Covonia Vapour Drops

Covonia Vapour Drops

Covonia Vapour Drops contains the foliowing active ingredients:Menthol natural or Menthol synthetic 17.5% w/vPeppermint Oil 0.2% v/vFor excipients, see 6.1

Inhalation vapour, solution.A clear yellow liquid.

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

Adults, the elderly and children over 2 years:

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

Hypersensitivity to menthol, peppermint oil or any of the ingredients.Children under 2 years of age.

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.

None known.

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.

No or negligible influence.

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.

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.

R0lA X - Other nasal preparations, combinationsMenthol, 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.

Not applicable.

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

Eucalyptus OilCajuput OilSpike Lavender Fragrance OilIndustrial Methylated Spirit

None stated.

36 months

Do not store above 25°C

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

Not applicable.

Thornton & Ross LimitedLinthwaiteHuddersfieldWest YorkshireHD7 5QHUnited Kingdom

PL 00240/0073

19^th June 2002

05/03/2015