Package leaflet: Information for the patient

GENTAMICIN EG 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 give it 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gentamicin EG is and what it is used for

Gentamicin EG 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).
Gentamicin EG acts locally (topically) and is effective in skin infections. It is indicated for:

inflammatory skin conditions caused by bacteria, 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 affecting hair-bearing areas;
sycosis, characterized by inflammations of hairy areas;
furunculosis;
microbial eczema, characterized by pruritic skin inflammations caused by microorganisms.
inflammatory conditions where bacterial infection occurs secondarily to the initial 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.
other skin infections such as:
acne;
pustular psoriasis, characterized by non-contagious skin inflammation with the formation of small yellow blisters filled with serum;
intertriginous conditions, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
bacterial paronychia, inflammations of the skin edge near the nail of bacterial origin.

Gentamicin EG is particularly indicated for recently developed (acute) conditions accompanied by the presence of inflammatory fluid (in the exudative phase).
In skin diseases caused by fungi, Gentamicin EG 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 where fungal or viral infections (superinfections) already exist.

2. What you need to know before using GENTAMICINA EG

Do not use GENTAMICINA EG
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 GENTAMICINA EG.
Do not use this medicine on 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. 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 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 simultaneous and/or sequential use of other medicines causing 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 with long-term treatment. In such cases, adverse effects associated with systemic use of gentamicin may occur. This should be particularly considered when treating infants or children.
Gentamicina EG is not effective against skin infections caused by viruses or fungi.

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

Other medicines and GENTAMICINA EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are 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
Gentamicina EG does not affect the ability to drive or operate machinery.

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

3. How to use GENTAMICINA EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
GENTAMICINA EG must not be applied to the eyes.
Apply the medicine 3–4 times a day until improvement is observed; thereafter, you may reduce the frequency to 1–2 applications per 24 hours.
After application, protect the area with sterile gauze.

If you use more GENTAMICINA EG than you should
In case of accidental ingestion/ingestion of GENTAMICINA EG, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to use Gentamicina EG
Do not use a double dose to make up for the missed dose.

If you stop using Gentamicina EG
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly through the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICINA 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.
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 GENTAMICINA EG contains

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

Description of the appearance of GENTAMICINA 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 – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.
Cosmo S.p.A. – Via C. Colombo, 1 – 20020 Lainate (MI) – Italy.
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino – S.S. 16 Zona Industriale – 73010 Zollino (LE) –
Italy.