SIOFOR Prolonged-release tablet Ref.[49802] Active ingredients: Metformin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: A. Menarini Pharmaceuticals Ireland Ltd, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co Dublin, Ireland

Product name and form

Siofor SR 500 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

White to off-white, capsule shaped tablet, debossed on one side with ‘SR 500’ and plain on the other side.

Tablet dimensions: length 16.50 mm, breadth 8.20 mm, thickness 6.10 mm.

Qualitative and quantitative composition

Each prolonged-release tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base.

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.

List of Excipients

Magnesium stearate
Silica colloidal anhydrous
Carmellose sodium
Hypromellose
Water

Pack sizes and marketing

15, 30, 60, 90 or 120 prolonged-release tablets in blister strips composed of aluminium foil and PVC.

Not all pack sizes may be marketed.

Marketing authorization holder

A. Menarini Pharmaceuticals Ireland Ltd, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co Dublin, Ireland

Marketing authorization dates and numbers

PA1833/002/001

Date of first authorisation: 3rd May 2019

Drugs

Drug Countries
SIOFOR Albania, Germany, Croatia, Ireland, Poland, Romania

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