SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vicks Vaporub

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Name of the active substances:	Quantity	Unit	Reference standards
LEVOMENTHOL	2.75	% W/W	Eur. Ph
CAMPHOR	5.00	% W/W	Eur. Ph
EUCALYPTUS OIL	1.50	% W/W	Eur. Ph
TURPENTINE OIL	5.00	% W/W	Eur. Ph

3. PHARMACEUTICAL FORM

An ointment which is rubbed on chest or added to hot water and the aromatics are inhaled.

4    CLINICAL PARTICULARS

4.1.    Therapeutic indications

For the symptomatic relief of nasal catarrh and congestion, sore throat, also cough due to colds.

4.2. Posology and Method of Administration

Adults:

Rub Vaporub liberally on the chest, throat and back. Rub in well over the whole area and leave nightclothes loose for easy inhalation.

or

Melt two teaspoons of Vaporub in very hot water and inhale the vapours.

Apply lightly to chest and back. Rub gently and leave clothes loose for easy inhalation.

4.3    Contraindications

Hypersensitivity to any of the ingredients.

Do not administer to children < 2 years.

Do not use as an inhalation for children < 12 years.

4.4    Special warnings and precautions for use

The following patient groups should use with caution or consult a doctor before use;

History of airway disease or pronounced hypersensitivity of the airways / asthma

Keep out of reach and sight of children.

If symptoms persist, consult your doctor

Topical:

Do not apply to broken skin, wounds or mucous membranes.

Do not swallow or apply directly onto the nostrils, eyes, mouth or face.

For external use only

Do not bandage tightly. Do not use with heat wrap or any kind of heat. Inhalation:

Do not use boiling water to prepare inhalations.

Do not heat or re-heat the mixture in a microwave.

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation

As with all medicines in pregnancy, care should be taken and as a precaution this product should not be used without medical advice during pregnancy. Vaporub should not be used on the mother’s chest during lactation, due to the theoretical risk of apnoea reflex in the infant whilst feeding in close proximity to the site of application.

Effects on ability to drive and use machines

This product does not interfere with the ability to drive vehicles or use machinery

4.8 Undesirable effects

Local effects :

Redness, irritation of the skin, irritation of the eyes (by inhalation), allergic dermatitis.

Irritations or allergic reactions are usually mild and occur rarely.

Systemic effects:

Due to the recommended route of administration; systemic exposure is very low and undesirable effects due to systemic exposure have not been observed.

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.

After significant accidental consumption, acute poisoning was observed after significant accidental consumption, with nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot / flushing, convulsions, respiratory depression and coma.

In case of accidental ingestion seek medical assistance.

Patients with severe gastrointestinal or neurological symptoms of poisoning should be observed and treated symptomatically. Do not induce vomiting.

5.1    Pharmacodynamic properties

Menthol, camphor, turpentine oil and eucalyptus oil act locally in the respiratory tract.

5.2.    Pharmacokinetic properties

The product exerts its action locally; little or no absorption is expected to occur.

5.3.    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1.    List of excipients

Thymol Nutmeg oil Cedarwood oil White soft paraffin

6.2.    Incompatibilities

None.

6.3.    Shelf Life

48 months.

6.4.    Special precautions for storage

Do not store above 25°C.

Nature and contents of container

VapoRub ointment is packed into 40g, 50g, 90g and 100g opaque, blue, polypropylene jars, closed with a green polypropylene thread screw cap and containing a 2mm thick PET/LDPE/EPE/LDPE/PET cap liner.

6.6. Instructions for use, handling and disposal

None.

7    MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 OXP

8. MARKETING AUTHORISATION NUMBER

PL 00129/0130

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15^th March 1999

10 DATE OF REVISION OF THE TEXT

14/08/2015