Package leaflet: Information for the patient

Gentamicin Zentiva 0.1% cream

Equivalent medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gentamicina Zentiva is a cream for application to the skin, containing the active substance gentamicin, which
belongs to a group of medicines called aminoglycoside antibiotics, used to treat bacterial infections.
Gentamicina Zentiva is indicated for the topical treatment of various types of bacterial skin infections, such as:

infections, even widespread ones, directly caused by bacteria, for example: redness and small fluid-filled blisters, sometimes itchy (microbial eczema), pus-filled blisters and sores (ecthyma), infections associated with hair follicles, both on the face and other body areas (sycosis, folliculitis, furunculosis);
skin inflammations that have become secondarily infected by bacteria, such as redness with blisters (dermatitis and eczema), various types of wounds (abrasions, traumatic lesions, and stasis ulcers), burns (thermal injuries);
other skin disorders, such as infections of the sebaceous glands of hair follicles (acne), redness with skin scaling and formation of small raised lesions (pustular psoriasis), redness due to friction in body folds (intertriginous forms), infection around the nails (paronychia).

This medicine is not effective against fungal diseases; however, it is useful in bacterial infections complicating
both fungal and viral skin conditions (bacterial superinfections) and severe burns.

2. What you need to know before using Gentamicina Zentiva

Do not use Gentamicina Zentiva

if you are allergic to the active substance, to substances with a similar chemical structure, 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 Zentiva.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if, after using this medicine:

you develop irritation or an allergic reaction (sensitization); these conditions may occur with the use of topical medicines, especially when used for prolonged periods;
the appearance of your infection does not improve or worsens. These situations, which are often caused by the growth of bacteria resistant to this antibiotic, or by new bacteria or certain types of fungi (moulds), may sometimes occur with all antibiotics used on the skin, particularly when used for prolonged periods. Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as you may also develop an allergic reaction (cross-sensitivity) to this medicine.

Children
In early infancy (generally within the first two years of life), use this medicine only when strictly necessary and under the direct supervision of a doctor.
Other medicines and Gentamicina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative effects (interactions) with other medicines are known.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when strictly necessary and under the direct supervision of your doctor, who has evaluated the benefit-risk ratio for both fetus and mother.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Gentamicina Zentiva contains chlorocresol and cetyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions.
This medicine contains cetyl alcohol, which may cause local skin irritation (e.g. contact dermatitis).

3. How to use Gentamicina Zentiva

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine must not be applied to the eyes.
Apply a small amount of cream to the affected area 3–4 times a day, until you notice improvement. After that, you may reduce the frequency to 1–2 times a day.
After applying the cream, protect the treated area with a sterile gauze dressing.
If you use more Gentamicina Zentiva than you should
Cases of overdose have not been reported.
In case of accidental ingestion/intake of this medicine, consult your doctor immediately or go to the nearest hospital.
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 will experience them.
Following administration of this medicine, temporary skin irritation may occur, such as redness (erythema) or itching.

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 through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gentamicina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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.

6. Package contents and other information

What Gentamicina Zentiva 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, cetyl alcohol, monobasic sodium phosphate, purified water.

Description of the appearance of Gentamicina Zentiva and package contents
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
ZENTIVA ITALIA S.r.l., Viale Bodio 37/b, 20158, Milan.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)