Menaderm neomycin 0.25 mg/7.2 mg/ml cutaneous emulsion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Menaderm Neomycin 0,25 mg/ 7,2 mg/ ml cutaneous emulsion

beclometasone dipropionate/ neomycin (sulphate)

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.

Leaflet contents

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

5 Storage of Menaderm Neomycin

1. Contents of the pack and other information

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

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

Menaderm Neomycin is indicated for:

Inflammatory and pruritic (itchy) skin conditions responsive 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 common use such as, for example, soap (irritant contact dermatitis), atopic dermatitis (related to patient factors), dyshidrotic eczema (eczema with itchy rash on hands and feet), unspecified eczema (common eczema).

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

2. What you need to know before using Menaderm Neomicina cutaneous emulsion

Do not use Menaderm Neomicina

• If you are allergic to beclometasone, neomycin, other aminoglycoside antibiotics, or any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (e.g. herpes or chickenpox).
• On areas of skin affected by rosacea (chronic inflammation with redness around the nose and cheeks), perioral inflammation (perioral dermatitis), ulcers, or skin conditions causing 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 deep wounds.
• In children under 1 year of age.
• In case of fungal infections of the skin (see the next section).

Warnings and precautions

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

• If any hypersensitivity reaction occurs during use of this medicine, treatment must be discontinued and medical advice sought.

• Anti-inflammatory drugs (corticosteroids), such as one of the active substances in this medicine, should be used at the lowest possible dose and only for the shortest time necessary to treat the skin condition, especially in children.

  • Exercise great caution if using the medicine on skin folds (e.g. armpits or groin), as this may increase absorption of the medicine.
  • Do not use under occlusive dressings such as airtight and waterproof bandages, dressings, or non-breathable diapers.
  • Prolonged use of antibiotics on the skin may occasionally lead to overgrowth of non-susceptible organisms, including fungi. In such cases, treatment should be discontinued and medical advice sought.
  • Prolonged use of antibiotics such as neomycin on the skin may occasionally result in systemic effects such as ear and kidney toxicity (nephrotoxicity), especially when used over large areas of skin, on wounds, or in patients with renal disease.
  • Menaderm Neomicina must 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. This medicine is not recommended for use in children under 5 years of age, as the safety and efficacy of beclometasone have not been established in this age group.

In children, corticosteroids are more likely to pass through the skin into the body and cause adverse effects in other parts of the body. In children treated with corticosteroids, disturbances of glands near the kidneys or a condition characterized, among other symptoms, by obesity and growth retardation, etc. (Cushing's syndrome) may occur, among other effects.

Other medicines and Menaderm Neomicina

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Aminoglycoside antibiotics (e.g.: amikacin, tobramycin, or gentamicin): if you are being treated with any of these antibiotics orally or by another route, the risk of adverse reactions in other parts of the body may increase.

Pregnancy, breast-feeding and fertility

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

Pregnancy

There are insufficient data on the use of Menaderm Neomicina in pregnant women.

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

As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.

Breast-feeding

The safety of Menaderm Neomicina during breast-feeding has not been established; therefore, its use is not recommended.

Women who are breast-feeding should not apply the medicine to the breasts.

Driving and using machines

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

Menaderm Neomicina cutaneous emulsion contains 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, which includes geraniol, citronellol, lilial, cinnamyl alcohol, hexyl cinnamaldehyde, 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 instructions given by your doctor for administering this medicine. If in doubt, consult your doctor again.

The recommended dose is:

Adults:

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

Use in children

• Children over 5 years of age: Two applications to 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, instructs you to continue for a longer period.

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

Cutaneous use.

Administration should be performed by gently applying a thin layer to the affected area, preferably after cleansing.

If you use more Menaderm Neomycin than you should

Excessive use of topical corticosteroids (repeated overdosing) may cause adverse effects (see section 4).

Excessive or prolonged use of topical antibiotics may lead to proliferation of fungi or bacteria that are not sensitive to the antibiotic in the lesions.

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

If you forget to use Menaderm Neomycin

Do not use a double dose to make up for missed doses; if you have forgotten a dose, continue with your usual schedule according to your doctor's instructions or those described in this leaflet.

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.

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 site) due to absorption. If this occurs, topical treatment should be discontinued.

Adverse reactions that may occur, especially if large areas are treated with large amounts or for prolonged periods of time, or if an occlusive dressing is used, include:

At the application site: Atrophy (thinning of the skin), striae, burning sensation, pruritus, redness, dryness, appearance of red spots, bruising, foliculitis (inflammation of hair follicles), increased hair growth, perioral dermatitis (skin condition around the mouth), skin discoloration, hypersensitivity reactions such as contact dermatitis (skin reaction), development of pimples; rarely, a more severe allergic reaction may occur.

Glaucoma (increased pressure in the eye) or a condition characterized by: round face, fat accumulation, delayed wound healing, etc. (Cushing's syndrome), ototoxicity (toxicity to the ears), nephrotoxicity (toxicity to the kidneys) could also occur. 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Menaderm Neomicina

• The active substances 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 components (excipients) are: cetyl alcohol, stearyl alcohol, propylene glycol, methylparaben (E-218), propylparaben (E-216), extract of Althaea officinalis root, liquid paraffin, soft paraffin, glycerol, cetomacrogol 700, stearic acid, sorbitol (E-420), simeticone emulsion, essence (containing ethanol and allergens, see section 2), and water.

Appearance of the product and contents of the container

Menaderm Neomicina cutaneous emulsion is a uniform liquid emulsion of white appearance.

It is presented in 60 ml polypropylene bottles.

Other presentations: Menaderm Neomicina cream.

Marketing Authorization Holder and Manufacturer

Laboratorios Menarini, S.A.

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

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

Date of the most recent revision of this summary: June 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.