Leaflet: information for the user

Otocerum eye drops in solution

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this

leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

1. What Otocerum eye drops are and what they are used for

2. What you need to know before using Otocerum eye drops

3. How to use Otocerum eye drops

4. Possible side effects

5. Storage of Otocerum eye drops

6. Contents of the pack and additional information

Contains the active principles: turpentine oil, chlorobutanol, benzocaine, phenol, and castor oil; which act as cerumen solvents (earwax), antimicrobials, or itching relievers.

Otocerum ear drops is indicated for: Cerumen auricular solvent, antimicrobial, and mild analgesic. Pain-free extraction of cerumen auricular.

Otocerum ear drops is indicated for adults and children over 2 years old.

Do not use Otocerum eye drops:

• If you are allergic to turpentine oil, chlorobutanol, benzocaine, phenol or ricin oil or to the other component of this medicine (including in section 6).
• If you have a perforation of the eardrum (membrane that separates the outer ear from the middle ear).
• If your ear is discharging any product.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Otocerum eye drops.

• Apply only to the ear. Do not ingest or apply to the eyes.
• When applying the medicine, avoid contact between the dropper and the ear and fingers, to prevent the risk of contamination.

Children

Do not use this medicine in children under 2 years.

Use of Otocerum eye drops with other medicines

Do not use this preparation with other ear medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precaution, before applying this medicine during pregnancy or breastfeeding, you must evaluate that the benefit is greater than the possible risk.

Driving and operating machines

The influence of this medicine on the ability to drive and operate machines is none.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Otic route (in the external auditory canal).

The recommended dose is:

-Adults and children over 2 years old:

Apply 2 or 3 drops of Otocerum in the affected ear, in the morning and at night, for 3 to 4 days. If, after these days, the earwax plug does not come out easily, go to a medical center for earwax plug removal.

Before the first use, remove the plug from the bottle and place the dropper plug that is packaged in the box.

To apply the preparation correctly, it is recommended to hold the bottle between your hands for a certain time to warm it up before use; in this way, you can reduce the feeling of cold that the direct application of the medication produces in the ear.

At the time of application, it is recommended to tilt your head and keep it in that position for 30 seconds to facilitate the entry of the drops into the external auditory canal. If you need to treat the other ear, repeat this process.

Use in children

Do not use in children under 2 years old.

If you use more Otocerum than you should

Due to the presentation of the preparation (ear drops in solution) and its otic administration route, it is practically impossible to produce an overdose.

In case of using more than you should or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Otocerum

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent applications may produce skin irritation and dryness.

Allergic reactions, such as inflammation or skin changes, may occur. In very rare instances, more serious allergic reactions, such as rapid skin inflammation, have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special conservation conditions are required.

Discard once a month has passed after the packaging has been opened.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe turbidity in the solution.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Otocerum eye drops in solution

• The active principles are: oil of turpentine, chlorobutanol, benzocaine, phenol, and castor oil. Each ml of solution contains 150 mg of oil of turpentine, 50 mg of chlorobutanol, 30 mg of benzocaine, 10 mg of phenol, and 400 mg of castor oil.

• The other component (excipient) is ethanol.

Appearance of the product and content of the packaging

Otocerum is presented in eye drops in solution, yellow in color and with a turpentine odor. .....

It is presented in a multidose container containing 10 ml of solution. A transparent glass vial provided with a screw cap. Additionally, it includes a screw cap dropper packaged inside a case.

Holder of the marketing authorization and responsible for manufacturing

Reig Jofre, S.A. Laboratory

Gran Capità, 10

08970 Sant Joan Despí

Spain

Last review date of this leaflet: January 2023.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

(AEMPS)http://www.aemps.gob.es/.