Menaderm neomycin 0.25 mg/7.2 mg/g cream
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Menaderm Neomicina 0.25 mg/7.2 mg/g cream
beclometasone dipropionate / neomycin (sulfate)
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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 effects not listed in this leaflet. See section 4.
Contents of the leaflet
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What Menaderm Neomicina is and what it is used for
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What you need to know before using Menaderm Neomicina
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How to use Menaderm Neomicina
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Possible side effects
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Storage of Menaderm Neomicina
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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 on 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. Types of such conditions include: 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 (vulgar eczema).
It is indicated in adults and children over 5 years of age.
2. What you need to know before using Menaderm Neomicina
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 varicella).
- In areas of skin affected by rosacea (chronic inflammation with redness around the nose and cheeks), perioral inflammation (perioral dermatitis), ulcers, or skin conditions involving skin thinning (atrophy).
- In areas of skin showing a vaccine 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
Talk to your doctor or pharmacist before starting to use Menaderm Neomicina.
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If any hypersensitivity reaction occurs during use of this medicine, treatment must be stopped and you should consult your doctor.
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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 absorption of the medicine may increase.
- Do not use under occlusive dressings such as non-breathable bandages, dressings, or 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 lead to systemic effects such as ear and kidney toxicity (nephrotoxicity), especially if used over large areas, on wounds, or in patients with kidney 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 indicated 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 may occur in glands located near the kidneys or a condition characterized, among other symptoms, by obesity, growth retardation, etc. (Cushing's syndrome), among other effects.
Other medicines and Menaderm Neomicina cream
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, 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
There are insufficient data on the use of Menaderm Neomicina in pregnant women.
In general, during the first trimester of pregnancy, topical preparations containing corticosteroids and/or neomycin should be avoided.
As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.
Breastfeeding
The safety of Menaderm Neomicina during breastfeeding has not been established; therefore, its use is not recommended.
Women who are breastfeeding 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 contains cetyl alcohol, stearyl alcohol, propylene glycol, and methyl parahydroxybenzoate (E-218)
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).
This medicine contains 40 mg of propylene glycol in each gram of cream.
3. How to use Menaderm Neomycin
Follow exactly the instructions for use of this medicine given by your doctor. 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: Two applications to the skin per day.
- Children under 5 years: Menaderm Neomycin is contraindicated in children under 1 year of age and is not indicated in children under 5 years.
In general, treatment should not exceed one week unless your doctor, under their supervision, instructs you to extend it longer.
In children, treatment should be as short as possible, for brief periods, and using the smallest 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 not sensitive to the antibiotic 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 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 may produce 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 when treating large areas, using large amounts, for prolonged periods of time, or when using an occlusive dressing, 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 condition (perioral dermatitis), skin discoloration, hypersensitivity reactions such as contact dermatitis (skin reaction), acne-like eruptions; rarely, a more severe allergic reaction may occur.
Glaucoma (increased eye pressure) 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 appear with unknown frequency (frequency cannot be estimated from the 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 through 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 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, 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 gram of cream 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, stearic alcohol, propylene glycol, extract of root of Althaea officinalis, liquid paraffin, soft paraffin, stearic acid, sorbitol (E-420), methyl parahydroxybenzoate (E-218), Cetomacrogol-700 and water.
Appearance of the product and contents of the pack
Menaderm Neomicina 0.25 mg/7.2 mg/g cream is white in colour. It is supplied in flexible aluminium tubes of 30 g and 60 g.
Other presentations: Menaderm Neomicina 0.25 mg/7.2 mg/g cutaneous emulsion.
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 review of this package leaflet: June 2024.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.