ACECLOFENAC Film-coated tablet

Active ingredients: Aceclofenac

Product name and form

Aceclofenac 100 mg film-coated Tablets.

Pharmaceutical Form

100 mg: Film-coated tablet.

White to off-white, round shaped, biconvex, film-coated tablet debossed with “100” on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of Aceclofenac.

For a full list of excipients, see section 6.1.

Active Ingredient

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.

List of Excipients

Core Tablet:

Cellulose microcrystalline
Croscarmellose sodium
Povidone K-30
Glyceryl palmitostearate

Tablet coating:

Hypromellose 15 cps
Macrogol 400
Titanium dioxide (E171)

Pack sizes and marketing

Aceclofenac Tablets 100 mg are packed in aluminium -aluminium blister packs.

The aluminium blister foil is soft temper, plain, one side bright, dull side lacquer laminated to 25 μm OPA, bright side lacquer laminated to 60 μm PVC.

The aluminium foil is 0.025 mm thick aluminium alloy hard temper foil with mat finish.

The blisters are further pack in to carton along with leaflet in pack sizes of 10, 20, 30, 40, 60 and 100 tablets per pack.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 20075/0350