MENTHOL & EUCALYPTUS INHALATION B.P.1980
Active substance(s): EUCALYPTUS OIL / MENTHOL / EUCALYPTUS OIL / MENTHOL / EUCALYPTUS OIL / MENTHOL
NAME OF THE MEDICINAL PRODUCT
Menthol and Eucalyptus Inhalation BP 1980
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP 2.0% w/v
Eucalyptus Oil BP 10.0% v/v
For excipients, see 6.1.
For the relief of the symptoms of coughs, colds and nasal congestion.
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
The dose may be repeated every four hours if required.
Children under three months of age
Route of administration
Hypersensitivity to menthol or any of the other ingredients.
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
No significant interactions have been reported.
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.
Effects on Ability to Drive and Use Machines
No significant effects would be expected under therapeutic use.
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.
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).
Empty the stomach by gastric lavage and aspiration. Administer a saline
laxative by mouth. Convulsions may be controlled by parenteral
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.
After absorption, menthol is excreted in the urine and bile as
glucuronide. No information has been found available on eucalyptus oil.
Preclinical Safety Data
No relevant data.
List of Excipients
Light Magnesium Carbonate
No significant incompatibilities have been reported.
6 months in use.
Special Precautions for Storage
Do not store above 25°C.
Nature and Contents of Container
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.
Instruction for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
9th March 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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