Transvasin Heat Rub Cream
SUMMARY OF PRODUCT 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
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.
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.
Methylhydroxybenzoate (E218) may cause allergic reactions (possibly delayed) and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). 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
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 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 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.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Purified Water Methylhydoxybenzoate Cetostearyl Alcohol Stearic Acid Polysorbate 20 Sorbitan Monostearate Perfume
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 HD75QH United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0062
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/04/2004
10
DATE OF REVISION OF THE TEXT
31/07/2014