Eucalyptus Oil Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eucalyptus Oil BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eucalyptus Oil 100.0% v/v.
3. PHARMACEUTICAL FORM
Essential Oil.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of the symptoms of catarrhal colds.
For relief of the symptoms of minor muscular sprains and cramps.
4.2 Posology and method of administration
1a. By inhalation from drops of oil spilled onto a handkerchief which is then sniffed.
b. By inhalation of vapour from drops of oil spilled into a bowl of hot water (50oC)
‘steam inhalation’ and the humid vapour inhaled.
2. As a rubefacient during massage of sprains and cramps where massage is an
appropriate treatment.
Recommended Dose and Dosage Schedule Adults, the elderly and children over 1 year:
1 (a) Sprinkle a few drops on to a handkerchief and inhale as required.
(b) A few drops into warm/hot water (50oC) and inhale the humid vapour, as required.
2. A few drops on the hand to lubricate the massage of appropriate areas as required.
4.3 Contra-indications
Sensitivity to Eucalyptus Oil.
Not recommended for infants under 1 year.
4.4 Special warnings and special precautions for use
Keep all medicines out of the reach and sight of children. Not to be take orally.
If symptoms persist consult your doctor.
4.5 Interactions with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No evidence can be found as to the safety of the product in pregnancy or lactation. The use of all drugs should be avoided during the first trimester.
4.7 Effects on ability to drive and use machines
At the dosage indicated, no evidence can be found that the product affects the ability to drive or to use machinery.
4.8 Undesirable effects
When used as a rubefacient it may induce skin sensitisation and eczema.
No adverse effects of inhalation are reported but in sensitised individuals the precipitation of hay fever or asthma are potential unwanted effects.
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
Symptoms: poisoning with eucalyptus oil may cause epigastric burning, nausea and vomiting, dizziness, muscular weakness, miosis, tachycardia, a feeling of suffocation, cyanosis, ataxia, pulmonary damage, delirium, convulsions and CNS depression, including coma. Deaths have been recorded from doses as low as 3.5ml.
Emergency procedures: after ingestion the stomach should be emptied by aspiration and lavage. Demulcent drinks may be given. Large volumes of fluid should be given provided renal function is adequate. Effects of excessive inhalation should be treated by removal to fresh air.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
When the vapour is inhaled eucalyptus oil acts to ventilate the bronchial passages and relieve bronchitis and associated conditions. It is also a rubefacient.
5.2 Pharmacokinetic properties
After ingestion excretion takes place via the lungs, skin and kidneys.
5.3 Preclinical safety data
None.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
None.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
Store below 25oC.
Keep container tightly closed.
6.5 Nature and contents of container
25ml: Amber glass bottle with white plastic child resistant cap with EPE/Saranex liner.
6.6 Instructions for use/handling
None.
7. MARKETING AUTHORISATION HOLDER
L. C. M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.
MARKETING AUTHORISATION NUMBER
PL: 12965/0011
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/12/2004
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DATE OF REVISION OF THE TEXT
16/03/2015