4.1. Therapeutic indications

To prevent bed sores and for hardening the skin of the feet.

4.2. Posology and method of administration

Topical application.

Apply directly to the skin with cotton wool.

Recommended Dose and Dosage Schedule

The product is suitable for use by adults, children and the elderly. To be used as required.

4.3. Contraindications

Hypersensitivity to methyl salicylate or any of the excipients.

4.4. Special warnings and precautions for use

Do not apply to broken skin.

Labels state:

FOR EXTERNAL USE ONLY.

Keep out of the sight and reach of children.

Do not use on broken skin.

Caution: this preparation is flammable, keep away from naked flames.

This medicine contains 90.25% v/v ethanol in each application. It may cause burning sensation on damaged skin.

4.5. Interaction with other medicinal products and other forms of interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6. Fertility, pregnancy and lactation

No evidence is available as to the safety of the product when used during pregnancy and lactation. In such cases therefore use with caution.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

None known.

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.

4.9. Overdose

This product is recommended for external use only and as such overdose is unlikely. Absorption of methyl alcohol through the skin, ingestion or inhalation of the vapour may produce systemic effects. Methyl salicylate may be absorbed through intact skin after excessive topical application.

Industrial methylated spirit

If taken internally the immediate symptoms will be those of alcohol intoxication followed by characteristic symptoms after a latent period of up to 48 hours (usually 12-18 hours). The symptoms of methanol poisoning include severe abdominal pain, metabolic acidosis with rapid, shallow breathing and visual disturbances which may proceed to irreversible blindness. Other symptoms include headache, nausea, vomiting, diarrhoea, weakness, vertigo, ataxia, mild tachycardia, confusion, dizziness, delirium and coma which in severe cases may terminate in death due to respiratory failure or rarely in circulatory collapse.

Management of industrial methylated spirit poisoning

Recent ingestion should be treated by gastric lavage with sodium bicarbonate solution 2-5%, together with treatment for shock and respiratory failure. Acidosis should be corrected with intravenous sodium bicarbonate or compound sodium lactate. Delirium if it occurs may be treated with diazepam. If significant amounts of methyl alcohol have been ingested, early treatment with an antidote (ethanol or fomepizole) is recommended. In severe cases haemodialysis may be effective. Treatment should not be stopped prematurely since oxidation and excretion of methyl alcohol may continue for several days; patients should, therefore, be closely observed and monitored. Suitable supportive treatment should be carried out as required.