VICKS VAPORUB Ointment Jar/50g

Ointment.

Camphor ..........................................................................................................................................5,00 g

Essential oil of turpentine ....................................................................................................5,00 g

Levomenthol ....................................................................................................................................2,75 g

Essential oil of eucalyptus .........................................................................................................1,50 g

Thymol ............................................................................................................................................0,25 g

For 100 g of ointment.

Excipients:

Adjunctive treatment with decongestant intent in the course of common respiratory conditions (colds, cough, simple bronchitis).

Do not swallow.

For cutaneous application : this medicine is RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.

Apply the amount of one teaspoon one to two times per day on the chest or neck preferably after washing.

Never exceed 2 applications per day.

Directions for use in cutaneous application - jar :

• Fill the teaspoon with ointment level to the brim.

• Turn it toward the inside of the jar and remove excess ointment if needed by scraping the teaspoon on the edge of the jar to obtain the exact dose.

• Apply with the fingers.

• Wash the teaspoon thoroughly after use.

• Wash hands thoroughly after use.

Directions for use in cutaneous application - multidose container :

• On first use of the product: remove the cap and the seal then prime the product by turning the base of the container 3 to 4 times.  

• Turn the base of the container to release a quantity equivalent to one teaspoon. Apply directly using the container on the chest or neck.

• Clean the container with a paper tissue after each use and replace the cap.

 

 

By inhalation by fumigation : this medicine is RESERVED FOR THE ADULT AND THE CHILD OVER 12 YEARS.

1 to 3 times per day, melt the volume of one to two teaspoons in a bowl of hot water (caution do not use water brought to boiling (boiling)) and inhale the vapors through the nose and mouth.

Mode of preparation by fumigation - pot :

• Pour hot water (caution do not use water brought to boiling (boiling) into a bowl or into an inhaler,

• Fill the coffee spoon with ointment to the brim, then turn it over towards the inside of the pot and remove the excess if necessary,

• Incorporate the ointment into the hot water (caution do not use water brought to boiling (boiling) to melt it.

• Wash the teaspoon thoroughly after use.

Mode of preparation by fumigation - multidose container :

• Pour a little hot water (make sure not to use boiling water) into a bowl or an inhaler.

• Turn the base of the container to release a quantity equivalent to a teaspoon.

• Mix the ointment in the hot water (make sure not to use boiling water) to melt it.

• Clean the container with a paper tissue after each use and replace the cap.

NEVER HEAT THE PREPARATION OR REHEAT IT EVEN IN THE MICROWAVE OVEN BECAUSE OF THE RISKS OF PROJECTION.

NEVER USE BOILING WATER DURING PREPARATION BECAUSE OF THE RISKS OF BURNS BY PROJECTION.

The maximum duration of treatment is 3 days.

• Hypersensitivity to the active substances or to any of the excipients mentioned in the section Composition.,

• dermatoses and evolving skin lesions,

• due to the presence of terpenes and their effect of lowering the epileptogenic threshold, this medicine should never be administered :

• in children under 6 years,
• in adults and children with a history of convulsions (febrile or not) or epilepsy (see section Warnings and precautions).

Special warnings

VICKS VAPORUB is not recommended during pregnancy and in women of childbearing potential not using effective contraception (see section Fertility, pregnancy and breastfeeding).

This medicine contains volatile flammable substances. Never expose to a flame. Advise patients that after application, it is advisable to avoid proximity to a flame.

When inhaling the product by fumigation, stay at a sufficient distance from the preparation to avoid a burn to the face following contact with hot vapors.

This specialty contains terpene derivatives (camphor, menthol, thymol, essential oils of eucalyptus and turpentine), which can lower the epileptogenic threshold. Due to the risk of convulsions, this medicine should not be used in children under 6 years or in patients (adults and children) with a history of convulsions or epilepsy (see section Contraindications.).

In addition, in case of administration exceeding the recommended doses or non-compliance with the instructions for use, neurological effects such as agitation and confusion may occur particularly in elderly subjects as well as convulsions. Respect the recommended dosages and duration of treatment.

In order to limit the risks of adverse effects, it is necessary to respect strictly the posology and the instructions for use, in particular :

• do not apply on an extensive surface of the body,

• do not apply on the breasts in case of breastfeeding,

• do not apply on damaged skin (risk of increased systemic passage of the active ingredients),

• do not continue the treatment beyond 3 days.

Precautions for use

In case of high or persistent fever, occurrence of signs of superinfection or persistence of symptoms beyond 3 days, a re-evaluation of the treatment must be carried out.

For cutaneous application :

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

• The product must never be swallowed, applied to the nostrils, eyes, mouth or face.

• Reserved for external use only.

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

By inhalation by fumigation :

• Do not use water brought to boiling point (boiling) to prepare the inhalation.

• NEVER HEAT THE PREPARATION NOR REHEAT IT EVEN IN A MICROWAVE OVEN IN ORDER TO AVOID RISKS OF PROJECTION.

Pregnancy

VICKS VAPORUB contains terpene derivatives. There are no or few data on the use of terpene derivatives in pregnant women. VICKS VAPORUB is not recommended during pregnancy and in women of childbearing potential not using contraception 

Breastfeeding

In case of breastfeeding, this medicine must not be used, due to:

• the absence of kinetic data on the passage of terpene derivatives into breast milk.

• their potential neurological toxicity in the infant.

• respiratory exposure of the infant due to the proximity of the application site.

In no case should VICKS VAPORUB be applied to the breasts of breastfeeding women.

VICKS VAPORUB, ointment has no effect on the ability to drive vehicles and use machines.

Due to the presence of terpene derivatives (camphor, menthol, thymol, essential oil of eucalyptus and turpentine) and in particular in case of administration higher than the recommended doses or non-compliance with the instructions for use, agitation and confusion may occur in elderly subjects, as well as convulsions in children and adults.

At the application site :

• Possibility of erythema, pruritus, rash, burning (frequency undetermined), allergic or irritative reaction of the skin or eyes (during inhalation). In this case, discontinue treatment. If the sensation of heat after application becomes too intense, suspend treatment. In case of overdose an intense burning sensation may be felt.

Reporting of suspected adverse effects

The reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr

Intense burning effect disappearing upon discontinuation of treatment.

An overdose may cause skin irritation.

Misuse :

Ingestion of the ointment may cause gastrointestinal symptoms such as vomiting and diarrhea. In this situation, symptomatic treatment is sufficient.

Following accidental ingestion, severe intoxication has been observed with the appearance of nausea, vomiting, abdominal pain, headache, dizziness, hot flashes, convulsions, respiratory depression and coma.

Patients suffering from severe gastrointestinal or neurological disorders following intoxication must be monitored and receive symptomatic treatment. In this situation, never induce vomiting.

Pharmacotherapeutic class: OTHER RESPIRATORY SYSTEM MEDICINES, ATC code: R07AX.

Camphor, menthol, thymol, eucalyptus: traditionally used as antiseptics of the respiratory tract, these terpene derivatives may lower the epileptogenic threshold.

Jar: 4 years.

Multidose container: 2 years.

Store at a temperature not exceeding 25°C.

The multidose container must be stored in an upright position.

No special requirements.

MA	CIP 3400935281739 (Jar/50g). CIP 3400935281968 (Jar/100g).

Not reimbursed by Social Security (Jar/50g, Jar/100g).