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Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251

Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

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Summary of Product Characteristics last updated on the eMC: 24/11/2011

SPC	Surgical Spirit BP

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. DOSIMETRY
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

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1. NAME OF THE MEDICINAL PRODUCT

Surgical Spirit BP.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Virgin Castor Oil 2.5% v/v

Methyl Salicylate 0.5% v/v

For full list of excipients see section 6.1

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3. PHARMACEUTICAL FORM

Cutaneous Solution.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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

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4.2 Posology and method of administration

Topical application.

Applied directly to the skin.

Recommended Dose and Dosage Schedule

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

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4.3 Contraindications

None known.

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4.4 Special warnings and precautions for use

For external use only.

Keep all medicines away from children.

Do not apply to broken skin.

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

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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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.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

This product is recommended for external use only and as such overdose is unlikely, although methyl alcohol is absorbed through the skin and may produce systemic effects.

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.

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. In severe cases haemodialysis may be effective.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Castor oil is used as an emollient.

Methyl salicylate has the action of salicylates, causing dilation of the skin vessels also.

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5.2 Pharmacokinetic properties

Methyl salicylate is absorbed through the skin.

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5.3 Preclinical safety data

None.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Industrial Methylated Spirit 660P (95%)

Diethyl Phthalate

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6.2 Incompatibilities

None known.

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6.3 Shelf life

36 months.

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6.4 Special precautions for storage

Do not store above 25°C.

Flammable: Keep away from a naked flame.

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6.5 Nature and contents of container

100ml	Glass bottle with plastic cap or polypropylene child-resistant cap with saranex faced EPE liner or white 28mm cap with tamper evident band and EPE saranex liner
200ml	Glass bottle with plastic cap or polypropylene child-resistant cap with saranex faced EPE liner or white 28mm cap with tamper evident band and EPE saranex liner
500ml	Amber glass bottle with polypropylene cap or polypropylene child-resistant cap with saranex faced EPE liner or white 20mm cap with tamper evident band and EPE saranex liner
2000ml	Polythene bottle with cap

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6.6 Special precautions for disposal and other handling

None.

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7. MARKETING AUTHORISATION HOLDER

L. C. M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

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8. MARKETING AUTHORISATION NUMBER(S)

PL: 12965/0035