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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

10 DATE OF REVISION OF THE TEXT 31/12/2014