DERMO-HUBBER 10 mg/g + 3.5 mg/g + 600 IU/g OINTMENT

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 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 experience 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 Package Leaflet

1. What is Dermo-Hubber and what is it used for
2. What you need to know before you start using Dermo-Hubber
3. How to use Dermo-Hubber
4. Possible side effects
5. Storage of Dermo-Hubber
6. Contents of the pack and further information

1. What is Dermo-Hubber and what is it used for

Dermo-Hubber ointment contains as active ingredients 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 coexists.

2. What you need to know before you start using Dermo-Hubber

Do not use Dermo-Hubber

• if you are allergic to the active ingredients, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other components of this medicine (listed in section 6),
• if you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes),
• on areas of skin affected by red/pink inflammation on the face (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with thinning of the skin (atrophy),
• on skin inflammation around the mouth (perioral dermatitis),
• on areas of skin showing a vaccination reaction, i.e., redness or inflammation after vaccination, in skin infections caused by bacteria or fungi (unless also treated with specific treatment),
• in children under 1 year of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermo-Hubber.

• If a hypersensitivity reaction occurs, treatment should be discontinued and appropriate therapy should be indicated.
• Anti-inflammatory drugs (corticosteroids), such as the active ingredient hydrocortisone, have significant effects on the body. Treatment should be avoided in extensive areas and for long periods, as this significantly increases the risk of side effects.
• Contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area) should be avoided.
• Dermo-Hubber should not be applied to skin folds, such as the groin or armpits.
• If you have circulatory problems, you should not apply medications with corticosteroids, as this may cause ulceration of the area.
• Dermo-Hubber should not be used under airtight and waterproof materials, such as bandages, dressings, or diapers, which are not very breathable. It should be taken into account that diapers can act as occlusive dressings.
• With the use of neomycin, adverse reactions typical of internal use can also occur, especially with excessive use and in the presence of skin wounds.
• Cross-allergic reactions with aminoglycoside antibiotics have been described.
• If you are being treated for psoriasis, medical supervision is recommended.
• Prolonged use of topical antibiotics can occasionally lead to the proliferation of non-sensitive organisms, including fungi. In these cases, treatment with this medicine should be discontinued and a doctor should be consulted.
• This medicine should 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 diseases other than those for which it has been prescribed, you may mask symptoms and make diagnosis and correct treatment more difficult.
• 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 controlled by the doctor, particularly if the medicine is applied to more than 5-10% of the body surface or if occlusive dressings or a tight diaper are used. This is because the skin surface in relation to body weight is greater in children, and they are more susceptible to systemic toxicity. In children, continuous and prolonged topical treatment with corticosteroids should be avoided whenever possible, as it can cause suppression of the hypothalamic-pituitary-adrenal axis, with or without clinical signs of Cushing's syndrome, even without using occlusive dressings. If this situation occurs, the topical corticosteroid should be gradually withdrawn under medical supervision, due to the risk of adrenal insufficiency (see section 4, Possible side effects).

Other medicines and Dermo-Hubber

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including 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 plan 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 of its use 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; do not let the child come into contact with treated areas.

Do not use this medicine during breastfeeding unless your doctor tells you to.

Driving and using machines

Treatment with Dermo-Hubber does not affect the ability to drive or use machines.

3. How to use Dermo-Hubber

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years:

Apply a thin layer of ointment to the affected area, one to three times a day, rubbing gently. When a favorable response is achieved, the frequency can be reduced to one or two times a day.

Elderly patients (over 65 years) and renal impairment

Dermo-Hubber can be administered to elderly patients, although precautions should be taken in cases where there is decreased renal function 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 of age should be carefully controlled by the doctor (see sections 2 and 4).

The same dose as in adults can be used, but caution should be exercised, as absorption may be greater through immature skin and elimination may be lower due to immature renal function.

Method of administration

Topical use.

A small amount of ointment should be applied directly to the affected area, giving a gentle massage. Clean the area before applying the ointment. Avoid touching any surface with the tube mouth to avoid 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 long periods, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, colonization of wounds by fungi or non-sensitive pathogens) that need to be treated.

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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Dermo-Hubber

Remember to always use your medicine.

Do not apply a double dose to make up for forgotten doses. If you forget an application, apply it as soon as you remember, however, if it is almost time for the next dose, skip the forgotten dose and return to the regular dosing schedule.

If you have any other 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 problem may reappear. Contact your doctor before stopping treatment without having completed the indicated period. 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.

The use of anti-inflammatory drugs (corticosteroids) on the skin can cause side effects, especially after prolonged application, in extensive areas, with occlusive dressings or materials, and/or in children.

Dermo-Hubber can cause some side effects, such as:

Common(may affect up to 1 in 10 people)

• Itching (pruritus), burning, local skin atrophy (thinner skin), pain, stinging, irritation, inflammation, or redness (at the application site).

Uncommon(may affect up to 1 in 100 people)

• Striae, rosacea-like facial papular dermatitis (allergic skin reaction), ecchymosis (appearance of spots in the form of eczema or bruises), folliculitis (inflammation of the hair follicles).

Rare(may affect up to 1 in 1,000 people)

• Hypercortisolism (increased corticosteroid levels), adrenal suppression (decreased cortisol production by the body), decreased plasma cortisol. Hypertrichosis (increased 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, condylomas (warts). Hypersensitivity reactions. A condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome). Decreased weight gain in children, hypokalemia (low potassium levels in the blood), hyperglycemia (high glucose levels in the blood). Blurred vision, exacerbation of glaucoma, cataracts (subcapsular). Glucosuria (glucose in urine). Increased intracranial pressure in children, edema. Acne, purpura, pustules, atypical papular-vesicular eruptions, paresthesia, skin discoloration, dryness, cracking. Delayed wound healing.

Side effects can occur not only in the treated area but also in completely different areas of the body. This occurs if the active ingredient passes into the body through the skin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dermo-Hubber 10mg/g + 3.5 mg/g + 600 IU/g ointment

• The active ingredients 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.
• The other ingredients are: liquid paraffin.

Appearance of the product and pack contents

Dermo-Hubber is a homogeneous ointment, white or off-white in color, and is presented in tubes containing 5 g of ointment.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Date of the last revision of this leaflet:September 2024

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