RALGEX HEAT SPRAY 6.0/1.6 %w/v Cutaneous Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLYCOL MONOSALICYLATE, METHYL NICOTINATE

Available from:

GR Lane Health Products Ltd

ATC code:

M02AX

INN (International Name):

GLYCOL MONOSALICYLATE, METHYL NICOTINATE

Dosage:

6.0/1.6 %w/v

Pharmaceutical form:

Cutaneous Spray Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other topical products for joint and muscular pain

Authorization status:

Authorised

Authorization date:

2015-02-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Heat Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol Monosalicylate 6.00 % w/v
Methyl Nicotinate 1.6 % w/v
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: for external application to the skin:
Adults and children 5 years and over: 
Shake well before use. 

Hold the container about 6 inches (15cm) 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 NSAIDs) or any other ingredients. 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/02/2015_
_CRN 2158609_
_page number: 1_
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