Vicks Inhaler - Summary of Product Characteristics (SPC)

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Procter & Gamble (Health & Beauty Care) Ltd.
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK Telephone: +44 (0)191 297 5000 Fax: +44 (0)191 297 6295 WWW: http://www.uk.pg.com Customer Care direct line: +44 (0) 8000 850367 (UK) Customer Care direct line: +353 (1) 800 509 301 (Ireland)

Summary of Product Characteristics last updated on medicines.ie: 11/05/2012

SPC	Vicks Inhaler

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 excipient(s)
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

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1. NAME OF THE MEDICINAL PRODUCT

Vicks Inhaler Nasal Stick

Menthol 125mg

Camphor 50mg

Siberian Pine Needle Oil 10mg

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS	mg/inhaler
Menthol	125.00
Camphor	50.00
Siberian Pine Needle Oil	10.00

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Nasal Stick

The nasal stick contains a cellulose wick soaked in 0.5ml of product.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

In the relief of symptoms of nasal congestion such as are associated with allergic and infectious upper respiratory tract disorders.

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4.2 Posology and method of administration

Adults and children over 6 years:

Vicks Inhaler is used by inserting the inhaler into each nostril, holding the other nostril closed and inhaling deeply.

It can be used as frequently as needed.

Children under 6 years:

Not recommended

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4.3 Contraindications

Use in patients hypersensitive to any of the ingredients

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4.4 Special warnings and precautions for use

If there is no improvement or aggravation of the disorder consult the doctor.

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4.5 Interaction with other medicinal products and other forms of interaction

None known

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4.6 Pregnancy and lactation

There is no evidence to indicate that this product should not be used during pregnancy and lactation.

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4.7 Effects on ability to drive and use machines

None

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4.8 Undesirable effects

In general no serious or severe side effects are expected with this product.

Very rarely cases of nasal discomfort have been reported.

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4.9 Overdose

No clinically significant cases of overdose have been reported.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Menthol, camphor and Siberian pine needle oil act locally in the respiratory tract.

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5.2 Pharmacokinetic properties

The product exerts its action locally; little or no absorption is expected to occur.

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5.3 Preclinical safety data

Not applicable

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Methyl salicylate

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

3 years.

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6.4 Special precautions for storage

Do not store above 25°C.

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6.5 Nature and contents of container

A cellulose wick soaked in medication (0.5 ml) enclosed in a polypropylene plastic holder, with a polypropylene cap.

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6.6 Special precautions for disposal and other handling

No special requirements.

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7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey KT13 0XP

United Kingdom

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8. MARKETING AUTHORISATION NUMBER(S)

PA 441/27/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18th November 1988

Date of last renewal: 18th November 2008

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10. DATE OF REVISION OF THE TEXT

May 2011

Link to this document from your website:
http://www.medicines.ie/medicine/14141/SPC/Vicks+Inhaler/

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Active Ingredients

Camphor

Menthol

Pine needle oil

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Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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Active Ingredients