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VICKS INHALER

Active substance: PINE NEEDLE OIL

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Vicks Inhaler

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
Menthol
Camphor
Siberian Pine Needle Oil

3

mg/inhaler
125.00
50.00
10.00

Specification
EP
EP
FP

PHARMACEUTICAL FORM
Nasal stick; for nasal use.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
The relief of nasal congestion associated with allergic and infectious upper
respiratory tract disorders.

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.

4.3

Contraindications
Use in patients hypersensitive to any of the ingredients.

4.4

Special warnings and precautions for use
If symptoms persist consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
No effects during pregnancy are anticipated, since systematic exposure to
Menthol, Camphor and Siberian Pine Needle Oil is negligible. Vicks Inhaler
can be used during pregnancy.

4.7

Effects on ability to drive and use machines
None.

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.

4.9

Overdose
Symptoms: No clinically significant cases of overdose have been reported.
Management of an overdose: None

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Menthol, Camphor and Siberian Pine Needle Oil act locally in the respiratory
tract.

5.2

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

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Methyl salicylate

6.2

Incompatibilities
None.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
A cellulose wick soaked in medication enclosed in a plastic holder with a
plastic wick.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Procter & Gamble (Health & Beauty Care) Limited
The Heights
Brooklands
Weybridge
Surrey
KT13 0XP
UK

8

MARKETING AUTHORISATION NUMBER
PL 00129/5009R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/06/2004

10

DATE OF REVISION OF THE TEXT
21/11/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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