Leaflet: information for the user

Menaderm Clio

0.25 mg / 30 mg/g cream

Beclometasone dipropionate / Clioquinol

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to use Menaderm Clio cream

4. Possible side effects

5. Storage of Menaderm Clio cream

6. Contents of the pack and additional information

It is a medication that contains beclometasona dipropionate as active principles, an anti-inflammatory corticosteroid, and clioquinol, with antifungal and antibacterial activity. It is for use on the skin.

Menaderm Clio cream is indicated for:

Treatment of local inflammatory manifestations and itching of skin conditions that respond to corticosteroids in complicated cases with infection by sensitive microorganisms to clioquinol.

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

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 (a skin condition on the face with red/inflamed skin) or inflammation around the mouth (perioral dermatitis).
• In acne or ulcers.
• In skin conditions with skin thinning (atrophy).
• In areas of the skin showing a vaccination reaction, i.e. redness or inflammation after the vaccine.
• In the eyes or open wounds.
• In children under 2 years old.

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, discontinue treatment and consult your doctor about your treatment.
• Do not use the medication on large areas of skin or for prolonged periods.
• The use of this medication may cause adverse effects typical of corticosteroids, especially in children, including adrenal gland alteration, due to absorption of the active ingredient into the body, particularly in treatments on large areas or for prolonged periods.
• Menaderm Clio cream should not come into contact with the eyes or around them, or with mucous membranes (e.g. the mouth or genital area).
• In skin folds, such as the groin or armpits, apply the medication with caution and for a short period, as absorption is greater in these areas.
• Do not use the medication covered with impermeable materials to air and water, such as non-breathable dressings, to avoid absorption of the active ingredients. Clioquinol used with occlusion may cause an increase in blood iodine levels.
• Clioquinol may cause irritation or some reaction in people with hypersensitivity to other products with related chemical structure (cross-sensitivity).
• Clioquinol in contact with clothing may stain it yellow and may also color the skin and nails and bleach the hair. Although these stains disappear from most tissues by washing with common detergents, it is recommended to take necessary precautions.
• The non-professional use of topical corticosteroids may mask symptoms and make it difficult to diagnose and treat correctly.
• Consult your doctor if you experience blurred vision or other visual disturbances.

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic test (including blood, urine, etc.) as this medication may alter the results, e.g. thyroid function tests.

Children and adolescents

Menaderm Clio cream is contraindicated in children under 2 years old and not recommended in children under 12 years old.

Other medications and Menaderm Clio cream

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

As a general rule, this medication should not be applied 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 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 put the baby in contact with treated areas.

Driving and operating machinery

The use of this medication does not affect your ability to drive and operate machinery.

Menaderm Clio cream contains cetomacrogol, cetearyl alcohol, propylene glycol, and methyl parahydroxybenzoate (E218)

This medication may cause local skin reactions (such as contact dermatitis) due to cetomacrogol and cetearyl alcohol.

It may cause allergic reactions (possibly delayed) due to methyl parahydroxybenzoate (E-218).This medication contains 40 mg of propylene glycol per gram.

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 and adolescents over 12 years old:

Two applications per day on the affected skin area.

The treatment duration should not exceed one or two weeks.

If the medication is used on the face, the 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 old and is not recommended for children under 12 years old.

If you use more Menaderm Clio cream than you should

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

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

If you use the cream more frequently than you should or on large areas of the 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 Toxicological Information Service, Phone 91 562 04 20, indicating the medication and the amount ingested (or go to a medical center).

If you forgot to use Menaderm Clio cream

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.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse effects that may occur are generally local and transient. They may be more frequent and even occur in different areas of the body from the application site, when treating large areas, with large doses, in occlusive conditions, or during prolonged periods of time.

The following may occur:

• Irritation
• Rash
• Burning sensation
• Redness (erythema)
• Dry skin
• Itching
• Increased hair growth
• Changes in skin color
• Folliculitis (inflammation of hair follicles)
• Bruising
• Fluid retention (edema)
• Acne
• Inflammation around the mouth (perioral dermatitis)
• Thinning of the skin (atrophy)
• Appearance of fine blood vessels under the skin's surface
• Striae (stretch marks)
• Contact dermatitis (allergic skin reaction)

Adverse effects may occur not only in the treated area, but also in completely different areas of the body, which occurs if the active principles pass into the body through the skin. This, for example, may increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, fat accumulation, delayed healing, etc. (Cushing's syndrome).It may also appear blurred vision 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 the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Menaderm Clio cream

• The active principles are Beclometasona dipropionate and Clioquinol. Each gram of cream contains 0.25 mg of beclometasona dipropionate (0.025%) and 30 mg of clioquinol (3%).
• The other components (excipients) are: ceteareth-25, light liquid paraffin, petrolatum, cetyl alcohol, stearic acid, stearyl alcohol, sorbitol (E420i), propylene glycol (E1520), methyl parahydroxybenzoate (E218), disodium edetate, extract of Althaea officinalis root, water.

Appearance of the product and contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Phone: 934 628 800

Last review date of this leaflet:March 2020.

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