Menthol & Eucalyptus Inhalation B.P.1980
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Menthol and Eucalyptus Inhalation BP 1980
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP 2.0% w/v Eucalyptus Oil BP 10.0% v/v
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Inhalation solution.
4 CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the relief of the symptoms of coughs, colds and nasal congestion.
4.2. Posology and Method of Administration
Adults, elderly and children over three months of age
Add one 5ml spoonful to a pint of hot but not boiling water. Inhale the vapour.
The dose may be repeated every four hours if required.
Children under three months of age Not suitable.
Route of administration
Respiratory use.
Contra-Indications
4.3.
Hypersensitivity to menthol or any of the other ingredients.
4.4. Special Warnings and Special Precautions for Use
Shake the bottle well before use. Use within 6 months of opening. Not to be taken by mouth. If symptoms persist consult your doctor. Keep all medicines out of the reach of children.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
No significant interactions have been reported.
4.6. Pregnancy and Lactation
No significant effects have been reported. As with all medicines, the use of the product during pregnancy or lactation should only be undertaken when the benefits are considered to outweigh the risks.
4.7. Effects on Ability to Drive and Use Machines
No significant effects would be expected under therapeutic use.
4.8. Undesirable Effects
Menthol may give rise to hypersensitivity reactions including contact dermatitis. There have been reports of apnoea and instant collapse in infants following local application of menthol to their nostrils.
4.9. Overdose
Symptoms
Prolonged inhalation of menthol (from mentholated cigarettes) has been reported to produce insomnia, unsteady gait, thick speech, tremor of the
hands, mental confusion, depression, vomiting, cramp in the legs and bradycardia. The acute inhalation of 200mg menthol has been reported to produce ataxia, confusion, euphoria, nystagmus and diplopia. Other symptoms of poisoning with menthol include severe abdominal pain, nausea, vertigo, drowsiness and coma. The fatal dose of menthol in man has been estimated to be about 2g (i.e. 100ml of Menthol & Eucalyptus Inhalation B.P. 1980).
Symptoms of ingestion of eucalyptus oil include epigastric burning, nausea and vomiting, and CNS depression including coma. Cyanosis, ataxia, miosis, pulmonary damage, delirium and convulsions may occur. Deaths have been recorded from doses as low as 3.5ml (i.e. 35ml of Menthol & Eucalyptus Inhalation B.P. 1980).
Emergency procedures
Empty the stomach by gastric lavage and aspiration. Administer a saline laxative by mouth. Convulsions may be controlled by parenteral anticonvulsant agents.
5 PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Inhalation of the volatile ingredients, menthol and eucalyptus oil, encourages inspiration of warm moist air providing relief from coughing and nasal obstruction. Menthol also produces an analgesic effect and a sensation of coldness which may give a sensation of increased air flow.
5.2. Pharmacokinetic Properties
After absorption, menthol is excreted in the urine and bile as glucuronide. No information has been found available on eucalyptus oil.
5.3. Preclinical Safety Data
No relevant data.
6.1. List of Excipients
Light Magnesium Carbonate Potable water
6.2. Incompatibilities
No significant incompatibilities have been reported.
6.3. Shelf Life
36 months.
6 months in use.
6.4. Special Precautions for Storage
Do not store above 25 °C.
6.5. Nature and Contents of Container
Dispensing packs
500ml amber glass bottle with white plastic screw cap with an aluminium faced EPE liner.
Patient packs or OTC pack as appropriate
100ml amber glass bottle with white Jay cap closure.
Not all pack sizes may be marketed.
6.6. Instruction for Use, Handling and Disposal
None.
7.
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd Hani Wells Business Park, Unit 7,
Hardicker Street, Manchester,
M19 2RB United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 18374/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9th March 2005
10 DATE OF REVISION OF THE TEXT
09/03/2005