Ralgex Freeze Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Freeze Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol monosalicylate 10.0% w/w
Methoxymethane 14.41% w/w
Isopentane 67.77%w/w
3 PHARMACEUTICAL FORM
Topical spray
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.
Symptomatic relief of sprains, strains and bruises associated with sports injuries, and stiffness following sporting exercise.
4.2 Posology and method of administration
Method of Administration: External application to the skin
Adults, the elderly and children 5 years and over
Hold the container about 6 inches from the skin with the arrow pointing to the site of pain. Press the button to spray in 2-3 short bursts. This may be repeated up to 4 times daily.
Not to be used on children under 5 years of age.
4.3 Contraindications
Hypersensitivity to salicylates, Saliclic acid (or other non-steroidal antiinflammatory drugs) or to any of the excipients listed in section 6.1.
Injuries involving broken or inflamed skin.
Raynaud’s disease.
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.
The following appear on the product labelling:
Some people experience stronger effects with Ralgex than others. Try on a small area first.
Not for use with occlusive dressings.
Caution: Do not spray on 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 the body.
If symptoms persist, consult your doctor.
For external use only.
Keep out of the sight and reach of children.
Caution: extremely flammable. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 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.
4.5 Interaction with other medicinal products and other forms of interaction
Salicylates in the form of gels, or ointment applied to the skin, have been found to increase the effects of warfarin. Bleeding and bruising, and/or raised INRs have been seen with both high and low doses of topical salicylates.
4.6 Fertility, Pregnancy and lactation
Pregnancy:
No evidence of safety of this product has been determined in pregnany. It is not necessary to contracindicate this product in pregnancy provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought before the product is used.
Breast feeding:
Salicylates should be given with caution to breast -feeding mothers because of possible risk of Reye’s syndrome in nursing infants and there is no data on the use of the combination product in breast feeding women.
Fertility:
There is no information on the effects of the product on fertility.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Mild irritation of the skin (reddening, burning sensations and rarely swelling) have been reported, which may be enhanced after a hot bath or hot weather. Rashes have also been rarely reported.
Although rare, anaphylactic reactions have been reported, symptoms of which may include flushing, shortness of breath and a fall in blood pressure.
Glycol Monosalicylate:
Salicylism can also occur following excessive topical application of salicylates. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion, and may be controlled by reducing the dosage.
4.9 Overdose
Prolonged and excessive spraying may temporarily freeze the skin and possibly cause reversible skin frost damage.
It is most unlikely that even the most excessive use of this product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects, although salicylism may occur following excessive topical application.
Overdose resulting from intentional abusive inhalation of propellants could cause CNS depression, palpitations, cardiac arrhythmias and ultimately asphyxiation.
Treatment: after withdrawal of the product the treatment is symptomatic.
In the case of accidental oral ingestion, the advice of a doctor should be sought.
Glycol Monosalicylate: Ingestion of salicylates pose the threat of salicylate poisoning. Symptoms are similar to those of salicylate poisoning in general.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glycol monosalicylate is a topical analgesic/anti-inflammatory agent. Isopentane and methoxymethane are a propellant/refrigerant mixture in an appropriate ratio, which provides a counter-irritant effect through rapid skin cooling and associated numbing.
Pharmacokinetic properties
5.2
Isopentane and methoxymethane: these remain on the skin surface for a period of seconds only, prior to evaporation, therefore no precutaneous absorption occurs.
Glycol monosalicylate: adequate absorption of glycol monosalicylate through intact skin has been demonstrated in the literature. Salicylates are extensively bound to plasma proteins and rapidly distributed. They are rapidly excreted in conjugated form.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Isopropyl alcohol, levomenthol.
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months unopened.
6.4 Special precautions for storage
Protect from sunlight and do not expose to temperatures exceeding 50°C.
6.5 Nature and contents of container
Printed aerosol cans fitted with an arrowed valve and covered with a protective cap containing 125ml or 150ml of product.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
G R Lane Health Products Ltd.
Sisson Road
Gloucester
GL2 0GR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 01074/0245
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/09/1996
10 DATE OF REVISION OF THE TEXT
04/03/2015