HUMEX FOURNIER 0,04 % S nasal powder Fl spray/15mL

Benzalkonium chloride.......................................................................................................................... 0,04 g

For 100 ml of nasal spray solution.

Adjunctive local treatment of infections of the rhinopharyngeal mucosa.

Dosage

KEEP OUT OF REACH OF ADULTS AND CHILDREN OVER 30 MONTHS.

Adults: 1 to 2 sprays in each nostril 4 to 5 times a day.

Children over 30 months: 1 spray in each nostril 3 to 4 times a day.

Method of administration

Nasal sprays should be administered with the bottle in an upright position and the head slightly tilted forward, in order to avoid swallowing the product.

• Hypersensitivity to any of the constituents, in particular to quaternary ammoniums.

• Related to the presence of cineole as an excipient: children with a history of convulsions (febrile or not).

Special warnings

This specialty contains cineole (a terpene derivative) as an excipient, which may lower the epileptogenic threshold. At excessive doses, risk of:

• convulsive-type accidents, in infants and children,

• breathing pauses and collapse in infants.

Respect the instructions for use and dosages, in particular: never exceed the recommended doses.

This medicine contains 0,04 g of benzalkonium chloride per 100 ml of nasal spray solution. Benzalkonium chloride may cause irritation or oedema of the nasal mucosa, particularly with long-term use.

Precautions for use

As soon as the container is opened, and even more so from the first use of a preparation for nasal use, microbial contamination is possible.

• The indication does not justify prolonged treatment.

• In the presence of associated general clinical signs, systemic treatment should be considered.

• In case of a history of epilepsy, take into account the presence of terpene derivatives as an excipient.

The data available to date do not suggest the existence of clinically significant interactions.

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.

HUMEX FOURNIER 0,04 PER CENT, nasal spray solution has no effect on the ability to drive vehicles and use machines.

• Possibility of allergy.

• Local irritation.

• Due to the presence of cineole as an excipient and in case of not respecting the recommended doses:

• risk of convulsions in children,
• possibility of agitation, 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: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported.

Pharmacotherapeutic class: Antiseptic nasal preparation, ATC code: R: respiratory system.

3 years.

No special precautions for storage.

No special requirements.