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Procter & Gamble (Health & Beauty Care) Ltd.
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
Telephone: +44 (0)191 297 5000
Fax: +44 (0)191 297 6295
WWW: http://www.uk.pg.com
Customer Care direct line: +44 (0) 8000 850367 (UK)
Customer Care direct line: +353 (1) 800 509 301 (Ireland)


Summary of Product Characteristics last updated on medicines.ie: 06/08/2010
SPC Vicks Vaporub



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1. NAME OF THE MEDICINAL PRODUCT

Vicks Vaporub


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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

FP


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3. PHARMACEUTICAL FORM

Inhalation vapour, ointment

A soft, white or yellow unctuous ointment with a characteristic odour.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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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.

Children (over 2 years):

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


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4.3 Contraindications

Should not be swallowed or placed near mouth or nostrils.


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4.4 Special warnings and precautions for use

In case of fever consult your doctor.

Do not swallow or place in nostrils.

As with all medicines keep out of the reach of children.

If symptoms persist consult your doctor.


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4.5 Interaction with other medicinal products and other forms of interaction

None.


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4.6 Pregnancy and lactation

Although there is no evidence of any risk when Vaporub is used in pregnancy, such use is not recommended without medical advice.


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4.7 Effects on ability to drive and use machines

None.


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4.8 Undesirable effects

Mild erythema may occasionally occur.


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4.9 Overdose

Symptoms of overdose following misuse of oral ingestion may include nausea and vomiting, abdominal pain, headache, dizziness, a feeling of warmth, tachycardia, delirium, muscle twitching and rigidity, epileptiform convulsions, depression of the central nervous system and coma. Breathing may be difficult. Treatment consists of gastric lavage if the patient presents soon after ingestion. Ipecac is contraindicated due to the potential for rapid deterioration of mental status.

Breathing should be closely monitored. Benzodiazepines can be used as a first line choice for controlling seizures.

Specialist advice from a poisons information centre is recommended.

Over dose may result in skin irritation.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

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


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Thymol

Cedarwood oil

White soft paraffin


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6.2 Incompatibilities

None known.


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6.3 Shelf life

40 months.


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6.4 Special precautions for storage

Do not store above 25oC.


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6.5 Nature and contents of container

The product is contained in a blue, polypropylene, injection/blow moulded jar with a green polypropylene, wadless cap containing a 2 mm thick PET / LDPE / EPE / LDPE / PET cap liner. The jar is enclosed in a printed cardboard carton. Pack sizes of 40g, 50g, 90g and 100g are available.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PA 441/2/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 June 2000

Date of last renewal: 23 June 2005


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10. DATE OF REVISION OF THE TEXT

October 2009



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Active Ingredients

 
  Camphor
  Eucalyptus Oil
  Turpentine Oil
  Levomenthol