GENTAMICINA 0.1 % Cream

Зміст інструкції

1. Gentamicina Zentiva 0.1% cream
   1. What Gentamicina Zentiva is and what it is used for
   2. What you need to know before using Gentamicina Zentiva
   3. How to use Gentamicina Zentiva
   4. Possible side effects
   5. How to store Gentamicina Zentiva
   6. Contents of the pack and other information

Gentamicina Zentiva 0.1% cream

Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gentamicina Zentiva is and what it is used for
• 2. What you need to know before using Gentamicina Zentiva
• 3. How to use Gentamicina Zentiva
• 4. Possible side effects
• 5. How to store Gentamicina Zentiva
• 6. 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 on the skin, that contains the active ingredient gentamicin, which
belongs to the group of medicines called aminoglycoside antibiotics, used against bacterial
infections.
Gentamicina Zentiva is indicated for the topical treatment of various types of skin infections caused by bacteria
such as:

• infections, even extensive, caused directly by bacteria, such as: redness and small blisters with serum, also with itching (microbial eczema), blisters and pustules (ecthyma), infections in conjunction with hair, both of the face and other areas of the body (sycosis, folliculitis, furunculosis);
• skin inflammations that are subsequently infected by bacteria, such as redness with blisters (dermatitis and eczema), wounds of various types (abrasions, traumatic lesions and stasis ulcers), burns (burns);
• other skin diseases, such as infections of the sebaceous glands of the hair (acne), redness with scaling of the skin and formation of small elevations (pustular psoriasis), redness from rubbing of body folds (intertriginous forms), infection around the nails (paronychia).

This medicine is not active against fungal diseases, however it is useful in infections caused by bacteria
that complicate both fungal and viral diseases (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 ingredient, to substances with a similar chemical structure or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina Zentiva.
This medicine should not be applied to the eyes.
Stop treatment and inform your doctor if, following use of this medicine:

• you develop irritation or an allergic reaction (sensitization); these situations can occur with the use of medicines for the skin, especially if 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 new bacteria or certain types of fungi (mycoses), can sometimes occur with all antibiotics used on the skin, especially for prolonged periods. Use the medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, because an allergic reaction (cross-hypersensitivity) may also occur with this medicine.

Children
In very early infancy (usually in the first two years) use this medicine only in case of
actual need and under the direct control of the 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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct
control of the doctor who has assessed the benefit/risk ratio for the fetus and for the mother.

Driving and operating machinery
This medicine does not affect the ability to drive vehicles or operate machinery.

Gentamicina Zentiva contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions.
This medicine contains cetostearyl alcohol, which can cause local skin irritation (e.g.
contact dermatitis).

3. How to use Gentamicina Zentiva

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
This medicine should not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until you notice an
improvement. Afterwards, you can reduce applications to 1-2 times a day.
Protect the treated area with a sterile gauze after applying the cream.

If you use more Gentamicina Zentiva than you should
No cases of overdose have been reported.
In case of ingestion/accidental intake of this medicine, consult your doctor immediately or
go to 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 everybody gets them.
Following the intake of this medicine, temporary irritation of the skin may occur, such as
redness (erythema) or itching.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can 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 which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain or with household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gentamicina Zentiva contains

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

Description of the appearance of Gentamicina Zentiva and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
ZENTIVA ITALIA S.r.l., Viale Bodio 37/b, 20158, Milano.

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)