This information is intended for use by health professionals

1. Name of the medicinal product

Boots Vapour Chest Rub

2. Qualitative and quantitative composition

Active Ingredients

Racemic Camphor

Levomenthol natural or synthetic

Eucalyptus Oil

%w/w

6%

1%

1.5%

3. Pharmaceutical form

Ointment

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

For topical application

For Adults and Children over 2 years

Apply a small amount on the chest and back particularly at bedtime. Rub gently and leave clothes loose for easy inhalation. Apply a moderate amount on older children and adults.

Children under 2 years

Not recommended for children under 2 years of age.

For inhalation

For adults and children over 12 years

Add one teaspoonful of Vapour Rub to half a pint of hot – not boiling – water and inhale the vapour.

Children under 12 years

Not recommended for children under 12 years of age.

Elderly

There is no need for dosage reduction.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Do not use on children under 2 years.

Do not use for inhalation in children under 12 years.

4.4 Special warnings and precautions for use

For external use only.

Do not apply around the nostrils, mouth, eyes or face.

Do not use on broken skin or wounds.

Keep all medicines out of the sight and reach of children.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.

4.6 Fertility, pregnancy and lactation

The safety of Vapour Rub during fertility, pregnancy and lactation has not been established. As a precaution this product should not be used without medical advice during pregnancy. This product should not be used on the mother's chest during breastfeeding.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Occasional hypersensitivity and irritant skin reactions.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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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.

5. Pharmacological properties
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.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

White Soft Paraffin

Thymol

Turpentine Oil

Pumilio Pine Oil BP'80

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

None.

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.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/5331R

9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation:

Date of Last Renewal:

29 August 1984

23 May 1996

10. Date of revision of the text

22nd January 2020