GENTAMICINA 0.1% Cream

Зміст інструкції

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

Gentamicina Idi 1mg/g cream

“Equivalent medicine”

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gentamicina Idi is and what it is used for
• 2. What you need to know before using Gentamicina Idi
• 3. How to use Gentamicina Idi
• 4. Possible side effects
• 5. How to store Gentamicina 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 ingredient gentamicin sulfate, which belongs to a group of medicines
called antibiotics active against many microorganisms called bacteria (broad-spectrum activity) and belongs
to the group of antibiotics and chemotherapeutic drugs for dermatological use.
Gentamicina Idi acts locally (topically), is effective in skin infections and is indicated:

• in inflammatory forms of the skin, caused by bacteria, such as:
• pyodermas, characterized by skin inflammations of varying severity and extent, including ecthyma, characterized by blisters, vesicles and pustules that, when broken, give rise to a lesion that heals with difficulty;
• folliculitis, skin inflammations in which hair grows;
• sycosis, characterized by inflammation of the hairy parts;
• furunculosis;
• microbial eczemas, characterized by itchy skin inflammations caused by microbes.
• in inflammatory forms in which bacterial infection occurs at a later stage than the manifestation of the skin disease (secondary infections) such as:
• dermatitis, characterized by skin inflammations;
• impetiginized eczemas, characterized by vesicle-pustular lesions;
• stasis ulcers, skin lesions that are difficult to heal caused by impaired blood circulation;
• traumatic lesions;
• burns of varying degree and extent in which bacteria, particularly aggressive ones, can easily develop on the burned skin;
• infected abrasions.
• 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, scaling, irritation and itching due to rubbing of two close parts of the body;
• perionychia, bacterial inflammation of the skin border near the nail.

Gentamicina Idi is particularly indicated in forms that have appeared recently (acute) accompanied by
the presence of inflammatory fluid (in the exudative phase).
In skin diseases caused by fungi, Gentamicina Idi for local (topical) use is not effective, as
gentamicin is not active on any type of fungus. The medicine can be used in bacterial infections
that develop where fungal and other microorganisms called viruses already exist
(bacterial superinfections).
Particular efficacy has been demonstrated by the preparation in burns of varying degree and extent, in which the
"death of the ground", implemented by the exceptional intensity of the thermal insult, 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 gentamicina or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina Idi.
Do not use this medicine in the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction
(sensitization) following the use of this medicine, especially for prolonged periods.
Prolonged and excessive use of gentamicina, as well as other antibiotics, may lead to the development of resistant microorganisms; in this case, your doctor will advise you to discontinue treatment and
prescribe appropriate therapy. Use the medicine with caution and inform your doctor if you are allergic to other
antibiotics of the aminoglycoside group, as an allergic reaction (cross-hypersensitivity) may occur.
Avoid the simultaneous and/or sequential use of other drugs that cause kidney toxicity (nephrotoxic) and/or
brain toxicity (neurotoxic) systemically or topically.
Systemic absorption (into the bloodstream) of topical gentamicina increases when treating large areas of the
body, especially in the presence of skin damage or in case of long-term treatments. In this
case, undesirable effects may occur that are evident with systemic use of gentamicina. Keep this in
mind especially in the case of treatment of infants or children.
Gentamicina Idi is not active in skin infections caused by viruses and fungi.

Children
In early infancy, the product should be administered only when absolutely necessary and under the direct
supervision of a doctor.

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 known at this time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of a doctor.

Driving and operating machinery
It does not impair the ability to drive vehicles and operate machinery.

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

3. How to use Gentamicina Idi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply the medicine 3-4 times a day until the first results are achieved, after which the number
of dressings may be reduced to 1-2 within 24 hours.
After application, protect the area with a sterile gauze.

If you use more Gentamicina Idi than you should
In case of ingestion/accidental intake of Gentamicina Idi, immediately inform your doctor or go to the
Emergency Room of the nearest hospital.

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

If you stop the treatment with Gentamicina Idi
If you have any doubts about the use of 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:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
adverse reaction system.
By reporting side effects you can help to provide more information on the safety of this
medicine.

5. How to store Gentamicina Idi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
This date applies to the product in intact packaging and correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gentamicina Idi contains

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

Description of the appearance of Gentamicina Idi and contents of the pack
Cream. Tube containing 30 g.

Marketing authorisation holder and manufacturer
IDI FARMACEUTICI S.r.l. – Via dei Castelli Romani n. 83/85 - Pomezia (RM)

Other sources of information
Through the QR Code or at the address http://www.leafletidi.it/gentamicina it is possible to read or listen to the