Gentamicin and betamethasone Aurobindo Italia

Package leaflet: Information for the user

Gentamicin and Betamethasone Aurobindo Italia 0.1% + 0.1% cream

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, 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 Aurobindo Italia is and what it is used for
2. What you need to know before using Gentamicin and Betamethasone Aurobindo Italia
3. How to use Gentamicin and Betamethasone Aurobindo Italia
4. Possible side effects
5. How to store Gentamicin and Betamethasone Aurobindo Italia
6. Contents of the pack and other information

1. What Gentamicina e Betametasone Aurobindo Italia is and what it is used for

Gentamicina e Betametasone Aurobindo Italia is a topical cream containing two active substances: gentamicin and betamethasone. Gentamicin belongs to the aminoglycoside antibiotics group, used to treat bacterial infections. Betamethasone belongs to the corticosteroid group, used to relieve inflammation and allergic reactions.

Gentamicina e Betametasone Aurobindo Italia is indicated for the local treatment of allergic or inflammatory skin irritations (infected or when there is a risk of infection), such as:

• Atopic eczema, infantile eczema, characterized by itching, redness, desquamation, and skin elevations;
• Nummular eczema, characterized by itchy, round or oval lesions;
• Anal and genital itching (anogenital);
• Itching occurring in the elderly (senile);
• Contact dermatitis, characterized by redness, desquamation, small blisters, vesicles, minor superficial wounds, and crusts appearing upon contact with certain substances;
• Seborrheic dermatitis, characterized by skin eruptions affecting areas rich in sebaceous glands such as scalp, face, chest, and ears;
• Neurodermatitis, characterized by itching and desquamation;
• Intertrigo, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
• Sunburn (solar erythema), characterized by itching, pain, burning sensation, and blistering;
• Exfoliative dermatitis, characterized by small blisters, redness, swelling, crusts, and scaly lesions, generally itchy;
• Radiation dermatitis, characterized by itchy redness, patches of darker skin, hair loss, blisters, and pain;
• Stasis dermatitis, characterized by darker areas, red, thin, sometimes thickened patches, accompanied by itching and pain;
• Psoriasis, characterized by red patches, thickening, silvery-white desquamation, and sometimes itching.

2. What you need to know before using Gentamicin and Betamethasone Aurobindo Italia

Do not use Gentamicin and Betamethasone Aurobindo Italia:

• if you are allergic to betamethasone, gentamicin sulfate, or any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection called cutaneous tuberculosis;
• if you have a skin infection caused by herpes simplex or other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicin and Betamethasone Aurobindo Italia.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine.
Any adverse effects reported with 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 Aurobindo Italia over a large area of skin, particularly if the skin is damaged, 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.
This medicine must not be applied to the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In children, this medicine should be used only when clearly necessary and under direct medical supervision, as it may increase the risk of adverse effects due to higher absorption of corticosteroids.
Children may be more sensitive than adults to the effects of the active substance betamethasone on hormones (hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, delayed linear and weight growth, and intracranial hypertension).

Other medicines and Gentamicin and Betamethasone Aurobindo Italia
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are pregnant, use this medicine only if clearly necessary and under direct medical supervision. Your doctor will evaluate the benefit-risk balance for both you and the fetus. Do not use this medicine at high doses or for prolonged periods during pregnancy.

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

Driving and using machines
This medicine has no effect on the ability to drive or operate machinery.

Gentamicin and Betamethasone Aurobindo Italia contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Gentamicina e Betametasone Aurobindo Italia

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Gentamicina e Betametasone Aurobindo Italia must not be applied to the eyes.
Apply a small amount of cream to the affected area 2–3 times daily.
For treating psoriatic lesions that do not respond to treatment (refractory psoriatic lesions) or infected deep dermatoses, occlusive dressing may be used to achieve a better therapeutic response.

Occlusive dressing technique:

1. Apply a thick layer of cream over the entire surface of the lesion, cover with a light gauze, and then cover with transparent, waterproof, flexible plastic material extending beyond the edges of the treated area;
2. Seal the edges onto healthy skin using adhesive tape or other means;
3. Leave the dressing on the affected area for 1 to 3 days and repeat the procedure 3–4 times as needed.

With this method, you will observe significant improvement within a few days. Rarely, skin inflammation may develop under the dressing, requiring removal of the occlusive dressing. However, if you notice skin irritation, remove the plastic covering.

If you use more Gentamicina e Betametasone Aurobindo Italia than you should
In case of accidental ingestion/overdose of Gentamicina e Betametasone Aurobindo Italia, contact your doctor immediately or go to the nearest hospital emergency department.
Excessive or prolonged use of Gentamicina e Betametasone Aurobindo Italia may alter certain hormones in the body (suppression of pituitary-adrenal function, leading to secondary adrenal insufficiency and signs of hypercorticism including Cushing's syndrome).
A single episode of gentamicin overdose is unlikely to cause symptoms.
Excessive or prolonged use of this medicine may lead to the development of lesions caused by fungi and bacteria that are not sensitive to the treatment.

If you forget to use Gentamicina e Betametasone Aurobindo Italia
Do not use a double dose to make up for a forgotten dose.

If you stop using Gentamicina e Betametasone Aurobindo Italia
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;
• skin rash;
• skin discolouration.

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

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

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

• 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 Aurobindo Italia

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 Aurobindo Italia contains

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

Description of the appearance of Gentamicina e Betametasone Aurobindo Italia and contents of the
package
Packaging containing one 30 g tube of cream.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. - Via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer
IDI Farmaceutici s.r.l., Via dei Castelli Romani, 83/85 – 00071 Pomezia (Rome)