GENTAMICINA 0.1% Krem

Treść ulotki

1. Gentamicina Aurobindo 0,1% cream
   1. What Gentamicina Aurobindo is and what it is used for
   2. What you need to know before using Gentamicina Aurobindo
   3. How to use Gentamicina Aurobindo
   4. Possible side effects
   5. How to store Gentamicina Aurobindo
   6. Contents of the pack and other information

Gentamicina Aurobindo 0,1% cream

Generic 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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gentamicina Aurobindo contains the active ingredient gentamicin sulfate, which belongs to a group of
medicines called antibiotics active against many microorganisms called bacteria (broad-spectrum activity).
Gentamicina Aurobindo 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 breaking, 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 eczema, characterized by itchy skin inflammations caused by microorganisms.
• In inflammatory forms in which bacterial infection occurs secondarily to the manifestation of skin disease (secondary infections) such as:
• dermatitis, characterized by skin inflammation;
• impetiginized eczema, characterized by vesicle-pustular lesions;
• stasis ulcers, skin lesions that are difficult to heal caused by impaired blood circulation;
• traumatic lesions;
• burns of varying degrees and extent in which the development of particularly aggressive bacteria can be facilitated 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 bubbles filled with serum;
• intertriginous forms characterized by redness, scaling, irritation and itching due to the rubbing of two close parts of the body;
• perionychia, inflammation of the skin border near the nail of bacterial origin.

Gentamicina Aurobindo 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 Aurobindo for local (topical) use is not effective,
because gentamicin is not active on any type of fungus. The medicine can be used in infections
from bacteria that develop where there are already fungal and other microorganisms called viruses
(bacterial superinfections).

2. What you need to know before using Gentamicina Aurobindo

Do not use Gentamicina Aurobindo:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina Aurobindo.
This medicine should not be applied to 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. It may occur,
following prolonged and excessive use of gentamicin, as well as other antibiotics, that resistant
microorganisms develop. In this case, your doctor will advise you to stop treatment and prescribe you a
suitable therapy.
Use the medicine with caution and inform your doctor if you are allergic to other antibiotics of the
aminoglycoside group, because an allergic reaction (cross-hypersensitivity) may occur.
Avoid the simultaneous and/or sequential use of other medicines that cause toxicity to the kidneys (nephrotoxic) and/or to the
brain (neurotoxic) systemically or topically.
The systemic absorption (into the bloodstream) of topical gentamicin 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 the systemic use of gentamicin. Keep
this in mind especially in the case of treatment of infants or children.
Gentamicina Aurobindo is not active in skin infections caused by viruses and fungi.

Children
In early infancy, the medicine should only be administered in cases of actual necessity and under the direct
supervision of the doctor.

Other medicines and Gentamicina Aurobindo
Inform 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, or are planning a pregnancy, or if you 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 your doctor.

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

Gentamicina Aurobindo contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions.
This medicine contains cetostearyl alcohol, which may cause local skin reactions (e.g.
contact dermatitis).

3. How to use Gentamicina Aurobindo

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 an
improvement is noticed, after which you can reduce applications to 1-2 times a day.
Protect the treated area with a sterile gauze after applying the cream.

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

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

If you stop using Gentamicina Aurobindo
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 reporting system at: 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 Gentamicina Aurobindo

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.
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 Aurobindo contains

• The active ingredient is gentamicin sulfate. 100 g of cream contains 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, sodium phosphate monobasic, chlorocresol, purified water.

Description of the appearance of Gentamicina Aurobindo and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer
IDI Farmaceutici S.r.l. – Via dei Castelli Romani 83/85 – 00040 Pomezia (RM)