MENADERM NEOMICIN 0.25 mg / 7.2 mg/ml CUTANEOUS EMULSION

Introduction

Package Leaflet: Information for the User

Menaderm Neomycin 0.25 mg/7.2 mg/ml Cutaneous Emulsion

beclometasone dipropionate/neomycin (sulfate)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Menaderm Neomycin and what is it used for
2. What you need to know before you use Menaderm Neomycin
3. How to use Menaderm Neomycin
4. Possible side effects

5 Conservation of Menaderm Neomycin

1. Contents of the pack and other information

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

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

Menaderm Neomycin is indicated in:

Inflammatory and pruritic skin conditions (with itching) that respond to corticosteroids complicated by secondary infection caused by microorganisms sensitive to neomycin; 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 (dyshidrotic eczema), unspecified eczema (vulgar eczema).

It is indicated in adults and children over 5 years of age.

2. What you need to know before you use Menaderm Neomycin cutaneous emulsion

Do not useMenaderm Neomycin

• If you are allergic to beclometasone, neomycin, other aminoglycoside antibiotics 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).
• In areas of skin affected by rosacea (chronic inflammation with redness of the skin around the nose and cheeks), inflammation around the mouth (perioral dermatitis), ulcers, diseases with skin thinning (atrophy).
• In areas of the skin that show a vaccination reaction, i.e. redness or inflammation after vaccination.
• In the eyes or in deep wounds.
• In children under 1 year of age.
• In case of fungal skin infections (see the following section).

Warnings and precautions

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

• If you experience any hypersensitivity reaction with the use of this medicine, you should discontinue treatment and consult your doctor.

• Anti-inflammatory drugs (corticosteroids), such as one of the active ingredients of this medicine, should be used in the lowest possible doses and only for the strictly necessary time to treat the skin condition, especially in children.
  • If you use the medicine on skin areas with folds (e.g. armpits or groin), you should be very careful because it can increase the absorption of the medicine.
  • It should not be used under impermeable materials to air and water, such as bandages, dressings or diapers, which are not very breathable.
  • Prolonged use of antibiotics on the skin can occasionally lead to an overgrowth of non-sensitive organisms, including fungi. In these cases, treatment should be discontinued and the doctor consulted.
  • Prolonged use of antibiotics, such as neomycin, on the skin can occasionally lead to systemic effects such as ear and kidney toxicity (nephrotoxicity), especially if used on large areas or on wounds and in patients with kidney disease.
  • Menaderm Neomycin 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 of age. In children under 5 years of age, the use of this medicine is not indicated, as the safety and efficacy of beclometasone have not been established in this age group.

In children, it is more likely that the corticosteroid will pass into the body through the skin and have adverse effects in other areas of the body. In children treated with corticosteroids, it could lead to the alteration of glands located next to the kidneys or an alteration characterized by, among other symptoms, obesity, growth retardation, etc. (Cushing's syndrome), among other effects.

Other medicines and Menaderm Neomycin

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

• Aminoglycoside antibiotics (e.g. amikacin, tobramycin or gentamicin): if you are being treated with any antibiotic of this type, orally or by another route, it could increase the risk of adverse reactions in other areas of the body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

There is not enough data on the use of Menaderm Neomycin in pregnant women.

In general, during the first trimester of pregnancy, the use of topical preparations containing corticosteroids and/or neomycin should be avoided.

As a precautionary measure, it is preferable to avoid the use of this medicine during pregnancy.

Breastfeeding

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

Women who are breastfeeding should not apply the medicine to their breasts.

Driving and using machines

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

Menaderm Neomycincutaneous emulsioncontains cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol, fragrance and ethanol (present in the fragrance).

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

It may also cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains 9 mg of propylene glycol in each ml of cutaneous emulsion.

This medicine contains 0.0005 ml of fragrance in each ml of cutaneous emulsion, with geraniol, citronellol, lilial, cinnamic alcohol, hexyl cinnamal, benzyl salicylate, cinnamaldehyde, citral and linalool, which may cause allergic reactions.

This medicine contains 0.000095 mg of ethanol in each ml of cutaneous emulsion. It may cause a burning sensation on damaged skin.

3. How to use Menaderm Neomycin

Follow exactly the administration instructions of this medicine 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 of age: Two applications on the skin per day.
• Children under 5 years of age: Menaderm Neomycin is contraindicated in children under 1 year of age and is not indicated in children under 5 years of age.

In general, treatment should not exceed one week, unless your doctor, under their supervision, indicates that it should be prolonged for a longer time.

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 gently applying a thin layer over the affected area, preferably after cleaning.

If you use more Menaderm Neomycin than you should

Excessive use of topical corticosteroids (repeated overdoses) may produce adverse effects (see section 4).

Excessive or prolonged use of topical antibiotics may lead to an overgrowth of non-sensitive fungi or bacteria in the lesions.

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

If you forget to useMenaderm Neomycin

Do not use a double dose to make up for forgotten doses; if you have forgotten a dose, continue with your usual schedule as indicated by your doctor or as described in the leaflet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Prolonged use of large amounts of Menaderm Neomycin 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 extensive areas are treated, with large amounts or for prolonged periods, or if an occlusive dressing is used, are:

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

It may cause glaucoma (increased eye pressure) or a condition characterized by: round face, fat accumulation, delayed wound healing, etc. (Cushing's syndrome), ototoxicity (ear toxicity), nephrotoxicity (kidney toxicity). It may also cause blurred vision with an unknown frequency (cannot be estimated from the available data).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Menaderm Neomycin

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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofMenaderm Neomycin

• The active ingredients are beclometasone dipropionate and neomycin (sulfate).

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

• The other ingredients (excipients) are: cetyl alcohol, stearyl alcohol, propylene glycol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), Althaea officinalis root extract, liquid paraffin, white soft paraffin, glycerin, cetomacrogol 700, stearic acid, sorbitol (E-420), simethicone emulsion, fragrance (with ethanol and allergens, see section 2) and water.

Appearance of the product and contents of the pack

Menaderm Neomycin cutaneous emulsion is a liquid emulsion with a uniform appearance and white color.

It is presented in 60 ml polypropylene bottles.

Other presentations: Menaderm Neomycin cream.

Marketing authorization holder and manufacturer

Laboratorios Menarini, S.A.

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

Phone: +34 934 628 800 – Email: [email protected]

Date of last revision of thisleaflet: June 2024.

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