Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCOL MONOSALICYLATE METHYL NICOTINATE
SSL International PLC
GLYCOL MONOSALICYLATE METHYL NICOTINATE
6.0/1.6 %w/v
Cutaneous Spray Solution
Product not subject to medical prescription
Authorised
0000-00-00
RALGEX HEAT SPRAY Glycol monosalicylate 6.0% w/v and methyl nicotinate 1.6% w/v. PATIENT INFORMATION LEAFLET Please read this leaflet carefully before using Ralgex Heat Spray. • Keep this leaflet, you may wish to read it again. • Ask your pharmacist if you need more information or advice. What is this spray used for? This cutaneous spray solution is used for the symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis, rheumatic pain. Glycol monosalicylate is a topical analgesic and anti-inflammatory agent which provides pain relief. Methyl nicotinate is a warming agent, assisting in the relief of muscular pain. Before using this spray Do not use… • If you are allergic to any of the ingredients in this product, in particular salicylates (e.g. aspirin), salicylic acid (or other non-steroidal anti- inflammatory drugs) or to any constituents of the spray. See 'What this spray contains' for the full list of ingredients. • On broken or inflamed skin. Take special care… • Some people experience stronger effects with Ralgex Heat Spray than others. Try on a small area first. • Do not spray on the head or neck. • Avoid inhalation and contact with the eyes or mouth. • Always spray sparingly; over application can cause discomfort. • Do not spray on sensitive body areas or broken skin or large areas of body. • This spray is for external use only. • Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather. • Use with caution during pregnancy. How to use this spray Adults, the elderly and children 5 years and over: • Shake well before use. • Hold the can about 6 inches from the skin with the arrow pointing to the site of pain. • Press button to spray 2-3 short bursts. • Further application m Read the complete document
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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/07/2013_ _CRN 2130854_ _page number: 1_ Some people experience stronger effects w Read the complete document