AULIN Gel Ref.[7325] Active ingredients: Nimesulide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2010  Publisher: Helsinn Birex Pharm. Limited, Damastown, Mulhuddart, Dublin 15, Ireland

Therapeutic indications

Symptomatic relief of pain associated with sprains and acute traumatic tendinitis.

Posology and method of administration

Adults

Nimesulide 3% w/w gel (usually 3 g, corresponding to a line 6-7 cm long) should be applied in a thin layer to the affected area 2-3 times daily and massaged until it is completely absorbed.

Duration of treatment: 7–15 days.

Children under 12 years

Nimesulide 3% w/w gel has not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children (see section 4.3).

Overdose

Intoxication with nimesulide as a result of topical application of Nimesulide 3% w/w gel is not to be expected since the highest plasma levels of nimesulide following application of Nimesulide gel are far below those found following systemic administration.

Shelf life

2 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

15g, 30g, 50g and 100 g aluminium tubes lined with lacquer made of an epoxyphenolic resin and closed with a polypropylene cap.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Wash hands after use.

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