MENADERM CLIO 0.25 mg/30 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Menaderm Clio

0.25 mg / 30 mg/g cream

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 questions, 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Menaderm Clio cream is and what it is used for
2. What you need to know before using Menaderm Clio cream
3. How to use Menaderm Clio cream
4. Possible side effects
5. Storage of Menaderm Clio cream
6. Package contents and additional information

1. What Menaderm Clio cream 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. It is for use on the skin.

Menaderm Clio cream is indicated for:

Local treatment of inflammatory and itchy manifestations of skin conditions that respond to corticosteroids in cases complicated by infection with microorganisms sensitive to clioquinol.

Menaderm Clio cream is indicated for adults and adolescents over 12 years of age.

2. What you need to know before using Menaderm Clio cream

Do not use Menaderm Clio cream:

• If you are allergic to beclometasone, clioquinol, iodine, or any of the other components of this medication (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (e.g., herpes or chickenpox).
• If you suffer from rosacea (skin condition of the face with red/pink inflammation) or inflammation around the mouth (perioral dermatitis).
• For acne or ulcers.
• For skin diseases with thinning of the skin (atrophy).
• In areas of the skin showing a vaccination reaction, i.e., redness or inflammation after vaccination.
• In the eyes or on open wounds.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Menaderm Clio cream.

• If you experience any hypersensitivity reaction or excessive dryness, or if your skin condition worsens, you should discontinue treatment and consult your doctor about your treatment.
• The medication should not be applied to large areas of skin or for prolonged periods.
• The use of this medication can cause side effects typical of corticosteroids, especially in children, including adrenal gland disorders, due to absorption into the body of the active ingredient, especially in treatments of large areas or prolonged use.
• Menaderm Clio cream should not come into contact with the eyes or the area around them, or with mucous membranes (e.g., the mouth or genital area).
• In skin folds, such as the groin or armpits, the medication should be applied with caution and for a short period, as absorption is greater in these areas.
• The medication should not be used under airtight and waterproof dressings, such as non-breathable bandages, to avoid absorption of the active ingredients. Clioquinol used with occlusion can increase iodine levels in the blood.
• Clioquinol may cause irritation or an allergic reaction in some cases in people with hypersensitivity to other products with a related chemical structure (cross-sensitivity).
• Clioquinol can stain clothing yellow and can also discolor skin and nails and decolorize hair. Although these stains can be removed from most fabrics by washing with regular detergents, it is recommended to take precautions.
• The non-professional use of topical corticosteroids can mask symptoms and make diagnosis and correct treatment more difficult.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Interference with laboratory tests

If you are going to have any diagnostic tests (including blood or urine tests), inform your doctor that you are using this medication, as it may alter the results, for example, thyroid function tests.

Children and adolescents

Menaderm Clio cream is contraindicated in children under 2 years of age and is not recommended for children under 12 years of age.

Other medications and Menaderm Clio cream

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

As a general rule, during the first trimester of pregnancy, this medication should not be applied.

Menaderm Clio cream should not be used during pregnancy, unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

Pregnant women or those planning to become pregnant should not use this medication on large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not use Menaderm Clio cream during breastfeeding, unless your doctor advises you to do so, and do not use it on large areas of skin, for prolonged periods, or with occlusive dressings.

Do not apply the medication to the breasts during breastfeeding; do not let the child come into contact with treated areas.

Driving and using machines

The use of this medication does not affect the ability to drive or use machines.

Menaderm Clio cream contains cetyl alcohol, stearic alcohol, propylene glycol, and methylparaben (E218)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearic alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218). This medication contains 40 mg of propylene glycol per gram.

3. How to use Menaderm Clio cream

Follow the instructions for administration of this medication indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and adolescents over 12 years of age:

Two applications per day to the affected skin area.

The duration of treatment should not exceed one or two weeks.

If the medication is used on the face, the treatment should be as short as possible.

Topical use (on the skin)

The cream should be administered by spreading a thin layer after cleaning the affected area with water and soap.

Use in children and adolescents

Menaderm Clio cream is contraindicated in children under 2 years of age and is not recommended for children under 12 years of age.

If you use more Menaderm Clio cream than you should

Due to its topical use, the possibility of intoxication is very low.

Excessive use of the medication can cause side effects (see section 4).

If you use the cream more frequently than you should or on large areas of skin, it may be absorbed into the body and cause various disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 Clio cream

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.

If you have any other questions 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. They may be more frequent and even cause side effects in areas other than the application site when large areas are treated, with high doses, under occlusive conditions, or for prolonged periods.

The following may occur:

• Irritation
• Rash
• Burning sensation
• Redness (erythema)
• Dryness of the skin
• Itching
• Increased hair growth
• Changes in skin color
• Inflammation of hair follicles (folliculitis)
• Bruises
• Fluid retention (edema)
• Acne
• Inflammation around the mouth (perioral dermatitis)
• Thinning of the skin (atrophy)
• Appearance of fine blood vessels under the skin surface
• Stretch marks
• Allergic skin reaction (contact dermatitis)

Side effects may occur not only in the treated area but also in completely different areas of the body, which can happen if the active ingredients pass into the body through the skin. This, for example, can increase pressure in the eye (glaucoma) or could cause a condition characterized by a rounded face, fat accumulation, delayed healing, etc. (Cushing's syndrome). Blurred vision may also occur with an unknown frequency (cannot be estimated from available data).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Menaderm Clio cream

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after EXP. 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 any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Menaderm Clio cream

• The active ingredients are Beclometasone dipropionate and Clioquinol. Each gram of cream contains 0.25 mg of beclometasone dipropionate (0.025%) and 30 mg of clioquinol (3%).
• The other components (excipients) are: cetostearyl ether of macrogol, light liquid paraffin, paraffin wax, cetyl alcohol, stearic acid, stearic alcohol, sorbitol (E420i), propylene glycol (E1520), methylparaben (E218), disodium edetate, extract of Althaea officinalis root, water.

Appearance of the product and package contents

Menaderm Clio is presented as a cream, with a pasty consistency and yellowish color.

It is available in tubes containing 30 g or 60 g of cream.

Marketing authorization holder and manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Tel: 934 628 800

Date of the last revision of this package leaflet:March 2020.

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