NOTICE
ANSM - Last updated: 20/06/2012
Name of the medicinal product
VICKS VAPORUB, ointment
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 after 3 days, consult a physician.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT VICKS VAPORUB, Ointment AND WHAT IT IS USED FOR?
2. BEFORE YOU USE VICKS VAPORUB, ointment?
3. HOW TO USE VICKS VAPORUB, ointment?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VICKS VAPORUB, Ointment?
6. ADDITIONAL INFORMATION
1. WHAT VICKS VAPORUB, Ointment AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is used as a decongestant during common respiratory conditions (colds, coughs, simple bronchitis).
2. BEFORE YOU USE VICKS VAPORUB, ointment?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use VICKS VAPORUB, ointment for this medication in the following cases:
· allergy to any of the constituents,
· diseases and skin lesions.
Due to the presence of terpenes, this medication should never be used in children younger than 6 years of age or with a history of convulsions (febrile or not).
Precautions for use; special warnings
Take special care with VICKS VAPORUB, ointment:
Special warnings
This medicinal product contains flammable volatiles. Never expose it to a flame . After application, avoid the proximity of a flame.
In case of inhalation of the product by fumigation do not use water brought to boiling (boiling).
When inhaling the product by fumigation, keep at a sufficient distance from the preparation to avoid burning of the face as a result of contact with hot vapors.
If there is a history of epilepsy or seizures, old or recent, REQUEST ADVICE TO YOUR DOCTOR BEFORE USING THIS MEDICINE.
In order to limit the risk of adverse effects, the following should be strictly observed :
· do not apply over an extended surface of the body,
· do not apply the product to the nostrils, eyes, mouth or face,
· do not apply on the breasts in case of breastfeeding,
· do not apply on injured skin,
· do not continue treatment beyond 3 days.
Precautions for use:
· Avoid contact with eyes, mucous membranes, irritated skin and sores.
· Never swallow the product.
· Never apply the product to the nostrils, eyes, mouth or face.
· Reserved for external use only.
· Never apply a dressing to the application site. Never cover the application site with warm clothing or any other source of heat.
· If persistent fever, purulent sputum, purulent nasal discharge, aggravation of symptoms or lack of improvement after 3 days of treatment, CONSULT YOUR DOCTOR.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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. |
Pregnancy
As a precaution, it is preferable not to use this medication during pregnancy. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need for further treatment.
feeding
It is best not to use this medication and in no case should it be applied on the breasts.
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 VAPORUB, ointment?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
RESERVED FOR EXTERNAL USE ONLY.
TO OPEN THE SAFETY CAP, PRESS AND TURN at the same time according to the drawing engraved on the cap.
Dermal application : This medication is RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Apply the value of a teaspoon one to twice a day on the chest or neck preferably after the toilet.
Never exceed 2 applications per day.
Wash hands thoroughly after application.
Application in dermal application:
· Fill the teaspoon of ointment to the brim.
· Turn this one towards the inside of the jar and remove the excess ointment if necessary by scraping the teaspoon on the edge of the jar to get the right dose.
· Apply with your fingers.
· Wash the spoon thoroughly after use.
· Wash hands thoroughly after use.
· Leave your clothes loose at the application site to allow a good diffusion of the product.
· Never apply bandage or bandage to the application site. Never cover the application site with warm clothing or any other source of heat.
Inhalation by fumigation : This medication is reserved for adults and children over 12 years of age. 1 to 3 times a day, melt the volume from one to two teaspoons in a bowl of warm water (be careful not to use boiling water) and inhale the vapors through the nose and stuffy.
Method of preparation for fumigation :
· Pour very hot water (be careful not to use boiling water (boiling)) in a bowl or in an inhaler.
· Fill the teaspoon of ointment to the brim, then return it to the inside of the pot and remove excess if necessary.
· Incorporate the ointment in hot water (be careful not to use boiling water (boiling)) to melt it.
· Wash the spoon thoroughly after use.
NEVER HEAT THE PREPARATION OR REHAUL THE SAME IN THE MICROWAVE OVEN DUE TO PROJECTION RISKS.
NEVER USE BURNING WATER WHEN PREPARING FOR RISKS OF PROJECTION BURNS.
Inhale the vapors for 10 to 15 minutes.
The duration of use is limited to 3 days. |
If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
your pharmacist.
Symptoms and Instructions for Overdose
If you take more VICKS VAPORUB, ointment than you should: and especially in case of accidental overdose, STOP THE TREATMENT AND QUICKLY CONSULT A DOCTOR.
Following an accidental ingestion of Vicks Vaporub, an ointment by a child, it is important to consult a doctor promptly if necessary. In this case, never induce vomiting.
Instructions for omission of one or more doses
If you forget to take VICKS VAPORUB Ointment:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, VICKS VAPORUB, ointment is likely to have side effects, although not everyone is subject to it.
· Possibility of local irritation and allergy. If you experience an allergic skin reaction or if the feeling of heat becomes too severe, stop treatment. In case of excessive application, an intense cooking sensation may be felt.
· Due to the presence of terpene derivatives (camphor, menthol, thymol, eucalyptus) and in case of administration higher than recommended doses or non-compliance with advice for use, agitation and confusion in elderly risk of convulsions in children.
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 VAPORUB, Ointment?
Keep out of the reach and sight of children.
Expiration date
Do not use VICKS VAPORUB, ointment after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding 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 VAPORUB, ointment contain?
The active substances are: camphor, turpentine essential oil, levomenthol, eucalyptus essential oil, thymol.
The other components are: essential oil of cedar bark, petroleum jelly.
Pharmaceutical form and content
What is VICKS VAPORUB, ointment and contents of the pack?
This medication is in the form of an ointment. Pot of 40, 50, 90 or 100 g.
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 STRASSE 40-50
65824 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.