NOTICE
ANSM - Last updated: 11/05/2017
Name of the medicinal product
HUMEX FOURNIER 0.04 PERCENT, nasal spray solution
Benzalkonium chloride
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT HUMEX SUPPLIER 0.04 PERCENT, nasal spray solution AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE HUMEX FOURNIER 0.04 PER CENT, nasal spray solution?
3. HOW TO USE HUMEX FOURNIER 0.04 PERCENT, solution for nasal spray?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX FOURNIER 0.04 PERCENT, solution for nasal spray?
6. ADDITIONAL INFORMATION
1. WHAT HUMEX SUPPLIER 0.04 PERCENT, nasal spray solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTIC NASAL PREPARATION
(R: respiratory system)
Therapeutic indications
This medicine is indicated for colds and rhinopharyngitis in adults and children over 30 months.
2. BEFORE YOU USE HUMEX FOURNIER 0.04 PER CENT, nasal spray solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use HUMEX FOURNIER 0.04 PERCENT, nasal spray solution in the following cases:
· in the case of a known allergy to antiseptics of the quaternary ammonium class,
· in children with seizures due to fever or not (contraindication linked to the presence of eucalyptol as an excipient).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with HUMEX FOURNIER 0.04 PERCENT, solution for nasal spray:
Special warnings
This specialty contains eucalyptol (terpene derivative) as an excipient, which can lead, in excessive doses:
· seizure-type accidents in infants and children,
· respiratory breaks and discomfort in the infant.
Observe the instructions for use, in particular:
· never exceed the recommended doses ( see Dosage ),
· adhere to the recommended processing times,
· spray this medicine while holding the bottle upright, the tip upwards.
Precautions for use
As soon as the packaging is opened, and a fortiori the first use of a preparation for nasal use, microbial contamination is possible. To be used within 15 days after opening.
In case of fever, severe headache, ear pain or other symptoms, consult your doctor.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Use of other medicines:
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, speak to your pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
If you are breast-feeding, you should not use this medication.
Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect:
Terpene derivatives. In the event of non-compliance with recommended doses:
· risk of convulsions in children,
· possibility of agitation, confusion in the elderly.
3. HOW TO USE HUMEX FOURNIER 0.04 PERCENT, solution for nasal spray?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 30 MONTHS.
Adult: 1 to 2 sprays in each nostril 4 to 5 times a day.
Child over 30 months: 1 spray into each nostril 3 to 4 times a day.
With the head in a vertical position, insert the end of the nosepiece into the nostril. Press the bottle walls while inhaling.
Note: The correct operation of the sprayer requires incomplete filling of the bottle.
Method and route of administration
Nasal route
Duration of treatment
The treatment should not exceed a few days.
Symptoms and Instructions for Overdose
If you used more HUMEX FOURNIER 0.04 PER CENT, nasal spray solution you should:
CONSULT YOUR PHYSICIAN OR YOUR PHARMACIST.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HUMEX FOURNIER 0.04 PERCENT, nasal spray solution is likely to have unwanted effects, although not everyone is subject to it:
· possibility of allergy,
· local irritation.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HUMEX FOURNIER 0.04 PERCENT, solution for nasal spray?
Keep out of the reach and sight of children.
Expiration date
Do not use HUMEX FOURNIER 0.04 PERCENT, nasal spray solution after the expiry date stated on the outer packaging.
Storage conditions
No special precautions for storage.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What HUMEX FOURNIER contains 0.04 PER CENT, nasal spray solution?
The active substance is:
Benzalkonium chloride ............................................... .................................................. .................. 0.04 g
For 100 ml of nasal spray solution.
The other components are:
Cineole (eucalyptol), polysorbate 80, sodium chloride, purified water.
Pharmaceutical form and content
What is HUMEX FOURNIER 0.04 PERCENT, solution for nasal sprays and contents of the pack?
This medication is in the form of a nasal spray solution.
Bottle of 15 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
exploiting
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
Maker
URGO LABORATORIES
AVENUE OF STRASBOURG
ZONE EXCELLENCE 2000
21800 CHEVIGNY-SAINT-SAUVEUR
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.