Gentalyn

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PACKAGE LEAFLET
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Package leaflet: Information for the patient

Gentalyn 0.1% cream

sulfate gentamicin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 substance gentamicin sulfate, which belongs to a group of medicines called antibiotics effective against many microorganisms known as bacteria (broad-spectrum activity).
Gentalyn acts locally (topically) and is effective in skin infections. It 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, skin inflammations occurring in hair-bearing areas;
  • sycosis, characterized by inflammations in hairy areas;
  • furunculosis;
  • microbial eczema, characterized by itchy skin inflammations caused by microorganisms.
• in inflammatory conditions where bacterial infection occurs secondarily to the onset of the skin disease (secondary infections), such as:
  • dermatitis, characterized by skin inflammations;
  • impetiginized eczema, characterized by vesiculopustular lesions;
  • stasis ulcers, skin lesions that are difficult to heal due to impaired blood circulation;
  • traumatic wounds;
  • burns (thermal injuries) of varying degree and extent, in which 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 serum-filled blisters;
  • intertriginous forms, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
  • bacterial perionychia, inflammations of the skin edge near the nail of bacterial origin.

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Gentalyn 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, Gentalyn for local (topical) use is not effective, as gentamicin is not active against any type of fungus. The medicine may be used in bacterial infections developing in areas already affected by fungal infections or by other microorganisms known as viruses (bacterial superinfections).

2. What you should know before using Gentalyn

Do not use Gentalyn

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

Warnings and precautions
Talk to 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 after prolonged use.
Prolonged and excessive use of gentamicin, as with other antibiotics, may lead to the development of resistant microorganisms; in such cases, your doctor will instruct you to discontinue treatment and will 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 may occur (cross-sensitivity).
Avoid concomitant and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic) administered either systemically or topically.
Systemic absorption (into the bloodstream) of topical gentamicin increases when large body areas are treated, especially if the skin is damaged or with long-term treatment. In such cases, adverse effects associated with systemic use of gentamicin may occur. Please keep this in mind, particularly when treating infants or children.
Gentalyn is not effective against viral or fungal skin infections.
Children
In newborns and very young infants, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Gentalyn
Inform your doctor or pharmacist if you are using, have recently used, or might use 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 a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when clearly needed and under direct medical supervision.
Driving and using machines
Gentalyn does not affect the ability to drive or operate machinery.
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Gentalyn contains chlorocresol, which may cause allergic reactions, and cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Gentalyn

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 improvement is observed; thereafter, you may
reduce the frequency to 1–2 applications in 24 hours.
After application, protect the area with sterile gauze.
If you use more Gentalyn than you should
In case of accidental ingestion/intake of Gentalyn, inform your doctor immediately or
go to the Emergency Department of the nearest hospital.
If you forget to use Gentalyn
Do not use a double dose to make up for a forgotten dose.
If you stop using Gentalyn
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 everyone experiences 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, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, 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 stated on the packaging after "Exp.". The expiry
date refers to the last day of that month.
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.
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6. Package contents and other information

What Gentalyn contains

• The active substance is gentamicin sulfate. 100 g of cream contain 0.166 g of gentamicin sulfate.
• The other ingredients are chlorocresol, polyethylene glycol monostearate (cetomacrogol 1000), cetyl alcohol, white soft paraffin, liquid paraffin, monosodium phosphate, 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 Rome
Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg, Belgium