SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Prosport Heat Spray

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

2-hydroxyethyl salicylate    5%w/w

Diethylamine salicylate    5%w/w

Methyl nicotinate    1%w/w

3    PHARMACEUTICAL FORM

Spray for topical administration

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of muscular and rheumatic pain.

4.2 Posology and method of administration

There is no difference between the dosage for adults, children or the elderly.

Shake the can well before use. Holding the can about 6 inches from the skin surface, point nozzle arrow towards painful area. Spray evenly using short bursts. There is no need to massage.

Do not use on children under five years of age.

Prosport Heat Spray is for external use only. Do not allow the spray to enter the eyes. Do not use on skin which is inflamed or broken or where there is known hypersensitivity to salicylates.

4.4 Special warnings and precautions for use

Caution, Prosport Heat Spray is flammable. Do not use near fire or flame.

Pressurized container: Protect from sunlight and do not expose to temperatures exceeding 50°C.

Keep away from the eyes, nose and other sensitive areas.

Do not pierce or burn the can, even after use.

Do not spray on a naked flame or any incandescent material.

Do not use near, and do not place the container on, polished or painted surfaces. Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

As with all medicinal compounds care should be taken when administering the product to pregnant or lactating women

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

After application a slight transient erythema may develop.

Owing to the nature of this product and its clinical indications it is highly unlikely overdose can occur.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

The active ingredients of Prosport Heat Spray are commonly found in topical analgesic and rubefacient preparations. 2-hydroxyethyl salicylate is a rubefacient as is methyl nicotinate and diethylamine salicylate is a topical analgesic for rheumatic and muscular pain

5.2 Pharmacokinetic properties

Methyl nicotinate percutaneous absorption may occur dependent on the vehicle base and is via the intercellular route. There is no evidence to suggest that percutaneous absorption of the other constituents occurs to any great extent.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Isopropyl alcohol

Butane propellant

6.2 Incompatibilities

None known.

Shelf life

36 months unopened.

Special precautions for storage

Protect from sunlight and do not expose to temperatures exceeding 50°C.

6.5 Nature and contents of container

Internally lacquered, three piece, tin plate aerosol can containing 125m1 or 150m1 of product with a standard aerosol valve and high density polyethylene cap.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

AYRTON SAUNDERS LIMITED NORTH WAY

WALWORTH INDUSTRAIL ESTATE

ANDOVER

SP10 5AZ

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0077

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31 August 1993 / 17 November 1998

10. DATE OF (PARTIAL) REVISION OF THE TEXT

29 January 2008