Menaderm Clio 0.25 mg/30 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Menaderm Clio

0.25 mg / 30 mg/g cream

Beclometasone dipropionate / Cliquinol

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, ask 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 may 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.

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

1. What Menaderm Clio cream is and what it is used for

It is a medicine containing as active substances beclometasone dipropionate, a corticosteroid anti-inflammatory agent, and clioquinol, with antifungal (against fungi) and antibacterial activity. It is for topical 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 in 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 medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (e.g., herpes or chickenpox).
• If you suffer from rosacea (a facial skin condition with red, inflamed patches) or inflammation around the mouth (perioral dermatitis).
• In acne or ulcers.
• In skin diseases associated with thinning of the skin (atrophy).
• On areas of skin showing a vaccine reaction, such as redness or inflammation after vaccination.
• In the eyes or on open wounds.
• In children under 2 years of age.

Warnings and precautions

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

• If you experience any hypersensitivity reactions or excessive dryness, or if your skin condition worsens, you must stop treatment and consult your doctor about your treatment.
• Do not use the medicine over large areas of skin or for prolonged periods.
• Adverse effects typical of corticosteroids may occur with use of this medicine, especially in children, including adrenal gland suppression due to systemic absorption of the active ingredient, particularly with treatment over large areas or for long durations.
• Menaderm Clio cream must not come into contact with the eyes or the area around them, or with mucous membranes (e.g., mouth or genital area).
• Use the medicine with caution and for short periods in skin folds such as the groin or armpits, as absorption is greater in these areas.
• Do not use the medicine covered with air- and water-impermeable materials, such as non-breathable dressings, to avoid increased absorption of the active ingredients. Using clioquinol under occlusion may increase blood iodine levels.
• Clioquinol may in some cases cause irritation or reactions in individuals hypersensitive to other products with related chemical structures (cross-sensitivity).
• Clioquinol may stain clothing yellow and may also color the skin and nails and discolor hair. Although these stains usually disappear from most fabrics when washed with common detergents, appropriate precautions are recommended.
• Non-professional use of topical corticosteroids may mask symptoms and hinder correct diagnosis and treatment.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Interference with diagnostic tests

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

Children and adolescents

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

Other medicines and Menaderm Clio cream

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

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 women planning pregnancy should not use this medicine over large areas of skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not use Menaderm Clio cream during breastfeeding unless instructed by your doctor, and do not use it over large skin areas, for prolonged periods, or with occlusive dressings.

Do not apply the medicine to the breasts during breastfeeding; avoid contact between the child and treated areas.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

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

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

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E218). This medicine contains 40 mg of propylene glycol per gram.

3. How to use Menaderm Clio cream

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

The recommended dose is:

• Adults and adolescents over 12 years of age:

Apply twice daily to the affected area of skin.

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

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

Cutaneous use (on the skin)

The cream should be applied in a thin layer after thoroughly 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 in children under 12 years of age.

If you use more Menaderm Clio cream than you should

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

Excessive use of the medicine may cause adverse effects (see section 4).

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine 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 missed doses.

If you forget a dose, apply it as soon as possible and then continue with your usual prescribed schedule.

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 can cause adverse effects, although not everyone will experience them.

The adverse effects that may occur are generally local and transient. They may become more frequent, and adverse effects in body areas other than the application site may even occur, when large areas are treated, high doses are used, occlusive conditions are applied, or treatment is prolonged.

The following may occur:

• Irritation
• Rash
• Burning sensation
• Redness (erythema)
• Dry skin
• Itching
• Increased hair growth
• Changes in skin color
• Inflammation of hair follicles (folliculitis)
• Bruising
• 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 (striae)
• Skin allergic reaction (contact dermatitis)

Adverse effects may occur not only in the treated area but also in completely different areas of the body, which may happen if the active substances pass through the skin into the body. This, for example, could increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, delayed wound healing, etc. (Cushing's syndrome). Blurred vision may also occur, 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Menaderm Clio cream

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

No special storage conditions are required.

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 drains or household waste. Unused medicines and their containers should be taken to a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Menaderm Clio cream

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

Appearance of the product and contents of the pack

Menaderm Clio is a cream with a pasty consistency and yellowish colour.

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 most recent revision of this leaflet: March 2020.

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