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BOOTS VAPOUR CHEST RUB

Active substance(s): EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR / EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR / EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR

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SUMMARY OF PRODUCT CHARACTERISTICS

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
4.1

CLINICAL PARTICULARS
Therapeutic indications
For head colds, stuffy nose, coughs and chest colds.

4.2.

Posology and Method of Administration Unless otherwise directed by the doctor: For Adults and Children over 3 Months Apply liberally to the chest and back particularly at bedtime. Use sparingly on infants and young children. Massage gently. For faster relief from a stuffy nose and tight chest, add one teaspoonful of Vapour Rub to half a pint of hot not boiling - water and inhale the vapour. Children under 3 Months Not recommended for children under 3 months of age.

Elderly There is no need for dosage reduction. For topical application and inhalation.

4.3.

Contra-indications Hypersensitivity to any of the ingredients.

4.4.

Special Warnings and Precautions for Use For external use only. If symptoms do not go away talk to your pharmacist or doctor. Keep all medicines out of the reach of children.

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.

4.8.

Undesirable Effects Occasional hypersensitivity and irritant skin reactions.

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
5.1

PHARMACOLOGICAL PROPERTIES
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
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
White Soft Paraffin Thymol Turpentine Oil Pumilio Pine Oil BP80

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: Date of Last Renewal: 29 August 1984 23 May 1996

10

DATE OF REVISION OF THE TEXT
25/08/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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