Cerulyse is a medicine in the form of an atrial instillation solution. It is recommended to dissolve the ear plugs of the ear canal in order to facilitate their evacuation.
Composition of Cerulysis against Earplugs
Cerulysis is composed of xylene (5 g /100 g), which is its active substance. The excipients are alpha tocopherol acetate, lavender essential oil and almond oil.
Dosage of Cerulyse solution for cerumen stopper
This medicine is taken by the ear tract.To avoid contact of a cold solution in the ear, it is recommended to slightly warm the vial (hollow of the hand) before use.
Use of Cerulysis in soft stoppers
In case of soft cerumen plugs: the head tilted, insert a few drops (ear intestine) tilted head, about 10 minutes, then wash the ear.
Use of Cerulysis in case of hard stoppers
In case of hard stoppers: carry out an ear bath 3 times a day, for the 3 to 4 days before the scheduled excavation.
Precautions for use with Cérulyse drop for mouthful ear
You should not use Cerulyse when the eardrum is perforation with an infectious or traumatic origin or if you are allergic to any of the ingredients.
As a precautionary measure, the integrity of your eardrum should be checked by a doctor before taking this medicine.
Pregnancy, breast-feeding: can Cerulyse be used?
If you are pregnant or breast-feeding or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not store above 25oC.
Once the vial has been opened, the solution should be used within 30 days.
Pack size: 10 ml vial.
ANSM - Updated on: 04/12/2022
CERULYSE 5 g/100 g, solution for ear instillation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylene................................................................................................................................. 5.00 g
For 100 g of solution.
For the full list of excipients, see section 6.1.
Solution for ear instillation.
4.2. Dosage and method of administration
Auricular route.
· Soft earplugs: keeping the head tilted, instill a few drops (ear bath), about ten minutes before washing the ear.
· Hard earwax: during the 3 to 4 days before removing the earwax, rinse your ear 3 times a day.
Mode of administration
Remove the white screw cap with the teat, remove the seal, and screw the cap back onto 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.
Tympanic perforation of infectious or traumatic origin (see warning).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
ENSURE TYMPANIC INTEGRITY BEFORE ANY ADMINISTRATION.
In case of tympanic destruction, intra-auricular administration risks bringing the product into contact with the structures of the middle ear and causing adverse effects at their level.
4.5. Interactions with other medicinal products and other forms of interaction
The data available to date do not suggest the existence of clinically significant interactions.
4.6. Fertility, pregnancy and breastfeeding
Use with caution, even in the absence of eardrum perforation, in pregnant or breastfeeding women, due to the lack of usable clinical data.
4.7. Effects on ability to drive and use machines
Cérulyse is not expected to have an impact on the ability to drive vehicles and use machines.
Possibility of local reactions such as allergy and irritation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions 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 .
No cases of overdose have been reported.
In the event of accidental ingestion of the contents of the bottle, xylene poisoning remains unlikely given the limited quantity of xylene ingested.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: CERUMENOLYTIC (S: Sense organs), ATC code: S02DC .
Xylene is a lipophilic solvent, it facilitates the removal of earwax plugs by dissolving them.
5.2. Pharmacokinetic properties
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Alpha-tocopheryl acetate, lavender essential oil, almond oil.
Before opening the bottle: 3 years.
After first opening the bottle, the product must be used within 30 days.
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
For storage conditions of the medicinal product after first opening, see section 6.3.
6.5. Nature and contents of outer packaging
10 ml bottle (type III brown glass), seal (tresylene-S), dropper cap (PVC, polypropylene) and cap (polyethylene).
6.6. Special precautions for disposal and handling
Any unused medicine or waste material should be disposed of in accordance with local regulations.
7. MARKETING AUTHORISATION HOLDER
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
8. MARKETING AUTHORISATION NUMBER(S)
· 34009 302 004 9 0 10 ml in bottle (brown glass) + dropper (PVC).
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
Date of first authorization: {DD month YYYY}
Last renewal date: {DD month YYYY}
[to be completed later by the holder]
{DD month YYYY}
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Drug not subject to medical prescription.
ANSM - Updated on: 04/12/2022
CERULYSE 5 g/100 g, solution for ear instillation
Xylene
Please 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 directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any 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 should contact your doctor if you do not feel any improvement or if you feel worse.
· Keep this medicine out of reach of children.
What does this leaflet contain?
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. What are the possible side effects?
5. How to store CERULYSE 5 g/100 g, solution for ear instillation?
6. Package contents 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 to dissolve earwax plugs in the ear canal.
2. WHAT INFORMATION DO 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 medicine, listed in section 6.
· in case of perforation of the eardrum 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, solution for ear instillation .
Special warnings
If the eardrum is open, this medication may cause side effects in the middle ear.
AS A PRECAUTIONARY MEASURE, before any administration, it is advisable to have the integrity of your eardrum checked by a DOCTOR.
Children
Not applicable.
Other medicines and CERULYSE 5 g/100 g, solution for ear instillation
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
CERULYSE 5 g/100 g, solution for ear instillation 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medication 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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
· Soft earplugs: keeping your head tilted, instill a few drops (ear bath), about ten minutes before washing your ear.
· Hard earwax: during the 3 to 4 days before removing the earwax, rinse your ear 3 times a day.
Method and route of administration
Auricular route.
|
|
Remove the white screw cap with a teat on top |
|
|
remove the gasket |
|
|
screw the cap back onto the bottle |
|
|
Unscrew the orange cap and perform the ear instillation. |
To avoid unpleasant contact of 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
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. WHAT ARE THE 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 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 bottle, the product must be used within 30 days.
Clearly write the opening date 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 substance is:
Xylene............................................................................................................................ 5.00 g
For 100 g of solution
· The other components are:
Alpha-tocopheryl acetate, lavender essential oil, almond oil.
What is CERULYSE 5 g/100 g, solution for ear instillation and contents of the outer packaging?
The medicine comes in the form of a solution for ear instillation. 10 ml bottle.
Marketing Authorisation Holder
416, RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
