Package leaflet: Information for the patient

CERULISINA 4.6 g/100 ml + 87 g/100 ml ear drops solution

Dimethylbenzene; Sweet almond oil
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What CERULISINA is and what it is used for
What you need to know before using CERULISINA
How to use CERULISINA
Possible side effects
How to store CERULISINA
Contents of the pack and other information

1. What CERULISINA is and what it is used for

CERULISINA is a solution used to remove cerumen or epithelial plugs (earwax and desquamated skin) that form in the ear canal, even after ear surgery, which are often responsible for significant symptoms such as hearing loss, tinnitus, dizziness, sometimes accompanied by headache and earache.
This medicinal product works through the combined action of sweet almond oil, which has an emollient effect and softens the earwax plug, and dimethylbenzene, which has a solvent effect and dissolves it.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using CERULISINA

Do not use CERULISINA if:

you are allergic to dimethylbenzene or sweet almond oil.
you have middle ear diseases such as inflammations (otitis) or a perforated eardrum.

Warnings and precautions
There are no special precautions for the use of CERULISINA. If you have any doubts, consult your doctor or pharmacist before using this medicine.
During treatment with CERULISINA, especially if prolonged, you may experience itching and/or redness (signs of sensitization). If this occurs, discontinue treatment and consult your doctor.
Other medicines and CERULISINA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. However, no interactions between CERULISINA and other drugs are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Nevertheless, no harmful effects on pregnant women are known at the therapeutic doses indicated in this leaflet.
Driving and using machines
CERULISINA does not affect the ability to drive vehicles or operate machinery.

3. How to use CERULISINA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is equal to the content of the dropper.
If necessary (hard plugs), you may repeat the instillations 2–3 times a day and continue treatment for 3–5 days, depending on the amount of earwax to be removed.
Do not exceed the recommended doses. Consult your doctor if the condition recurs or if you notice any changes in its characteristics.

Method of administration
CERULISINA is a medicine for use only in the ear (to be used in the ear canal). To use it:

Fill the dropper.
Tilt your head and instil the drops into the ear.
Remain in this position for 5–10 minutes.
Rinse the ear with lukewarm water.

If you use more CERULISINA than you should
In case of accidental ingestion of an excessive dose of CERULISINA, immediately contact a doctor or go to the nearest hospital.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Prolonged use of CERULISINA may cause redness and itching (sensitization phenomena). If this occurs, discontinue treatment and consult your doctor.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store CERULISINA

Keep this medicine out of the sight and reach of children.
No special storage precautions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CERULISINA contains
The active substances are: dimethylbenzene and almond oil.
1 ml of solution contains 46 mg of dimethylbenzene and 870 mg of almond oil.
Description of the appearance of CERULISINA and contents of the pack
CERULISINA is a solution contained in a 20 ml glass bottle with a dropper.
Marketing Authorization Holder
IBSA FARMACEUTICI ITALIA S.R.L.
VIA MARTIRI DI CEFALONIA, 2, 26900 - LODI (LO).
Manufacturer
Alfa-Wassermann S.p.A. - Via E. Fermi, 1 - 65020 Alanno (PE)
Tel: 0858571321; Fax: 0858543128