TRANSVASIN HEAT RUB CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Transvasin Heat Rub Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexyl Nicotinate 2% w/w

Ethyl Nicotinate 2% w/w

Tetrahydrofurfuryl Salicylate 14% w/w

Excipient(s) with known effect

Perfume (containing amyl cinnamal, citronellol,   D-limonene,   geraniol,

hydroxycitronellal, linalool) 1.2% w/w

Methyl Hydroxybenzoate 0.1% w/w

Cetostearyl Alcohol 8.25% w/w

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of rheumatic and muscular pain and the symptoms of sprains and strains.

4.2 Posology and method of administration

Route of administration: Cutaneous

Adults, the elderly and children over 12 years old:

Apply a small amount and massage gently into the affected area until the cream is entirely absorbed. Apply twice daily until the symptoms abate.

4.3 Contraindications

Hypersensitivity to tetrahydrofurfuryl salicylate, ethyl nicotinate, hexyl nicotinate or

to any of the excipients listed in section 6.1.

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.

4.4 Special warnings and precautions for use

Transvasin Cream should not be applied to broken or sensitive skin, for example around the eyes or scrotal skin. Avoid use on mucous membranes.

Not recommended for use in children under 12 years old.

Transvasin is a rubefacient and within a few minutes of application a sensation of warmth is felt, followed by a reddening of the skin. This erythema does not indicate intolerance.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Discontinue use if rash develops.

Hands should be washed immediately after use.

Not for use with occlusive dressings.

Patients are advised against excessive exposure to sunlight of treated areas in order to avoid the possibility of photosensitivity.

Labels state:

Keep out of the sight and reach of children.

FOR EXTERNAL USE ONLY

Ingredients with specified warnings

Methylhydroxy­benzoate (E218) may cause allergic reactions (possibly delayed) and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

This medicine contains fragrance with amyl cinnamal, citronellol, D-limonene, geraniol, hydroxycitronellal and linalool which may cause allergic reactions.

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 Fertility, pregnancy and lactation

Although there have been no reports of adverse effects, as with all medicines, care should be taken when administering to pregnant or lactating women.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Reported effects have taken the form of localised sensitisation reactions (possibly delayed) or local skin reactions such as contact dermatitis. These may be associated with excipients (see section 4.4) and have invariably subsided following withdrawal of the medication.

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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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 cause systemic adverse effects depending on the amount absorbed. Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700mg/L (5.1mmol/L). Single doses less than 100mg/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 250mg/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 >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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Hexyl Nicotinate and Ethyl Nicotinate are rubefacients. Tetrahydrofurfuryl Salicylate is used for musculoskeletal, joint, peri-articular and soft tissue disorders.

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified Water

Methylhydroxy­benzoate

Cetostearyl Alcohol

Stearic Acid

Polysorbate 20

Sorbitan Monostearate

Perfume (Containing amyl cinnamal, citronellol, D-limonene, geraniol, hydroxycitronellal, linalool)

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Collapsible aluminium tubes with membrane, containing, 40g & 80g of product with a polyamide-imide lacquer internal coating and polypropylene piercer cap packed in a cardboard outer.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00240/0062

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

12/04/2004