Pharmacokinetic properties

Absorption Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration. Proportional increases ...

Preclinical safety data

In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys. ...

List of excipients

Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Pioglitazone Accord 15 mg tablets: 3 years. Pioglitazone Accord 30 mg/45 mg tablets: 4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

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

Marketing authorization number(s)

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 ...

Date of first authorization / renewal of the authorization

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

Date of revision of the text

14/02/2019

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