Covonia Vapour Drops

1. Name Of The Medicinal Product

Covonia Vapour Drops

2. Qualitative And Quantitative Composition

Covonia Vapour Drops contains the following active ingredients:

Menthol BP natural or Menthol BP synthetic 17.5% w/v

Peppermint Oil BP 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 3 months:

Sprinkle a few drops on a handkerchief and inhale the vapour.

Children under 3 months:

Not recommended for children under 3 months.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Not recommended for children under 3 months.

4.4 Special Warnings And Precautions For Use

In young children, menthol can cause spasm of the glottis and cases of collapse have been reported in children following local application.

The label states:

1 If symptoms persist, consult your doctor.

2 Avoid contact with the eyes.

3 Not to be taken internally.

4 Keep all medicines out of the sight and reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Covonia Vapour Drops in pregnancy and lactation has not been established, but is not thought to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Occasional hypersensitivity reactions are a possibility.

4.9 Overdose

Following oral ingestion, the following symptoms may be expected: insomnia, unsteady gait, tremor of hands, nausea and vomiting, delirium, epileptiform convulsions, depression and coma. 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

R01A 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 Ph. Eur

Cajuput Oil BPC 1973

Spike Lavender Fragrance Oil HSE

Industrial Methylated Spirit BP

6.2 Incompatibilities

None stated.

6.3 Shelf Life

10ml: 36 months

15ml: 36 months

30ml: 36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

10ml, 15ml & 30ml pack - 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

19 June 2002

10. Date Of Revision Of The Text

19/09/03

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable