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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

fluocinonide / gentamicin sulfate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Novoter Gentamicin cream is a combined topical preparation containing two active substances:

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

Novoter Gentamicin cream is used in adults and adolescents over 12 years of age for localized, inflammatory, and small-area skin conditions requiring treatment with a high-potency glucocorticoid, in cases where a bacterial infection is also present.

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 using Novoter Gentamicina

Do not use Novoter Gentamicina

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

• if you have tuberculosis, syphilis, or viral infections (for example: herpes or varicella)

• on areas of skin affected by rosacea (inflammatory redness of the facial skin), ulcers, sebaceous gland inflammation (acne), or skin diseases with thinning of the skin (atrophy)

• in perioral dermatitis (skin inflammation around the mouth)

• on areas of skin showing a vaccine reaction, such as redness or inflammation after vaccination

• in fungal skin infections (unless also treated with specific antifungal therapy)

• in children under 1 year of age

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Novoter Gentamicina

• If any hypersensitivity reaction occurs, treatment must be discontinued and appropriate therapy should be initiated.
• Anti-inflammatory medicines (corticosteroids), such as the active ingredient fluocinonide in Novoter Gentamicina cream, have significant effects on the body. This medicine should not be used over large areas of the body or for prolonged periods, as this substantially increases the risk of adverse effects.
• Avoid contact with eyes, deep open wounds, and mucous membranes (e.g., mouth, nose, or genital area).
• Do not apply the cream to skin folds such as the groin or armpits.
• Do not apply the medicine under occlusive dressings (or air-impermeable materials such as certain diapers).
• With the use of gentamicin, the second component of this medicine, adverse reactions typical of systemic use may also occur, especially with excessive use or in the presence of skin wounds.
• Cross-allergic reactions with aminoglycoside-type antibiotics have been reported.
• 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 medical advice sought.
• This medicine must not be used during the first trimester of pregnancy.
• Women of childbearing potential should use effective contraceptive methods during treatment.
• .
• If you use Novoter Gentamicina cream for conditions other than those for which it was prescribed, it may mask symptoms and complicate correct diagnosis and treatment.
• 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, corticosteroids are more likely than in adults to be absorbed through the skin and cause adverse effects in other parts of the body.

In children treated with topical corticosteroids, disturbances of glands located near the kidneys have been reported, leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), or increased pressure inside the skull (intracranial hypertension), which may manifest, among other signs, as bulging of the fontanelle in infants and headaches.

Other medicines and Novoter Gentamicina

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. No interactions with Novoter Gentamicina cream have been reported to date.

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

Novoter Gentamicina cream should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

.

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

Breastfeeding

Do not apply Novoter Gentamicina cream 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 Novoter Gentamicina does not affect the ability to drive or operate machinery.

Novoter Gentamicina cream contains propylene glycol and stearyl alcohol

This medicine contains 590.6 mg of propylene glycol per 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 Gentamicin

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

Recommended dose:

Adults, adolescents and children over 1 year of age:

Apply a thin layer of Novoter Gentamicin cream to cover the affected area 3 to 4 times a day. Once a favorable response has been achieved, the frequency may be reduced to 3 times a day.

If treatment duration longer than one week is required, re-evaluation of the treatment is recommended after 7 days. If the medicine is used on the face, treatment should be as short as possible, with a maximum of one week. If no improvement is observed 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 for use in children under 12 years of age, except in cases of psoriasis.

Method of administration

For cutaneous use.

Apply the cream in a thin layer over the affected skin areas and gently rub in with a light massage.

If you use more Novoter Gentamicin than you should

If you have used Novoter Gentamicin cream in excess or for excessively prolonged periods of time, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, fungal colonization of wounds or colonization by non-sensitive pathogens) which require treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Novoter Gentamicin

If you forget to use this medicine at the scheduled time, apply the missed dose as soon as possible. However, if it is almost time for the next dose, wait and apply the next dose at the regular time.

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

If you stop using Novoter Gentamicin

The original symptoms of your skin condition may reappear. Contact your doctor before stopping treatment prematurely, without having completed 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.

Novoter Gentamicina may cause some adverse effects such as:

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

Immune system disorders: Hypersensitivity reactions

Endocrine disorders: Hypothalamic-pituitary-adrenal axis suppression (reduced cortisone production by the body) and Cushing's syndrome in children (moon face, growth retardation, increased body hair).

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

Eye disorders: Blurred vision, cataracts (subcapsular)

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

Skin and subcutaneous tissue disorders: Burning, pruritus (itching), skin irritation, dryness, cracking, folliculitis (inflammation of hair follicles), telangiectasia (spider veins), hypertrichosis (excessive hair growth), steroid acne, acneiform eruption, changes in skin pigmentation, perioral rosacea (allergic skin reaction around the mouth), allergic contact dermatitis, dermatological infection, skin maceration (skin swelling), cutaneous atrophy (thinning of the skin), striae, miliaria (red and white bumps in various parts of the body), erythema (redness at the application site), skin discoloration, alopecia, hypertrichosis (changes in hair growth), numbness or tingling sensation (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

Topical use of the active substance gentamicin may lead to poor wound healing. In addition, ototoxic, vestibular and nephrotoxic effects (hearing disorders, vestibular system disorders [which controls balance], and kidney disorders) may occasionally occur even after external use of gentamicin, particularly with repeated use of gentamicin on extensive wounds.

Adverse effects may occur not only in the treated area but also in completely different parts of the body. This may happen if 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of 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 Novoter Gentamicin

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. Unused containers and medicines should be taken to a SIGRE collection point at your 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 pack and other information

Composition of Novoter Gentamicin

• The active substances 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: stearyl alcohol, sodium bisulfite (E222), dimethicone, glycerol (E422), macrogol 4000, propylene glycol (E1520), anhydrous citric acid, and purified water.

Nature of the product and pack contents

Novoter Gentamicin 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 the most recent revision of this leaflet: July 2024.

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