Gentamicin Teva

Patient Information Leaflet

Gentamicin Teva 0.1% cream

Gentamicin sulfate
Equivalent medicine
Please read all of this leaflet carefully before you start 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gentamicina Teva contains gentamicin, a substance that belongs to a group of antibiotic medicines called aminoglycosides and which works by fighting bacterial infections.
Gentamicina Teva acts locally (topically), is effective in skin infections, and is indicated for:

• inflammatory skin conditions caused by bacteria, such as:
• pyodermitis, characterized by skin inflammations of varying severity and extent, including ecthyma, characterized by blisters, vesicles, and pustules that, when ruptured, lead to lesions that heal with difficulty;
• folliculitis, including sycosis, characterized by skin inflammations at sites where hair grows;
• furunculosis;
• microbial eczema, characterized by skin inflammations presenting with redness, small blisters, and itching, caused by microorganisms.
• inflammatory conditions in which bacterial infection occurs secondarily to the onset of the skin disease (secondary infections), such as:
• dermatitis, characterized by skin irritation presenting with redness, swelling, and itching;
• impetiginized eczema, characterized by vesiculopustular lesions;
• stasis ulcers, skin lesions that are difficult to heal due to impaired blood circulation;
• traumatic lesions;
• burns (burns) of varying degree and extent, where the burned skin may facilitate the growth of particularly aggressive bacteria;
• infected excoriations.
• other skin infections such as:
• acne;
• pustular psoriasis, characterized by non-contagious skin inflammation with formation of small yellow serum-filled blisters;
• intertriginous conditions, characterized by redness, desquamation, irritation, and itching due to friction between adjacent body parts;
• paronychia, bacterial inflammations of the skin edge near the nail.

This medicine is not effective against infections caused by fungi (moulds), since gentamicin is not active against any type of fungus. However, the medicine may be used in cases of bacterial infections superimposed on existing fungal or viral infections (bacterial superinfections).
Consult 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 substance, to any of the antibiotics belonging to the aminoglycoside class (you may develop a 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 intend to give it to your child, unless the paediatrician considers it strictly necessary.

Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicina Teva.
This medicine must not be applied to the eyes.
Stop treatment and contact your doctor immediately if you experience irritation or an allergic reaction (sensitisation) after using this medicine, especially with prolonged use.
Also, consult your doctor if the appearance of your infection does not improve or worsens, as the bacterium causing your infection might be resistant to gentamicin (antibiotic resistance). Prolonged and excessive use of gentamicin, as with other antibiotics, may lead to the development of resistant microorganisms (such as fungi or other bacteria). In such cases, your doctor will advise you to stop treatment and will prescribe appropriate therapy.
Use this medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as you may also be allergic to gentamicin and develop an allergic reaction (cross-hypersensitivity).
Avoid the simultaneous and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic), whether administered systemically (oral intake or injection) or topically (local application on skin or mucous membranes). Consult your doctor, who will advise you which medicines should not be taken together with Gentamicina Teva.
Systemic absorption (into the bloodstream) of gentamicin applied to the skin increases when large areas of the body are treated, especially if there is skin damage or with prolonged treatment. This increases the risk of adverse effects associated with systemic use of gentamicin. Please bear this in mind, particularly when treating infants or children.

Children
In early infancy, Gentamicina Teva should be administered only when strictly necessary and under direct medical supervision.

Other medicines and Gentamicina Teva
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.

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.
Pregnancy
If you are pregnant, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
Gentamicina Teva does not affect the ability to drive vehicles or 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 exactly as instructed by your doctor or pharmacist. 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;
afterwards reduce application to 1 - 2 times a day.
After each application, protect the treated area with a sterile gauze dressing.
If you use more Gentamicina Teva than you should
Excessive or prolonged use of gentamicin for local treatment of the skin may lead to an
increase or appearance of lesions caused by fungi or by bacteria resistant to this antibiotic
(see "Warnings and precautions").
If you stop treatment with Gentamicina Teva
Ask your doctor for advice if you intend to discontinue treatment.
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 gets them.
This medicine is generally well tolerated.
Stop treatment and contact your doctor immediately if you experience symptoms such as:

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

Treatment with Gentamicina Teva may cause temporary skin irritation with redness (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, talk to your doctor or pharmacist. You may also report side effects directly via 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 the 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 "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gentamicina Teva 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: cetostearyl alcohol, macrogol cetostearyl ether, white soft paraffin, liquid paraffin, sodium dihydrogen phosphate dihydrate, chlorocresol, and purified water.

Description of the appearance of Gentamicina Teva and package contents
Gentamicina Teva is presented in a box containing one 30 g tube 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)