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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 27/09/2010

SPC	Boots Vapour Chest Rub

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

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1. NAME OF THE MEDICINAL PRODUCT

Boots Vapour Chest Rub or

Boots Vapour Rub

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients	%w/w
Racemic Camphor	6%
Levomenthol natural or synthetic	1%
Eucalyptus Oil	1.5%

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3. PHARMACEUTICAL FORM

Ointment

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For head colds, stuffy nose, coughs and chest colds.

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4.2 Posology and method of administration

Unless otherwise directed by the doctor:

For Adults and Children over 3 Months

Apply liberally to the chest and back particularly at bedtime. Use sparingly on infants and young children. Massage gently. For faster relief from a stuffy nose and tight chest, add one teaspoonful of Vapour Rub to half a pint of hot - not boiling - water and inhale the vapour.

Children under 3 Months.

Not recommended for children under 3 months of age.

Elderly

There is no need for dosage reduction.

For topical application and inhalation.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

For external use only.

If symptoms do not go away talk to your pharmacist or doctor.

Keep all medicines out of the reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.

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4.6 Pregnancy and lactation

The safety of Vapour Rub during pregnancy and lactation has not been established but its use during these periods is not considered to constitute a hazard.

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4.7 Effects on ability to drive and use machines

No adverse effects known.

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4.8 Undesirable effects

Occasional hypersensitivity and irritant skin reactions.

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4.9 Overdose

Overdosage may result in skin irritation.

Misuse:

Swallowing of the ointment might cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.

Following oral ingestion, symptoms of overdosage may include colic, dizziness, delirium, muscle twitching, epileptiform convulsions and depression of the central nervous system. Breathing may be difficult. There may also be haematuria and albuminuria.

Acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain and headache, vertigo, feeling hot/flushing, convulsions, respiratory depression and coma.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

Convulsions may be controlled by the intravenous administration of diazepam 5-10 mg.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Eucalyptus Oil, Camphor and Levomenthol are volatile substances and are thought to produce an irritant effect on the respiratory tract, probably via a nasal/pulmonary arc.

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5.2 Pharmacokinetic properties

None stated.

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5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

White Soft Paraffin

Thymol

Turpentine Oil

Pumilio Pine Oil BP'80

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6.2 Incompatibilities

None stated.

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6.3 Shelf life

36 months.

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6.4 Special precautions for storage

None.

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6.5 Nature and contents of container

An amber glass jar with a tinplate cap with waxed aluminium faced pulpboard liner or a thermoset plastic cap with waxed aluminium faced pulpboard liner.

Pack size 45g.

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6.6 Special precautions for disposal and other handling

None stated.

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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

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8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/5331R