Package leaflet: Information for the patient

GENTAMICIN PENSA 0.1% cream

Gentamicin sulfate
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, as it may 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 PENSA is and what it is used for
What you need to know before using GENTAMICIN PENSA
How to use GENTAMICIN PENSA
Possible side effects
How to store GENTAMICIN PENSA
Contents of the pack and other information

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

GENTAMICINA PENSA 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 PENSA is indicated for the treatment of bacterial skin inflammations such as:

skin infections with lesions and blisters (ecthema), boils, microbial eczema, stasis ulcers, and traumatic wounds;
inflammation of hair follicles (folliculitis, 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 inflammations caused by persistent friction between body parts (intertrigo);
bacterial infections of the superficial layers of the skin and nails (paronychia).

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

2. What you need to know before using GENTAMICINA PENSA

Do not use GENTAMICINA PENSA:

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 PENSA.
This medicine must not be applied to the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) after using this medicine, especially after 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).
Paediatric population
In very early infancy, this product should be administered only when clearly necessary and under direct medical supervision.
Other medicines and GENTAMICINA PENSA
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 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 if clearly necessary and under direct medical supervision.
Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive or operate machinery.
GENTAMICINA PENSA contains chlorocresol and cetyl stearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions, and cetyl stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).

3. How to use GENTAMICINA PENSA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
GENTAMICINA PENSA must not be applied to the eyes.
Apply a small amount of cream to the affected area 3–4 times a day until desired results are achieved.
Thereafter, you may reduce application to 1–2 times a day.
After applying the cream, protect the treated area with a sterile gauze dressing.
If you use more GENTAMICINA PENSA than you should
In case of accidental ingestion/ingestion of GENTAMICINA PENSA, contact your doctor or go immediately
to the Emergency Department of the nearest hospital.
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 everyone experiences them.
Treatment with this medicine may cause temporary skin irritation such as rash, erythema, or pruritus, which does not require discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist.
You may 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 GENTAMICIN PENSA

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 PENSA 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: cetyl stearyl alcohol, cetomacrogol, white soft paraffin, liquid paraffin, monobasic sodium phosphate, chlorocresol, purified water.

Description of the appearance of GENTAMICINA PENSA and pack contents
Pack containing one 30 g tube of cream.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A. – Via Enrico Tazzoli, 6 – 20154 Milan – Italy
Manufacturer
IDI Farmaceutici S.r.l. – Via dei Castelli Romani 83/85 – 00040 Pomezia (RM)