GOMENOL SOLUBLE 82,5 mg/5 ml S p inh/nébulis en ampoule 5Amp/5ml

Niaouli (Melaleuca quinquenervia (Cav.) S.T. Blake) (essential oil)........................................................ 82,5 mg

For one ampoule of 5 ml.

Adjunctive treatment in congestive states of the upper airways.

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.

Respiratory route: as an aerosol.

1 to 2 sessions per day of 15 to 20 minutes.

• Children with a history of convulsions (febrile or not) due to the presence of terpene derivatives.
• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Special warnings

This specialty contains terpene derivatives which may cause, at excessive doses:

• Neurological accidents such as convulsions in infants and children,
• Respiratory pauses and collapse in infants.

The patient should be advised of the instructions for use and recommended dosages, and should never exceed the recommended doses.

Precautions for use

• If symptoms persist and/or signs of superinfection appear, the therapeutic approach should be reassessed.
• Do not swallow.
• Do not inject.
• In case of allergic reaction, stop the treatment.
• It is preferable to dilute the aqueous solution with physiological saline or distilled water in asthmatics or in the presence of certain allergic rhinitis.
• In adults, with a history of epilepsy, take into account the presence of terpene derivatives.

During 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.

• Hypersensitivity reactions.
• In case of non-compliance with the recommended doses:
  • Risk of convulsions in children,
  • Possibility of agitation and confusion 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: www.signalement-sante.gouv.fr.

DECONGESTANT PURPOSE (R: Respiratory system)

Niaouli essential oil is a terpene derivative. Terpene derivatives may lower the epileptogenic threshold.

3 years.

No special precautions for storage.

No special requirements.