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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Heat Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol Monosalicylate 6.00 % w/v
Methyl Nicotinate 1.6 % w/v
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
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
Adults and children 5 years and over:
Shake well before use.
Hold the container about 6 inches (15cm) 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 adult directions for use can be used.
4.3 CONTRAINDICATIONS
Hypersensitivity to salicylates or any other ingredients. Injuries involving broken skin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Some people experience stronger effects with Ralgex Heat Spray than others; the products should be tried on a small
area first.
Avoid inhalation and contact with the eyes, mouth, head, neck or on sensitive body areas.
Always spray sparingly: over application can cause discomfort.
Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.
If symptoms persist, consult your doctor.
IRISH MEDICINES BOARD
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