Covonia Vapour Drops

Inhalation vapour, solution. A clear yellow liquid.

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. **Ingredients with specified warnings** This medicine contains 69mg of alcohol (ethanol) per 3 droplets. The amount in 3 droplets of this medicine is equivalent to less than 2ml of beer or 1ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains 0.5% v/v benzyl alcohol per dose. Benzyl alcohol may cause allergic reactions.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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.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.

5.1 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.

6.1 List of excipients Eucalyptus Oil Cajuput Oil (Contains Benzyl Alcohol E1519) Spike Lavender Fragrance Oil Industrial Methylated Spirit (Contains Ethanol)6.2 Incompatibilities None stated.6.3 Shelf life 36 months6.4 Special precautions for storage Do not store above 25°C6.5 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.