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METHYL SALICYLATE LINIMENT B.P.

Active substance(s): METHYL SALICYLATE

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SUMMARY OF PRODUCT CHARACTERISTICS
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.

3

PHARMACEUTICAL FORM
Liniment

4
4.1

CLINICAL PARTICULARS
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
As 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

PHARMACOLOGICAL PROPERTIES

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
Methyl 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

PHARMACEUTICAL PARTICULARS

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
None

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7, Hardicker Street,
Manchester
M19 2RB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0030

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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