NOTICE
ANSM - Last updated: 05/05/2011
Name of the medicinal product
VICKS INHALER, impregnated inhaler for fumigation
Racemic Camphor / Levomenthol
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT VICKS INHALER, impregnated fumigant inhalation pad AND IN WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE VICKS INHALER, impregnated fumigant inhalation pad?
3. HOW TO USE VICKS INHALER, impregnated fumigant inhalation pad?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VICKS INHALER, impregnated fumigant inhalation pad?
6. ADDITIONAL INFORMATION
1. WHAT VICKS INHALER, impregnated fumigant inhalation pad AND IN WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
HAS BEEN DISCONFERRED.
(R. Respiratory system).
Therapeutic indications
Decongestant during common respiratory infections (colds, rhinitis, nasopharyngitis) in adults and children over 12 years.
2. BEFORE YOU USE VICKS INHALER, impregnated fumigant inhalation pad?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use VICKS INHALER, impregnated fumigant inhalation pad in the following cases:
· allergy known to any of the constituents of the product,
· children with a history of febrile seizures or not.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with VICKS INHALER, impregnated fumigant inhalation pad:
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
This specialty contains terpenes that can lead to excessive dose, neurological convulsions in children. Observe the instructions for use: do not exceed 2 inspirations per nostril and 3 catches per day.
A MEDICAL ADVICE IS NECESSARY in case of a history of epilepsy.
Use this medicine only with caution
· If you have an allergic reaction, stop treatment.
· In case of fever, purulent nasal discharge, purulent expectoration, CONSULT YOUR DOCTOR.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
This medicinal product contains terpene derivatives: camphor and levomenthol . Other medicines contain this medication. Do not combine them in order not to exceed the maximum recommended doses ( see directions for use and dosage ). |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Do not take this medicine without consulting your doctor or pharmacist. |
Do not use this medication while breastfeeding.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE VICKS INHALER, impregnated fumigant inhalation pad?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Do not use this medication in children less than 12 years of age. |
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.
2 inspirations per nostril and per cat, to be renewed if necessary without exceeding 3 catches per day, distributing the catches regularly during the day.
Method and route of administration
Airway.
Apply to each nostril and deeply inhale.
Duration of treatment
The duration of use is limited to 3 days. |
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, VICKS INHALER, impregnated fumigant inhalation buffer is likely to have side effects, although not everyone is subject to it:
· possibility of local irritation and allergy.
· In the event of non-compliance with recommended doses:
o risk of convulsions in children,
o possibility of agitation, confusion in the elderly.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE VICKS INHALER, impregnated fumigant inhalation pad?
Keep out of the reach and sight of children.
Expiration date
Do not use VICKS INHALER, impregnated fumigant inhalation pad after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does VICKS INHALER, impregnated fumigant inhalation pad contain?
The active substances are :
Racemic Camphor ................................................ .................................................. ..................... 39.671 g
Levomenthol ................................................. .................................................. ............................... 39.671 g
For 100 ml of solution.
1 ml of solution impregnates a cellulose acetate buffer placed in the middle portion of the tube.
The other components are :
Essential oil of Siberian fir needles, methyl salicylate.
Pharmaceutical form and content
What is VICKS INHALER, impregnated fumigant inhalation pad and contents of the pack?
This medicinal product is in the form of an impregnated tampon for inhalation by fumigation in a tube.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163/165, QUAI AULAGNIER
92600 ASNIERES-SUR-SEINE
exploiting
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165, QUAI AULAGNIER
92600 ASNIERES-SUR-SEINE
Maker
PROCTER & GAMBLE MANUFACTURING GMBH
SULZBACHER STR, 40-50
658924 SCHWALBACH AM TAUNUS
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.