Label: Information for the User

Menaderm Otológico 0.25 mg/ 10 mg/ ml Ear Drops in Solution

Beclometasona dipropionato / Clioquinol

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Menaderm Otológico is and for what it is used

2.What you need to know before starting to use Menaderm Otológico

3.How to use Menaderm Otológico

4.Possible adverse effects

5.Storage of Menaderm Otológico

6.Contents of the package and additional information

It is a medication that contains beclometasona dipropionato as active principles, an anti-inflammatory corticosteroid, and clioquinol, with antifungal and antibacterial activity.

Menaderm Otológic is indicated for:

Treatment of inflammatory conditions and itching of the ear (external auditory canal) that respond to corticosteroids, with infection caused by microorganisms sensitive to clioquinol, such as bacteria or fungi.

Menaderm Otológico is indicated for adults over 12 years old.

Outer Ear Menaderm Allergy:

• If you are allergic to beclometasone, other corticosteroids, clioquinol, iodine, or any of the other components of this medication (listed in section 6).
• If you have skin infections caused by viruses (e.g. herpes or chickenpox).
• Over open wounds.
• If you have or may have a perforated eardrum.
• In children under 5 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Menaderm Otológico.

• This medication should only be applied to the ear. It should not come into contact with the eyes or mucous membranes (e.g. the mouth or nose).
• If a hypersensitivity reaction with irritation, itching, or swelling appears, you must suspend treatment and consult your doctor.
• Clioquinol may cause significant reactions in some users, even in people with hypersensitivity to other derivatives or iodides (cross-sensitivity).
• Do not use the medicated material covered with impermeable materials to air and water, such as non-breathable dressings, to avoid iodine absorption (which contains clioquinol).

- The prolonged use of clioquinol may cause overgrowth of other microorganisms different from those of your condition.

- Clioquinol in contact with clothing, skin, nails, and blonde hair may stain them. Although these stains disappear from most tissues after washing, it is recommended to take the necessary precautions.

• The non-professional use of topical corticosteroids may mask symptoms.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Interference with Analytical Tests

If you are to undergo any diagnostic test (including blood, urine, etc.) inform your doctor that you are being treated with this medication, as it may alter the results, for example: thyroid function tests.

Children and Adolescents

Do not use in children under 5 years old.

In children over 5 years and under 12 years, the use of this medication is not recommended.

Use of Menaderm Otológico with Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use Menaderm Otológico with other ear products.

Pregnancy, Breastfeeding, and Fertility

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

Menaderm Otológico should not be used during pregnancy or breastfeeding, except if the potential benefit justifies the potential risk to the fetus and always under medical supervision.

Driving and Operating Machines

No effects on the ability to drive and operate machines have been observed.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults 12 years and older:

Instill 2-3 drops, 3 times a day in the ear (external auditory canal), for 5-7 days.

If symptoms worsen or persist after 7 days of treatment, you must consult your doctor.

Do not exceed 2 weeks of treatment.

Usage Instructions

• Warm the bottle before use by holding it in the palm of your hand for a few minutes. This will prevent discomfort when the cold solution comes into contact with the ear.
• With your head tilted to one side, apply the drops to the affected ear. Keep your head tilted for at least 30 seconds to allow the drops to penetrate the external auditory canal.
• Repeat the procedure, if necessary, in the other ear.

Use in children and adolescents

Menaderm Otológico is contraindicated in children under 5 years and is not recommended for children under 12 years.

If you use more Menaderm Otológico than you should

Due to its otic use, the likelihood of poisoning is very unlikely.

Excessive use of the medication may cause adverse effects.

In case of accidental ingestion, it is recommended to induce vomiting, gastric lavage, and symptomatic treatment under medical supervision.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, Teléfono 91 562 04 20, indicating the medication and the amount ingested (or visit a medical center.

If you forget to use Menaderm Otológico

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

If you have forgotten a dose, apply it as soon as possible and continue with your regular schedule as prescribed or according to the package instructions.

If you interrupt treatment with Menaderm Otológico

Do not discontinue treatment before the recommended time by your doctor, as the condition may recur.

If you have any other doubts 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.

The adverse effects that may occur are generally local and transient.

Effects may appear at the application site: irritation, rash, sensation of burning, redness, itching, dryness, acne, swelling, inflammation of the hair follicle (folliculitis), skin allergic reaction (contact dermatitis).Blurred vision may also occur with an unknown frequency (the frequency cannot be estimated from the available data).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through theSpanish 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 requires special conservation conditions.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Chemical Composition of Menaderm Ological

- The active principles are Beclometasona dipropionato and Clioquinol. Each ml of solution contains 0.25mg of beclometasona dipropionato (0.025%) and 10mg of clioquinol (1%).

- The other component (excipient) is: macrogol.

Appearance of the product and content of the container

Menaderm Ological 0.25 mg/ 10 mg/ mlis presented in eye drops in solution, which are aclear liquid of yellow color.

It is presented in a glass bottle with a rubber stopper. A dropper is attached.

Each bottle contains 10ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona)

Tel: 934 628 800

Revision date of this leaflet: July 2014.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.