Ralgex Low Odour Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Heat Spray Ralgex Low Odour Spray Ralgex Low Odour Heat Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol monosalicylate 6.0%w/v
Methyl nicotinate BP 1.6%w/v
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Topical spray
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis, rheumatic pain.
4.2 Posology and method of administration
Route of administration: external application to the skin.
Adults and children 5 years and over
Shake well before use.
Hold the container about 6 inches 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 non steroidal antiinflammatory drugs) or to any of the excipients listed in 6.1.
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.
Some people experience stronger effects with Ralgex Heat Spray than others. Try on a small area first.
Do not spray on head or neck. Avoid inhalation and contact with the eyes or mouth. Do not spray on sensitive body areas or broken skin or large areas of the body.
Always spray sparingly: over application can cause discomfort.
If symptoms persist, consult your doctor.
For external use only. Keep out of the sight and reach of children.
Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.
Other precautions are necessary as Ralgex Heat Spray is in a pressurized container. 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, oils, or ointment applied to the skin have been found to increase the effects of warfarin. Bleeding and brusing 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
Over use would probably cause excessive localised redness, swelling and burning sensation of the skin owing to the counterirritant effect of the product. Rashes and blisters may also develop. These should subside on withdrawal of the product. But occasionally may require treatment. Where treatment is indicated, relief would be obtained from gently swabbing the area with gauze or white lint soaked in vegetable oil. Rarely, the application of a cream or ointment containing corticosteroid may be necessary.
It is most unlikely that even the most excessive use of the product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects, although salicylism may occur following excessive topical application.
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
Pharmacotherapeutic group: Topical products for joint and muscular pain, ATC code: M02A.
Glycol monosalicylate provides topical analgesic and anti-inflammatory effects for the symptomatic relief of muscular aches and pains. Methyl nicotinate provides rubefacient activity for the symptomatic relief of muscular aches and pains.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Isopropyl alcohol Goliath perfume SE 83.0502 Butane 30 psig
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
Protect from sunlight and do no expose to temperatures exceeding 50°C.
6.5
Nature and contents of container
Tin plate, double-lacquered aerosol can fitted with a valve and actuator which are covered with a plastic cap containing 125 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 01074/0246
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/02/2009
10 DATE OF REVISION OF THE TEXT
04/03/2015