Vicks Vaporub Ointment 50g

1. WHAT IS VICKS VAPORUB Ointment AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

Not applicable.

Therapeutic indications

This medicine is used as a decongestant for common respiratory disorders (colds, coughs, simple bronchitis).

2. WHAT YOU SHOULD KNOW BEFORE USING VICKS VAPORUB Ointment

List of information needed before taking the medicine

Not applicable.

Contraindications

Never use VICKS VAPORUB, ointment in the following cases:

Allergyto any of the ingredients,

Skindiseasesand lesions.

Due to the presence of terpenes, this medicine should never be administered to children under 6 years of age or to children with a history of convulsions (febrile or not).

Precautions; special warnings

Use caution with VICKS VAPORUB Ointment:

Special warnings

This medicine contains flammable volatile substances. Never expose to flame. After application, avoid the vicinity of a flame.

When inhaling the product by fumigation, do not use boiling water.

When inhaling the product by fumigation, keep a sufficient distance from the preparation to avoid facial burns due to contact with hot vapours.

If you have a history of epilepsy or convulsions, old or recent, ASK YOUR DOCTOR BEFORE USING THIS MEDICATION.

In order to limit the risks of undesirable effects, it is advisable to strictly respect the dosage and the advice of use in particular:

Donot apply to a large area of the body,

Donot apply the product to the nostrils, eyes, mouth or face,

Donot apply to the breasts if you are breastfeeding,

Donot apply to injured skin,

Donot continue the treatment beyond 3 days.

Precautions for use:

Avoid contact with eyes, mucous membranes, irritated skin and wounds.

Never swallow the product.

Never apply the product to the nostrils, eyes, mouth or face.

For external use only.

Never apply a bandage to the application site. Never cover the application site with warm clothing or any other heat source.

If fever persists, purulent sputum, purulent nasal discharge, worsening of symptoms or no improvement after 3 days of treatment, CONSULT YOUR DOCTOR.

Interactions with other drugs

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 drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and breastfeeding

Pregnancy and breastfeeding

Pregnancy

As a precautionary measure, this medicine should not be used during pregnancy. If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether or not you should continue treatment.

Breastfeeding

It is preferable not to use this medicine and under no circumstances should it be applied to the breasts.

Sportsmen

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW TO USE VICKS VAPORUB Ointment

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

FOR EXTERNAL USE ONLY.

TO OPEN THE SAFETY CAP, PRESS AND TURN at the same time according to the drawing on the cap.

For skin application This medicine is FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.

Apply a teaspoonful once or twice a day to the chest or neck, preferably after washing.

Never exceed 2 applications per day.

Wash your hands well after application.

Instructions for use in cutaneous application:

Fill the teaspoon of ointment to the brim.

Turn it 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 well after use.

Wash your hands well after use.

Leave your clothes loose at the application site to allow good diffusion of the product.

Never apply a bandage or dressing to the application site. Never cover the application site with warm clothing or any other heat source.

For inhalation by fumigation This medicine is reserved for adults and children over 12 years of age. 1 to 3 times a day, melt the volume of one to two teaspoons in a bowl of hot water (be careful not to use water brought to a boil (boiling)) and inhale the vapors through the nose and mouth.

Method of preparation for fumigation:

Pour very hot water (do not use boiling water) into a bowl or inhaler.

Fill the teaspoon with ointment to the brim, then turn it over towards the inside of the jar and remove the excess if necessary.

Stir the ointment into hot water (do not use boiling water) to melt it.

Wash the spoon well after use.

NEVER HEAT THE PREPARATION OR REHEAT IT EVEN IN A MICROWAVE OVEN BECAUSE OF THE RISK OF SPLASHING.

NEVER USE BOILING WATER WHEN PREPARING BECAUSE OF THE RISK OF BURNS BY PROJECTION.

Inhale the vapours for 10 to 15 minutes.

If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

your pharmacist.

Symptoms and instructions in case of overdose

If you have taken more VICKS VAPORUB, ointment than you should have and in particular in case of if you have taken more VICKS VAPORUB Ointment than you should have: accidental overdose, STOP THE TREATMENT AND SEEK MEDICAL ATTENTION QUICKLY.

If a child accidentally swallows Vicks Vaporub Ointment, it is important to consult a doctor as soon as possible so that appropriate treatment can be given if necessary. In this case, never induce vomiting.

Instructions in case of missed doses

If you forget to take VICKS VAPORUB Ointment :

Do not take a double dose to make up for the dose you forgot to take.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, VICKS VAPORUB Ointment may have side effects, although not everyone is susceptible.

Local irritation and allergy may occur. If an allergic skin reaction occurs or if the sensation of heat becomes too strong, discontinue use. If too much is applied, an intense burning sensation may be felt.

Due to the presence of terpene derivatives (camphor, menthol, thymol, eucalyptus) and in the event of administration in excess of the recommended doses or failure to follow the instructions for use, there is a possibility of agitation and confusion in the elderly or a risk of convulsions in children.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

5. HOW TO USE VICKS VAPORUB Ointment

Keep out of the reach and sight of children.

Expiry date

Do not use VICKS VAPORUB Ointment after the expiry date stated on the box.

Storage conditions

Store at a temperature not exceeding 25°C.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does VICKS VAPORUB ointment contain?

The active substances are: - VAPORUB, ointment: camphor, turpentine essential oil, levomenthol, eucalyptus essential oil, thymol.

The other ingredients are: essential oil of cedar bark, vaseline.

Pharmaceutical form and content

What is VICKS VAPORUB ointment and what does it contain?

This medicine is in the form of an ointment. Jar of 40, 50, 90 or 100 g.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

PROCTER & GAMBLE PHARMACEUTICALS FRANCE

163-165, QUAI AULAGNIER

92600 ASNIERES-SUR-SEINE