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Ralgex Freeze Spray

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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 anti-inflammatory 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 Interactions 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. 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.

5.2 Pharmacokinetic properties

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.

Nature and contents of container

6.5


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

SSL International plc No. 1 Old Park Lane Trafford Park Manchester M41 7HA

8    MARKETING AUTHORISATION NUMBER(S)

PL 17905/0053

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

11/9/96

12/08/2013