This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.

eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
New eMC coming June 2013...

Thornton & Ross Ltd

Linthwaite, Huddersfield , West Yorks, HD7 5QH
Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.co.uk
Medical Information Direct Line: +44(0)1484 848 251
Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 15/11/2012
SPC Menthol and Eucalyptus Inhalation BP 1980


Go to top of the page
1. Name of the medicinal product

Menthol and Eucalyptus Inhalation BP 1980.


Go to top of the page
2. Qualitative and quantitative composition

Menthol BP

2.0% w/v

Eucalyptus Oil BP

10.0% v/v


Go to top of the page
3. Pharmaceutical form

Suspension.


Go to top of the page
4. Clinical particulars

Go to top of the page
4.1 Therapeutic indications

For relief of the symptoms of coughs, colds and blocked noses.


Go to top of the page
4.2 Posology and method of administration

Inhaled via the mouth and nasal passages.

Adults, children over 3 months of age and the elderly:

Add one 5ml spoonful to a pint of hot, but not boiling water.

The dose may be repeated after 4 hours if required.


Go to top of the page
4.3 Contraindications

Not suitable for children under 3 months.

Contra-indicated in patients with hypersensitivity to menthol, eucalyptus or any of the other ingredients.


Go to top of the page
4.4 Special warnings and precautions for use

Not suitable for children under 3 months

For external use only

Keep all medicines away from children.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Fertility, pregnancy and lactation

Use of this product in the above conditions is not considered likely to cause any harmful effects.


Go to top of the page
4.7 Effects on ability to drive and use machines

None known.


Go to top of the page
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 the local application of menthol to their nostrils.


Go to top of the page
4.9 Overdose

Symptoms of poisoning with swallowed menthol and eucalyptus inhalation include epigastric burning, severe abdominal pain, central nervous system depression, pulmonary damage, nausea and vomiting, drowsiness, dizziness and muscular weakness, ataxia, miosis, coma and a feeling of suffocation. Cyanosis, delirium and convulsions may occur. Deaths have been recorded from doses as low as 3.5ml of eucalyptus oil (equivalent to 35ml of the inhalation). The fatal dose of menthol in man has been estimated to be about 2g (equivalent to 100ml of the inhalation).

Treatment should consist of emptying the stomach by gastric lavage and aspiration. Administer a saline laxative by mouth, such as sodium sulphate, 30g in 250ml of water, or a dilute solution of sodium phosphate. Convulsions may be controlled by the use of parenteral anticonvulsant agents. The latter treatment would require hospitalisation.


Go to top of the page
5. Pharmacological properties

Go to top of the page
5.1 Pharmacodynamic properties

Eucalyptus oil has been used as an inhalation, often in combination with other volatile substances. It has also been taken by mouth for catarrh and applied externally as a rubefacient.

Menthol is used to relieve symptoms of bronchitis, sinusitis and similar conditions.


Go to top of the page
5.2 Pharmacokinetic properties

No information available.


Go to top of the page
5.3 Preclinical safety data

None.


Go to top of the page
6. Pharmaceutical particulars

Go to top of the page
6.1 List of excipients

Magnesium carbonate light BP, benzalkonium chloride BP and purified water BP.


Go to top of the page
6.2 Incompatibilities

None known.


Go to top of the page
6.3 Shelf life

36 months unopened.


Go to top of the page
6.4 Special precautions for storage

Store below 25°C.


Go to top of the page
6.5 Nature and contents of container

100ml: Glass bottle with white 28mm Child-Resistant cap with tamper evident band and EPE/Saranex Liner.


Go to top of the page
6.6 Special precautions for disposal and other handling

None.


Go to top of the page
7. Marketing authorisation holder

L. C. M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.


Go to top of the page
8. Marketing authorisation number(s)

PL 12965/0027


Go to top of the page
9. Date of first authorisation/renewal of the authorisation

21.09.93 /13.11.98


Go to top of the page
10. Date of revision of the text

11/11/2012



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25457/SPC/


Active Ingredients/Generics