RALGEX 10/1/0.12% %v/v Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
GLYCOL MONOSALICYLATE METHYL NICOTINATE CAPSICUM OLEORESIN
Available from:
SSL International plc
INN (International Name):
GLYCOL MONOSALICYLATE METHYL NICOTINATE CAPSICUM OLEORESIN
Dosage:
10/1/0.12% %v/v
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Ralgex Cream
lycol Monosalicylate 10% w/w, Methyl Nicotinate 1% w/w and Capsicum
G
Oleoresin 0.12% w/w
ease
PATIENT INFORMATION LEAFLET
Pl
read this leaflet carefully before using Ralgex Cream.
Keep this leaflet, you may wish to read it again.
you need more information or advice.
•
•
Ask your pharmacist if
What is this cream used for?
his cream provides rapid warming relief for muscular pain and stiffness,
ica, lumbago, fibrositis and rheumatic pain.
T
including backache, sciat
Before using this cream
Do not use…
•
If you are allergic to salicylates (e.g. aspirin), salicylic acid (or other non‐
rugs)
or to any of other ingredient in this
contains' for the full list of ingredients.
steroidal anti‐inflammatory d
product. See 'What this cream
inflamed skin.
•
On broken or
Take special care…
•
Some people experience stronger effects with Ralgex Cream than others.
The product should be tried on a small area first.
as
•
Do not apply near the eyes or mouth, or on sensitive body areas (such
lips, bottom and genitals).
•
nsitivity of the skin, which is
weather.
Day‐to‐day variation may occur in the se
more sensitive after a hot bath or in hot
•
Do not apply to large areas of the body.
Important information about some of the ingredients…
•
This cream contains methyl hydroxybenzoate (E218) which may cause
allergic reactions (possible delayed) and emulsifying wax of which
cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
you a
f
re pregnant or breast feeding…
ctor or pharmacist before using.
I
•
Speak to your do
How to use this cream
Adults, the elderly and children 12 years and over:
ed.
a.
•
After trial
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ralgex Cream contains:
Excipients: Contains
Methylhydroxybenzoate (E218)
0.20 %w/w
Butylhydroxybenzoate (E216)
0.10 % w/w
Emulsifying wax
9.0 % w/w
(contains cetostearyl alcohol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Thick, off-white, homogeneous cream with a characteristic odour.
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 AGED 12 YEARS AND OVER:
After trial use, rub into the skin until absorbed.
To be applied as required to the affected area. Repeat as necessary up to four times a day.
Not to be used on children under 12 years except on medical advice.
THE ELDERLY:
The normal adult directions for use can be followed.
4.3 CONTRAINDICATIONS
Known hypersensitivity to salicylates, salicylic acid (or other NSAIDs) or to any of the ingredients of the cream.
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.
Glycol Monosalicylate
10.0 % w/w
Methyl Nicotinate
1.0 % w/w
Capsicum Oleoresin
0.12 % w/w
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/07/2013_
_CRN 2130886_
_page number: 1_
Side effects include local irritation and occasionally allergic reactions.
Some people experience stronger effects with Ralgex than others; t
Read the complete document
