PYRALVEX Oromucosal solution Ref.[115951] Active ingredients: Anthraquinone glycosides Salicylic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2007  Publisher: Norgine Limited, Chaplin House, Widewater Place, Moorhall Road, Harefield, Uxbridge, Middlesex, UB9 6NS, Untied Kingdom

4.1. Therapeutic indications

For the symptomatic relief of pain associated with recurrent mouth ulcers and denture irritation.

4.2. Posology and method of administration

Adults (including the elderly)

To be applied to the inflamed oral mucosa (after removing any dentures) three or four times daily using the brush provided. Avoid rinsing of the mouth or eating for 15 minutes after application. Any discolouration which may occur will disappear during normal cleaning of the teeth.

Children

Not recommended below the age of 12 years.

4.9. Overdose

Overdose associated with local application is unlikely, although the extent of systemic absorption of salicylic acid and anthranoid derivatives is not known. Systemic overdose following ingestion might lead to abdominal cramping, diarrhoea and possibly salicylism (presenting as hyperventilation, tinnitus, deafness, vasodilation, sweating).

6.3. Shelf life

The shelf life is 5 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

An amber glass bottle with brush applicator (PP screw cap with PE stem and nylon filament brush), containing 10 ml of solution.

6.6. Special precautions for disposal and other handling

No special requirements.

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