ESSENCE ALGERIENNE Inhalation/fumigation spray Bottle/20ml

Eucalyptol.....................................................................................................................................................97,80 g

Menthol............................................................................................................................................................1,20 g

Guaiacol............................................................................................................................................................1,00 g

For 100 g of solution.

Adjunctive treatment in congestive states of the upper airways.

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.

Pour a few drops into a container of very hot water and inhale the vapours. Repeat the inhalations 3 times a day.

Method of administration

Inhalation by fumigation. DO NOT SWALLOW.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

Children with a history of convulsions (febrile or not) due to the presence of terpene derivatives.

Special warnings

This specialty contains terpene derivatives (eucalyptol (cineole), menthol (levomenthol)) which may cause, at excessive doses in children:

• neurological accidents such as convulsions in infants and children,

• breathing pauses and collapse in infants.

Follow the instructions for use and dosage, in particular: never exceed the recommended doses.

Precautions for use

In case of a history of epilepsy, take into account the presence of terpene derivatives.

Pregnancy

ALGERIAN ESSENCE contains terpene derivatives. There is little or no data on the use of terpene derivatives in pregnant women. ALGERIAN ESSENCE is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

In case of breastfeeding, it is preferable not to use this medicine due to:

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

• and their potential neurological toxicity in infants.

No effect on the ability to drive vehicles or operate machinery has been reported.

In case of failure to respect the recommended doses, due to the presence of terpene derivatives:

· risk of convulsions in infants and children,

· possibility of agitation, confusion and drowsiness in elderly subjects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Pharmacotherapeutic class: FOR DECONGESTANT USE, ATC code: R. (Respiratory system).

Eucalyptol (cineole), menthol (levomenthol): terpene derivatives, traditionally used as respiratory tract antiseptics, which may lower the epileptogenic threshold.

5 years.

No special precautions for storage.

No special requirements.