EUTOPIC 1 mg /G Cream

Зміст інструкції

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

EUTOPIC 1 mg/g cream

Gentamicin
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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EUTOPIC is and what it is used for

EUTOPIC is a cream for topical application that contains the active ingredient gentamicin,
belonging to a group of medicines called aminoglycoside antibiotics, used
against bacterial infections (broad-spectrum activity).
EUTOPIC is indicated for:

• the treatment of skin inflammations 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, skin inflammations in which hair grows;
• sycosis, characterized by inflammation of hairy areas;
• furunculosis;
• microbial eczema, characterized by itchy skin inflammation caused by microbes.
• in inflammatory conditions where bacterial infection occurs at a later stage than the manifestation of the skin disease (secondary infections) such as:
• dermatitis, characterized by skin inflammation;
• impetiginized eczema, characterized by vesiculo-pustular lesions;
• stasis ulcers, skin lesions that are difficult to heal caused by impaired blood circulation;
• traumatic lesions;
• burns of varying degrees and extent in which bacteria 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 friction between two adjacent parts of the body;
• paronychia, bacterial inflammation of the skin border near the nail.

In skin diseases caused by fungi, Eutopic for topical use is not
effective, as gentamicin is not active against any type of fungus. However, the medicine
can be used in bacterial infections that develop where fungal infections already exist and by other microorganisms called viruses (bacterial superinfections).

2. What you need to know before using EUTOPIC

Do not use EUTOPIC:

• if you are allergic to the active ingredient, to similar substances or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor or pharmacist before using EUTOPIC. This medicine should not be applied to the eyes. Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization) following use of this medicine, especially for prolonged periods or if microorganisms resistant to the drug develop, which may occur after prolonged use of gentamicina as well as other antibiotics. In this case, your doctor will advise you to stop treatment and prescribe appropriate therapy. Use the medicine with caution and inform your doctor if you are allergic to other antibiotics of the aminoglycoside group, as an allergic reaction (cross-hypersensitivity) may occur. Avoid the simultaneous and/or sequential use of other drugs that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic) systemically or topically. Systemic absorption (into the bloodstream) of topical gentamicina increases when treating large areas of the body, especially in the presence of skin damage or in case of long-term treatments. In this case, undesirable effects may occur that are evident with systemic use of gentamicina. Keep this in mind especially in the case of treatment of infants or children. Eutopic is not active in skin infections caused by viruses and fungi.

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

Other medicines and EUTOPIC
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Currently, no interactions of EUTOPIC with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
In pregnant women and in early infancy, the product should be administered
only in cases of actual need and under the direct control of the doctor. This medicine should not
be used in pregnancy in large quantities or for prolonged periods of time.

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

EUTOPIC contains chlorocresol
This medicine contains chlorocresol, which may cause allergic reactions.

EUTOPIC contains cetostearyl alcohol
This medicine contains cetostearyl alcohol, which may cause local skin reactions (for
example contact dermatitis).

3. How to use EUTOPIC

Use this medicine following the instructions of your doctor or pharmacist exactly as given.
If you have any doubts, consult your doctor or pharmacist.
EUTOPIC should not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until an improvement is noticed, after which, 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 EUTOPIC than you should
In case of ingestion/accidental intake of EUTOPIC, immediately inform your doctor
or go to the Emergency Room of the nearest hospital.

If you forget to use EUTOPIC
Do not use a double dose to make up for a missed dose.

If you stop using EUTOPIC
If you have any doubts about using 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.
The following side effects may occur:

• contact allergic reactions
• temporary skin irritation such as erythema or itching, which usually does not require discontinuation of therapy.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the
safety of this medicine.

5. How to store EUTOPIC

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
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 EUTOPIC 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 petrolatum, chlorocresol, cetomacrogol, cetostearyl alcohol, sodium phosphate monobasic, purified water.

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

Marketing Authorisation Holder
Laboratorio Farmacologico Milanese S.r.l., Via Monterosso 273, 21042, Caronno Pertusella
(VA)

Manufacturer and final batch release
Idi Farmaceutici S.r.l.
Via dei Castelli Romani, 83/85
00071 Pomezia (RM)