NABUMETONE Film-coated tablet Ref.[8412] Active ingredients: Nabumetone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT

Product name and form

Nabumetone 500 mg Tablets.

Pharmaceutical Form

Film-coated tablet.

Brown, capsule-shaped biconvex tablet marked ‘NEO’ on one side ‘NBU500’ on the other.

Qualitative and quantitative composition

Nabumetone 500 mg.

For a full list of excipients see section 6.1.

Active Ingredient Description
Nabumetone

Nabumetone is a non acidic non steroidal anti-inflammatory agent with weak prostaglandin synthesis properties. Nabumetone undergoes rapid and extensive metabolism in the liver to 6-methoxy-2-naphthylacetic acid (6-MNA), the principal active metabolite which is a potent inhibitor of prostaglandin synthesis.
List of Excipients

Maize starch
Sodium starch glycollate (Type A)
Povidone
Sodium lauryl sulphate
Colloidal silicon dioxide
Magnesium stearate

Film Coating:

Hypromellose
Titanium dioxide
Talc
Red iron oxide
Glycerol triacetate

Pack sizes and marketing

Blisters of PVC/PVdC/aluminium.

Pack sizes of 8, 56 and 100 tablets.

Marketing authorization holder

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT

Marketing authorization dates and numbers

PL 20417/0054

8 January 2004/13 January 2012

 
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