GENTALYN 0.1% Cream

Зміст інструкції

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

Gentalyn 0,1% cream

gentamicina solfato

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

1. What Gentalyn is and what it is used for

Gentalyn contains the active ingredient gentamicin sulfate, which belongs to a group of medicines called
antibiotics active against many microorganisms called bacteria (broad-spectrum activity).
Gentalyn 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 eczema, characterized by itchy skin inflammations caused by microorganisms.
• 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 eczema, characterized by vesiculo-pustular lesions;
• stasis ulcers, skin lesions that are difficult to heal caused by impaired blood circulation;
• traumatic lesions;
• burns of various 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 blisters filled with serum;
• intertriginous forms characterized by redness, scaling, irritation and itching due to the rubbing of two adjacent parts of the body;
• paronychia, bacterial inflammation of the skin border near the nail.

Gentalyn 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, Gentalyn 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 there are already fungal and other microorganisms called viruses
(bacterial superinfections).

2. What you need to know before using Gentalyn

Do not use Gentalyn

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

Warnings and precautions
Consult your doctor or pharmacist before using Gentalyn.
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 gentamicin, as well as other antibiotics, may lead to the development of resistant microorganisms; in this case, your doctor will advise you to stop treatment and
prescribe suitable 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 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 systemic use of gentamicin.
Keep this in mind especially in the case of treatment of infants or children.
Gentalyn 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 need and under the direct
supervision of a doctor.

Other medicines and Gentalyn
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, 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 a doctor.

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

Gentalyn contains chlorocresolwhich may cause allergic reactions and cetostearyl alcoholwhich may cause
local skin reactions (e.g. contact dermatitis).

3. How to use Gentalyn

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 an improvement is noticed, after which you can reduce the
number of applications to 1-2 within 24 hours.
After application, protect the area with sterile gauze.

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

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

If you stop using Gentalyn
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 that usually does not require discontinuation of therapy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Gentalyn

After first opening, the medicine is valid for 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Gentalyn contains

• The active ingredient is gentamicin sulfate. 100 g of cream contains 0.166 g of gentamicin sulfate.
• The other ingredients are chlorocresol, polyethylene glycol monoethyl ether (cetomacrogol 1000), cetostearyl alcohol, white petrolatum, liquid paraffin, sodium phosphate monobasic, purified water.

Description of the appearance of Gentalyn and contents of the pack
Gentalyn 0.1% cream - tube of 30 g.
Marketing authorisation holder and manufacturer

Marketing authorisation holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer
Schering-Plough Labo N.V., Industriepark 30, 2220 Heist-Op-Den-Berg, Belgium.