Package leaflet: Information for the patient

GENTAMICINA ALTER 0.1% cream

Gentamicin
Generic 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, consult 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, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What GENTAMICINA ALTER is and what it is used for

GENTAMICINA ALTER is a topical cream containing the active substance
gentamicin, which belongs to a group of medicines called aminoglycoside antibiotics,
used to treat bacterial infections.
GENTAMICINA ALTER is indicated for the treatment of skin inflammations caused by
bacteria such as:

skin infections with lesions and blisters (ecthyma), boils, microbial-induced eczema, stasis ulcers, and traumatic wounds;
inflammation of the hair follicles (folliculitis, sycosis);
secondary bacterial infections of skin lesions (impetiginized dermatitis and eczema);
infected burns and abrasions;
acne with pimples;
a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
skin inflammations caused by persistent friction between body surfaces (intertrigo);
bacterial infection of the superficial layers of the skin and nails (paronychia).

This medicine is not active against fungal infections; however, it is useful in infections
caused by resistant bacteria, particularly in the treatment of burns.

2. What you should know before using GENTAMICINA ALTER

Do not use GENTAMICINA ALTER:
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if you are allergic to gentamicin sulfate 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 ALTER.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially with prolonged use, or if resistant microorganisms develop, including certain types of fungi, which may occur following prolonged use of gentamicin, as with other antibiotics.
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).
Other medicines and GENTAMICINA ALTER
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or in early infancy, use this medicine only if clearly needed and under direct medical supervision.
If you are breastfeeding, use this medicine with caution and under direct medical supervision.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
GENTAMICINA ALTER contains chlorocresol
It may cause allergic reactions.
GENTAMICINA ALTER contains cetyl stearyl alcohol
It may cause localized skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICINA ALTER

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
GENTAMICINA ALTER must not be applied 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 application to 1-2 times a day.
Protect the treated area with a sterile gauze dressing after applying the cream.
If you use more GENTAMICINA ALTER than you should
Cases of overdose have not been reported.
In case of accidental ingestion/ingestion of GENTAMICINA ALTER, contact your doctor or go immediately to the Emergency Room of the nearest hospital.
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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 will experience them.
Treatment with this medicine may cause temporary skin irritation such as erythema or itching, which usually does not require discontinuation of therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GENTAMICINA ALTER

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 ALTER contains

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

Description of the appearance of GENTAMICINA ALTER and package contents
Pack containing one tube of 30 g of cream.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan
Manufacturer
Consorzio Farmaceutico e Biotecnologico Bioprogress a.r.l. - Strada Paduni, 240 – 03012 Anagni (FR) - Italy
Laboratorio Italiano Biochimico Farmaceutico Lisapharma – Via Licinio 11 – 22036 Erba (CO) - Italy
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