GENTAMICIN AND BETAMETHASONE EG

Patient Information Leaflet

GENTAMICIN and BETAMETHASONE EG 0.1% + 0.1% cream

Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as 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 they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENTAMICINA and BETAMETASONE EG is and what it is used for

GENTAMICINA and BETAMETASONE EG 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.

GENTAMICINA and BETAMETASONE EG 0.1% + 0.1% 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.
GENTAMICINA and BETAMETASONE EG 0.1% + 0.1% is indicated for the treatment of the following skin conditions:

• atopic eczema, a childhood condition characterized by itching, redness, scaling, and skin elevations;
• nummular eczema, characterized by itchy, round or oval lesions;
• anal and genital itching;
• itching in the elderly;
• contact dermatitis, characterized by redness, scaling, small blisters, vesicles, minor superficial wounds, and crusts that appear 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 caused by friction between adjacent body parts;
• solar erythema, characterized by itching, pain, burning sensation, and blistering;
• exfoliative dermatitis, characterized by small blisters, redness, swelling, crusts, and generally itchy scales;
• radiation dermatitis, characterized by itchy redness, areas of skin with increased pigmentation, hair loss, blisters, and pain;
• stasis dermatitis, characterized by darker areas, red spots, thin or sometimes thickened skin, accompanied by 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 EG

Do not use GENTAMICIN and BETAMETHASONE EG

• 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 EG.
If GENTAMICIN and BETAMETHASONE EG causes irritation or sensitization, your doctor will discontinue treatment and prescribe appropriate therapy.
Any adverse effects reported with systemic corticosteroids (taken orally or by injection), including adrenal suppression, may also occur with topical corticosteroids (used locally), especially in children.
If you apply GENTAMICIN and BETAMETHASONE EG over a large area of skin, particularly when skin damage is present, under occlusive dressing, or for prolonged periods, absorption of betamethasone and gentamicin into the body 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, especially in infants and children (see “Children and adolescents”).
Gentamicin sulfate may cause allergic reactions to other antibiotics in 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.
Do not use GENTAMICIN and BETAMETHASONE EG in the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Children may be more sensitive than adults to the hormonal effects of the active substance betamethasone, such as suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, delayed growth (both height and weight), and intracranial hypertension.

Other medicines and GENTAMICIN and BETAMETHASONE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use GENTAMICIN and BETAMETHASONE EG 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
GENTAMICIN and BETAMETHASONE EG does not affect the ability to drive or operate machinery.

GENTAMICIN and BETAMETHASONE EG contains:
Chlorocresol, which may cause allergic reactions, and alcohol cetostearyl, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICIN and BETAMETHASONE EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Apply a small amount of cream to the affected area 2–3 times daily.
Psoriatic lesions that do not respond to treatment and deep dermatoses that have become infected may respond better to therapy with GENTAMICIN and BETAMETHASONE EG when this medicine is used with the occlusive bandage technique described below.

Occlusive bandage 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 with 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, you will often observe significant improvement within a few days.
Rarely, skin inflammation may develop under the dressing, requiring removal of the occlusive bandage.

If you use more GENTAMICIN and BETAMETHASONE EG than you should
If an excessive dose of GENTAMICIN and BETAMETHASONE EG is accidentally swallowed or ingested, contact your doctor immediately or go to the nearest hospital.
Excessive or prolonged use of GENTAMICIN and BETAMETHASONE EG may alter certain body hormones (it may suppress pituitary-adrenal function, causing secondary adrenal insufficiency and signs of hypercorticism, including Cushing's syndrome).
A single episode of overdose with the antibiotic gentamicin is unlikely to produce symptoms.
Excessive and prolonged use of gentamicin on the skin may lead to the development of infections caused by fungi and bacteria that are not sensitive to the antibiotic.

If you forget to use GENTAMICIN and BETAMETHASONE EG
Do not apply a double dose to make up for the missed dose.

If you stop using GENTAMICIN and BETAMETHASONE EG
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• hypersensitivity
• rash
• skin discoloration.

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

• burning
• itching
• irritation
• dryness of the skin
• inflammation of the hair-bearing skin (folliculitis)
• excessive hair growth (hypertrichosis)
• acne (acneiform eruptions)
• change in skin color (hypopigmentation)
• skin inflammation with red rashes around the mouth (perioral dermatitis)
• skin inflammation due to contact with substances causing allergy (allergic contact dermatitis)
• skin maceration
• further skin infection (secondary infection)
• thinning of the skin (cutaneous atrophy)
• skin streaks (striae)
• acute skin inflammation with itching and sweat retention beneath the skin layers (miliaria).

Treatment with the antibiotic gentamicin may cause temporary irritation (erythema and itching), which usually does not require discontinuation of treatment.
The following side effect 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 GENTAMICIN and BETAMETHASONE EG

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 EG 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, disodium phosphate dihydrate, sodium phosphate dodecahydrate, purified water.

Description of the appearance of GENTAMICINA e BETAMETASONE EG and package contents
Packaging containing one tube of 30 g of cream.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, - 20136 Milan.
Manufacturers
Doppel Farmaceutici S.r.l., Via dei Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
Cosmo S.p.A., Via C. Colombo 1, 20020 Lainate (MI)
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino, S.S. Zona Industriale, 73010 Zollino (LE)