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:

SSL International PLC

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

 
RALGEX HEAT SPRAY 

Glycol monosalicylate 6.0% w/v and methyl nicotinate 1.6% w/v. 

PATIENT INFORMATION LEAFLET 

Please read this leaflet carefully before using Ralgex Heat 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. 

Glycol monosalicylate is a topical analgesic and anti-inflammatory
agent which 
provides pain relief.  Methyl nicotinate is a warming
agent, assisting in the relief of 
muscular pain. 

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), salicylic acid (or other non-steroidal
anti-
inflammatory drugs) or to any constituents of the spray. See 'What
this spray 
contains' for the full list of ingredients.  

• 
On broken or inflamed skin. 

Take special care… 

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

• 
Do not spray on the head or neck. 

• 
Avoid inhalation and contact with the eyes or mouth.  
• 
Always spray sparingly; over application can cause discomfort.  
• 
Do not spray on sensitive body areas or broken skin or large areas of
body.  
• 
This spray is for external use only.  
• 
Day-to-day variation may occur in the sensitivity of the skin, which
is more 
sensitive after a hot bath or in hot weather. 
• 
Use with caution during pregnancy. 

How to use this spray 
Adults, the elderly and children 5 years and over: 

• 
Shake well before use.  
• 
Hold the can about 6 inches from the skin with the arrow pointing to
the site 
of pain. 
• 
Press button to spray 2-3 short bursts. 
• 
Further application m

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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/07/2013_
_CRN 2130854_
_page number: 1_
Some people experience stronger effects w