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Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251

Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

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Summary of Product Characteristics last updated on the eMC: 07/11/2011

SPC	Covonia Vapour Drops

Table of Contents

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 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
11. DOSIMETRY
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

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1. NAME OF THE MEDICINAL PRODUCT

Covonia Vapour Drops

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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

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3. PHARMACEUTICAL FORM

Inhalation vapour, solution.

A clear yellow liquid.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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

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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.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

Not recommended for children under 3 months.

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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.

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4.5 Interaction with other medicinal products and other forms of interaction

None stated.

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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.

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4.7 Effects on ability to drive and use machines

No or negligible influence.

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4.8 Undesirable effects

Occasional hypersensitivity reactions are a possibility.

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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.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

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

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Eucalyptus Oil Ph. Eur

Cajuput Oil BPC 1973