OTOCERUM Ear Drops in Solution

Introduction

Package Leaflet: Information for the User

Otocerum Ear Drops in Solution

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What Otocerum Ear Drops are and what they are used for
2. What you need to know before starting to use Otocerum Ear Drops
3. How to use Otocerum Ear Drops
4. Possible side effects
5. Storage of Otocerum Ear Drops
6. Contents of the packaging and additional information

1. What Otocerum Ear Drops are and what they are used for

They contain the following active ingredients: turpentine essence, chlorobutanol, benzocaine, phenol, and castor oil; which act as solvents for earwax (cerumen) or as antiseptics (antimicrobial) or relieving itching.

Otocerum Ear Drops are indicated for: Earwax solvent, antiseptic, and mildly analgesic. Painless removal of earwax.

Otocerum Ear Drops are indicated for adults and children over 2 years of age.

2. What you need to know before starting to use Otocerum Ear Drops

Do not use Otocerum Ear Drops:

• If you are allergic to turpentine essence, chlorobutanol, benzocaine, phenol, or castor oil or to any other component of this medication (listed in section 6).
• If you have a perforated eardrum (membrane that separates the outer ear from the middle ear).
• If your ear is secreting any product.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Otocerum Ear Drops.

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

Children

Do not use this medication in children under 2 years of age.

Using Otocerum Ear Drops with other medications

Do not use this preparation with other medications via the otic route.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, before applying this medication during pregnancy or breastfeeding, the benefit must be greater than the possible risk.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil.

3. How to use Otocerum Ear Drops

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Otic route (in the external ear canal).

The recommended dose is:

• Adults and children over 2 years of age:

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

Before the first use, remove the cap from the bottle and place the dropper cap that is attached to the packaging.

For the correct application of the preparation, it is recommended to keep the bottle between your hands for a while to warm it up before use; in this way, the sensation of cold that produces the direct application of the medication in the ear is reduced.

At the time of application, it is recommended to tilt your head and keep it in this position for 30 seconds to facilitate the penetration of the drops into the external auditory canal. If it is necessary to treat the other ear, this same process should be repeated.

Use in Children

Do not use in children under 2 years of age.

If you use more Otocerum than you should

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

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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Otocerum

Do not use a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Frequent applications can cause skin irritation and dryness.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

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

5. Storage of Otocerum Ear Drops

Keep below 30°C.

Discard one month after opening the packaging.

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

Do not use this medication after the expiration date shown 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Otocerum Ear Drops in Solution

• The active ingredients are: turpentine essence, chlorobutanol, benzocaine, phenol, and castor oil. Each ml of solution contains 150 mg of turpentine essence, 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 Contents of the Packaging

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

It is presented in a multidose container containing 10 ml of solution. Transparent glass bottle with a screw cap. It also includes a dropper cap attached to the packaging.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capità, 10

08970 Sant Joan Despí

Spain

Date of the Last Revision of this Package Leaflet: February 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.