Label: information for the user

Novoter Gentamicina 0.5 mg/g + 1 mg/g cream

fluocinonide / gentamicin sulfate

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 read 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 is Novoter Gentamicina and how it is used

2.What you need to know before starting to use Novoter Gentamicina

3.How to use Novoter Gentamicina

4.Possible adverse effects

5.Storage of Novoter Gentamicina

6.Contents of the package and additional information

Novoter Gentamicina cream is a combined preparation for external use that contains two active ingredients:

• Fluocinonide, an anti-inflammatory (a corticosteroid)
• Gentamicin (as gentamicin sulfate), an antibiotic from the aminoglycoside group.

Novoter Gentamicina cream is used in adults and adolescents over 12 years old for localized, inflammatory skin conditions and small areas that require treatment with a high-potency glucocorticoid, in cases where a bacterial infection also coexists.

It is also indicated for the treatment in adults, adolescents, and children over 1 year old with psoriasis.

Do not use Novoter Gentamicina

• if you are allergic to fluocinonide, gentamicin, other corticosteroids, other aminoglycoside antibiotics, or any of the other components of this medication (listed in section 6).

• if you have tuberculosis, syphilis, viral infections (e.g., herpes or chickenpox)
• on skin areas affected by rosacea (inflammation with redness of the skin on the face), 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 skin areas showing a vaccination reaction, i.e., redness or inflammation after vaccination
• on skin infections caused by fungi (unless treated with a specific treatment in addition)
• in children under 1 year

Warnings and precautions

Consult your doctor or pharmacist before starting to use Novoter Gentamicina

• If any hypersensitivity reaction occurs, discontinue treatment and seek appropriate therapy.
• Topical anti-inflammatory medications (corticosteroids), such as the active ingredient fluocinonide in Novoter Gentamicina cream, have significant effects on the body. It is not recommended to use this medication on large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.
• Avoid contact with the eyes, deep open wounds, and mucous membranes (e.g., the mouth, nose, or genital area).
• Do not apply the cream to skin folds, such as the groin or armpits.
• Do not apply the medication with occlusive dressings (or impermeable materials, such as some diapers).
• With the use of the second component of this medication, gentamicin, adverse reactions specific to internal use may also occur, especially with excessive use and in the presence of skin lesions.
• Cross-reactive allergic reactions with aminoglycoside antibiotics have been described.
• 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 Novoter Gentamicina cream 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

This medication is contraindicated in children under 1 year and not recommended in children under 12 years.

In children, corticosteroids are more likely to pass through the skin and have adverse effects in other areas of the body than in adult patients.

In children treated with topical corticosteroids, adrenal gland dysfunction has been reported, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure, which may manifest as a bulging fontanelle in infants and headaches.

Other medications and Novoter Gentamicina

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 interactions with Novoter Gentamicina cream have been described.

Pregnancy and breastfeeding

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

Pregnancy

Novoter Gentamicina cream will not be used during pregnancy unless your doctor considers that the potential benefits of its use outweigh the potential risk to the fetus.

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

Breastfeeding

Do not apply Novoter Gentamicina 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

Novoter Gentamicina treatment does not affect the ability to drive or operate machinery.

Novoter Gentamicina cream contains propylene glycol and stearic acid alcohol

This medication contains 590.6 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation. Do not use on open wounds or large areas of damaged skin (such as burns).

This medication may cause local skin reactions (such as contact dermatitis) because it contains stearic acid alcohol.

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

The recommended dose is:

Adults and adolescents and children over 1 year:

Apply a thin layer of Novoter gentamicin cream covering the affected area 3 to 4 times a day. When a favorable response is achieved, the frequency can be reduced to 3 times a day.

If a treatment duration of more than one week is required, reevaluation of the treatment is recommended after 7 days. If the medication is used on the face, the treatment should be as short as possible, a maximum of one week.If no improvement is observed within these time periods, consult your doctor.

Use in children

This medication is contraindicated in children under 1 year. It is not recommended in children under 12 years, except for psoriasis.

Administration form

Cutaneous use.

The cream is applied in a thin layer over the affected skin areas and gently massaged with a soft massage.

If you use more Novoter Gentamicin than you should

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If you have usedNovoter Gentamicin cream in excess, or used it for excessively prolonged periods, you must 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 must be treated.

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 ingested.

If you forgot to use Novoter Gentamicin

If you forgot to use this medication when due, apply the corresponding dose as soon as possible or, if the next application is near, wait until then.

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Novoter Gentamicin

The original symptoms of your skin problem may reappear. Contact your doctor before interrupting treatment without completing it until the indicated period.

If you have any other questions 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.

Novoter Gentamicina may cause some side effects, such as:

Unknown frequency(frequency cannot be estimated from available data)

Immune system disorders:Hypersensitivity reactions

Endocrine disorders:Suppression of the hypothalamic-pituitary-adrenal axis (decreased production of cortisol by the body) and Cushing's syndrome in children (moon face, growth retardation, increased body hair).

Metabolism and nutrition disorders:Decreased weight gain in children, hypokalemia (low potassium levels in blood), hyperglycemia (high glucose levels in blood).

Eye disorders:Blurred vision, cataracts (subcapsular)

Vascular disorders:Intracranial hypertension in children (bulging fontanelles, headache, optic nerve swelling), edema.

Skin and subcutaneous tissue disorders:Redness, pruritus (itching), skin irritation, dryness, cracking, folliculitis (inflammation of hair follicles), telangiectasia (vascular spiders), hirsutism (excessive hair growth), steroid acne, acneiform eruption, skin pigmentation changes, perioral rosacea dermatitis (skin reaction around the mouth), contact dermatitis, skin infection, skin maceration (skin swelling), skin atrophy (thinning of skin), striae, miliaria (red and white papules on various parts of the body), erythema (redness at the application site), skin discoloration, alopecia, hirsutism (changes in hair growth), paresthesia (numbness or tingling).

Musculoskeletal and connective tissue disorders:Delayed growth in children.

Renal and urinary disorders:Glucosuria (glucose in urine)

Respiratory, thoracic, and mediastinal disorders:Nasal congestion, rhinitis (nasopharyngitis)

Nervous system disorders:Headache, dizziness

The topical use of the active ingredient gentamicin may cause poor wound healing. Additionally, occasional ototoxic and nephrotoxic effects (auditory and vestibular system disorders and kidney disorders) may occur even after external use of gentamicina, particularly with repeated use of gentamicin on extensive wounds.

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

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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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 medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Novoter Gentamicina

• The active principles are fluocinonide and gentamicin sulfate. Each gram of cream contains 0.5 mg of fluocinonide and 1 mg of gentamicin sulfate.
• The other components are: stearic acid alcohol, sodium bisulfite (E222), dimethicone, glycerol (E422), macrogol 4000, propylene glycol (E1520), anhydrous citric acid, and purified water.

Appearance of the product and contents of the packaging

Novoter Gentamicina is presented in the form of a homogeneous white cream, in tubes containing 30 g and 60 g of cream.

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:July 2024.

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