Patient Information Leaflet

GEXI 1 mg/g cream

Gentamicin
Equivalent medicine
Please read all of 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 others, 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:

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

1. What GEXI is and what it is used for

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

in inflammatory skin conditions caused by bacteria, such as:
pyoderma, characterized by skin inflammations of varying severity and extent, including ecthyma, characterized by blisters, vesicles, and pustules which, upon rupture, lead to lesions that heal with difficulty;
folliculitis, inflammations of the skin at the hair follicle level;
sycosis, characterized by inflammations of hairy areas;
furunculosis;
microbial eczema, characterized by pruritic 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 difficult to heal due to impaired blood circulation;
traumatic wounds; 1/4
burns (thermal injuries) of varying degree and extent, in which the burned skin may facilitate the growth of particularly aggressive bacteria;
infected excoriations.
in other skin infections such as:
acne;
pustular psoriasis, characterized by non-contagious skin inflammation with formation of small yellow serum-filled blisters;
intertriginous conditions, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
paronychia, inflammations of the skin edge near the nail of bacterial origin.

GEXI is particularly indicated in recently developed (acute) conditions accompanied by the presence of inflammatory fluid (in the exudative phase).
In skin diseases caused by fungi, GEXI for topical use is not effective, since 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 GEXI

Do not use GEXI
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 GEXI.
Do not use this medicine in the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction
(sensitization) after using this medicine, especially with prolonged use.
With prolonged and excessive use of gentamicin, as with other antibiotics, resistant microorganisms may develop. In such cases, your doctor will instruct you to discontinue treatment and will prescribe an appropriate therapy.
Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as an allergic reaction may occur (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, especially if there is skin damage or with long-term treatment. In such cases, adverse effects associated with systemic use of gentamicin may occur. Please keep this in mind, particularly when treating infants or children.
2/4
GEXI is not effective against skin infections caused by viruses or fungi.

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

Other medicines and GEXI
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 breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision. Avoid using large amounts or prolonged treatment during pregnancy.

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

GEXI contains chlorocresol and cetyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl alcohol, which may cause localized skin reactions (e.g., contact dermatitis).

3. How to use GEXI

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 initial results are achieved. After that, you may reduce application to 1-2 times a day.
Protect the treated area with a sterile gauze dressing after applying the cream.
If you use more GEXI than you should
In case of accidental ingestion/intake of GEXI, inform your doctor immediately or go to the Emergency Room of the nearest hospital.
If you forget to use GEXI
Do not use a double dose to make up for the forgotten dose.
If you stop using GEXI
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

3/4
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 pruritus, 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 may also report side effects directly through 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 GEXI

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 GEXI contains

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

Description of the appearance of GEXI and contents of the pack
Pack containing one 30 g tube 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)
4/4