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GEORGES AMERICAN LINIMENT - summary of medicine characteristics

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Summary of medicine characteristics - GEORGES AMERICAN LINIMENT

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

George’s American Liniment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Eucalyptus Oil BP

2.00% v/v

5.02% v/v

2.47% w/v

0.30% v/v

2.01% w/v

Turpentine Oil BP

Capsicum BPC 1973

Rosemary Oil BPC

Camphor, Synthetic, BP

PHARMACEUTICAL FORM

Liquid (Liniment)

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

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: Oil of Eucalyptus: Oil of Rosemary: Oil of Terebintli: Capsicum:

Counter-irritant

Antiseptic and rubefacient Mild irritant

Counter-irritant

Counter-irritant

5.2 Pharmacokinetic properties

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

Soft soap

6.010% v/v

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

6.6 Special precautions for disposal

No special instructions for handling.