Humex Benzalkonium Chloride Nasal Spray 0.04% is a medicine recommended to relieve the symptoms of colds and nasopharyngitis . It is intended for the whole family, from adults to children aged at least 30 months.
It is formulated with benzalkonium chloride at a rate of 0.04 g per 100 ml of solution. The other ingredients are cineole (eucalyptol), polysorbate 80, sodium chloride, citric acid monohydrate, sodium citrate and purified water.
Dosage of Humex Rhume nasal spray
The route of administration must be exclusively nasal, in the form of sprays.
Their number varies between 1 to 2 in each nostril, 4 to 5 times a day.
For children over 30 months, the dosage is 1 spray in each nostril, 3 to 4 times a day.
The duration of treatment should not exceed a few days, and a medical consultation is recommended in the event that you have used Humex nasal solution 0.04% by mistake.
For precise and effective administration, spray the solution, the bottle in an upright position, with the head slightly tilted forward.
Precautions for use of Humex spray for colds
In order to limit contamination of the tip by microbes, it is recommended to use the solution within 15 days.
In case of headaches and/or fever, consult your doctor, the same thing if you are prone to epilepsy.
Medical advice is also recommended if you are pregnant, breastfeeding or planning a pregnancy.
Packaging: 15 ml spray bottle
Please read the following full disclosure before taking our using this item.
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 05/10/2020
1. NAME OF THE MEDICINE
HUMEX FOURNIER 0.04 PERCENT, nasal spray solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium chloride...................................................................................................... 0.04 g
Per 100 ml of nasal spray solution.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray solution.
4. CLINICAL DATA
4.1. Therapeutic indications
Adjunctive local treatment for infections of the nasopharyngeal mucosa.
4.2. Dosage and method of administration
Dosage
FOR 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 applied with the bottle in a vertical position and the head slightly tilted forward to avoid swallowing the product.
4.3. Contraindications
- Hypersensitivity to any of the ingredients, particularly quaternary ammoniums.
- Due to the presence of cineole as an excipient: children with a history of convulsions (febrile or otherwise).
4.4. Special warnings and precautions for use
Special warnings
This product contains cineole (a terpene derivative) as an excipient, which may lower the seizure threshold. In excessive doses, there is a risk of:
- Convulsions in infants and children.
- Respiratory pauses and collapse in infants.
Follow usage instructions and dosages carefully, particularly: never exceed the recommended doses.
This medicine contains 0.04 g of benzalkonium chloride per 100 ml of nasal spray solution. Benzalkonium chloride can cause irritation or swelling of the nasal mucosa, especially with long-term use.
Precautions for use
Once the packaging is opened, and especially after the first use of a nasal preparation, microbial contamination is possible.
- The indication does not justify prolonged treatment.
- If general clinical signs are present, systemic treatment should be considered.
- In case of a history of epilepsy, consider the presence of terpene derivatives as excipients.
4.5. Interactions with other medications and other forms of interactions
Available data do not suggest the existence of clinically significant interactions.
4.6. Fertility, pregnancy, and breastfeeding
In case of breastfeeding, it is preferable not to use this medication due to:
- The lack of kinetic data on the passage of terpene derivatives into breast milk.
- Their potential neurological toxicity in infants.
4.7. Effects on the ability to drive and use machines
HUMEX FOURNIER 0.04 PERCENT, nasal spray solution has no effect on the ability to drive and use machines.
4.8. Undesirable effects
- Possibility of allergy.
- Local irritation.
- Due to the presence of cineole as an excipient and in case of non-compliance with the recommended doses:
- Risk of convulsions in children.
- Possibility of agitation and confusion in the elderly.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: Antiseptic nasal preparation, ATC code: R - Respiratory system.
5.2. Pharmacokinetic properties
Not provided.
5.3. Preclinical safety data
Not provided.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Cineole (eucalyptol), polysorbate 80, sodium chloride, citric acid monohydrate, sodium citrate, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
No special storage conditions.
6.5. Nature and contents of the outer packaging
15 ml brown glass bottle with a polypropylene metered pump.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
LABORATOIRES URGO HEALTHCARE
42 RUE DE LONGVIC
21300 CHENOVE
8. MARKETING AUTHORIZATION NUMBER(S)
- 34009 348 257 7 4: 15 ml glass bottle with metered pump (polypropylene).
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
Date of first authorization: 28 August 1996.
Date of last renewal: 28 August 2011 (unlimited duration).
10. DATE OF TEXT REVISION
[To be completed later by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND DISPENSING CONDITIONS
Medicine not subject to a medical prescription.
