RADIAN B MUSCLE RUB

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CAMPHOR; CAPSICUM OLEORESIN; MENTHOL; METHYL SALICYLATE

Tilgængelig fra:

DEVRIES & CO. LTD

ATC-kode:

M02AC

Lægemiddelform:

CREAM

Sammensætning:

MENTHOL 2.54 %W/W; CAMPHOR 1.43 %W/W; CAPSICUM OLEORESIN 0.005 %W/W; METHYL SALICYLATE 0.42 %W/W

Indgivelsesvej:

TOPICAL

Recept type:

Not required

Fremstillet af:

THORNTON & ROSS LTD, UK

Terapeutisk gruppe:

PREPARATIONS WITH SALICYLIC ACID DERIVATIVES

Terapeutiske indikationer:

Relief of rheumatic pains and mild muscle pains.

Autorisation dato:

2022-06-30

Indlægsseddel

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is supplied without physician’s prescription
RADIAN
® B MUSCLE RUB
Cream
ACTIVE INGREDIENTS:
Menthol
2.54%
Camphor
1.43%
Methyl salicylate 0.42%
Capsicum oleoresin 0.005%
Inactive ingredients and allergens: See under “_Important
information about _
_some of the medicine’s ingredients_” in section 2 and section 6
“_Additional _
_information_”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your physician or pharmacist.
Use this product according to the instructions in the section about
dose in this
leaflet. Consult the pharmacist if you need further information.
1. WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is indicated for relief of rheumatic pain and mild muscle
pain.
THERAPEUTIC GROUP: methyl salicylate which belongs to the salicylate
group.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to the active ingredients or to any of
the
other ingredients that this medicine contains.
•
If you are allergic to salicylates (e.g. aspirin), or to any other
non-
steroidal anti-inflammatory drug.
•
On open wounds, irritated skin, face, eyes and sensitive areas.
•
In children under the age of 6 years.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
Do not allow contact
of the product with
the eyes. In case of contact,
rinse with water immediately.
•
Avoid contact of the product with mucosal tissue (such as the mouth
and the nose).
•
Do not light a cigarette or go near open flames: there is a risk of
severe
burns. Fabric (clothing, bed and table linen, etc.) that has been in
contact
with this product burns more easily and is a serious fire hazard.
Laundering the clothing and linen may reduce product residues but will
not
necessarily remove them completely.
CHILDREN AND ADOLESCENTS
Do not use in children under 6 years old.
RAD

Produktets egenskaber

1
NAME OF THE MEDICINAL PRODUCT
Radian B Muscle Rub
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol
2.54% w/w
Camphor
1.41% w/w
Methyl Salicylate
0.42% w/w
Camphor Oil, White
0.32%w/w
Oleoresin Capsicum
0.005% w/w
Camphor and Camphor Oil, White
are collectively declared as:
Camphor
Excipient(s) with known effect
Emulsifying Wax (containing
Sodium laurilsulfate and
Cetostearyl alcohol)
For the full list of excipients, see
section 6.1.
1.43% w/w
9.70%
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of rheumatic pains and mild muscle pains
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For external use application
Adults and children over 6
Apply to the affected parts and slowly massage well into the skin. For
muscular
strains
and
stiffness
it
is
best
used
after
a
hot
bath.
Repeat
application up to three times daily, reducing to morning and evening
when
acute symptoms subside.
Elderly
The adult dose is appropriate.
Children
Do not use on children under 6 years old.
4.3
CONTRAINDICATIONS
Hypersensitivity to salicylates, to other active substances or to any
of the
excipients listed in section 6.1. If irritation develops, use of the
product should
be discontinued.
Not to be used on children under 6 years old.
Do not apply to skin abrasions.
Do not apply to irritated skin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep away from eyes and sensitive areas. If symptoms persist consult a
doctor.
Wash hands thoroughly after use.
The excipients cetostearyl alcohol, lanolin and 0.91% w/w sodium
laurilsulfate
may cause local skin reactions (e.g. contact dermatitis, stinging or
burning
sensations) or increased skin reactions caused by other products when
applied
to the same area.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There
have
been
reports
that
topical
salicylates
may
potentiate
the
anticoagulant effects of warfarin. Menthol has also been reported to
interact
with warfarin (when taken orally), decreasing its effectiveness.
4.6
FERTILITY, PRE