Package leaflet: Information for the patient

Gentamicin Hexal 0.1% cream

Gentamicin sulfate
Equivalent medicine
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gentamicin Hexal is and what it is used for
What you need to know before using Gentamicin Hexal
How to use Gentamicin Hexal
Possible side effects
How to store Gentamicin Hexal
Contents of the pack and other information

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

Gentamicina Hexal is a topical cream containing the active substance gentamicin, which belongs to a group of medicines known as aminoglycoside antibiotics, used to treat bacterial infections.
Gentamicina Hexal is indicated for the treatment of bacterial skin inflammations such as:

skin infections with lesions characterized by blisters, vesicles, and pustules that, when ruptured, lead to wounds that heal poorly (ecthyma), boils (furunculosis), eczema caused by microorganisms (microbial eczema), stasis ulcers, and traumatic wounds;
skin inflammation involving hair follicles (folliculitis), inflammation of hairy areas (sycosis);
secondary bacterial infections of skin lesions (impetigo);
infected burns and abrasions;
acne with pimples;
a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
skin inflammation caused by constant friction between body parts (intertrigo);
bacterial infection of the superficial layers of the skin and nails (paronychia).

Gentamicina Hexal is particularly indicated for recently developed (acute) conditions accompanied by the presence of inflammatory fluid (exudative phase).
Gentamicina Hexal is not effective in fungal skin infections, as gentamicin is not active against any type of fungus.
The medicine may be used in bacterial infections occurring in areas where fungal or viral infections are already present.

2. What you need to know before using Gentamicina Hexal

Do not use Gentamicina Hexal

if you are allergic to the active substance, to similar substances, 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 Gentamicina Hexal.
Do not use this medicine on the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially with 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 an 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 the simultaneous and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic), whether administered systemically or topically.
Systemic absorption (into the bloodstream) of topical gentamicin increases when large areas of the body are treated, especially if the skin is damaged or when treatments are prolonged. In such cases, adverse effects associated with systemic use of gentamicin may occur. Please bear this in mind, particularly when treating infants or children.
Gentamicina Hexal is not effective against skin infections caused by viruses or fungi.

Children
In very early infancy, this medicine should be used only when clearly necessary and under the direct supervision of a doctor.

Other medicines and Gentamicina Hexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when clearly necessary and under the direct supervision of a doctor.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

Gentamicina Hexal contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions.
This medicine contains cetyl stearyl alcohol, which may cause contact skin reactions (e.g. contact dermatitis).

3. How to use Gentamicina Hexal

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not apply Gentamicina Hexal to the eyes.
Apply a small amount of cream to the affected area 3–4 times a day until results are achieved. After that, you may reduce applications to 1–2 times a day.
Protect the treated area with a sterile gauze dressing after applying the cream.
If you use more Gentamicina Hexal than you should
In case of accidental ingestion/ingestion of Gentamicina Hexal, inform your doctor immediately or go to the nearest hospital emergency department.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use Gentalyn
Do not use a double dose to make up for a forgotten dose.
If you stop treatment with Gentalyn
If you have any doubts about how to use 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:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 Hexal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gentamicina Hexal contains

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

Description of the appearance of Gentamicina Hexal and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Sandoz S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA), Italy
Manufacturers
Doppel Farmaceutici Srl - Via Martiri delle Foibe 1 – 29016 Cortemaggiore (PC)
Mipharm S.p.A. – Via B. Quaranta, 12 – 20141 Milano