Dermo-Hubber 10 mg/g + 3.5 mg/g + 600 IU/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dermo-Hubber 10 mg/g + 3.5 mg/g + 600 IU/g ointment
hydrocortisone acetate/neomycin sulfate/bacitracin zinc
Read the entire leaflet carefully before you start using this medicine, because 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 others, even if they have the same symptoms as you, because it may harm them.
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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.
Contents of the leaflet
- What Dermo-Hubber is and what it is used for
- What you need to know before using Dermo-Hubber
- How to use Dermo-Hubber
- Possible side effects
- How to store Dermo-Hubber
- Contents of the pack and other information
1. What Dermo-Hubber is and what it is used for
Dermo-Hubber ointment contains, as active substances, two antibiotics (bacitracin and neomycin) and a corticosteroid, hydrocortisone acetate, which provides anti-inflammatory and vasoconstrictive activity. It belongs to the group of medicines called topical corticosteroids.
Dermo-Hubber ointment is indicated in adults, adolescents, and children over 1 year of age for the treatment of inflammatory dermatoses that respond to topical treatment with corticosteroids and in which bacterial infection is present.
2. What you need to know before using Dermo-Hubber
Do not use Dermo-Hubber
- if you are allergic to the active substances, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other ingredients of this medicine (listed in section 6),
- if you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes),
- in areas of skin affected by red/rosy facial inflammation (rosacea), ulcers, sebaceous gland inflammation (acne), or skin diseases with skin thinning (atrophy),
- in skin inflammation occurring around the mouth (perioral dermatitis),
- in areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination, or in skin infections caused by bacteria or fungi (unless treated additionally with specific therapy),
- in children under 1 year of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Dermo-Hubber.
- If any hypersensitivity reaction occurs, treatment must be discontinued and appropriate therapy will be indicated.
- Anti-inflammatory drugs (corticosteroids), such as the active ingredient hydrocortisone, have significant effects on the body. Treatment over large areas and for prolonged periods should be avoided, as this substantially increases the risk of adverse effects.
- Avoid contact with eyes, mouth, open wounds, or mucous membranes (e.g., genital area).
- Dermo-Hubber should not be applied to skin folds, such as the groin or armpits.
- If you have circulatory problems, you should not apply corticosteroid medicines, as ulceration of the area may occur.
- Dermo-Hubber should not be used under air- and water-impermeable materials, such as bandages, dressings, or non-breathable diapers. It should be noted that diapers may act as occlusive dressings.
- With the use of neomycin, adverse reactions typical of systemic use may also occur, especially with excessive use and in the presence of skin wounds.
- Cross-allergic reactions with aminoglycoside-type antibiotics have been reported.
- If you are being treated for psoriasis, medical supervision should be especially close.
- Prolonged use of topical antibiotics may occasionally lead to overgrowth of non-susceptible organisms, including fungi. In such cases, treatment with this medicine should be discontinued and you should consult your doctor.
- This medicine must not be used during the first trimester of pregnancy.
- Women of childbearing age should use effective contraceptive methods during treatment.
- If you use Dermo-Hubber for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Dermo-Hubber is contraindicated in children under 1 year of age. Its use in children under 12 years of age should be carefully monitored by a doctor, particularly if the medicine is applied to more than 5–10% of the body surface or if occlusive dressings or tight diapers are used. This is because the skin surface area relative to body weight is greater in children, making them more susceptible to systemic toxicity. In children, prolonged and continuous topical corticosteroid treatment should always be avoided when possible, as it may lead to suppression of the hypothalamic-pituitary-adrenal axis, with or without clinical signs of Cushing's syndrome, even without the use of occlusive dressings. If this occurs, topical corticosteroids should be withdrawn gradually under medical supervision due to the risk of adrenal insufficiency (see section 4 Possible side effects).
Other medicines and Dermo-Hubber
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription, especially if you are receiving treatment with other steroids. To date, no interaction studies have been conducted with Dermo-Hubber ointment.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Dermo-Hubber ointment should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.
Women of childbearing age should use effective contraceptive methods during treatment.
Breastfeeding
Do not apply Dermo-Hubber ointment to the breasts during breastfeeding; avoid contact between the infant and treated areas.
Do not use this medicine during breastfeeding unless instructed by your doctor.
Driving and using machines
Treatment with Dermo-Hubber does not affect the ability to drive or operate machinery.
3. How to use Dermo-Hubber
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and children over 12 years of age:
Apply a thin layer of ointment to the affected area one to three times daily, rubbing gently. Once a favorable response has been achieved, the frequency may be reduced to once or twice daily.
Elderly patients (over 65 years of age) and renal impairment
Dermo-Hubber may be administered to elderly patients; however, caution should be exercised in cases where renal function is reduced and significant systemic absorption of neomycin sulfate may occur (see section 2).
Use in children
Dermo-Hubber is contraindicated in children under 1 year of age, and its use in children under 12 years should be carefully monitored by the physician (see sections 2 and 4).
The same dose as in adults may be used, but caution is advised, as absorption may be greater through immature skin and elimination may be reduced due to immaturity of renal function.
Method of administration
For cutaneous use.
Apply a small amount of ointment directly to the affected area, gently massaging it in. Clean the area before applying the ointment. Avoid touching any surface with the tube opening to prevent possible contamination of the tube contents.
Wash your hands after applying the ointment.
If you use more Dermo-Hubber than you should
If you have used Dermo-Hubber excessively or for excessively prolonged periods, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, fungal colonization of wounds or infection by non-sensitive pathogens) that require treatment.
Due to the characteristics of the preparation, intoxication phenomena are not expected with topical use of the medicine.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.
If you forget to use Dermo-Hubber
Remember to always use your medicine as prescribed.
Do not apply a double dose to make up for missed doses. If you forget to apply a dose, apply it as soon as you remember; however, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
If you have any further questions about the use of this product, consult your doctor or pharmacist.
If you stop treatment with Dermo-Hubber
The original symptoms of your skin condition may reappear. Contact your doctor before stopping treatment prematurely, without completing the prescribed duration. 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.
The use of anti-inflammatory drugs (corticosteroids) on the skin may cause adverse effects, especially after prolonged use, application over large areas, use under occlusive dressings or materials, and/or in children.
Dermo-Hubber may cause some adverse effects such as:
Frequent (may affect up to 1 in 10 people)
- Pruritus (itching), burning, local cutaneous atrophy (thinning of the skin), pain, stinging, irritation, inflammation, or erythema (redness at the site of application).
Uncommon (may affect up to 1 in 100 people)
- Striae, papular facial rosacea, ecchymosis (appearance of eczema-like or bruise-like spots), foliculitis (inflammation of hair follicles).
Rare (may affect up to 1 in 1,000 people)
- Hypercortisolism (increased levels of corticosteroids), adrenal suppression (reduced production of cortisol by the body), decreased plasma cortisol. Hypertrichosis (excessive hair growth), alopecia, sensitization, hyper/hypopigmentation, telangiectasias (spider veins), perioral dermatitis, contact dermatitis.
Frequency not known (frequency cannot be estimated from available data)
- Microbial or fungal skin infections, molluscum contagiosum, condylomata acuminata (warts). Hypersensitivity reactions. A condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome). Reduced weight gain in children, hypokalemia (low potassium levels in blood), hyperglycemia (high blood glucose levels). Blurred vision, exacerbation of glaucoma, cataracts (subcapsular). Glucosuria (glucose in urine). Intracranial hypertension in children, edema. Acne, purpura, pustules, atypical papular-vesicular eruptions, paresthesia, skin discoloration, dryness, cracking. Delayed wound healing.
Adverse effects may occur not only in the treated area but also in completely different parts of the body. This happens when the active substance passes into the body through the skin.
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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dermo-Hubber
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.
Do not use this medicine if you notice signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the Sigre Point in the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Dermo-Hubber 10 mg/g + 3.5 mg/g + 600 IU/g ointment
- The active substances are: hydrocortisone acetate, neomycin sulfate and bacitracin zinc. Each gram of ointment contains 10 mg of hydrocortisone acetate, 3.5 mg of neomycin sulfate and 600 International Units (IU) of bacitracin zinc.
- Other components: white soft paraffin.
Appearance of the product and contents of the container
Dermo-Hubber is a homogeneous ointment, white or almost white in colour, supplied in tubes containing 5 g of ointment.
Marketing Authorisation Holder and Manufacturer
Teofarma S.r.l.
Via Fratelli Cervi, 8
27010 Valle Salimbene
Pavia – Italy
Date of the most recent revision of this leaflet: September 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.