GLIMEPIRIDE Tablet Ref.[7273] Active ingredients: Glimepiride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Glimepiride 1 mg Tablets.

Pharmaceutical Form

Tablet.

Glimepiride Tablets 1 mg: Pink coloured round, flat uncoated tablets with bevelled edges and score line one side & plain on other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 1 mg of glimepiride.

Each tablet contains 78.37 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glimepiride

Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group. It may be used in non-insulin dependent (type 2) diabetes mellitus. Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells.

List of Excipients

Lactose monohydrate
Sodium starch glycolate (type A)
Povidone K-30
Magnesium stearate
Iron oxide red (E172)

Pack sizes and marketing

The blisters, of PVC/PVdC, are heat sealed with hard tempered aluminium foil and packaged in a carton with a pack insert. PVC/PVdC/Aluminium blisters are clear/transparent.

Pack sizes: 10, 30, 60, 90, 120 and 180 tablets in blister strips of 10 tablets.

Not all pack size may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0087

27/11/2008

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