NOTICE
ANSM - Last updated: 23/01/2017
Name of the medicinal product
CERULYSE 5 g / 100 g, solution for atrial instillation
xylene
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.
Do not use this medication for children.
What is in this leaflet?
1. What is CERULYSE 5 g / 100 g, solution for atrial instillation and in which cases it is used?
2. What information should be known before using CERULYSE 5 g / 100 g, solution for atrial instillation?
3. How to use CERULYSE 5 g / 100 g, solution for atrial instillation?
4. What are the possible side effects?
5. How to store CERULYSE 5 g / 100 g, solution for atrial instillation?
6. Package contents and other information.
1. WHAT IS CERULYSE 5 g / 100 g, solution for atrial instillation AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group CERUMENOLYTIQUE (S: Organs of the senses) - ATC code: S02DC
This medication is recommended to dissolve ear wax earplugs.
2. BEFORE YOU USE CERULYSE 5 g / 100 g, solution for atrial instillation?
Never use CERULYSE 5 g / 100 g, solution for atrial instillation:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· in case of perforation of the tympanum of infectious origin or of traumatic.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before using CERULYSE 5 g / 100 g, solution for atrial instillation.
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.
children
Not applicable.
Other medicines and CERULYSE 5 g / 100 g, solution for atrial instillation
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
CERULYSE 5 g / 100 g, solution for atrial instillation with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
This medication should be used with caution during pregnancy and lactation.
Sport
Not applicable.
Driving and using machines
Not applicable.
CERULYSE 5 g / 100 g, solution for atrial instillation contains
Not applicable.
3. HOW TO USE CERULYSE 5 g / 100 g, solution for atrial instillation?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Soft corks: keeping the head bent, instill a few drops (ear bath), about ten minutes before the ear wash.
Hard plugs: during the 3 to 4 days preceding the extraction of the wax plug, proceed to an ear bath, 3 times a day.
Method and route of administration
Ear canal.
Remove the white screw cap with a teat, remove the seal and screw the cap back onto the bottle. Unscrew the orange cap and perform atrial instillation. To avoid unpleasant contact of the cold solution in the ear, cool the bottle in the palm of the hand before use.
If you have used more CERULYSE 5 g / 100 g, solution for ear instillation you should:
Immediately consult your doctor or pharmacist.
If you forget to use CERULYSE 5 g / 100 g, solution for atrial instillation:
Not applicable.
If you stop using CERULYSE 5 g / 100 g, solution for atrial instillation:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· possibility of local reactions (allergy, irritation).
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 CERULYSE 5 g / 100 g, 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 after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
After first opening the vial, the product should be used within 30 days.
Please note the opening date on the packaging.
Do not use this medication if you notice any signs of deterioration.
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 CERULYSE contains 5 g / 100 g, solution for atrial instillation
· The active substance is:
Xylene ................................................. .................................................. ........................... 5.00 g
For 100 g of solution
· The other components are:
Acetate of alpha-tocopherol, essential oil of lavender, almond oil.
What is CERULYSE 5 g / 100 g, solution for ear instillation and contents of the pack
The drug is in the form of a solution for atrial instillation. Bottle of 10 ml.
Marketing Authorization Holder
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER CEDEX 2
Marketing Authorization Operator
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER CEDEX 2
Maker
CHAUVIN LABORATORY
ZI RIPOTIER HAUT
07200 AUBENAS
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]
{MM / YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).