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BOOTS PAIN RELIEF HEAT SPRAY

Active substance(s): ETHYL NICOTINATE / METHYL SALICYLATE / RACEMIC CAMPHOR

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SUMMARY OF PRODUCT CHARACTERISTICS

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 4.1.

CLINICAL PARTICULARS 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. Interactions 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.

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.

Pre-clinical 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 front sunlight; do not expose to temperatures above 50C; do not pierce or burn even when empty.

6.5.

Nature and Content 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.

Instructions for Use, Handling and Disposal 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 0014/0275

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19 July 1982/19 July 1992

10.

DATE OF (PARTIAL) REVISION OF THE TEXT February 2004

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