Bausch + Lomb Cerulyse Ear Drops

Cerulyse is a medication in the form of a solution for ear instillation. It is recommended to dissolve earwax plugs in the ear canal to facilitate their removal.

Composition of Cerulyse for earwax blockages

Cerulyse is composed of xylene (5 g/100 g), which is its active ingredient. The excipients are alpha tocopheryl acetate, lavender essential oil, and almond oil.

Dosage of Cerulyse solution for earwax blockages
This medication is taken by ear.

To avoid contact of a cold solution in the ear, it is recommended to warm the bottle slightly (in the palm of your hand) before use.

Using Cerulyse for Soft Earwax

For soft earwax: with your head tilted, instill a few drops (ear rinse) for about ten minutes, then rinse your ear.

Using Cerulyse for Hard Earwax

For hard earwax: Rinse your ear 3 times a day for 3 to 4 days before your scheduled ear extraction appointment.

Precautions for Use with Cerulyse Ear Drops

You should not use Cerulyse if you have a perforated eardrum due to infection or trauma, or if you are allergic to any of the ingredients.
As a precaution, you should have your eardrum checked by a doctor before taking this medication.

Pregnancy, Breastfeeding: Can Cerulyse Be Used?

If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Do not store above 25°C.
Once opened, the solution must be used within 30 days.

Pack size: 10 ml bottle.

To prevent the formation of new earwax, Ceruspray solution must be used regularly.


LEAFLET
ANSM - Updated on: 04/12/2022
Name of the medicinal product
CERULYSE 5 g/100 g, solution for ear instillation
Xylene
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may 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 includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
Keep this medicine out of the reach of children.

What is in this leaflet? 1. What is CERULYSE 5 g/100 g, solution for ear instillation and what is it used for?
2. What you need to know before using CERULYSE 5 g/100 g, solution for ear instillation?
3. How to use CERULYSE 5 g/100 g, solution for ear instillation?
4. Possible side effects?
5. How to store CERULYSE 5 g/100 g, solution for ear instillation?
6. Contents of the pack and other information.

1. WHAT IS CERULYSE 5 g/100 g, solution for ear instillation AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: CERUMENOLYTIC (S: Sense organs) - ATC code: S02DC
This medication is recommended for dissolving earwax buildup in the ear canal.

2. WHAT YOU NEED TO KNOW BEFORE USING CERULYSE 5 g/100 g, solution for ear instillation?

Never use CERULYSE 5 g/100 g, solution for ear instillation:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication, listed in section 6.
· in case of an eardrum perforation due to infection or trauma.
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Warnings and Precautions
Talk to your doctor or pharmacist before using CERULYSE 5 g/100 g, ear instillation solution.
Special Warnings
If the eardrum is open, this medicine may cause adverse effects in the middle ear.
AS A PRECAUTION, before administration, have your eardrum checked by a doctor.
Children

Not applicable.
Other medicines and CERULYSE 5 g/100 g, ear instillation solution
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
CERULYSE 5 g/100 g, ear instillation solution with food and drink

Not applicable.
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should be used with caution during pregnancy and breastfeeding.
Athletes

Not applicable.
Driving and operating machinery
Not applicable.
CERULYSE 5 g/100 g, solution for ear instillation contains {name the excipient(s)}
Not applicable.

3. HOW TO USE CERULYSE 5 g/100 g, solution for ear instillation?
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 unsure.

Dosage
Soft earplugs: Keeping your head tilted, instill a few drops (ear wash) about ten minutes before washing your ear. · Hard earwax: For 3 to 4 days before removing the earwax, rinse the ear 3 times a day.
Method and route of administration
Auricular use.

Remove the white screw cap with the nipple.

Remove the seal.

Retighten the cap on the bottle.

Unscrew the orange cap and perform the ear instillation.

To avoid unpleasant contact with the cold solution in the ear, warm the bottle in the palm of your hand before use.
If you use more CERULYSE 5 g/100 g, solution for ear instillation than you should, consult your doctor or pharmacist immediately.
If you forget to use CERULYSE 5 g/100 g, solution for ear instillation,
Not applicable.
If you stop using CERULYSE 5 g/100 g, solution for ear instillation
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Possibility of local reactions (allergy, irritation).
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CERULYSE 5 g/100 g, solution for ear instillation?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening the bottle, the product must be used within 30 days.
Clearly write the date of opening on the packaging.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What CERULYSE 5 g/100 g, solution for ear instillation contains
· The active ingredient is:
Xylene.................................................................................................................................. 5.00 g
Per 100 g of solution
· The other ingredients are:
Alpha-tocopherol acetate, lavender essential oil, almond oil.
What CERULYSE 5 g/100 g, solution for ear instillation looks like and contents of the outer packaging
The medicine is presented as a solution for ear instillation. 10 ml bottle.
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER
50 AVENUE JEAN MONNET
07200 AUBENAS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicinal product is available on the ANSM website (France).