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 Rotavex Solution should be used by only one person.
Rotavex Solution contains 59.50 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
Rotavex Solution, it is not known whether these, or salicylic acid are excreted in breast milk. A decision on Rotavex Solution whether to continue breast-feeding or to continue therapy with Rotavex Solution should be made taking into
account the benefit of breast-feeding to the child and benefit of Rotavex Solution 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.

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 Rotavex Solution display anti-inflammatory,
analgesic and anti-microbial properties, which are the basis of its clinical efficacy.

Systemic availability of Rotavex Solution 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 Rotavex Solution is unknown.

 Ethanol
 Water

None known.

The shelf life of unopened bottle is 2 years. The shelf life after first opening is 30 days.

Store below 30°C.

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

Rotavex Solution