GENTAMICINA 0.1 % Cream

Зміст інструкції

1. Gentamicina Teva 0,1% cream
   1. What is Gentamicina Teva and what is it used for
   2. What you need to know before using Gentamicina Teva
   3. How to use Gentamicina Teva
   4. Possible side effects
   5. How to store Gentamicina Teva
   6. Contents of the pack and other information

Gentamicina Teva 0,1% cream

Gentamicina solfato

Equivalent 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 any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gentamicina Teva contains gentamicin, a substance that belongs to the group of antibiotic drugs
called aminoglycosides and which works by counteracting bacterial infections.
Gentamicina Teva works at a local (topical) level, is effective in skin infections and is indicated:

• in inflammatory forms of the skin caused by bacteria, such as:
• pyodermas, characterized by skin inflammation of varying severity and extent, including ecthyma, characterized by blisters, vesicles and pustules that, when ruptured, lead to a lesion that heals with difficulty;
• folliculitis, including sycosis, characterized by skin inflammation at the points where hair grows;
• furunculosis;
• microbial eczemas, characterized by skin inflammation that manifests with redness, small blisters and itching, caused by microbes.
• in inflammatory forms in which bacterial infection occurs at a later stage than the manifestation of the skin disease (secondary infections) such as:
• dermatitis, characterized by skin irritation that manifests with redness, swelling and itching;
• impetiginized eczemas, characterized by vesiculo-pustular lesions;
• stasis ulcers, skin lesions that are difficult to heal caused by impaired blood circulation;
• traumatic lesions;
• burns (burns) of varying degrees and extent in which bacteria, particularly aggressive ones, can easily develop on the burned skin;
• infected abrasions.
• in other skin infections such as:
• acne;
• pustular psoriasis, characterized by non-contagious skin inflammation with the formation of small yellow blisters filled with serum;
• intertriginous forms, characterized by redness, scaling, irritation and itching due to the rubbing of two adjacent parts of the body;
• perionychia, bacterial inflammation of the edge of the skin near the nail.

This medicine is not effective against infections caused by fungi (mycoses), as gentamicin
is not active on any type of fungus. The medicine can still be used in case of bacterial
infections that overlap with already ongoing infections, caused by fungi or viruses (bacterial
superinfections).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Gentamicina Teva

Do not use Gentamicina Teva

• if you are allergic to the active ingredient, to any of the antibiotics belonging to the class of aminoglycosides (you may develop cross-allergy to these substances) or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, unless your doctor considers it strictly necessary;
• if you need to give it to your child, unless your pediatrician considers it strictly necessary.

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina Teva.
This medicine should not be applied to the eyes.

Stop treatment and inform your doctor immediatelyif you experience irritation or an allergic reaction (sensitization) following the use of this medicine, especially for prolonged periods.
Also, consult your doctor if the appearance of your infection does not improve or worsens, as the bacterium causing your infection may be resistant to the action of gentamicin (antibiotic resistance); following prolonged and excessive use of gentamicin, as well as other antibiotics, it is possible that resistant microorganisms (fungi or other bacteria) develop, and in this case your doctor will advise you to stop treatment and prescribe suitable therapy.
Use the medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, because you may also be allergic to gentamicin and develop an allergic reaction (cross-hypersensitivity).
The simultaneous and/or sequential use of other drugs that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic) systemically (oral or injection) or topically (local application on skin or mucous membranes) should be avoided. Ask your doctor for advice, who will indicate which medicines you should not take together with Gentamicina Teva.
Systemic absorption (into the blood) of gentamicin applied to the skin increases if extensive areas of the body are treated, especially in the presence of skin damage or in case of prolonged treatments. This increases the risk of undesirable effects that manifest with the systemic use of gentamicin. Keep this in mind especially in the case of treatment of infants or children.

Children
In early infancy, Gentamicina Teva should only be administered in cases of actual necessity and under the direct control of the doctor.

Other medicines and Gentamicina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, use this medicine only if absolutely necessary and under the direct control of your doctor.

Driving and operating machinery
Gentamicina Teva does not impair the ability to drive vehicles and operate machinery.

Gentamicina Teva contains

• chlorocresol: may cause allergic reactions;
• cetostearyl alcohol: may cause local skin reactions (e.g. contact dermatitis).

3. How to use Gentamicina Teva

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Apply a small amount of cream 3 - 4 times a day until the first signs of improvement;
then reduce applications to 1 - 2 times a day.
After each application of cream, protect the treated area with a sterile gauze.

If you use more Gentamicina Teva than you should
Excessive or prolonged use of gentamicin for local skin treatment may lead to an
increase or appearance of lesions caused by fungi or bacteria resistant to this antibiotic
(see “Warnings and precautions”).

If you stop using Gentamicina Teva
Ask your doctor for advice if you intend to stop the treatment.
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.
This medicine is generally well tolerated.

Stop treatment and immediately inform your doctorif you experience symptoms
such as:

• difficulty breathing;
• swelling of the face, eyes, mouth or throat;
• severe skin rashes; as these may be symptoms of an allergic reaction to the medicine.

Treatment with Gentamicina Teva may cause temporary skin irritation with the appearance of
redness (erythema) or itching, which usually does not require discontinuation of therapy.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at: 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 Teva

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Scad.”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or 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 Teva 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: cetostearyl alcohol, macrogol cetostearyl ether, white soft paraffin, liquid paraffin, sodium phosphate monobasic dihydrate, chlorocresol and purified water.

Description of the appearance of Gentamicina Teva and contents of the pack
Gentamicina Teva is presented in a carton containing a tube of 30 g of cream.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano

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