Surgical Spirit Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Surgical spirit BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Salicylate 0.5% v/v
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Solution.
4 CLINICAL PARTICULARS
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.
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. 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Methyl salicylate has the action of salicylates, causing dilation of the skin vessels.
5.2 Pharmacokinetic properties
Methyl salicylate is absorbed through the skin.
5.3. Pre-clinical Safety Data
None.
6 PHARMACEUTICAL PARTICULARS
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Industrial Methylated Spirit 660P (95%)
Diethyl Phthalate
Virgin Castor Oil
6.2. Incompatibilities
None known.
6.3. Shelf Life
36 months.
6.4 Special precautions for storage
Do not store above 25°C.
Flammable: Keep away from a naked flame.
6.5 Nature and contents of container
200ml: Amber glass bottle with 28mm tamper evident polypropylene child resistant cap with Saranex faced EPE liner.
6.6. Instructions for Use, Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.
8. MARKETING AUTHORISATION NUMBER(S)
PL 12965/0035
OF
9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATION
25.08.93 / 10.12.98
10
DATE OF REVISION OF THE TEXT
18/11/2016