GEBEXONE

Package leaflet: Information for the user

GENTAMICIN AND BETAMETASONE ESAPHARMA 1 mg/g + 1 mg/g cream
Gentamicin sulfate and betamethasone valerate
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GENTAMICIN AND BETAMETASONE ESAPHARMA is and what it is used for
2. What you need to know before using GENTAMICIN AND BETAMETASONE ESAPHARMA
3. How to use GENTAMICIN AND BETAMETASONE ESAPHARMA
4. Possible side effects
5. How to store GENTAMICIN AND BETAMETASONE ESAPHARMA
6. Contents of the pack and other information

1. What GENTAMICIN AND BETAMETASONE ESAPHARMA is and what it is used for

GENTAMICIN AND BETAMETASONE ESAPHARMA contains two active substances:

• gentamicin sulfate, an antibiotic active against many bacteria;
• betamethasone valerate, which belongs to a class of medicines called corticosteroids, hormones that perform numerous functions, with an important role in controlling inflammation.

GENTAMICIN AND BETAMETASONE ESAPHARMA is indicated for the local treatment of skin diseases (dermatoses) due to allergies or inflammation that have become infected or when there is a risk of infection.
GENTAMICIN AND BETAMETASONE ESAPHARMA is indicated for the treatment of the following skin conditions:

• atopic eczema in infants, characterized by itching, redness, scaling, and skin elevations;
• nummular eczema, characterized by redness, scaling, and skin elevations;
• anal and genital (anogenital) itching;
• itching in the elderly;
• contact dermatitis, characterized by redness, scaling, small blisters, vesicles, minor superficial wounds, and crusts, occurring upon contact with certain substances;
• seborrheic dermatitis, characterized by skin eruptions affecting areas rich in sebaceous glands such as the scalp, face, chest, and ears;
• neurodermatitis, characterized by itching and scaling;
• intertrigo, characterized by redness, scaling, irritation, and itching due to friction between adjacent body parts;
• sunburn, characterized by itching, pain, burning sensation, and the presence of blisters;
• exfoliative dermatitis, characterized by small blisters, redness, swelling, crusts, and itchy scales;
• radiation dermatitis, characterized by itchy redness, discolored patches, hair loss, blisters, and pain;
• stasis dermatitis, characterized by darker areas, red spots, thin or sometimes thickened skin, with itching and pain;
• psoriasis, characterized by red patches, thickening, silvery-white scaling, and sometimes itching.

2. What you need to know before using GENTAMICIN AND BETAMETHASONE ESAPHARMA

Do not use GENTAMICIN AND BETAMETHASONE ESAPHARMA

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have tuberculosis of the skin, herpes simplex, or other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using GENTAMICIN AND BETAMETHASONE ESAPHARMA.
This medicine must not be applied to the eyes.
If GENTAMICIN AND BETAMETHASONE ESAPHARMA causes you irritation or sensitization, your doctor will discontinue treatment and prescribe an appropriate therapy.
Any adverse effects reported with the use of systemic corticosteroids (taken orally or by injection), including adrenal suppression (reduced function of the adrenal glands), may also occur with topical corticosteroids (used locally), especially in children.
If you apply GENTAMICIN AND BETAMETHASONE ESAPHARMA over a large area of skin, particularly if the skin is damaged, under occlusive dressing, or for prolonged periods, absorption into the body of betamethasone and gentamicin increases (see "Occlusive dressing technique" in section 3). In such cases, adverse effects associated with systemic use of gentamicin may occur. Your doctor will take special precautions, particularly in infants and children (see "Children and adolescents").
Gentamicin sulfate may cause allergic reactions to other antibiotics of the same family (cross-allergenicity among aminoglycosides).
Prolonged use of topical antibiotics may sometimes lead to overgrowth of organisms not sensitive to the antibiotic, including fungi. In such cases, or if irritation, sensitization, or further infections develop, your doctor will discontinue treatment with gentamicin and prescribe specific therapy. Contact your doctor if blurred vision or other visual disturbances occur.

Children and adolescents
Children may be more sensitive than adults to the hormonal effects of the active substance betamethasone (hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, delayed growth in height and weight, and intracranial hypertension) (see section "Additional undesirable effects in children").

Other medicines and GENTAMICIN AND BETAMETHASONE ESAPHARMA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Use GENTAMICIN AND BETAMETHASONE ESAPHARMA only if your doctor considers that the expected benefit outweighs the potential risk to the fetus. If you are pregnant, do not use this medicine at high doses or for prolonged periods.

Breastfeeding
Your doctor will decide whether you should discontinue breastfeeding or stop the treatment, taking into account the importance of the medicine for your condition.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

GENTAMICIN AND BETAMETHASONE ESAPHARMA contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICINA E BETAMETASONE ESAPHARMA

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
GENTAMICINA E BETAMETASONE ESAPHARMA must not be applied to the eyes.
Apply a small amount of cream to the affected area 2-3 times daily.
Psoriatic lesions unresponsive to treatment and deep dermatoses that have become infected may
respond better to therapy with GENTAMICINA E BETAMETASONE ESAPHARMA when this medicine
is used with the occlusive dressing technique described below.
Occlusive dressing technique:

1. Apply a thick layer of cream over the entire surface of the lesion, cover with a light
   gauze and then with a transparent, waterproof, flexible plastic material extending beyond the
   edges of the treated area.
2. Seal the edges to the surrounding healthy skin using adhesive tape or other means.
3. Keep the dressing in place on the affected area for 1 to 3 days, and repeat the procedure 3-4 times as needed.
   With this method, significant improvement is often observed within a few days. Rarely, skin
   inflammation may develop under the dressing, requiring removal of the occlusive dressing.

If you use more GENTAMICINA E BETAMETASONE ESAPHARMA than you should
In case of accidental ingestion/overdose of GENTAMICINA E BETAMETASONE ESAPHARMA, inform
your doctor immediately or go to the nearest hospital.
Excessive or prolonged use of this medicine may cause corticosteroid-related adverse effects such as:
adrenal gland dysfunction, increased steroid levels in the body (hypercorticism), Cushing's syndrome—a condition in which the body produces too much cortisol—and development of lesions caused by bacteria and fungi.
A single episode of antibiotic gentamicin overdose is unlikely to produce symptoms.
Excessive and prolonged use of gentamicin on the skin may lead to the development of lesions caused by fungi and bacteria that are not sensitive to the antibiotic.
In case of accidental ingestion/overdose of GENTAMICINA E BETAMETASONE ESAPHARMA,
contact your doctor or go immediately to the Emergency Department of the nearest hospital.

If you forget to use GENTAMICINA E BETAMETASONE ESAPHARMA
Do not use a double dose to make up for the missed dose.

If you stop treatment with GENTAMICINA E BETAMETASONE ESAPHARMA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported very rarely:

• hypersensitivity
• rash
• skin discoloration.

The following side effects, due to the use of corticosteroids applied to the skin, have been described, especially after using occlusive dressings:

• burning
• itching
• irritation
• dryness of the skin
• inflammation of the hair follicles (folliculitis)
• increased hair growth (hypertrichosis)
• acne (acneiform eruptions)
• skin inflammation with red rashes around the mouth (perioral dermatitis)
• allergic contact dermatitis (skin inflammation due to contact with allergenic substances)
• maceration of the skin
• secondary skin infection
• thinning of the skin (cutaneous atrophy)
• skin streaks (striae)
• acute skin inflammation with itching and sweat retention in the layers beneath the skin (miliaria).

Treatment with gentamicin may cause temporary irritation (erythema and itching), which usually does not require discontinuation of treatment.
The following side effects may occur with frequency not known:

• blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICINA E BETAMETASONE ESAPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GENTAMICINA E BETAMETASONE ESAPHARMA contains

• The active substances are gentamicin sulfate and betamethasone valerate. 100 g of cream contain 0.166 g of gentamicin sulfate, equivalent to 0.1 g of gentamicin, and 0.122 g of betamethasone valerate, equivalent to 0.1 g of betamethasone.
• The other components are: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, phosphoric acid, purified water.

Description of the appearance of GENTAMICINA E BETAMETASONE ESAPHARMA and contents of the
package
Packaging containing one tube of 30 g of cream.
Marketing Authorization Holder
ESAPHARMA S.P.A. VIA GIUSEPPE MAZZINI, 18 20066 – MELZO (MI)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.