Summary of Product Characteristics (SmPC) - Georges American Liniment
1 NAME OF THE MEDICINAL PRODUCT
George’s American Liniment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eucalyptus Oil BP 2.00% v/v
Turpentine Oil BP 5.02% v/v
Capsicum BPC 1973 2.47% w/v
Rosemary Oil BPC 0.30% v/v
Camphor, Synthetic, BP 2.01% w/v
3 PHARMACEUTICAL FORM
Liquid (Liniment)
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of rheumatic pain, lumbago, sciatica, stiff joints, backache and cramp.
4.2 Posology and method of administration
For cutaneous use only
.
Adults , elderly, children over 12 years Apply to the affected area up to three times a day. Do not apply to broken skin.
If symptoms persist or worsen consult a doctor .
Not recommended for use in children under 12 years of age (see section 4.4. Special warnings and precautions for use’
4.3 Contraindications
Hypersensitivity to any of the active ingredients or the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose
For external use only. Do not apply to broken skin or the face.
Avoid contact with the eyes.
If symptoms persist or worsen consult a doctor
If applied directly onto the nostrils of infants CNS overstimulation can occur.
Camphor is highly lipophilic and can accumulate in the body following prolonged exposure which may result in CNS toxicity.
The use of this product in children or adolescents under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Fertility, Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
None known.
If adverse reactions occur a doctor or pharmacist should be consulted
4.9 Overdose
Overdose may result in skin irritation
Monitor for up to 12 hours after suspected ingestion.
Misuse
Swallowing of the product may cause gastrointestinal symptoms like vomiting and diarrhoea. Treatment is symptomatic.
After accidental consumption of a camphor containing product, acute poisoning was observed with nausea, vomiting, abdominal pain, headache, vertigo, feeling hot, flushing, convulsions, respiratory depression and coma.
Recommended treatment is nasogastric suctioning and lavage. Camphor-induced seizures have been successfully treated with benzodiazepines.
Patients with severe gastrointestinal or neurological symptoms should be observed and treated symptomatically. Do not induce vomiting
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Camphor, synthetic: Counter-irritant Oil of Eucalyptus: Antiseptic and rubefacient Oil of Rosemary: Mild irritant Oil of Terebintli: Counter-irritant Capsicum: Counter-irritant
5.2 Pharmacokinetic properties
No data available.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Industrial methylated spirits BP 86.670% v/v Water 6.010% v/v Soft soap 7.914%w/v
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions
6.5 Nature and contents of container
Liniment contained in white flint glass bottles (75ml and 150ml): 24mm plastic caps
6.6 Special precautions for disposal
No special instructions for handling.
7 MARKETING AUTHORISATION HOLDER
Hubert A C Thomas & Company Glyneithin
Burry Port
Carmarthenshire
SA16 0TB
8 MARKETING AUTHORISATION NUMBER(S)
PL 1354/5002R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/06/85 and 26/03/2003
10 DATE OF REVISION OF THE TEXT
21/06/2011