Medicines
Update of 10/07/2025
*CÉRULYSE®
xylene
Forms and presentations
Solution for auricular instillation at 5 g/100 g: Bottle of 10 ml, with dropper stopper.Composition
| p bottle | |
| Xylene
|
500 mg |
Indications
Extraction of earwax plugs.Dosage and administration
DosageAuricular route.
- Soft plugs: with the head tilted, instil a few drops (ear bath), about ten minutes before ear washing.
- Hard plugs: during the 3 to 4 days preceding extraction of the earwax plug, perform an ear bath 3 times a day.
Method of administration:
Remove the white screw cap topped with a teat, remove the sealing gasket and screw the cap back onto the bottle. Unscrew the orange cap and perform the auricular instillation. To avoid the unpleasant contact of the cold solution in the ear, warm the bottle in the palm of your hand before use.
Contraindications
- Tympanic perforation of infectious or traumatic origin (see Warnings and Precautions for Use).
- Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
Warnings and precautions
Warnings:
Ensure tympanic membrane integrity before any administration.
In case of tympanic destruction, intra-auricular administration risks bringing the product into contact with middle ear structures and causing undesirable effects at their level.
Interactions
The data available to date do not suggest the existence of clinically significant interactions.
Fertility, pregnancy and breastfeeding
To be used with caution, even in the absence of tympanic perforation, in pregnant or breastfeeding women, due to lack of usable clinical data.
Driving and using machines
No impact of Cérulyse on the ability to drive vehicles and use machines is expected.Adverse effects
Possibility of local reactions such as allergy or irritation.
Reporting of suspected adverse reactions:Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.
Overdose
No cases of overdose have been reported.
In case of accidental ingestion of the contents of the vial, xylene poisoning remains unlikely given the limited quantity of xylene ingested.
Pharmacodynamics
Pharmacotherapeutic class: cerumenolytic (ATC code: S02DC; S: sense organs).
Xylene is a lipophilic solvent; it facilitates removal of the earwax plug by dissolving it.
Preclinical safety
Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenesis, and reproduction and developmental functions revealed no particular risk for humans.
Storage conditions
- Shelf life before opening the vial:
- 3 years.
Store at a temperature not exceeding 25 °C.
- After 1re opening the vial:
- The product must be used within 30 days.
HANDLING/DISPOSAL INSTRUCTIONS
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400930200490 (1957/96, SmPC rev 23.01.2017). |
| Not reimbursed by Social Security. Collect. |
CHAUVIN Laboratory
416, rue Samuel-Morse. CS 99535. 34961 Montpellier
Tel: 04 67 12 30 30
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.