ACECLOFENAC Film-coated tablet Ref.[6050] Active ingredients: Aceclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: RIVOPHARM UK Ltd., 100 Bishopsgate, London, EC2N 4AG, United Kingdom

Product name and form

Aceclofenac 100 mg film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, biconvex film-coated tablets, 8 mm diameter.

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 Description
Aceclofenac

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:

Microcrystalline cellulose (E460i)
Croscarmellose sodium
Copovidone
Talc (E553b)
Silica colloidal anhydrous
Glicerol distearate

Film-coating Opadry O3A0280002:

HPMC 2910/Hypromellose
Microcrystalline cellulose
Titanium dioxide (E171)
Polyoxyl 40 (Macrogol) stearat

Pack sizes and marketing

Aceclofenac 100 mg Film-Coated Tablets are packaged in Aluminium/aluminium blisters placed into cardboard boxes containing 20, 30, 40, 60, 90, 100 or 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

RIVOPHARM UK Ltd., 100 Bishopsgate, London, EC2N 4AG, United Kingdom

Marketing authorization dates and numbers

PL 33155/0029

11/02/2015

Drugs

Drug Countries
ACECLOFENAC Nigeria

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