Radian B Muscle Lotion

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

LEVOMENTHOL, CAMPHOR, ACETYLSALICYLIC ACID, METHYL SALICYLATE

Dostupno od:

Thornton & Ross Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC koda:

M02AC

INN (International ime):

LEVOMENTHOL 1.4 % (W/V) CAMPHOR 0.6 % (W/V) ACETYLSALICYLIC ACID 1.2 % (W/V) METHYL SALICYLATE 0.6 % (W/V)

Farmaceutski oblik:

CUTANEOUS SOLUTION

Sastav:

LEVOMENTHOL 1.4 % (W/V) CAMPHOR 0.6 % (W/V) ACETYLSALICYLIC ACID 1.2 % (W/V) METHYL SALICYLATE 0.6 % (W/V)

Tip recepta:

OTC

Područje terapije:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Status autorizacije:

Withdrawn

Datum autorizacije:

2007-01-04

Uputa o lijeku

RADIAN B MUSCLE LOTION 125ML – LABEL AND PEELABLE LABEL-LEAFLET
FRONT LABEL
NEW SAFETY INFORMATION: SEE REVERSE
Radian B Muscle Lotion
Effective relief from aches and pains
Multi-Action Painkiller
PEELABLE BACK LABEL
TOP PLY FACE
RADIAN®B MUSCLE LOTION: For the symptomatic relief of muscular and
rheumatic
aches and pains.
PLEASE READ THIS LEAFLET BEFORE USING YOUR MEDICINE.
DIRECTIONS: ADULTS (OVER 12). Smooth or massage onto affected area and
repeat after
10-15 minutes, if needed. Repeat up to 3 times a day, reducing to
morning and
evenings, as symptoms improve. Wash hands thoroughly after use. If
symptoms persist
consult a doctor.
DO NOT USE: on children under 12, on sensitive areas. If you are
taking warfarin without
first consulting your doctor, if you are pregnant or breast-feeding.
WARNING: Flammable. Do not use on or near painted or polished
surfaces.
Do not use near open flame. Avoid inhalation.
KEEP OUT OF SIGHT AND REACH OF CHILDREN.
ACTIVE INGREDIENTS W/V: Levomenthol 1.4%, Racemic Camphor 0.6%,
Ammonium salicylate 1.0%, Salicylic acid (as methyl and ethyl esters)
0.54%.
ALSO CONTAINS: industrial methylated spirit, water, glycerol,
citronella oil, ammonia.
FOR EXTERNAL USE ONLY
Licence Holder and Manufacturer:
Thornton & Ross Ltd.,
Huddersfield, HD7 5QH, UK, PL 00240/0359
CARRIER
FIRE HAZARD. DO NOT SMOKE OR GO NEAR
NAKED FLAMES; CLOTHING & BEDDING WITH
THIS PRODUCT DRIED ON THEM CAN CATCH FIRE
EASILY.
RADIAN® B MUSCLE LOTION 125ML, contains painkilling ingredients, see
page 1. It
provides symptomatic relief from muscular and rheumatic aches and
pains, including
fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle
stiffness, strains,
tennis elbow, golf shoulder.
HOW TO USE: ADULTS, THE ELDERLY AND CHILDREN OVER 12.
Sprinkle lotion onto the palm of hand or apply to cotton wool and
smooth into affected
area. Apply again after 10-15 minutes, if needed. Repeat if necessary,
up to 3 times a
day, reducing to morning and evenings when acute symptoms subside.
When
convenient use after a warm

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Radian B Muscle Lotion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol
1.4
%w/v
Camphor
0.6
%w/v
Aspirin
1.2
%w/v
Equivalent to ammonium salicylate
1.0
%w/v
Methyl Salicylate
0.6
%w/v
Equivalent to salicylic acid
(as Methyl and Ethyl Esters)
For the full list of excipients, see
section 6.1.
0.54
%w/v
3.
PHARMACEUTICAL FORM
Liniment for topical application to human beings.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For symptomatic relief of muscular aches and pains, including
fibrositis, sciatica,
lumbago, sprained ligaments, bruises, muscle stiffness, strains,
tennis elbow, golf
shoulder.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology: For external application.
For Adults and Children Over 12 Years:
Apply the lotion on the affected part once or twice, leaving 10-15
minutes between
applications. Smooth in or massage if preferred. If necessary, repeat
application up to
three times daily, reducing to morning and evening when acute symptoms
subside.
When convenient, use after a warm bath.
Children Under 12: Do not use on children under 12 years of age.
Elderly: The adult dose is appropriate.
4.3.
CONTRAINDICATIONS
Not to be used on children under 12 years old.
Do not apply to skin abrasions.
Do not apply to irritated skin.
Hypersensitivity to the active substances or to any of the excipients.
Contraindicated where there is known hypersensitivity to aspirin,
other salicylates, or
other non-steroidal anti-inflammatory drugs (including when taken by
mouth)
especially where associated with a history of asthma.
If irritation develops, use of the product should be discontinued.
Pregnancy and lactation.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep away from eyes and other sensitive areas. If symptoms persist,
consult a doctor.
_ _
Wash hands thoroughly after use.
Flammable: Do not use near naked flame. Should not be placed on or
used near
polished or painted surfaces.
Labels state:
Keep out of sight and reachof children.
For externa