Active ingredients: Dimethylbenzene, Almond oil
CERULISIN 5 g / 100 g + 95 g / 100 g ear drops solution
Why is Cerulisin used? What is it for?
CERULISIN is a solution used to eliminate excess ear wax in the ear.
WHY IT IS USED
CERULISIN is used for the dissolution of earwax and epidermal plugs. In dressing for cleaning operating cavities following interventions in the middle ear
Contraindications When Cerulisin should not be used
Middle ear diseases (otitis, perforated eardrum).
Known hypersensitivity to components or other closely related substances from a chemical point of view.
It is advisable to consult your doctor if these disorders have already occurred.
See also chapter on PREGNANCY AND BREASTFEEDING.
Precautions for use What you need to know before taking Cerulisin
The use of the preparation does not involve particular precautions.
Interactions Which drugs or foods can modify the effect of Cerulisin
There are no known incompatibilities with other medicines or foods.
If you are using other medicines, ask your doctor or pharmacist for help.
Warnings It is important to know that:
WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
In pregnant and lactating women, the product should be used only in case of real need and under direct medical supervision.
CERULISIN should not be used in cases of perforated eardrum.
The use, especially if prolonged, of the product can give rise to sensitization phenomena (allergy). If this occurs, stop the treatment and consult the doctor in order to establish suitable therapy.
CERULISIN has no effect on the ability to drive and use machines.
Dose, Method and Time of Administration How to use Cerulisin: Posology
- How many: the contents of a dropper, preferably warmed, is poured, after tilting the head, into the ear canal. The subject should remain in this position for 5-10 minutes. The ear is then washed with lukewarm water.
WARNING: DO NOT EXCEED THE INDICATED DOSES WITHOUT THE ADVICE OF THE DOCTOR.
- When and for how long: for hard plugs, the instillations are performed 2-3 times a day and the treatment must be continued for 3-5 days in relation to the amount of earwax to be extracted.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Overdose What to do if you have taken too much Cerulisin
No phenomena occurred following excessive administration of the drug have been reported.
In case of accidental ingestion / intake of an overdose of CERULISIN, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Cerulisin
No undesirable effects are known, however prolonged use of the product may give rise to sensitization phenomena (allergy).
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. Side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Request and fill in the undesirable effects report form available at the pharmacy.
Expiry and Retention
See the expiry date indicated on the package. The expiry date indicated refers to the product in intact and correctly stored packaging.
CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE INDICATED ON THE PACKAGE.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
It is important to always have the information on the medicine available, so keep both the box and the package leaflet
COMPOSITION
1 gram of solution contains: Active ingredient: 50 mg dimethylbenzene and 950 mg almond oil, for a total of 1 g of dimethylbenzene and 19 g of almond oil per 20 ml bottle.
HOW IT LOOKS
CERULISIN comes in the form of drops for ear use in solution (for use in the ear canal), contained in a glass vial. The contents of the package are 20 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CERULISIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g contain: Dimethylbenzene 5 g, sweet almond oil 95 g.
03.0 PHARMACEUTICAL FORM
Otological solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For the dissolution of earwax and epidermal plugs. In the cleaning dressings of the operating cavities following interventions in the middle ear.
04.2 Posology and method of administration
The contents of a dropper, preferably warmed, are poured, after tilting the head, into the ear canal. The subject should remain in this position for 5-10 minutes. Afterwards, the ear is washed with warm water. For hard plugs, the instillations are performed 2-3 times a day and the treatment must be continued for 3-5 days in relation to the amount of earwax to be extracted.
Do not exceed the recommended dose.
04.3 Contraindications
Middle ear diseases (otitis, perforated eardrum).
Individual ascertained hypersensitivity to the product.
04.4 Special warnings and appropriate precautions for use
The use of the preparation does not involve particular precautions.
Warnings
Do not use in cases of perforated eardrum.
The use, especially if prolonged, of the product can give rise to sensitization phenomena.
If this occurs, stop the treatment and consult your doctor in order to establish appropriate therapy.
Do not use the medicine after the expiry date indicated on the package.
Notify your doctor or pharmacist of any undesirable effects not described in the package leaflet.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
No harmful effects are known at normal therapeutic doses.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
None known.
04.9 Overdose
There are no known overdose syndromes.
05.0 PHARMACOLOGICAL PROPERTIES
Cerulisin is an otological solution composed of 5% dimethylbenzene (Chilean) in sweet almond oil. These two associated substances carry out a lipo-keratolic action against the earwax or epidermal plugs that form in the ear canal and which often cause considerable disturbances, such as deafness, buzzing, dizziness, sometimes accompanied by migraines and otalgia. This pathology is due to the swelling of the earwax plugs which when they come into contact with water, for example following a bath, with consequent obstruction of the ear canal. In other cases, the pathological state is caused, paradoxically, by used instruments for cleaning, cotton or other, which converge towards the eardrum particles of earwax.
The epidermal plugs, on the other hand, are formed when a hypersecretion of earwax and a desquamation of the duct coexists and are difficult to extract due to their hardness.
The extraction of these caps is therefore necessary and is facilitated by the local administration of Cerulisin which adds the solvent action, without swelling, of dimethylbenzene to the emollient action of sweet almond oil.
The extraction is also painless and does not cause irritation in both adults and children.
05.1 Pharmacodynamic properties
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05.2 Pharmacokinetic properties
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05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
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06.2 Incompatibility
None known.
06.3 Period of validity
5 years in intact packaging.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Glass bottle containing 20ml of solution, polythene dropper.
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
S.p.A. Italiana Laboratori BOUTY - Milan
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. N ° 020157018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
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10.0 DATE OF REVISION OF THE TEXT
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