Boots Mild Vapour Rub 3 Months Plus
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
Levomenthol natural or synthetic 1.0
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
4.8
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
or A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.
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