Package leaflet: Information for the patient

EUTOPIC 1 mg/g cream

Gentamicin
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 you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EUTOPIC is and what it is used for

EUTOPIC is a topical cream containing the active substance gentamicin,
belonging to a group of medicines called aminoglycoside antibiotics, used
against bacterial infections (broad-spectrum activity).
EUTOPIC is indicated for:

the treatment of bacterial skin inflammations such as:
pyoderma, 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 where hair grows;
sycosis, characterized by inflammations of hairy 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 (burn 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 forms, characterized by redness, desquamation, irritation, and pruritus due to friction between adjacent body parts;
paronychia, bacterial inflammations of the skin bordering the nail.

In skin diseases caused by fungi, Eutopic for local (topical) use is not
effective, as gentamicin is not active against any type of fungus. However, the medicine
may be used in bacterial infections developing in areas where fungal infections and
infections caused by other microorganisms known as viruses already exist (bacterial superinfections).

2. What you need to know before using EUTOPIC

Do not use EUTOPIC:

if you are allergic to the active substance, to similar substances, 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 EUTOPIC.
This medicine must not be applied to 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, or if resistant microorganisms develop, which may occur following prolonged use of gentamicin, as with other antibiotics. 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 an allergic reaction (cross-sensitivity) may occur.
Avoid the simultaneous 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 increases when large areas of the body are treated, especially if the skin is damaged or if treatment is prolonged. In such cases, adverse effects associated with systemic use of gentamicin may occur. This is particularly important to consider when treating infants or children.
EUTOPIC is not effective against skin infections caused by viruses or fungi.

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

Other medicines and EUTOPIC
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
At present, no interactions between EUTOPIC and other medicines are known.

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.
In pregnant women and in early infancy, this product should be administered only when strictly necessary and under direct medical supervision. This medicine should not be used during pregnancy in large amounts or for prolonged periods.

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

EUTOPIC contains chlorocresol
This medicine contains chlorocresol, which may cause allergic reactions.

EUTOPIC contains cetostearyl alcohol
This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use EUTOPIC

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
EUTOPIC must not be applied to the eyes.
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 EUTOPIC than you should
In case of accidental ingestion/ingestion of EUTOPIC, inform your doctor immediately or go to the Emergency Department of the nearest hospital.
If you forget to use EUTOPIC
Do not apply a double dose to make up for the missed dose.
If you stop using EUTOPIC
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 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 may also report side effects directly through the national reporting system at the following address:
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 EUTOPIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 EUTOPIC 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: liquid paraffin, white soft paraffin, chlorocresol, cetomacrogol, cetyl alcohol, sodium dihydrogen phosphate, purified water.

Description of the appearance of EUTOPIC and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Laboratorio Farmacologico Milanese S.r.l., Via Monterosso 273, 21042, Caronno Pertusella (VA)
Manufacturer and final controller
Idi Farmaceutici S.r.l.
Via dei Castelli Romani, 83/85
00071 Pomezia (RM)