Ralgex Freeze Spray

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Common Technical Document    Ralgex Freeze Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Text to appear on the Patient Information Leaflet RALGEX FREEZE SPRAY

Glycol Monosalicylate 10% w/w, Methoxymethane 14.41% w/w and Isopentane 67.77% w/w PATIENT INFORMATION LEAFLET

Pl ease read this leaflet carefully before using Ralgex Freeze 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.

It is also used for the symptomatic relief of sprains, strains and bruises associated with sports injuries, and stiffness following sporting exercise.

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) or other non-steroidal anti inflammatory drugs (including pain killers). See ‘What this spray contains' for the full list of ingredients.

•    On broken or inflamed skin.

•    If you suffer from poor blood circulation which makes the toes and fingers numb and pale (Raynaud's disease).

Take special care.

•    Some people experience stronger effects with Ralgex Freeze Spray than others. Try on a small area first.

•    Not for use with occlusive dressings.

•    Do not spray on the head or neck.

•    Avoid inhalation and contact with the eyes.

•    Always spray sparingly; over application can cause discomfort.

•    Do not spray on sensitive body areas or broken skin or on large areas of body.

•    This spray is for external use only.

•    Use with caution during pregnancy.

How to use this spray

Adults, the elderly and children 5 years and over:

•    Shake well before use. in with the arrow pointing to the site of pain

•    Hold the can about 6 inches from the skin.

•    Press button to spray 2-3 short bursts.

•    This may be repeated up to 4 times daily

If symptoms persist, consult your doctor.

Common Technical Document    Ralgex Freeze Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

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 that you should, speak to your doctor or pharmacist.

Possible side effects

As with all medicines this liquid can have side effects in some people.

•    Rarely, mild skin irritation has been reported. 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: Pressurised 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 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® Freeze Spray contains 10% by weight of the active ingredient glycol monosalicylate, 14.41% by weight of the active ingredient methoxymethane and 67.77% by weight of the active ingredient isopentane. Glycol monosalicylate is a topical analgesic and anti-inflammatory agent which provides pain relief. The mixture of methoxymethane and isopentane rapidly cools the skin and numbs it, providing a counter-irritant effect. It also contains isopropyl alcohol and menthol.

The spray comes in aerosols containing either 125 or 150ml.

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: July 2013.

Ralgex is a trade mark of the SSL Group.

January 2015 - LB