GEXI 0.1 % Krem

Treść ulotki

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

GEXI 1 mg/g cream

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

1. What GEXI is and what it is used for

GEXI contains the active ingredient gentamicin sulfate, which belongs to a group of medicines
called antibiotics active against many microorganisms called bacteria (broad-spectrum activity).
GEXI 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 eczemas, characterized by itchy skin inflammations
• caused by microorganisms.
• in inflammatory forms in which bacterial infection occurs at a later stage compared to 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; 1/4
• burns of various degrees and extent in which the burned skin can facilitate the development of particularly aggressive bacteria;
• 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 adjacent parts of the body;
• perionychia, bacterial inflammation of the edge of the skin near the nail.

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

2. What you need to know before using GEXI

Do not use GEXI
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
Talk to your doctor or pharmacist before using GEXI.
Do not use this medicine in your 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 gentamicin, 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 this 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.
The systemic absorption (into the bloodstream) of topical gentamicin increases when treating
extensive 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.
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GEXI 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
direct medical supervision.

Other medicines and GEXI
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
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
direct medical supervision. If you are pregnant, do not use the medicine in large
quantities or for long periods of time.

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

GEXI contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetostearyl alcohol
which may cause localized skin reactions (e.g. contact dermatitis).

3. How to use GEXI

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 the
first results are achieved. Afterwards, 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 GEXI than you should
In case of ingestion/accidental intake of GEXI, immediately inform your doctor or go to
the Emergency Room of the nearest hospital.

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

If you stop using GEXI
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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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 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 GEXI

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 “Expiry”.
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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GEXI contains

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

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

Marketing Authorisation Holder
ESAPHARMA S.P.A.
VIA GIUSEPPE MAZZINI, 18

• 20066 – MELZO(MI)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
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