Ralgex Heat spray

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Hydroxyethyl salicylate; Methyl nicotinate

Disponible desde:

G.R. Lane Health Products Ltd

Código ATC:

n/a

Designación común internacional (DCI):

Hydroxyethyl salicylate; Methyl nicotinate

Dosis:

60mg/1ml ; 16mg/1ml

formulario farmacéutico:

Spray

Vía de administración:

Cutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 10030200; GTIN: 5012509978648

Información para el usuario

C o m m o n
T e c h n i c a l
D o c u m e n t
R a l g e x
H e a t
S p r a y
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information
January 2015 - LB
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.
C o m m o n
T e c h n i c a l
D o c u

Ficha técnica

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 anti-
inflammatory 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