- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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|
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
For relief of the symptoms of coughs, colds and blocked noses
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.
Not suitable for children under 3 months.Contra-indicated in patients with hypersensitivity to menthol, eucalyptus or any of the other ingredients
4.4 Special warnings and precautions for use
Not suitable for children under 3 months.For external use onlyKeep all medicines away from children.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
Use of this product in the above conditions is not considered likely to cause any harmful effects.
4.7 Effects on ability to drive and use machines
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.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 35m1 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.
5. Pharmacological properties
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.
5.2 Pharmacokinetic properties
No information available.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Magnesium carbonate light BP, benzalkonium chloride BP and purified water BP.
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
|100ml:||Glass bottle with white 28mm Child-Resistant cap with tamper evident band and EPE/Saranex Liner.|
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
L. C. M. Ltd.Linthwaite LaboratoriesHuddersfieldHD7 5QH
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
21/09/1993 / 26/09/2002
10. Date of revision of the text
Thornton & Ross Ltd
Linthwaite, Huddersfield, West Yorks, HD7 5QH
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