Summary of Product Characteristics (SmPC) - Boots Vapour Chest Rub
1 NAME OF THE MEDICINAL PRODUCT
Boots Vapour Chest Rub
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients %w/w
Racemic Camphor 6% Levomenthol natural or synthetic 1% Eucalyptus Oil 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. Interactions with other Medicaments 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.
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 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. Instruction for Use/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 AUTHORISATION
Date of First Authorisation: 29 August 1984 Date of Last Renewal: 23 May 1996
10 DATE OF REVISION OF THE TEXT
22/01/2020