NOTICE
ANSM - Last updated: 11/05/2017
Description of the Medicine
HUMEX INHALER, impregnated inhalation pad
Levomenthol / Camphor Racemic / Methyl Salicylate
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Please read this leaflet carefully before using this medication. It contains important information for your treatment.
AT· This medication can be used in automation ie it is used without consultation or prescription of a doctor.
AT· If the symptoms persist, if they become worse or if new symptoms appear, seek the advice of your pharmacist or your doctor.
AT· This leaflet is designed to help you use this medication properly. Keep it there, you might need to re-read it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Summary sheet
In this notice :
1. WHAT IS HUMEX INHALER, impregnated buffer for inhalation AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE HUMEX INHALER, impregnated Inhalation Buffer?
3. HOW TO USE HUMEX INHALER, impregnated inhalation pad?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX INHALER, impregnated buffer for inhalation?
6. ADDITIONAL INFORMATION
1. WHAT IS HUMEX INHALER, impregnated buffer for inhalation AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
SCREWED DISCONTINUING.
(R. Respiratory system).
Therapeutic Indications
This medication is used as a disinfectant during common respiratory conditions (colds, rhinitis, rhinopharyngitis) in adults and children over 12 years of age.
2. BEFORE YOU USE HUMEX INHALER, impregnated Inhalation Buffer?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use HUMEX INHALER, impregnated inhalation buffer if:
AT· Allergy to one of the constituents,
AT· Children with convulsions due to fever or not.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment precautions; special warnings
Take special care with HUMEX INHALER, impregnated inhalation pad:
Special warnings
This specialty contains menthol and camphor (terpenic derivatives) which may have caused, in excessive doses:
AT· seizure-type accidents in infants and children,
AT· respiratory breaks and discomfort in the infant.
Do not exceed the recommended doses ( see section DOSAGE ).
Employment Precautions
In case of allergic reaction, stop treatment.
If symptoms persist after 3 days and / or signs of infection appear, if fever, purulent nasal discharge, purulent sputum SEE YOUR DOCTOR.
In case of old or recent sepsis, ASK YOUR DOCTOR ADVICE.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Use of other medicines
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
This medicinal product contains terpenic derivatives: camphor and levomenthol. Other medicines contain .... Do not associate them. so as not to exceed the maximum recommended doses ( see directions for use and dosage ). |
Interactions with food and beverages
Food and drinks
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In case of breast-feeding, it is preferable not to use this medication.
Generally, during pregnancy and breast-feeding, you should always seek advice from your doctor or pharmacist before taking a medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE HUMEX INHALER, impregnated inhalation pad?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.
2 breaths per nostril and per intake, to be renewed if necessary without exceeding 3 catches per day, by replacing the catches regularly in the day.
Administration mode
Airway.
Apply to each nostril and deeply inhale.
Duration of treatment
The duration of use is limited to 3 days |
If the symptoms persist beyond 3 days or become worse, consult your doctor.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to use HUMEX INHALER, impregnated inhalation buffer:
If you miss a dose, do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, HUMEX INHALER, impregnated buffer for inhalation is likely to have undesirable effects, although not everyone is subject to it.
AT· possibility of local irritation and allergy,
AT· because of the presence of menthol and camphor and in case of non-respect of the doses requesited :
o risk of convulsions in children,
o possibility of agitation and confusion in the elderly.
DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST.
If you notice any side effects not listed in this leaflet, or if certain undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE HUMEX INHALER, impregnated buffer for inhalation?
Keep out of the reach and sight of children.
Date of filing
Do not use HUMEX INHALER after the expiration date mentioned on the tube. The expiry date refers to the last day of the month.
Storage conditions
Keep at a temperature not exceeding 25 ° C.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away at the sewer or with household garbage. Ask your pharmacist what to do with unused medications. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does HUMEX INHALER contain, impregnated inhalation pad?
The active substances are :
LÃ © vomenthol ............................................... .................................................. ................................... 42.11 g
Rheumatic Camphor .............................................. .................................................. 42.11 g
Methyl salicylate ............................................. .................................................. 11.58 g
For 100 g of solution.
Hydrophilic cotton pad with 950 mg solution, placed in the median part of the tube.
The other component is :
Pine essential oil.
Pharmaceutical form and content
What is HUMEX INHALER, impregnated inhalation pad and contents of outer packaging?
This medication is in the form of an impregnated tube inhalation pad.
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 medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicinal product can be found on the website of AFssaps (France).
Information for health professionals
Not applicable.
Other
Not applicable.