This information is intended for use by health professionals

1. Name of the medicinal product

Boots Children's Vapour Rub

2. Qualitative and quantitative composition

Active ingredient

% w/w

Racemic Camphor

6.0

Levomenthol natural or synthetic

1.0

Eucalyptus oil

1.5

3. Pharmaceutical form

Ointment

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

For children over 2 years and adults

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.

Elderly

There is no need for dosage reduction.

Children under 2 years

Not recommended for children under 2 years of age.

For topical application.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Do not use on children under 2 years of age.

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.

Healthcare professionals should be aware that if this product comes into contact with dressings, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.

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.

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, 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

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

White soft paraffin

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months in amber glass jar.

20 months in polystyrene jar.

6.4 Special precautions for storage

Amber glass jar - None.

Polystyrene jar - Do not store above 25°C.

6.5 Nature and contents of container

Amber glass jar with either a tin plate cap with waxed aluminium faced pulpboard liner containing 45g or a thermoset plastic cap

or

A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0562

9. Date of first authorisation/renewal of the authorisation

31 May 1996

10. Date of revision of the text

27th January 2020