Package leaflet content

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

2. What you need to know before you start using Otocerum ear drops

3. How to use Otocerum ear drops

4. Possible side effects

5. How to store Otocerum ear drops

6. Package contents and additional information

It contains the following active ingredients: essence of turpentine, chlorobutanol, benzocaine, phenol and castor oil; that act as a solvent for cerumen (ear wax) or as antiseptics (antimicrobial) or relieving itchiness.

Otocerum ear drops are indicated in: Ear wax solvent, antiseptic and slightly analgesic. Painless removal of ear wax.

Otocerum ear drops are indicated in adults and children over 2 years of age.

Do not use Otocerum ear drops:

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

Warnings and cautions

Consult your doctor or pharmacist before using Otocerum ear drops.

• Apply only to the ear. Do not ingest or apply in 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 of age.

Using Otocerum ear drops with other medicines

You should not use this preparation together with other otic medications.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, before applying this medicine during pregnancy or lactation, you should assess that the benefit outweighs the possible risk.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is zero.

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

Otic route (in the external canal of the ear).

The recommended dose is:

- Adults and children over 2 years :

Apply 2 or 3 drops of Otocerum in the affected ear, in the morning and at night, for 3 or 4 days, plugging each time with a cotton ball. If after these days the plug does not come out easily, which happens frequently, go to a medical center to remove the wax plug.

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

For the correct application of the preparation, it is advisable to keep the bottle in your hands for a certain time to warm it up before use; in this way, it is possible to reduce the sensation of cold produced by the direct application of the medicine in the ear.

At the time of application, it is recommended to tilt the head and keep it in that position for 30 seconds to facilitate the drops to penetrate the external auditory canal. If the other ear needs to be treated, 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 administration route, it is practically impossible that overdose may occur.

In case of using more than you should or accidental ingestion, immediately consult your doctor or pharmacist, or go to a medical center or call the Toxicology Information Service, telephone 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 a forgotten dose.

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

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Frequent applications can cause skin irritation and dryness.

Allergic reactions such as inflammation or skin changes may occur. Major allergic reactions, such as rapid swelling under the skin, have been reported very rarely.

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es

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

It does not require any special storage conditions.

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 which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice cloudiness in the solution.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Otocerum ear drops solution

• The active principles are: essence of turpentine, 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.

What the product looks like and contents of the pack

Otocerum is presented as ear drops in solution, yellow in color and with the odor of turpentine. .....

It is presented in a multi-dose container containing 10 ml of solution. Transparent glass bottle fitted with a screw cap. It also includes an attached pocket dropper cap inside the case.

Holder of the marketing authorization and responsible for manufacturing

Laboratory Reig Jofre , SA

Great Captain, 10

08970 Sant Joan Despí

Date of the last revision of this leaflet: January 2014.

Detailed information on this medicine is available on the Agency's website.

Spanish Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ .