Otocerum solution for otic use

Patient Information Leaflet

Introduction

Patient Information Leaflet

Otocerum ear drops solution

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Leaflet Contents

1. What Otocerum ear drops are and what they are used for
2. What you need to know before using Otocerum ear drops
3. How to use Otocerum ear drops
4. Possible side effects
5. How to store Otocerum ear drops
6. Contents of the pack and other information

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

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

Otocerum ear drops are indicated for: dissolving earwax, as an antiseptic, and for mild analgesic effect. Painless removal of earwax.

Otocerum ear drops are indicated for use in 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, castor oil, or to any other component of this medicine (listed in section 6).
• If you have a perforation of the tympanic membrane (the membrane separating the outer ear from the middle ear).
• If your ear is discharging any substance.

Warnings and precautions

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

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

Children

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

Use of Otocerum ear drops with other medicines

Do not use this preparation together with other medicines administered by the otic route.

Pregnancy and breastfeeding

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

As a precautionary measure, before using this medicine during pregnancy or breastfeeding, the benefit should be weighed against any possible risk.

Driving and using machines

This medicine has no influence on the ability to drive or operate machinery.

3. How to use Otocerum Ear Drops

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For otic use (in the external ear canal).

Recommended dose:

• Adults and children over 2 years of age:

Apply 2 to 3 drops of Otocerum into the affected ear in the morning and at night for 3 or 4 days. If after this period the earwax plug has not come out easily—which frequently occurs—consult a medical center for removal of the earwax plug.

Before first use, remove the cap from the bottle and attach the dropper cap provided in a separate pouch inside the package.

For proper application of the solution, it is advisable to hold the bottle in your hands for a while before use to warm it; this helps reduce the sensation of cold caused by direct application of the medicine into the ear.

At the time of application, it is recommended to tilt the head and maintain this position for 30 seconds to facilitate the drops penetrating into the external auditory canal. If necessary, repeat the same procedure for the other ear.

Use in children

Do not use in children under 2 years of age.

If you use more Otocerum than you should

Due to the formulation of the product (ear drops in solution) and its route of administration (otic), overdose is practically impossible.

However, if you use more than recommended or accidentally ingest the product, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Otocerum

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

Frequent applications may cause skin irritation and dryness.

Allergic reactions may occur, such as swelling or skin changes. Very rarely, more serious allergic reactions have been reported, such as rapid swelling under the skin.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Otocerum ear drops

Store below 30º.

Discard one month after opening the container.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Otocerum ear drops solution

• The active substances are: turpentine oil, chlorobutanol, benzocaine, phenol, and castor oil. Each ml of solution contains 150 mg of turpentine oil, 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 container

Otocerum is presented as an ear drop solution, yellow in color and with a turpentine odor.

It is supplied in a multidose container containing 10 ml of solution. A transparent glass bottle with a screw cap. Also includes a dropper cap, individually pouch-packed, included within the carton.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capità, 10

08970 Sant Joan Despí

Spain

Date of the most recent revision of this leaflet: February 2025.

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .