Transvasin

Transvasin Heat Rub Cream

Hexyl Nicotinate 2% w/wEthyl Nicotinate 2% w/wTetrahydrofurfuryl Salicylate 14% w/w

Cream

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

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.

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.

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

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

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

None known

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 reactionsReporting 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.

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.

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

None stated

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

Purified Water Methylhydoxybenzoate Cetostearyl Alcohol Stearic Acid Polysorbate 20 Sorbitan Monostearate Perfume

None known

36 months

Do not store above 25°C.

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.

Not applicable

Thornton & Ross LtdLinthwaiteHuddersfieldWest YorkshireHD7 5QHUnited Kingdom

PL 00240/0062

12/04/2004

31/07/2013