Pyralvex

Pyralvex solution, oromucosal solution

PYRALVEX contains the following active ingredients in each 1ml of solution:

Oromucosal solution.

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

Adults (including the elderly) and children 16 years and over:

To be applied to the inflamed oral mucosa (after removing any dentures) three or four times daily using the brush provided.

Seek medical advice if no improvement in condition – maximum length of use is 7 days.

Children:

Contraindicated below the age of 16 years.

Hypersensitivity to any of the constituents.

Not to be used in children and adolescents under the age of 16. This is because there is a possible association between salicylates and Reye's Syndrome when given to children. Reye's Syndrome is a very rare disease which affects the brain and liver and can be fatal.

Salicylate toxicity can result if the stated frequency of application is exceeded.

Each bottle of PYRALVEX should be used by only one person.

Pyralvex contains 59,5 vol.-% alcohol.

None known.

Animal studies are insufficient with respect to effects on pregnancy and-or embryonal/foetal development. The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.

Anthranoid glycosides derived from rhubarb may be excreted in breast milk. However, at therapeutic doses of Pyralvex, it is not known whether these, or salicylic acid are excreted in breast milk. A decision on whether to continue breast-feeding or to continue therapy with Pyralvex should be made taking into account the benefit of breast-feeding to the child and benefit of Pyralvex therapy to the woman.

None.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Immune system disorders

Very rare: Allergic reactions

Gastrointestinal disorders

Common: Temporary discolouration of teeth or oral mucosa.

Skin and subcutaneous tissue disorders

Frequency not known: Rash and urticaria

General disorders and administration site conditions

Very common: Transient local burning sensation at the site of application.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

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).

Salicylate toxicity can result if the stated frequency of application is exceeded. Do not exceed the stated frequency of application.

Pharmacological studies have shown that the active ingredients of PYRALVEX display anti-inflammatory, analgesic and anti-microbial properties, which are the basis of its clinical efficacy.

Systemic availability of PYRALVEX is unlikely to be significant, owing to the low levels of ingredients administered.

There is some evidence of genotoxic risk with rhubarb extract and related anthranoids, the relevance of these findings to PYRALVEX is unknown.

Ethanol

Water

None known.

The shelf life is 3 years.

Store below 25°C.

An amber glass bottle with brush applicator containing 10ml of solution.

No special requirements.

Mylan Products Ltd,

Station Close,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

PL 46302/0139

May 1972

February 2018