NOTICE
ANSM - Updated: 14/05/2019
Name of the drug
AURIGOUTTE, ear drops
Hexamidine diisethionate, lidocaine hydrochloride
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 5 days.
What does this booklet contain ?
1. What is AURIGOUTTE, ear drops and in what cases is it used?
2. What information do you need to know before using AURIGOUTTE, ear drops?
3. How to use AURIGOUTTE, ear drops?
4. What are the possible side effects?
5. How to store AURIGOUTTE, auricular drops?
6. Contents of the package and other information.
1. WHAT AURIGOUTTE, ear drops AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: otological drugs - ATC code: S02DA01.
· Antiseptic for local application
· Local anesthetic
AURIGOUTTE, ear drops is an antiseptic treatment of otitis externa with closed eardrum and their painful manifestations.
You should talk to your doctor if you feel no improvement or feel worse after 5 days.
2. WHAT INFORMATION DO YOU KNOW BEFORE USING AURIGOUTTE, ear drops?
Never use AURIGOUTTE, ear drops:
· if you are allergic to hexamidine or lidocaine, or to any of the other ingredients of this medicine, listed in section 6.
· in case of perforation of the eardrum.
Warnings and precautions
Talk to your doctor or pharmacist before using AURIGOUTTE, ear drops .
It is imperative to have the eardrum checked by your doctor before use because of the risk of ear toxicity if the eardrum is torn.
Athletes attention, this specialty contains an active ingredient that can induce a positive reaction tests performed during doping control.
Other medicines and AURIGOUTTE, ear drops
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
AURIGOUTTE, ear drops with food and, drinks and alcohol
Not applicable.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
3. HOW TO USE AURIGOUTTE, auricular drops?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Dosage and method of administration
Infants and children: 2 drops 3 times a day in the ear.
Adults: 4 drops 3 times a day in the ear.
Duration of treatment
5 days
If symptoms persist for more than 5 days, consult a doctor.
If you have used more than AURIGOUTTE, DROPS OF DROPS that you should have
Not applicable.
If you forget to use AURIGOUTTE, DROPS AURICULAR
Not applicable.
If you stop using AURIGOUTTE, DROPS AURICULAIRES
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
5. HOW TO STORE AURIGOUTTE, auricular drops?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 30 ° C.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What AURIGOUTTE contains, ear drops
· Active substances are:
Hexamidine diisethionate ............................................ .................................................. ..... 0.100 g
Lidocaine Hydrochloride ............................................... .................................................. ..... 0.100 g
For 100 ml.
· The other excipients are:
Glycerin officinale, ethyl alcohol at 95 °.
What AURIGOUTTE, ear drops and contents of the pack
This medicine is in the form of ear drops in dropper bottle of 15 ml.
Marketing Authorization Holder
MERCK FAMILY MEDICATION SAS
37, rue Saint-Romain
69379 LYON CEDEX 08
Operator of the marketing authorization
MERCK FAMILY MEDICATION
18 C Winston Churchill Blvd.
21000 DIJON
Maker
LABORATORY FAMAR NEDERLAND BV
INDUSTRIEWEG 1
5531 AD BLADEL (NL)
NETHERLANDS
or
Richard Laboratories
Progress Street
ZI of the Reys of Saulce
26270 SAULCE-SUR-RHONE
la France
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date 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).