NAPROXEN Tablet

Active ingredients: Naproxen

Product name and form

Naproxen 250mg Tablets.

Pharmaceutical Form

Tablet.

White to off white circular flat faced bevelled edge, uncoated tablet with inscription ‘AP’ on one side and breakline on the other side.

Qualitative and quantitative composition

Each tablet contains 250 mg naproxen.

Excipient with known effect: Lactose monohydrate.

Each tablet contains 72 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Naproxen is a non-steroidal anti-inflammatory analgesic compound with antipyretic properties as has been demonstrated in classical animal test systems. Naproxen exhibits its anti-inflammatory effect even in adrenalectomised animals, indicating that its action is not mediated through the pituitary-adrenal axis.

List of Excipients

Lactose monohydrate
Maize Starch
Polyvinylpyrollidone (povidone K30)
Magnesium stearate (E572)

Pack sizes and marketing

White polypropylene containers with LDPE closure having tamper evident seal: 1000, 500, 250, 100, 84,70, 56,42, 28, 21, 15 and 14 tablets.

Blister Strips (composed of PVC film and aluminium foil): 84, 70, 56, 42, 28, 21, 15 and 14 tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 20075-0058

03/09/2007