NOTICE
ANSM - Last updated: 19/05/2017
Name of the medicinal product
ALGERIAN ESSENCE, solution for inhalation by fumigation
Eucalyptol, Menthol, Gaïacol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is ALGERIAN ESSENCE, solution for inhalation by fumigation and in which cases it is used?
2. What information should be known before using ALGERIAN ESSENCE, Fumigating Inhalation Solution?
3. How to use ALGERIAN ESSENCE, Fumigating Inhalation Solution?
4. What are the possible side effects?
5. How to store ALGERIAN ESSENCE, solution for inhalation by fumigation?
6. Package contents and other information.
1. WHAT IS ALGERIAN FUEL, Fumigating Inhalation Solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: A DISCONTINUED - R (Respiratory system)
This medication is used as a decongestant during common respiratory infections (colds, nasopharyngitis) in adults and children over 12 years of age.
2. BEFORE YOU USE ALGERIAN FUEL, Fumigating Inhalation Solution?
Never use ALGERIAN ESSENCE, Fumigating Inhalation Solution:
· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· in children with seizures due to fever or not due to the presence of terpene derivatives.
Warnings and Precautions
Talk to your doctor or pharmacist before using ALGERIAN ESSENCE, Fumigating Inhalation Solution .
Special warnings
In the event of a fever, sputum (sputum), as in the case of aggravation or lack of improvement of your condition after 5 days: consult a doctor.
This specialty contains terpenic derivatives (eucalyptol, menthol) which can lead to excessive doses in children:
· neurological accidents such as convulsions,
· respiratory breaks and discomfort.
Observe the instructions for use, in particular:
· never exceed the recommended doses (see How to use ALGERIAN FUEL, Fumigating Inhalation Solution)
· adhere to the recommended processing times.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Precautions for use
In adults, in case of epilepsy or old epilepsy, ask your doctor for advice.
Do not swallow.
children
Not applicable.
Other medicines and ALGERIAN ESSENCE, solution for inhalation by fumigation
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ALGERIAN ESSENCE, solution for inhalation by fumigation with food and drinks
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
It is best not to use this medication while breastfeeding.
Driving and using machines
No effects on the ability to drive vehicles or machinery have been reported.
ALGERIAN ESSENCE, solution for inhalation by fumigation contains
Not applicable.
3. HOW TO USE ALGERIAN ESSENCE, Fumigating Inhalation Solution?
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.
Pour a few drops into a container of very hot water and inhale the vapors.
Repeat inhalation 3 times daily.
This medication has been delivered to you personally in a specific situation:
· It may not be suitable for another case.
· Do not advise another person.
Method and route of administration
Inhalation by fumigation.
Duration of treatment
Treatment will usually not exceed 5 days.
If you used more ALGERIAN FATTY, Fumigating Inhalation Solution than you should have
Not applicable.
If you forget to use ALGERIAN ESSENCE, fumigating inhalation solution
Not applicable.
If you stop using ALGERIAN ESSENCE, Fumigating Inhalation Solution
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
In case of non-respect of the doses recommended and due to the presence of terpene derivatives:
· risk of convulsions in children,
· possibility of agitation, confusion in the elderly.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ALGERIAN FUEL, Fumigating Inhalation Solution?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging .
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ALGERIAN ESSENCE contains, solution for inhalation by fumigation
· The active substances are:
Eucalyptol ................................................. .................................................. ................... 97.80 g
Menthol ................................................. .................................................. ........................ 1.20 g
Gaïacol ................................................. .................................................. ......................... 1.00 g
For 100 g of solution.
What is ALGERIAN ESSENCE, solution for inhalation by fumigation and contents of the pack
This medicinal product is in the form of a solution for inhalation by fumigation. Box of 1 bottle of 20 ml.
Marketing Authorization Holder
GERDA LABORATORIES
24 RUE ERLANGER
75016 PARIS
Marketing Authorization Operator
GERDA LABORATORIES
24 RUE ERLANGER
75016 PARIS
Maker
GILBERT LABORATORIES
928 AVENUE OF THE GENERAL OF GAULLE
14200 HEROUVILLE SAINT-CLAIR
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).