SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Jackson’s Vapour Rub

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Terpineol    2.5    %

Methyl Salicylate    5.0 %

Camphor    2.5    %

Menthol    2.5    %

Eucalyptus Oil    5.0    %

3. PHARMACEUTICAL FORM

Ointment.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

Helps to relieve nasal congestion due to common colds and catarrh, and provides symptomatic relief of muscular pain and stiffness in backache, sciatica, lumbago, fibrositis, rheumatic pain and related conditions.

4.2. Posology and Method of Administration

Cutaneous use.

Adults, the elderly, children and infants over 3 months of age:

For nasal congestion, colds and catarrh: Rub onto the chest and throat as required.

Do not apply to the nostrils of infants.

For the relief of muscular pains and stiffness: Rub into the affected parts as required.

Do not use for infants under 3 months.

4.3    Contraindications

Known hypersensitivity to salicylates or to any of the other ingredients in the preparation. If irritation develops, use of the product should be discontinued.

4.4    Special warnings and precautions for use

Use this medicine only on your skin

To be applied to the unbroken skin only, avoiding sensitive skin areas.

Not to be applied to the nostrils of infants.

Do not use for infants under 3 months.

4.5    Interaction with other medicinal products and other forms of interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin. Menthol has also been reported to interact with warfarin (when taken orally), decreasing its effectiveness.

4.6    Fertility, pregnancy and lactation

There is no, or inadequate evidence of safety in human pregnancy or lactation. As a precautionary measure, this medicine should only be used during pregnancy and lactation when there is no safer alternative.

4.7. Effects on Ability to Drive and Use Machines

Not applicable.

4.8    Undesirable effects

If a skin rash occurs, stop using the product.

Known side effects of menthol - contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

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

When used externally as directed, overdose is unlikely. However, symptoms of systemic salicylate poisoning have been reported after the application of salicylates to large areas of skin or for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested.

Salicylate poisoning

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management

Activated charcoal may be administered if significant quantities have been ingested within an hour of presentation. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700mg/L (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Camphor and Menthol

Ingestion of the product or excessive use may also lead to camphor poisoning, the symptoms of which include nausea, vomiting, epigastric pain, headache, dizziness, oropharyngeal burning, delirium, muscle twitching, epileptiform convulsions, CNS depression and coma. Breathing is difficult and the breath has a characteristic odour; anuria may occur. Death from respiratory failure or status epilepticus may occur; fatalities in children have been recorded from 1g. Supportive care, including anticonvulsant therapy, is the mainstay of treatment of camphor intoxication. Gastric lavage may be considered if the patient presents within 1 hour of ingestion; any convulsions must be controlled first. Activated charcoal may be given orally.

Ingestion of significant quantities of menthol is reported to cause symptoms similar to those seen after ingestion of camphor, including severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma; they may be managed similarly.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic Properties

The active principles are volatile odorous substances which have one or more of the following properties: rubefacient, mild analgesic, mild irritant, antiinflammatory, antiseptic action. They are presented in an ointment base which permits local cutaneous absorption and volatilisation of the actives.

Terpineol: Essential oil, antiseptic.

Methyl Salicylate: Actions typical of salicylates including analgesic and antiinflammatory activity.

Camphor: Rubefacient, mild analgesic.

Menthol: Dilates superficial vessels, relieves minor local irritation.

Eucalyptus Oil: Essential oil, mild irritant and rubefacient.

5.2 Pharmacokinetic Properties

The active principles are absorbed through the skin and by inhalation. Excretion is via the lungs, skin and kidneys.

5.3. Pre-clinical Safety Data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients

White Soft Paraffin

6.2.    Incompatibilities

None stated.

6.3.    Shelf-Life

3 years.

6.4.    Special Precautions for Storage

No special storage precautions

6.5.    Nature and Content of Container

Plastic jar with polypropylene close fitting lid - 35 g and 50 g.

6.6.    Instructions for Use, Handling and Disposal

No special instructions for use/handling.

7.    MARKETING AUTHORISATION HOLDER

OTC Concepts Ltd 2 Park Street Woburn Bedfordshire MK17 9PG United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 20338/0009

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16 March 2004

DATE OF REVISION OF THE TEXT

30/06/2016