SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Menthol and Wintergreen Vapour Rub

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Actives	Quantity	Unit	Ref
Cajuput Oil	2.5	% V/W	BPC
Camphor	2.5	% W/W	BP
Cineole	2.5	% V/W	BPC
Menthol	5.0	% W/W	BP
Methyl Salicylate	15.0	% V/W	BP

3 PHARMACEUTICAL FORM

Ointment

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of muscular pain, rheumatic pain, fibre ositis, sciatica, strains, lumbago, colds.

4.2 Posology and method of administration

Adults, elderly and children over 3 months, use as directed, two to three times daily.

Do not give to children under 3 months old.

Contraindications

Menthol and Wintergreen Vapour Rub is contraindicated in patients with known hypersensitivity to any of the listed actives or the excipients (see section 6.1).

Children under 3 months

4.4 Special warnings and precautions for use

For external use only.

Keep out of the reach of children.

For use as an inhalant

Use with caution in patients with asthma (see section 4.8).

Cutaneous use

Do not use if the patient is taking warfarin unless clinically necessary (see section 4.5).

If symptoms persist or worsen after 2 weeks, a physician should be consulted.

Eye contact with unwashed hands after application may potentially cause irritation.

Do not apply to broken skin or mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

Menthol is absorbed through the skin; studies have indicated that methanol taken orally has the potential to affect drug metabolising enzymes. Patients should be monitored for any adverse effect when using this product especially for long periods.

There have been reports that topically applied methyl salicylate, can interact with warfarin. In all the reported cases the INR was significantly increased, in some cases the patients experienced severe bleeding. The topical use of this product with warfarin should be avoided unless clinically necessary, in which case the patient’s INR levels should be carefully monitored.

4.6 Fertility, pregnancy and lactation

Studies in animals have shown that topically applied methyl salicylate is teratogenic. The potential risk for humans is not known.

Do not use Menthol and Wintergreen Vapour Rub during pregnancy or lactation, unless clinically necessary.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

The following undesirable effects have been reported in post-marketing experience for the active substances in this product. The frequency of undesirable effects considered at least possibly related to treatment is unknown (cannot be estimated from available data).

Immune system disorders

Hypersensitivity reactions including: asthma, rhinitis and contact dermatitis

4.9 Overdose

There have been no reports of overdose or accidental poisoning with this product, however, in the event of overdose treatment should be symptomatic and supportive.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties ATC code:

Cajuput Oil: No code found Camphor: C01EB03 Cineole: No code found

Menthol: M02AC87 (in combination with methyl salicylate)

Methyl Salicylate: M02AC87 (in combination with menthol)

The properties of the five active constituents when applied topically are as follows:

Menthol dilates the blood vessels, causing a sensation of coldness followed by an analgesic effect.

Camphor acts as a rubefacient and mild analgesic.

Cineole is a rubefacient.

Cajuput oil is a stimulant and mild rubefacient. Wintergreen/ Methyl Salicylate relieves pain.

5.2    Pharmacokinetic properties

Not applicable to a product for topical application.

5.3    Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

White Soft Paraffin BP 70.1% W/W

6.2    Incompatibilities

None stated

6.3    Shelf life

36 Months

6.4    Special precautions for storage

Store in a cool place

6.5    Nature and contents of container

White polypropylene jar with white R3/48mm polypropylene screw cap (enclosed in a cardboard carton)

Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER

Bell Sons and Company (Druggists) Limited

Gifford House

Slaidburn Crescent

Southport

PR9 9AL

8    MARKETING AUTHORISATION NUMBER(S)

PL 03105/0110

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18/01/2012

10 DATE OF REVISION OF THE TEXT

20/11/2013