Ralgex cream

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Hydroxyethyl salicylate; Methyl nicotinate; Capsicum oleoresin

Tilgjengelig fra:

G.R. Lane Health Products Ltd

ATC-kode:

n/a

INN (International Name):

Hydroxyethyl salicylate; Methyl nicotinate; Capsicum oleoresin

Dosering :

100mg/1gram ; 10mg/1gram ; 1.2mg/1gram

Legemiddelform:

Cutaneous cream

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Never Valid To Prescribe As A VMP

Produkt oppsummering:

BNF: 10030200; GTIN: 5012509978624 5012509118204

Informasjon til brukeren

Common Technical Document
Ralgex Heat Rub Cream
Module 1 – Administrative and Prescribing Information
Module 1.3 – Product Information
January 2015 - LB
RALGEX CREAM
lycol Monosalicylate 1
G
0% w/w, Methyl Nicotinate 1% w/w and Capsicum
Oleoresin 0.12% w/w
PATIEN
Please
T INFORMATION LEAFLET
•
read this leaflet carefully before using Ralgex Cream.
Keep this leaflet, you may wish to read it again.
f you need more information or advice.
•
Ask your pharmacist i
What is this cream used for?
his cream provides rapid warming relief for muscular pain and
stiffness, including backache
tis and rheumatic pain.
T
sciatica, lumbago, fibrosi
Before using this cream
Do not use…
• If you are allergic to salicylates (e.g. aspirin), salicylic acid
(or other non steroidal
any of other ingredient in this product. See ‘What this cream
edients.
anti‐inflammatory drugs) or to
ontains’ for the full list of ingr
med skin.
c
• On broken or infla
Take special care…
ld
• Some people experience stronger effects with Ralgex Cream than
others. The product shou
be tried on a small area first.
• Do not apply near the eyes or mouth, or on sensitive body areas
(such as lips, bottom and
genitals).
ensitivity of the skin, which is more sensitive after a
• Day‐to‐day variation may occur in the s
ot bath or in hot weather.
h
•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).
f you are pregnant or breast feeding…
or pharmacist before using
I
• Speak to your doctor
ver:
How to use this cream
Adults, the elderly and children 12 years and o
• After trial use, rub into the skin until absorb
To be applied as required to the affected are
Repeat as necessary up to four times a day.
•
•
Children under 12 years:
Not to be used on children under 12 years unless

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ralgex Heat Rub Cream
Ralgex Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycol monosalicylate DAB
10.0% w/w
Methyl nicotinate BP
1.0% w/w
Capsicum oleoresin BPC 1973
0.12% w/w
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
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
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 than others; the
product
should be tried on a small area first. Do not apply near the eyes,
mouth or on
sensitive body areas. Do not apply to large areas of the body.
Day-to-day variation may occur in the sensitivity of the skin, which
is more
sensitive after a hot bath or in hot weather.
If symptoms persist, consult your doctor.
For external use only. Keep out of the sight and reach of children.
This cream contains methylhydroxybenzoate (E218) which may cause
hypersensitivity (possibly delayed) and emulsifying wax of which
cetostearyl
alcohol may cause local skin reaction (e.g. contact dermatitis)
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF