This information is intended for use by health professionals

1. Name of the medicinal product

Boots Pain Relief Heat Spray

2. Qualitative and quantitative composition

Active ingredients

Ethyl nicotinate

Methyl salicylate

Racemic camphor

1.1% w/w

1.25% w/w

0.625% w/w

3. Pharmaceutical form

Topical spray.

4. Clinical particulars
4.1 Therapeutic indications

For the relief of muscular and rheumatic pains, lumbago, fibrositis, sciatica, sprains, strains and stiffness.

For topical administration.

4.2 Posology and method of administration

Adults and children over 5 years: Spray the site of pain using 2 or 3 short bursts, holding the container about 6 inches (15cm) from the skin.

Children under 5 years: Not to be used by children under 5 years.

Elderly: The normal adult dose is still appropriate in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Children under 5 years.

4.4 Special warnings and precautions for use

For external use only.

Use sparingly as over-application can cause discomfort.

Discontinue use of the product if excessive irritation occurs.

Keep away from the eyes, face, mucous membranes and other sensitive parts of the body.

Do not use on broken or damaged skin or on open cuts.

If symptoms persist, consult your doctor.

Avoid inhalation.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.

4.6 Pregnancy and lactation

Although there are no data available to support the use of this product during pregnancy and lactation it is unlikely that use of this product would constitute a hazard to the foetus or breast fed infant.

4.7 Effects on ability to drive and use machines

No adverse effect known.

4.8 Undesirable effects

Occasional hypersensitivity reactions.

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

It is unlikely that overdosage will occur, but in the event, symptomatic treatment only should be sufficient.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Methyl salicylate has local analgesic and counter irritant properties.

Ethyl nicotinate has vasodilator properties and produces rubefacient activity.

Camphor acts as a mild analgesic, rubefacient and counter irritant.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Denatured ethanol

Hydrocarbon 40

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Pressurised container:

Protect from sunlight; do not expose to temperatures above 50EC; do not pierce or burn even when empty.

6.5 Nature and contents of container

A tinplate internally lacquered aerosol can, having an aervalve and a white/black polypropylene actuator spray fitted with a polyethylene or polypropylene cover.

Pack size: 125ml

6.6 Special precautions for disposal and other handling

Do not spray on a naked flame or any incandescent material. Do not use near, and do not place container on, polished or painted surfaces.

7. Marketing authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0275

9. Date of first authorisation/renewal of the authorisation

19 July 1982 / 7 December 2002

10. Date of revision of the text

04 December 2014