Menaderm Otologico 0.25 mg/10 mg/ml ear drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Beclometasone dipropionate / Clioquinol

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

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

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

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

Leaflet contents

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 adverse effects
5. How to store Menaderm Otológico
6. Contents of the pack and other information

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

Menaderm Otológico is a medicine that contains as active substances beclometasone dipropionate, a corticosteroid anti-inflammatory agent, and clioquinol, which has antifungal (against fungi) and antibacterial activity.

Menaderm Otológico is indicated for:

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

Menaderm Otológico is indicated in 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 of the other components of this medicine (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 perforation of the eardrum.
• In children under 5 years of age.

Warnings and precautions

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

• This medicine is for ear use only. It must not come into contact with the eyes or mucous membranes (e.g., mouth or nose).

• If any allergic reaction occurs, such as irritation, itching, or swelling, discontinue treatment and consult your doctor.

• Clioquinol may cause significant reactions in some users, even in individuals with hypersensitivity to other derivatives or iodides (cross-sensitivity).

• Do not use the medicine covered with air- and water-impermeable materials, such as non-breathable dressings, to avoid absorption of iodine (contained in clioquinol).

• Prolonged use of clioquinol may lead to overgrowth of microorganisms different from those causing your condition.

• Clioquinol may stain clothing, skin, nails, and blonde hair upon contact. Although these stains usually disappear from most tissues with washing, appropriate precautions are recommended.

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

Interference with laboratory tests

If you are scheduled to undergo any diagnostic tests (including blood or urine tests), inform your doctor that you are being treated with this medicine, as it may alter test results; for example, tests to assess thyroid function.

Children and adolescents

Do not use in children under 5 years of age.

The use of this medicine is not recommended in children over 5 years and under 12 years of age.

Use of Menaderm Otológico with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not use Menaderm Otológico together with other ear products.

Pregnancy, breastfeeding, and fertility

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.

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 or operate machinery have been observed.

3. How to use Menaderm Otic

Follow exactly the instructions for use of this medicine as given 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 into the ear (external auditory canal), for 5–7 days.

If symptoms worsen or persist after 7 days of treatment, you must 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 the head tilted to one side, apply the drops into the affected ear. Keep the head tilted for at least 30 seconds to allow the drops to penetrate into the external auditory canal.
• Repeat the procedure, if necessary, in the other ear.

Use in children and adolescents

Menaderm Otic 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 Otic than you should

Due to its topical otic use, the risk of intoxication is highly unlikely.

Excessive use of the medicine may cause adverse effects.

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

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

If you forget to use Menaderm Otic

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

If you have missed a dose, take it as soon as possible and continue with your usual dosing schedule as prescribed or according to the instructions in the package leaflet.

If you stop treatment with Menaderm Otic

Do not discontinue treatment earlier than indicated by your doctor, as the condition may recur.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

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

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 Menaderm Otológico

No special storage conditions are required.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Menaderm Otic

• The active substances 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 contents of the pack

Menaderm Otic 0.25 mg/10 mg/ml is available as ear drops in solution, a yellow, transparent liquid.

It comes in a glass bottle with a rubber stopper. A dropper is supplied.

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 most recent review of this leaflet: July 2014.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.