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MENTHOL & EUCALYPTUS INHALATION B.P.1980

Active substance(s): EUCALYPTUS OIL / MENTHOL

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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.

4.3.

Contra-Indications
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

PHARMACEUTICAL PARTICULARS

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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