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Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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 BP 100% V/V
3 PHARMACEUTICAL FORM
A colourless or pale yellow liquid with a characteristic odour intended for inhalation in humans.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Eucalyptus Oil BP can be used for the symptomatic relief of catarrh and coughs.
4.2 Posology and method of administration
Route of Administration: Orally or nasally.
When used as an inhalant, apply to a handkerchief.
Taken orally on a sugar lump.
Adults:(including the elderly) and children:
Use two drops on a handkerchief and inhale, or include three drops on a lump of sugar.
Use 3 or 4 times a day as required.
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
There is no evidence to suggest that this product should not be used during pregnancy and lactation, when used in normal dose.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Excessive doses of Eucalyptus Oils are irritant to the gastro-intestinal tract and may cause nausea, vomiting and diarrhoea. There may be occasional irritation of the urinary tract and aggravation of pre-existing inflammatory condition. There may be initial excitement. Severe poisoning leads to respiratory failure. The CNS may be depressed leading to stupor and respiratory failure or stimulated leading to excitement and convulsions.
4.9 Overdose
The symptoms of poisoning are epigastric burning, nausea and vomiting, diarrhoea, dizziness, muscular weakness, miosis, tachycardia and the feeling of suffocation. Cyanosis, delirium and convulsions may occur. Deaths have been recorded from doses varying from 3.5ml to 12ml. In acute poisoning the stomach should be emptied by aspiration and lavage. Give a saline purgative, such as sodium sulphate 30g in 250ml of water, unless catharsis is already present. Demulcent drinks may be given. Large volumes of fluid should be given provided renal function is adequate. Mannitol and dialysis have been used successfully in the treatment of poisoning by Eucalyptus oil.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Eucalyptus Oil is taken via the mouth for catarrh and inhaled. Sometimes with steam, for coughs in chronic bronchitis and asthma.
Eucalyptus Oil exerts a mild irritant action on the mucous membranes of the mouth and digestive tract, which induces a feeling of warmth and increases salivation, thus loosening any catarrh present and soothing inflammation.
5.2 Pharmacokinetic properties
After ingestion with air and saliva, excretion of the Eucalyptus Oil takes place through the lungs, skin and kidneys; during excretion by the bronchioles, it acts as a mild expectorant.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Keep all medicines out of sight and reach of children.
6.5 Nature and contents of container
Glass bottle in 25ml and 50ml with a plastic cap.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Bell Sons and Company (Druggists) Limited
Gifford House
Slaidburn Crescent
Southport
PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0109
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/05/2004
10 DATE OF REVISION OF THE TEXT
20/11/2013