Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCOL MONOSALICYLATE ; METHYL NICOTINATE
GR Lane Health Products Ltd
M02AX
GLYCOL MONOSALICYLATE ; METHYL NICOTINATE
6.0/1.6 %w/v
Cutaneous Spray Solution
Product not subject to medical prescription
Other topical products for joint and muscular pain
Not Marketed
1990-12-11
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 Method of administration: for external application to the skin: 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 (salicylic acid (or other NSAIDs) or any other ingredients. Injuries involving broken or inflamed skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains glycol salicylate and so should be used with caution in patients at increased risk of developing salicylate adverse effects. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document