SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Radian B Muscle Rub Radian Massage Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Menthol Camphor Methyl Salicylate Camphor Oil, White Oleoresin Capsicum 500,000 Water soluble (equivalent to 0.000125% capsaicin)

Camphor and Camphor Oil, White are collectively declared as:

Camphor

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of muscular and rheumatic aches and pains, including; muscular stiffness, bruising, sprains, fibrositis.

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.

Elderly

The adult dose is appropriate.

Children

Do not use on children under 6 years old.

4.3    Contraindications

Not to be used on children under 6 years old.

Do not apply to skin abrasions.

Do not apply to irritated skin.

Contraindicated in patients who are hypersensitive to salicylates or to any other ingredient in the preparation. If irritation develops, use of the product should be discontinued.

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 and lanolin may cause local skin reactions (e.g. contact dermatitis).

Labels state:

Keep out of the reach and sight of children.

For external use only.

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, Pregnancy and lactation

There is no, or inadequate evidence of safety in human pregnancy or lactation. As a precautionary measure, Radian B Muscle Rub should only be used during pregnancy or lactation when there is no safer alternative.

4.7    Effects on ability to drive and use machines

Not applicable

4.8    Undesirable effects

Use sparingly on tender skin and 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. Irritation of the skin may also be caused by the capsicum oleoresin in this product.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

When used externally as directed, overdose is unlikely. However, symptoms of systemic salicylate poisoning have been reported after the application of salicylates to large areas of skin or for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested.

Salicylate poisoning

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.

A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management

Activated charcoal may be administered if significant quantities have been ingested within an hour of presentation. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700mg/L (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Camphor and Menthol

Ingestion of the product or excessive use may also lead to camphor poisoning, the symptoms of which include nausea, vomiting, epigastric pain, headache, dizziness, oropharyngeal burning, delirium, muscle twitching, epileptiform convulsions, CNS depression and coma. Breathing is difficult and the breath has a characteristic odour; anuria may occur. Death from respiratory failure or status epilepticus may occur; fatalities in children have been recorded from 1g. Supportive care, including anticonvulsant therapy, is the mainstay of treatment of camphor intoxication. Gastric lavage may be considered if the patient presents within 1 hour of ingestion; any convulsions must be controlled first. Activated charcoal may be given orally.

Ingestion of significant quantities of menthol is reported to cause symptoms similar to those seen after ingestion of camphor, including severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma; they may be managed similarly.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Radian Massage Cream is a smooth, off-white cream which incorporates menthol, camphor, methyl salicylate, capsicine and white camphor oil as active ingredients and glycerol as emollient.

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. Methyl salicylate has the actions of the salicylates. It is readily absorbed through the skin and has counter-irritant properties. Capsicine has counter-irritant properties and white camphor oil is a rubefacient and mild counter-irritant.

5.2    Pharmacokinetic properties

None available

5.3    Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Argobase S.1 (Contains: Lanolin

Lanolin alcohol Cetostearyl alcohol Liquid paraffin)

Emulsifying Wax White Petroleum Jelly 2,4-dichlorobenzyl alcohol Imidurea

Industrial Methylated Spirit 95 Purified Water

6.2    Incompatibilities

None known

6.3    Shelf life

36 months

6.4    Special precautions for storage

Store below 25°C

6.5    Nature and contents of container

Lacquered aluminium tube and plastic cap. White plastic screw-cap jar. Pack sizes: 15, 25, 40, 70, 100, 650gm.

6.6    Special precautions for disposal

No special precautions necessary

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD75QH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/0360

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/04/2002

10 DATE OF REVISION OF THE TEXT

18/02/2015