NOVOTER GENTAMICIN 0.5 mg/g + 1 mg/g CREAM

Introduction

Package Leaflet: Information for the User

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

fluocinonide / gentamicin sulfate

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 get 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 pack

1. What is Novoter Gentamicina and what is it used for
2. What you need to know before you use Novoter Gentamicina
3. How to use Novoter Gentamicina
4. Possible side effects
5. Storage of Novoter Gentamicina
6. Contents of the pack and other information

1. What is Novoter Gentamicina and what is it used for

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 of the aminoglycoside group.

Novoter Gentamicina cream is used in adults and adolescents over 12 years of age for localized, inflammatory skin conditions of 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 of psoriasis in adults, adolescents, and children over 1 year of age.

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

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 medicine (listed in section 6).

• if you have tuberculosis, syphilis, viral infections (e.g., herpes or chickenpox)
• in areas of the skin affected by rosacea (inflammation with redness of the skin on the face), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy)
• in a skin inflammation that occurs around the mouth (perioral dermatitis)
• in areas of skin showing a vaccination reaction, i.e., redness or inflammation after vaccination
• in fungal skin infections (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 Novoter Gentamicina

• If a hypersensitivity reaction occurs, you should discontinue treatment and be indicated the appropriate therapy.
• Anti-inflammatory medicines (corticosteroids), such as the active ingredient fluocinonide present in Novoter Gentamicina cream, have significant effects on the body. It is not recommended to use this medicine on large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.
• Contact with the eyes, deep open wounds, and mucous membranes (e.g., mouth, nose, or genital area) should be avoided.
• The cream should not be applied to skin folds, such as the groin or armpits.
• The medicine should not be applied with occlusive dressings (or air-impermeable materials, such as some diapers).
• With the use of the second component of this medicine, gentamicin, 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.
• 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 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 Novoter Gentamicina cream for diseases other than those for which it has been prescribed, it may mask symptoms and make correct diagnosis and treatment difficult.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine is contraindicated in children under 1 year of age and is not recommended in children under 12 years of age.

In children, it is more likely that corticosteroids will pass through the skin and have adverse effects in other areas of the body than in adult patients.

In children treated with topical corticosteroids, alterations in glands located near the kidneys have been reported, which can lead to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure (intracranial hypertension) that can manifest as, among other signs, bulging fontanelles in infants and headaches.

Other medicines and Novoter Gentamicina

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Novoter Gentamicina cream should not be used during pregnancy unless your doctor considers that the potential benefit of its use justifies 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 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 Novoter Gentamicina does not affect the ability to drive or use machines.

Novoter Gentamicina cream contains propylene glycol and stearyl alcohol

This medicine 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 medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol.

3. How to use Novoter Gentamicina

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents and children over 1 year of age:

Apply a thin layer of Novoter gentamicina cream to 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 treatment for more than one week is required, reevaluation of treatment is recommended after 7 days. If the medicine is used on the face, treatment should be as short as possible, up to a maximum of one week. If you do not observe improvement within these time periods, consult your doctor.

Use in children

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

Method of administration

Topical use.

The cream is applied in a thin layer to the affected areas of the skin and gently rubbed in with a soft massage.

If you use more Novoter Gentamicina than you should

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If you have used Novoter Gentamicina cream excessively, or used it 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.

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 ingested.

If you forget to use Novoter Gentamicina

If you forget to use this medicine when you should, apply the dose as soon as possible or, if the next application is near, wait until then.

Do not apply a double dose to make up for forgotten doses.

If you stop using Novoter Gentamicina

The original symptoms of your skin problem may recur. Contact your doctor before stopping treatment without having completed the indicated period.

If you have any further questions on 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.

Novoter Gentamicina may cause some side effects, such as:

Frequency not known(frequency cannot be estimated from the available data)

Immune system disorders:Hypersensitivity reactions

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

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

Eye disorders:Blurred vision, cataracts (subcapsular)

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

Skin and subcutaneous tissue disorders:Burning, pruritus (itching), skin irritation, dryness, cracking, folliculitis (inflammation of the hair follicles), telangiectasia (spider veins), hirsutism (increased hair growth), steroid acne, acne-like eruption, changes in skin pigmentation, perioral dermatitis (allergic skin reaction around the mouth), allergic contact dermatitis, skin infection, skin maceration (skin swelling), skin atrophy (thinner skin), striae, miliaria (red and white bumps on several parts of the body), erythema (redness at the application site), skin discoloration, alopecia, hirsutism (changes in hair growth), numbness or tingling (paresthesia).

Musculoskeletal and connective tissue disorders:Growth retardation in children.

Renal and urinary disorders:Glucosuria (glucose in urine)

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

Nervous system disorders:Headache, dizziness

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Novoter Gentamicina

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 which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. 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 other information

Composition of Novoter Gentamicina

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

Appearance of the product and pack contents

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

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene

Pavia – Italy

Date of last revision of this leaflet:July 2024.

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