Gentamicin Idi

Package leaflet: Information for the user

Gentamicin Idi 1 mg/g cream

“Generic medicine”
Please read this leaflet carefully before 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 others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Gentamicin Idi is and what it is used for
2. What you need to know before using Gentamicin Idi
3. How to use Gentamicin Idi
4. Possible side effects
5. How to store Gentamicin Idi
6. Contents of the pack and other information

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

Gentamicina Idi contains the active substance gentamicin sulfate, which belongs to a group of medicines called antibiotics with activity against many microorganisms known as bacteria (broad-spectrum activity), and belongs to the group of antibiotic and chemotherapeutic agents for dermatological use.
Gentamicina Idi 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, which is characterized by blisters, vesicles, and pustules that, when ruptured, lead to lesions that heal with difficulty;
• folliculitis, inflammations of the skin where hair grows;
• sycosis, characterized by inflammations of skin areas covered with hair;
• furunculosis;
• microbial eczema, characterized by itchy skin inflammations caused by microorganisms.
• in inflammatory conditions where bacterial infection occurs secondarily, after the onset of the skin disease (secondary infections), such as:
• dermatitis, characterized by skin inflammations;
• impetiginized eczema, characterized by vesiculo-pustular lesions;
• stasis ulcers, skin lesions difficult to heal due to impaired blood circulation;
• traumatic wounds;
• burns (thermal injuries) of various degrees and extent, where 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 the formation of small yellow blisters filled with serum;
• intertriginous forms, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
• paronychia, bacterial inflammations of the skin border near the nail.

Gentamicina Idi is particularly indicated in recently developed (acute) conditions accompanied by the presence of inflammatory exudate (in the exudative phase).
In skin diseases caused by fungi, Gentamicina Idi for local (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 where fungal infections and infections caused by other microorganisms known as viruses are already present (bacterial superinfections).
Particular efficacy of the preparation has been demonstrated in burns of various degrees and extent, where the "devitalization of the tissue" caused by the exceptional intensity of thermal injury favors the development of a particularly virulent bacterial flora.

2. What you need to know before using Gentamicina Idi

Do not use Gentamicina Idi

• if you are allergic to gentamicin 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 Idi.
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.
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 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 when treatment is prolonged. In such cases, adverse effects associated with systemic use of gentamicin may occur. This should be particularly considered when treating infants or children.
Gentamicina Idi is not effective against viral or fungal skin infections.

Children
In very young infants, this product should be administered only when clearly necessary and under direct medical supervision.

Other medicines and Gentamicina Idi
Tell 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 might be pregnant, are planning to become pregnant, 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 affect the ability to drive or operate machinery.

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

3. How to use Gentamicina Idi

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the medicine 3–4 times a day until initial results are achieved; thereafter, the number of applications may be reduced to 1–2 times per 24 hours.
After application, protect the area with sterile gauze.
If you use more Gentamicina Idi than you should
In case of accidental ingestion/uptake of Gentamicina Idi, immediately inform your doctor or go to the Emergency Department of the nearest hospital.
If you forget to use Gentamicina Idi
Do not use a double dose to make up for the forgotten dose.
If you stop treatment with Gentamicina Idi
If you have any doubts 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, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national adverse reaction reporting system.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Gentamicin Idi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
This date applies to the product in its original packaging, if stored correctly.
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 Idi contains

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

Description of the appearance of Gentamicina Idi and package contents
Cream. 30 g tube.
Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI S.r.l. – Via dei Castelli Romani n. 83/85 - Pomezia (RM)
Other sources of information
By means of the QR Code or at the address http://www.leafletidi.it/gentamicina, it is possible to read or listen to
this package leaflet.