RADIAN B MUSCLE LOTION
Active substance: METHYL SALICYLATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Radian B Muscle Lotion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol Camphor Aspirin Equivalent to ammonium salicylate Methyl Salicylate Equivalent to salicylic acid (as Methyl and Ethyl Esters) 1.4 0.6 1.2 1.0 0.6 0.54 %w/v %w/v %w/v %w/v %w/v %w/v
3
PHARMACEUTICAL FORM
Liniment for topical application to human beings.
4
4.1
CLINICAL PARTICULARS
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: Not recommended for children under 12. 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. Not to be used by persons who are sensitive to any of the ingredients. 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. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.
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.
4.6
Pregnancy and lactation Use of the product during pregnancy and lactation is not recommended.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.
4.9
Overdose When used externally as directed, overdose is unlikely.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Radian B is manufactured using the following active ingredients; Menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have
analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.
5.2
Pharmacokinetic properties The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.
5.3
Preclinical safety data None
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Industrial Methylated Spirit 95 Glycerol Citronella oil Ammonia 880 Water (purified)
6.2
Incompatibilities None known
6.3
Shelf life 60 months
6.4
Special precautions for storage Store below 25oC
6.5
Nature and contents of container HDPE bottle with LDPE plug insert and spigot seal polypropylene cap. Pack sizes: 125ml, 250ml and 500ml oval bottle.
6.6
Special precautions for disposal No special precautions necessary
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited Linthwaite Huddersfield West Yorkshire HD7 5QH United Kingdom
8
MARKETING AUTHORISATION NUMBER
PL 00240/0359
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 April 2002
10
DATE OF REVISION OF THE TEXT
14/11/2012
1
NAME OF THE MEDICINAL PRODUCT
Radian B Muscle Lotion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol Camphor Aspirin Equivalent to ammonium salicylate Methyl Salicylate Equivalent to salicylic acid (as Methyl and Ethyl Esters) 1.4 0.6 1.2 1.0 0.6 0.54 %w/v %w/v %w/v %w/v %w/v %w/v
3
PHARMACEUTICAL FORM
Liniment for topical application to human beings.
4
4.1
CLINICAL PARTICULARS
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: Not recommended for children under 12. 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. Not to be used by persons who are sensitive to any of the ingredients. 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. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.
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.
4.6
Pregnancy and lactation Use of the product during pregnancy and lactation is not recommended.
4.7
Effects on ability to drive and use machines Not applicable.
4.8
Undesirable effects If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.
4.9
Overdose When used externally as directed, overdose is unlikely.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Radian B is manufactured using the following active ingredients; Menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have
analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.
5.2
Pharmacokinetic properties The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.
5.3
Preclinical safety data None
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Industrial Methylated Spirit 95 Glycerol Citronella oil Ammonia 880 Water (purified)
6.2
Incompatibilities None known
6.3
Shelf life 60 months
6.4
Special precautions for storage Store below 25oC
6.5
Nature and contents of container HDPE bottle with LDPE plug insert and spigot seal polypropylene cap. Pack sizes: 125ml, 250ml and 500ml oval bottle.
6.6
Special precautions for disposal No special precautions necessary
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited Linthwaite Huddersfield West Yorkshire HD7 5QH United Kingdom
8
MARKETING AUTHORISATION NUMBER
PL 00240/0359
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30 April 2002
10
DATE OF REVISION OF THE TEXT
14/11/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
