Summary of medicine characteristics - METHYL SALICYLATE LINIMENT B.P
1 NAME OF THE MEDICINAL PRODUCT
Methyl Salicylate Liniment B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Salicylate 25.0% v/v
For excipients, see 6.1.
Liniment
4.1 Therapeutic indications
For the relief of muscular and rheumatic pains, sciatica, lumbago, fibrositis, sprains and strains of ligaments and tendons, bruises and muscle stiffness.
4.2 Posology and method of administration
Adults, children and the elderly
Rub in gently as required.
4.3 Contraindications
Hypersensitivity to arachis oil and sensitivity to salicylates.
4.4 Special warnings and precautions for use
Methyl Salicylate Liniment B.P. contains arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Methyl Salicylate Liniment B.P.
The product is for external use only and should not be taken by mouth. Contact with eyes, mucous membrane, inflamed or broken skin should be avoided.
4.5 Interaction with other medicinal products and other forms of interaction Potentiation of warfarin anticoagulation has been reported following topical application of methyl salicylate.
4.6 Pregnancy and lactation
No significant problems have been reported thought, as with all medicines, it should be used under medical supervision in pregnant or lactating women.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Urticaria and angioedema have been reported in aspirin-sensitive patients.
4.9 Overdose
4.9 OverdoseAs the product is for topical use the likelihood of overdosage due to ingestion is small. Should it occur then treatment includes induction of emesis followed by supportive therapy accompanied by gastric lavage. Charcoal haemoperfusion has been used in the treatment of poisoning with methyl salicylate. As little a 4 ml has caused death in infants.
5.1 Pharmacodynamic properties
Methyl salicylate is absorbed through the skin and relieves pain in rheumatic and other conditions of sprains and muscle stiffness etc.
5.2 Pharmacokinetic properties
5.2 Pharmacokinetic propertiesMethyl salicylate is absorbed through the skin.
It is rapidly hydrolysed to salicylic acid, mainly in the liver and excreted, mainly by the kidney, as salicylic acid, as salicyluric acid, as salicylic phenolic and acyl glucuronide, and as gentisic acid. The excretion is pH dependent with up to 30% being excreted as salicylic acid under alkaline conditions and as low as 2% under acid conditions.
The plasma half- life of salicylates is 2–3 hours.
5.3 Preclinical safety data No relevant data.
6.1 List of excipients
Arachis Oil
6.2 Incompatibilities
No significant incompatibilities have been reported though it is a “phenol” and as such will react with certain metal salts e.g. iron.
6.3 Shelf life
36 months.
6.4 Special precautions for storage Store below 250C.
6.5 Nature and contents of container
500 ml and 2000 ml dispensing packs:
Amber glass bottle with a white plastic screw cap with an aluminium foil lined EPE liner.
Patient packs or OTC packs as appropriate:
100 ml and 200 ml amber glass bottles with plastic Jay cap closures.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNone
Wise Pharmaceuticals Ltd
Hani Wells Business Park, Unit 7, Hardicker Street, Manchester
M19 2RB
United Kingdom