NOTICE
ANSM - Last updated: 17/08/2017
Name of the medicinal product
OTIPAX, solution for atrial instillation
Phenazone / Lidocaine Hydrochloride
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 of the 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 OTIPAX, solution for ear instillation and in which cases it is used?
2. What information should be known before using OTIPAX, solution for ear instillation ?
3. How to use OTIPAX, solution for ear instillation ?
4. What are the possible side effects?
5. How to store OTIPAX, solution for atrial instillation ?
6. Package contents and other information.
1. WHAT IS OTIPAX, solution for atrial instillation AND WHAT IT IS USED FOR?
Pharmacotherapeutic group : ANTALGIC LOCAL / ANTI-INFLAMMATORY FOR OTOLOGICAL USE (S: Body of the senses), ATC code: S02DC
Therapeutic indications
Local treatment of pain due to certain otitis with closed eardrum:
· Otitis media acute congestive,
· Influenza-like sore called phlyctenular,
· Barotraumatic otitis.
2. BEFORE YOU USE OTIPAX, solution for ear instillation?
Never use OTIPAX, solution for ear instillation in the following cases:
· If you are allergic to any of the active ingredients or to any of the other ingredients of this medication mentioned in section 6.
· If you have a perforation of the eardrum,
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Special warnings
If the eardrum is opened, this drug may cause undesirable effects in the middle ear.
BY PRECAUTION, before any administration, the integrity of your eardrum should be checked by a DOCTOR.
Precautions for use
The treatment time should not exceed 10 days. If the symptoms persist, consult your doctor.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
children
Not applicable.
Other medicines and OTIPAX, solution for atrial instillation
Inform your doctor or pharmacist if you are taking, have recently taken, or may be taking any other medication.
OTIPAX, solution for ear instillation with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
Under normal conditions of use, this medication may be used during pregnancy or in case of breast-feeding.
Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before using any medication
Sport
The attention of athletes is drawn to the fact that this specialty contains an active principle that can induce a positive reaction of the tests carried out during anti-doping controls.
Driving and using machines
Not applicable.
OTIPAX, solution for ear instillation contains glycerol and ethanol.
3. HOW TO USE OTIPAX, solution for atrial instillation?
Instructions for proper use
Not applicable.
Dosage
· Dropper bottle or tube: pour 4 drops into the ear canal by exerting a slight pressure on the soft part of the dropper, 2 to 3 times a day in the painful ear.
Method and route of administration
Ear canal.
How to use the dropper bottle:
· Unscrew the cap from the bottle,
· Screw the dropper onto the bottle,
· Remove the cap from the dropper,
· Turn the bottle upside down and gently squeeze the tip to get 1 drop,
· Press again until 4 drops are obtained,
· Replace cap on cap after use.
Warm the bottle to avoid the unpleasant sensation of the cold solution in the ear.
Duration of treatment
Do not exceed 10 days of treatment. If the symptoms persist, consult your doctor.
If you have used more OTIPAX, solution for atrial instillation than you should have
Not applicable.
If you forget to use OTIPAX, solution for atrial instillation
Not applicable.
If you stop using OTIPAX, solution for auricular instillation
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· R isk of local reactions of allergy type, irritation or redness of the ear canal. Declaration of side effects
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 OTIPAX, solution for atrial instillation?
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. The expiry date refers to the last day of that month.
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.
Duration of use of the bottle after first opening: 30 days.
Duration of use of the tube after opening: 10 days.
Storage conditions
Store at a temperature not exceeding 30 ° C.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What OTIPAX contains, solution for atrial instillation
The active substances are:
Phenazone ................................................. .................................................. ............................. 4 g
Lidocaine Hydrochloride ............................................... .................................................. .......... 1 g
For 100 g of solution for atrial instillation.
The other components are:
Sodium thiosulfate, ethanol, glycerol, purified water.
What is OTIPAX, solution for ear instillation and contents of the outer packaging
This medication is in the form of a solution for atrial instillation in 16 g vial or 5 g tube.
Marketing Authorization Holder
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Marketing Authorization Operator
BIOCODEX
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Maker
BIOCODEX
1, AVENUE BLAISE PASCAL
60000 BEAUVAIS
LA FRANCE
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
Not applicable.