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Common Technical Document Ralgex Heat Spray
Module 1 - Administrative and Prescribing Information
Module 1.3 - Product Information
RALGEX LOW ODOUR 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 Low Odour 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 Low Odour 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 may be made at intervals of not less than two hours.
• This may be repeated up to 4 times daily.
As the spray is rapidly absorbed by the skin, 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. If symptoms persist, consult your doctor.
Children under 5 years:
• Not to be used on children under 5 years of age.
If you use too much of this spray...
If you use more of the spray than you should, speak to your doctor or pharmacist.
Possible side effects
As with all medicines this liquid can have side effects in some people.
• Although rare, anaphylactic reactions (serious allergic reactions) have been reported. Symptoms include flushing, shortness of breath and a fall in blood pressure, which may cause dizziness or light-headedness.
• Skin irritation may occur, which may be enhanced in hot weather or after a hot bath.
If you feel you are reacting badly to this medicine in any way, or notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store this spray
• Keep out of the sight and reach of children.
• Caution extremely flammable: Pressurized container. Protect from sunlight and do not expose to temperatures greater than 50°C. 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.
• Do not use after the expiry shown on the can.
• If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.
What this spray contains
Ralgex Low Odour Spray contains 6% by weight of the active ingredient glycol monosalicylate and 1.6% by weight of the active ingredient methyl nicotinate. It also contains isopropyl alcohol, goliath perfume SE 83.0502 and butane 30 psig. The spray comes in an aerosol containing 125ml.
Marketing Authorisation Holder:
G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2 0GR, UK.
Manufactured by: ColepCCL Rapid-Spray & Co. KG Fockestrasse 12, 88471 Laupheim, Germany Date of revision: January 2015.
Ralgex is a trade mark of the SSL Group.
January 2015 - LB