Transvasin Heat Spray
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Transvasin Heat Spray Radian B Heat Spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2-Hydroxyethyl Salicylate 5% w/w Diethylamme Salicylate 5% w/w Methyl Nicotinate 1% w/w
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Cutaneous spray, solution (Cutaneous Spray)
A pale yellow, clear liquid.
4 CLINICAL PARTICULARS
4.1. Therapeutic indications
For the symptomatic relief of muscular and rheumatic pain.
4.2 Posology and method of administration
Route of administration: Cutaneous
Adults, the elderly and children over 12 years old:
Shake the can well before use. Holding the can about 6 inches from the skin surface, point nozzle arrow towards painful area. Spray evenly using short bursts. There is no need to massage.
4.3 Contraindications
Hypersensitivity to 2-hydroxyethyl salicylate, diethylamine salicylate, methyl nicotinate 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.
Do not use on children under 12 years of age.
Do not use on skin which is inflamed or broken.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Discontinue use if excessive irritation occurs.
Avoid inhalation of the spray
Caution: The Spray is flammable. Do not use near fire or flame.
Pressurised container: Protect from sunlight and do not expose to temperatures exceeding 50°C.
Keep away from the eyes, nose and other sensitive areas.
Do not pierce or burn the can, even after use.
Do not spray on a naked flame or any incandescent material.
Do not use near, and do not place the container on, polished or painted surfaces. Labels state:
Use this medicine only on your skin.
Keep out of the sight and reach of children.
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
As with all medicinal compounds care should be taken when administering the product to pregnant or lactating women.
4.7. Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
After application a slight transient erythema may develop.
Contact dermatitis has been reported for hydroxyethyl salicylate.
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
Overdose is unlikely when used as recommended. If applied to a large area of skin, or in the unlikely event of oral ingestion, the product may result in symptoms of salicylate toxicity with systemic adverse effects depending on the amount absorbed and may also cause local sensitisation and irritation.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms
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
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. 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 >700 mg/L (5.1 mmol/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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
M02A C Topical products for joint and muscular pain. Preparations with salicylic acid derivatives.
The active ingredients are commonly found in topical analgesic and rubefacient preparations. 2-Hydroxyethyl Salicylate is a rubefacient as is Methyl Nicotinate and Diethylamine Salicylate is a topical analgesic for rheumatic and muscular pain.
5.2. Pharmacokinetic properties
Methyl Nicotinate percutaneous absorption may occur dependent on the vehicle base and is via the intercellular route. There is no evidence to suggest that percutaneous absorption of the other constituents occurs to any great extent.
5.3.
Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Isopropyl Alcohol Butane/Propane Propellant
6.2. Incompatibilities
None known
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Protect from sunlight and do not expose to temperatures exceeding 50°C.
6.5. Nature and contents of container
Internally lacquered, three piece, tin plate aerosol can containing 125ml or 150ml of product with a standard aerosol valve and high density polyethylene cap.
6.6. Instructions for use, handling and disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00240/0070
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6th September 2002