Label: information for the user

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

hydrocortisone acetate/neomycin sulfate/bacitracin zinc

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

2.What you need to know before starting to use Dermo-Hubber

3.How to use Dermo-Hubber

4.Possible adverse effects

5.Storage of Dermo-Hubber

6.Contents of the package and additional information

Dermo-Hubber ointment contains asactive ingredients two antibiotics (bacitracin and neomycin) and a corticosteroid, hydrocortisone acetate, which provides anti-inflammatory and vasoconstrictive activity. It belongs to the group of medications called topical corticosteroids.

Dermo-Hubber ointment is indicated in adults, adolescents, and children over 1 year for the treatment of inflammatory dermatosesthat respond to topical treatment with corticosteroids and in which bacterial infection coexists.

No use Dermo-Hubber

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

Warnings and precautions

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

• If a hypersensitivity reaction occurs, discontinue treatment and seek appropriate therapy.
• Anti-inflammatory drugs (corticosteroids), such as the active ingredient hydrocortisone, have significant effects on the body. Avoid treatment in extensive areas and for long periods of time, as this significantly increases the risk of adverse effects.
• Avoid contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• Do not apply Dermo-Hubber in skin folds, such as the groin or armpits.
• If you have circulatory problems, do not apply corticosteroid medications, as it may cause ulceration in the area.
• Do not use Dermo-Hubber under impermeable materials to air and water, such as bandages, dressings, or diapers, which are poorly breathable. Note that diapers can act as occlusive dressings.
• With the use of neomycin, adverse reactions may also occur, especially with excessive use and in the presence of skin wounds.
• Cross-reactive allergic reactions with aminoglycoside antibiotics have been described.
• If you are being treated for psoriasis, it is recommended to have close medical supervision.
• Prolonged use of topical antibiotics may occasionally lead to the proliferation of non-susceptible organisms, including fungi. In these cases, discontinue treatment with this medication and consult a doctor.
• Do not apply this medication 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, you may mask symptoms and make it difficult to diagnose and treat correctly.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Dermo-Hubber is contraindicated in children under 1 year. Its use in children under 12 years should be carefully controlled by a doctor, particularly if the medication 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 area in relation to body weight is greater in children and they are more susceptible to systemic toxicity. In children, it should be avoided whenever possible to apply a continuous and prolonged topical treatment with corticosteroids, as it may cause 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 situation occurs, the topical corticosteroid should be discontinued gradually under medical supervision due to the risk of adrenal insufficiency (see section 4 Possible adverse effects).

Other medications and Dermo-Hubber

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, especially if you are receiving treatment with other steroids. To date, no studies of interactions with Dermo-Hubber cream have been conducted.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Dermo-Hubber cream will not be used during pregnancy unless your doctor considers that the potential benefits of its use justify the potential risk to the fetus.

Women of childbearing age should use effective contraceptive methods during treatment.

Breastfeeding

Do not apply Dermo-Hubber cream to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Do not use this medication during breastfeeding unless your doctor advises you to.

Driving and operating machinery

The treatment with Dermo-Hubber does not affect the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication indicated 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 old:

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

Older patients (over 65 years old) and renal insufficiency

Dermo-Hubber can be administered to elderly patients, but precautions should be taken in cases where there is a decrease in 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 and its use in children under 12 years 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 less due to immature renal function.

Administration form

Cutaneous use.

A small amount of ointment will 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 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 in excess, or have used it for excessively prolonged 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-susceptible pathogens) that should be treated.

Due to the characteristics of the preparation, it is not expected to have intoxication phenomena with the topical use of the medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Dermo-Hubber

Remember to always use your medication.

Do not apply a double dose to compensate for the missed doses. If you forget to apply a dose, apply it as soon as you remember, but if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.

If you have any other doubts about the use of this product, consult your doctor or pharmacist.

If you interrupt treatment with Dermo-Hubber

The original symptoms of your skin problem may reappear. Contact your doctor before interrupting treatment without completing it to the indicated period. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• Striae, rosacea-like papular facial dermatitis (skin allergic reaction), ecchymosis (appearance of eczema-like or bruise-like patches), folliculitis (inflammation of hair follicles).

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

• Hypercortisolism (increased levels of corticosteroids), adrenal suppression (decreased production of cortisol by the body), decreased plasma cortisol.Hirsutism (excessive hair growth), alopecia, sensitization, hyper/hypopigmentation, telangiectasias (vascular spiders), perioral dermatitis, contact dermatitis.

Unknown frequency(the frequencycannot be estimated from available data)

• Microbial or fungal skin infections, molluscum contagiosum, condyloma acuminatum (warts). Hypersensitivity reactions.A condition characterized by rounded face, fat accumulation, weakness, etc. (Cushing's syndrome). Decreased weight gain in children, hypokalemia (low potassium levels in blood), hyperglycemia (high glucose levels in blood). 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.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the pharmacy's Take-Back Point. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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

• The active principles are: hydrocortisone acetate, neomycin sulfate, and zinc bacitracin. Each gram of ointment contains 10 mg of hydrocortisone acetate, 3.5 mg of neomycin sulfate, and 600 International Units (IU) of zinc bacitracin.
• The other components are: petrolatum.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Last review date of this leaflet:September 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.