SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Boots Mild Vapour Rub 3 Months Plus or

Boots Children’s 3 Months Plus 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 3 months and adults

To be used on the chest and back particularly at bedtimes. Massage gently. Use sparingly on infants and young children. Apply a moderate amount on older children and adults.

Elderly

There is no need for dosage reduction.

Children under 3 months

Not recommended for children under 3 months of age.

For topical application.

4.3. Contra-indications

Hypersensitivity to any of the ingredients.

4.4. Special Warnings and Precautions for Use

For external use only.

Keep all medicines out of the reach of children. Not recommended for children under 3 months.

4.5. Interactions with other Medicaments and other forms of Interaction

No clinically significant drug interactions known.

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.

4.7. Effects on Ability to Drive and Use Machines

No adverse effects known.

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

Over dosage 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/puhnonary 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

6.6. Instruction for Use/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 AUTHORISATION

31 May 1996

10 DATE OF REVISION OF THE TEXT

04/06/2015