Summary of Product Characteristics (SmPC) - White Liniment B.P
1 NAME OF THE MEDICINAL PRODUCT
White Liniment B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Turpentine Oil 25.0 % v/v
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Liniment
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
As a rubefacient for the relief of sciatica, sprains, lumbago and rheumatic pains.
4.2 Posology and method of administration
Adults, children (12 years and older) and the elderly
To be thoroughly rubbed into the affected parts as required.
This product is not recommended for children under 12 years, except under a doctor's instruction.
Method of administration
For topical application
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
The product is for external use only and should not be taken by mouth. Contact with eyes, mucous membranes, inflamed or broken skin should be avoided.
4.5. Interaction with other Medications and other forms of Interaction
None known for the route of administration used.
4.6 Fertility, pregnancy and lactation
No significant problems have been reported.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
May cause irritation. Sensitivity reactions have been reported.
Absorption of large amounts may cause some of the effects of poisoning with turpentine oil.
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
As the product is for topical use the likelihood of overdosage due to ingestion is small. Should it occur then there may be local burning and gastrointestinal upset, coughing and choking, pulmonary oedema, excitement, coma, fever, tachycardia, liver damage, haematuria and albuminuria may ensue. When applied topically , the liniment may cause irritation and absorption of large amounts may cause some of the effects listed above. Treatment includes induction of emesis followed by supportive therapy accompanied by gastric lavage.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
It is used as a rubefacient for the treatment of various rheumatic conditions such as lumbago, arthritis and neuralgias.
Little else is given in the literature on its pharmacological action by this route of administration.
5.2. Pharmacokinetic Properties
As a rubefacient it is absorbed through the skin and is partly eliminated with the breath and through the urine.
Little else is given in the literature about the pharmacokinetics of turpentine oil.
5.3. Preclinical Safety Data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Strong ammonia solution
Water potable
Oleic acid
Ammonium chloride
6.2. Incompatibilities
No significant incompatibilities have been reported.
6.3. Shelf Life
36 months.
6.4. Special Precautions for Storage
Store below 25oC.
6.5. Nature and Contents of Container
500 ml and 2000 ml dispensing packs
Amber glass bottle, plastic screw cap with an aluminium foil lined expanded polyethylene liner.
100 ml and 200 ml Patient or OTC pack as appropriate
Amber glass bottle with a plastic Jaycap closure.
6.6 Special precautions for disposal
None stated
7. MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 18374/0032
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
14th April 2005
10 DATE OF REVISION OF THE TEXT
30/11/2015