MENADERM OTOLOGICO 0.25 mg/10 mg/ml OTIC DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

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

Beclometasone dipropionate / Clioquinol

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

• Keep this package leaflet, as you may need to read it again.

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

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Menaderm Otológico is and what it is used for
2. What you need to know before using Menaderm Otológico
3. How to use Menaderm Otológico
4. Possible side effects
5. Storage of Menaderm Otológico
6. Package Contents and Additional Information

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

It is a medication that contains beclometasone dipropionate, a corticosteroid anti-inflammatory, and clioquinol, with antifungal (against fungi) and antibacterial activity.

Menaderm Otológico is indicated for:

Treatment of inflammatory and itchy ear conditions (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 of age.

2. What you need to know before using Menaderm Otológico

Do not use Menaderm Otológico:

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

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 any hypersensitivity reaction with irritation, itching, or swelling occurs, treatment should be discontinued and the doctor consulted.
• Clioquinol may cause significant reactions in some users, even in people with hypersensitivity to other derivatives or iodides (cross-sensitivity).
• The medication should not be used covered with impermeable materials to air and water, such as poorly breathable bandages, to avoid iodine absorption (which contains clioquinol).

• 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 can stain them. Although these stains disappear from most tissues when washed, precautions are recommended.

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

Interference with Analytical Tests

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

Children and Adolescents

Do not use in children under 5 years of age.

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

Using Menaderm Otológico with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, 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 plan 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 Using Machines

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

3. How to Use Menaderm Otológico

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

The recommended dose is:

• Adults from 12 years of age:

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, consult your doctor.

Treatment should not exceed 2 weeks.

Instructions for Use

• 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 operation, if necessary, in the other ear.

Use in Children and Adolescents

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

If You Use More Menaderm Otológico Than You Should

Due to its use via the ear, the possibility of intoxication is very unlikely.

Excessive use of the medication may cause side effects.

In case of accidental ingestion, vomiting should be induced, gastric lavage performed, and symptomatic treatment provided under medical supervision.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested (or go to a medical center).

If You Forget to Use Menaderm Otológico

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

If You Stop Using Menaderm Otológico

Do not stop treatment before the indicated 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.

4. Possible Side Effects

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

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

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Menaderm Otológico

No special storage conditions are required.

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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection 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. Package Contents and Additional Information

Composition of Menaderm Otológico

• The active ingredients are Beclometasone dipropionate and Clioquinol. Each ml of solution contains 0.25 mg of beclometasone dipropionate (0.025%) and 10 mg of clioquinol (1%).
• The other component (excipient) is: macrogol.

Appearance of the Product and Package Contents

Menaderm Otológico 0.25 mg/10 mg/mlis presented as ear drops in solution, which is a clear yellow liquid.

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

Each bottle contains 10 ml of solution.

Marketing Authorization Holder and Manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona)

Tel: 934 628 800

Date of the Last Revision of this Package Leaflet: July 2014.

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