Prospecto: information for the user

Menaderm Neomicin 0.25 mg/ 7.2 mg/ ml topical emulsion

beclometasona dipropionato/ neomicin (sulfate)

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

- This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Menaderm Neomicin

3.How to use Menaderm Neomicin

4.Possible adverse effects

5Storage of Menaderm Neomicin

6. Contents of the package and additional information

It is a combination of an anti-inflammatory (a corticosteroid) and an aminoglycoside antibiotic for administration on the skin.

Menaderm Neomicinais indicatedin:

Inflammatory and pruritic skin conditions (with itching) that respond to corticosteroids complicated by secondary infection caused by susceptible microorganisms; among the types of conditions are: acute forms of allergy to a substance that has come into contact with the skin (allergic contact dermatitis), to substances of habitual use such as, for example, soap (irritant contact dermatitis), atopic dermatitis (related to patient factors), eczema with itchy eruption on hands and feet (eczema dishidrotic), unspecified eczema (eczema vulgar).

It is indicatedinadults and children over 5 years old.

No useMenaderm Neomicina

• If you are allergic to beclometasona, neomicina, other aminoglucósidos antibiotics 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 varicela).
• In areas of skin affected by rosácea (chronic inflammation with redness of the skin around the nose and cheeks), inflammation around the mouth (dermatitis perioral), ulcers, diseases with skin thinning (atrofia).
• In areas of skin showing a vaccine reaction, that is, redness or inflammation after the vaccine.
• In the eyes or in deep wounds.
• In children under 1 year.
• In case of fungal skin infections (see the next section).

Advertencias and precautions

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

• If any hypersensitivity reaction appears with the use of this medication, you must suspend the treatment and consult your doctor.

- Anti-inflammatory drugs (corticosteroids), like one of the active principles of this medication, should be used in the lowest possible doses and only for the time strictly necessary to treat the skin condition, especially in children.

• If you use the medication in areas of skin with folds (e.g. armpits or groin), you must be very careful because it may increase the absorption of the medication.
• Do not use under impermeable materials to air and water, such as bandages, dressings or diapers, little transpirable.
• The prolonged use of antibiotics on the skin may occasionally lead to the proliferation of non-sensitive organisms, including fungi. In these cases, you must suspend the treatment and consult your doctor.
• The prolonged use of antibiotics, such as neomicina, on the skin may occasionally lead to systemic effects such as ototoxicity and nephrotoxicity, especially if used in large areas or in wounds and in patients with kidney disease.
• Menaderm Neomicina should not come into contact with the eyes, mouth, open wounds or mucous membranes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Do not use in children under 1 year. En children under 5 years, the use of this medication is not indicated, as the safety and efficacy of beclometasona have not been established in this age group.

In children, it is more likely that the corticosteroid will pass through the skin and have adverse effects in other areas of the body. In children treated with corticosteroids, Cushing's syndrome may occur, characterized by symptoms such as obesity, growth retardation, etc.

Other medications and Menaderm Neomicina

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

- Aminoglucósidos antibiotics (e.g. amikacina, tobramicina or gentamicina): if you are being treated with any of these antibiotics, either orally or by other routes, it may increase the risk of adverse reactions in other areas of the body.

Pregnancy, lactation and fertility

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

Pregnancy

There are no sufficient data on the use of Menaderm Neomicina in pregnant women.

Generally, during the first trimester of pregnancy, the use of topical preparations containing corticosteroids and/or neomicina should be avoided.

As a precaution, it is recommended to avoid the use of this medication during pregnancy.

Lactation

The safety of Menaderm Neomicina during lactation has not been established, so its use is not recommended.

Women who are breastfeeding should not apply the medication to the breasts.

Driving and operating machinery

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

Menaderm Neomicina emulsión cutáneacontains cetomacrogol, cetyl alcohol, parahidroxibenzoato de metilo (E-218), parahidroxibenzoato de propilo (E-216), propilenglicol, essence and ethanol (present in the essence).

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

It may also cause allergic reactions (possibly delayed) because it contains parahidroxibenzoato de metilo (E-218) and parahidroxibenzoato de propilo (E-216).

This medication contains 9 mg of propilenglicol in each ml of emulsión cutánea.

This medication contains 0.0005 ml of essence, in each ml of emulsión cutánea, with geraniol, citronelol, lilial, cinnamyl alcohol, hexyl cinnamaldehyde, benzyl salicylate, cinnamaldehyde, citral and linalol, which may cause allergic reactions.

This medication contains 0.000095 mg ethanol in each ml of emulsión cutánea. It may cause a burning sensation in damaged skin.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults:

Two applications on the skin per day (every 12 hours).

Use in children

- Children over 5 years old: Two applications on the skin per day.

-Children under 5 years old:Menaderm Neomicin is contraindicated in children under 1 year old and is not indicated in children under 5 years old.

Generally, treatment should not exceed one week, unless your doctor, under your supervision, indicates that it should be prolonged for a longer period.

In children, treatment should be as short as possible, in short periods of time, and with the minimum effective amount of the product.

Topical use.

Administration should be performed by applying a thin layer smoothly over the affected area, preferably after cleaning.

If you use more Menaderm Neomicin than you should

The excessive use of topical corticosteroids (repeated overdoses) may cause adverse effects (see section 4).

The excessive or prolonged use of topical antibiotics may cause an overgrowth of fungi or bacteria that are not sensitive.

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

If you forgot to useMenaderm Neomicin

Do not use a double dose to compensate for the missed doses; if you have forgotten a dose, continue with your regular schedule according to your doctor's instructions or those described in the prospectus.

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

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

Prolonged use of large quantities of Menaderm Neomicin or treatment of extensive areas may lead to systemic effects (inside the body and in areas other than the treated area) due to its absorption. If this occurs, topical treatment should be discontinued.

The adverse reactions that may occur, especially if large quantities are used or if extensive areas are treated, or if occlusive dressings are used, are:

At the application site: Atrophy (skin thinning), striae, burning sensation, pruritus, erythema, dryness, appearance of red patches, hematoma, folliculitis (inflammation of hair follicles), increased hair growth, perioral dermatitis (skin condition around the mouth), skin discoloration, hypersensitivity reactions such as contact dermatitis (skin reaction), appearance of acne; in rare cases, a more severe allergic reaction may occur.

Glaucoma (increased eye pressure) or a condition characterized by: round face, fat accumulation, delayed healing, etc. (Cushing's syndrome),ototoxicity (toxicity in the ears),nephrotoxicity (toxicity in the kidneys).Blurred vision may also occur with an unknown frequency (the frequency cannot be estimated from 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 not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products 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 usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointof 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 ofMenaderm Neomicin

• The active principles are beclometasone dipropionate and neomicin (sulfate).

1 ml of cutaneous emulsion contains 0.25 mg of beclometasone dipropionate (0.025 %) and 7.2 mg of neomicin (sulfate) (0.72 %).

• The other components (excipients) are:cetyl alcohol, stearic alcohol, propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), extract of Althaea officinalis root, liquid paraffin, paraffin wax, glycerin,cetomacrogol700, stearic acid, sorbitol (E-420), simethicone emulsion, essence (with ethanol and allergens, see section 2) and water.

Appearance of the product and contents of the packaging

Menaderm Neomicin cutaneous emulsionis a uniform liquid emulsion with a white color.

It is presented in polypropylene bottles of 60 ml.

Other presentations: Menaderm Neomicin cream.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona) Spain

Telephone: +34 934 628 800 – E-mail:[email protected]

Date of the last review of thisleaflet: June 2024.

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