Ralgex Heat Spray

1. Name Of The Medicinal Product

Ralgex Heat Spray.

2. Qualitative And Quantitative Composition

Glycol Monosalicylate 6.0% w/v; Methyl Nicotinate BP 1.6% w/v.

3. Pharmaceutical Form

Topical spray.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.

4.2 Posology And Method Of Administration

Route of administration: For external application to the skin. Adults and children aged 5 years and over: Shake well before use. Hold the container about 6 inches from the skin with the arrow pointing to the site of pain and depress the button to spray in 2-3 short bursts. Further applications may be made at intervals of not less than two hours. This may be repeated up to 4 times daily. The spray is rapidly absorbed by the skin and massage is not required. If, after use, an increased effect is required, cover the sprayed area with a pad of cotton wool held in place by adhesive tape. Not to be used on children under five years of age. The elderly: Normal directions for use can be used.

4.3 Contraindications

Hypersensitivity to salicylates or any constituents of the spray. Injuries involving broken skin.

4.4 Special Warnings And Precautions For Use

Label warnings: Some people experience stronger effects with Ralgex Heat Spray than others. Try on a small area first. Do not spray on head or neck. Avoid inhalation and contact with eyes. Always spray sparingly: over application can cause discomfort. Do not spray on sensitive body areas or broken skin. If symptoms persist, consult your doctor. For external use only. Keep out of the reach of children. Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather. Other precautions are necessary as Ralgex Heat Spray is in a pressurized container. Caution: Extremely flammable. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50^oC. Do not pierce or burn, even after use. Keep away from sources of ignition - no smoking. Do not spray on a naked flame or any incandescent material. Avoid contact with polished surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use during pregnancy and lactation is not contraindicated. However, as with all medicines during pregnancy and lactation, caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Skin irritation may occur in certain individuals that may be enhanced after a hot bath or in hot weather. Although rare, anaphylactic reactions have been reported, symptoms of which may include flushing, shortness of breath and fall in blood pressure.

4.9 Overdose

Over-use would probably cause excessive localised redness and burning sensation of the skin owing to the rubefacient action of the product. These should subside on withdrawal of the product. Where treatment is indicated, relief would be obtained from gently swabbing the area with gauze or white lint soaked in vegetable oil. Rarely, the application of a cream or ointment containing corticosteroid may be necessary. It is most unlikely that even the most excessive use of the product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects. Treatment: After withdrawal of the product, the treatment is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycol monosalicylate provides topical analgesic and anti-inflammatory effects for the symptomatic relief of muscular aches and pains. Methyl nicotinate provides rubefacient activity for the symptomatic relief of muscular aches and pains.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl Alcohol BP; Goliath Perfume SE 83.0502; Butane 30 psig.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Protect from sunlight and do not expose to temperatures not exceeding 50^oC.

6.5 Nature And Contents Of Container

Tin plate, double-lacquered aerosol can fitted with a valve and actuator which are covered with a plastic cap containing 125ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0075.

9. Date Of First Authorisation/Renewal Of The Authorisation

9^th October 1996/19^th October 2001.

10. Date Of Revision Of The Text

October 2001.