Package leaflet: Information for the patient

Gentamicin Aurobindo 0.1% cream

Equivalent 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 give it to other people, even if their symptoms are the same 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:

What Gentamicin Aurobindo is and what it is used for
What you need to know before using Gentamicin Aurobindo
How to use Gentamicin Aurobindo
Possible side effects
How to store Gentamicin Aurobindo
Contents of the pack and other information

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

Gentamicina Aurobindo contains the active substance gentamicin sulfate, which belongs to a group of medicines called antibiotics effective against many microorganisms known as bacteria (broad-spectrum activity).
Gentamicina Aurobindo acts locally (topically) and is effective in skin infections. It is indicated:

In inflammatory skin conditions caused by bacteria such as:
pyodermitis, characterized by skin inflammations of varying severity and extent, including ecthyma, which is characterized by blisters, vesicles, and pustules that, when ruptured, lead to lesions that heal with difficulty;
folliculitis, skin inflammations occurring at hair follicles;
sycosis, characterized by inflammations of hairy skin areas;
furunculosis;
microbial eczema, characterized by itchy skin inflammations caused by microorganisms.
In inflammatory conditions where bacterial infection occurs secondarily to the onset of the skin disease (secondary infections) such as:
dermatitis, characterized by skin inflammations;
impetiginized eczema, characterized by vesiculopustular lesions;
stasis ulcers, skin lesions that are difficult to heal due to impaired blood circulation;
traumatic wounds;
burns (thermal injuries) of various degrees and extent, in which the burned skin may facilitate the growth of particularly aggressive bacteria;
infected abrasions.
In other skin infections such as:
acne;
pustular psoriasis, characterized by non-contagious skin inflammation with formation of small yellow serum-filled blisters;
intertriginous forms, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body areas;
paronychia, bacterial inflammations at the edge of the skin near the nail.

Gentamicina Aurobindo is particularly indicated in recently developed (acute) conditions accompanied by the presence of inflammatory exudate (exudative phase).
In skin diseases caused by fungi, Gentamicina Aurobindo for topical use is not effective, as gentamicin is not active against any type of fungus. The medicine may be used in bacterial infections developing in areas already affected by fungal or viral infections (bacterial superinfections).

2. What you need to know before using Gentamicin Aurobindo

Do not use Gentamicin Aurobindo:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicin Aurobindo.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitisation) after using this medicine, especially with prolonged use.
Prolonged and excessive use of gentamicin, as with other antibiotics, may lead to the development of resistant microorganisms. In such cases, your doctor will instruct you to discontinue treatment and will prescribe appropriate therapy.
Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as you may experience an allergic reaction (cross-sensitivity).
Avoid the concomitant and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic), whether administered systemically or topically.
Systemic absorption (into the bloodstream) of topical gentamicin may increase when large areas of the body are treated, particularly if the skin is damaged or with long-term treatment. In such cases, adverse effects associated with systemic use of gentamicin may occur. This is particularly important to consider when treating infants or children.
Gentamicin Aurobindo is not effective against viral or fungal skin infections.

Children
In very early infancy, this medicine should be used only when clearly necessary and under direct medical supervision.

Other medicines and Gentamicin Aurobindo
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 currently known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only if clearly necessary and under direct medical supervision.

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

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

3. How to use Gentamicina Aurobindo

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 3–4 times a day until improvement is observed; thereafter, you may reduce application to 1–2 times a day.
After applying the cream, protect the treated area with a sterile gauze dressing.
If you use more Gentamicina Aurobindo than you should
In case of accidental ingestion/ingestion of Gentamicina Aurobindo, contact your doctor immediately or go to the Emergency Room of the nearest hospital.
If you forget to use Gentamicina Aurobindo
Do not use a double dose to make up for a forgotten dose.
If you stop using Gentamicina Aurobindo
If you have any questions 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 will experience them.
The following side effects may occur:

allergic contact reactions;
temporary skin irritation such as erythema or itching, which usually does not require discontinuation of treatment.

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 the following website: https://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 Aurobindo

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 Aurobindo contains

The active substance is gentamicin sulfate. 100 g of cream contains 0.166 g of gentamicin sulfate, equivalent to 0.1 g of gentamicin.
The other ingredients are: cetostearyl alcohol, cetomacrogol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, chlorocresol, purified water.

Description of the appearance of Gentamicina Aurobindo and package contents
Pack containing one tube of 30 g 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 – 00040 Pomezia (RM)