This information is intended for use by health professionals

1. Name of the medicinal product

Covonia Vapour Drops

2. Qualitative and quantitative composition

Covonia Vapour Drops contains the foliowing active ingredients:

Menthol natural or Menthol synthetic 17.5% w/v

Peppermint Oil 0.2% v/v

For excipients, see 6.1

3. Pharmaceutical form

Inhalation vapour, solution.

A clear yellow liquid.

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of catarrh, hay fever and nasal congestion.

4.2 Posology and method of administration

Adults, the elderly and children over 2 years:

Sprinkle a few drops on a handkerchief and inhale the vapour but avoiding direct skin contact.

4.3 Contraindications

Hypersensitivity to menthol, peppermint oil or any of the ingredients.

Children under 2 years of age.

4.4 Special warnings and precautions for use

The label states:

1 If symptoms persist, consult your doctor.

2 Avoid contact with the eyes and direct contact with the skin.

3 Do not place directly into the nostrils.

4 Not to be taken internally.

5 Keep out of the sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

The safety of Covonia Vapour Drops in pregnancy and lactation has not been established, but as a precautionary measure it is preferable to avoid the use of Covonia Vapour Drops during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8 Undesirable effects

Occasional hypersensitivity reactions are a possibility for menthol (contact dermatitis) and peppermint oil (local irritation).

Reporting of suspected adverse reactions

Reporting 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.

4.9 Overdose

Following oral ingestion, the following symptoms may be expected:

insomnia, ataxia (unsteady gait, tremor of hands, vertigo, muscle twitching), severe abdominal pain, nausea and vomiting, burning in the mouth and throat, delirium, headache, dizziness, drowsiness, bradycardia, cyanosis, miosis, pulmonary damage, epileptiform convulsions, CNS depression and coma. Inhalation of large doses of menthol may lead to dizziness, confusion, muscle weakness, nausea and double vision.

Treatment should consist of gastric lavage and aspiration. A saline purgative such as 30g of sodium sulphate in 250ml of water may be given and any convulsions controlled by intravenous diazepam.

5. Pharmacological properties
5.1 Pharmacodynamic properties

R0lA X - Other nasal preparations, combinations

Menthol, a frequent constituent of inhalation preparations, produces a sensation of decreased nasal congestion, possibly by virtue of its local anaesthetic action on the nasal mucosal surface. Peppermint Oil possesses the physiological actions and therapeutic uses of menthol.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Eucalyptus Oil

Cajuput Oil

Spike Lavender Fragrance Oil

Industrial Methylated Spirit

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

10ml (7.5ml fill), 15ml, 30ml - Amber glass bottle with polyethylene screw cap with integral polyethylene dropper.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0073

9. Date of first authorisation/renewal of the authorisation

19th June 2002

10. Date of revision of the text

05/03/2015