ERITROMICINA 3% Żel

Treść ulotki

1. ERITROMICINA IDI 30 mg/g gel
   1. What is ERITROMICINA IDI and what is it used for
   2. What you need to know before using ERITROMICINA IDI
   3. How to use ERITROMICINA IDI
   4. Possible side effects
   5. How to store ERITROMICINA IDI 30 mg/g gel
   6. Contents of the pack and other information
2. ERITROMICINA IDI 30 mg/g cream, mg/ml cutaneous solution
   1. What is ERITROMICINA IDI and what is it used for
   2. What you need to know before using ERITROMICINA IDI
   3. How to use ERITROMICINA IDI
   4. Possible side effects
   5. How to store ERITROMICINA IDI
   6. Contents of the pack and other information

ERITROMICINA IDI 30 mg/g gel

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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ERITROMICINA IDI and what is it used for

ERITROMICINA IDI contains the active ingredient erythromycin which belongs to the group of antimicrobial medicines for the treatment of acne.
ERITROMICINA IDI 30 mg/g Gel is indicated for the topical treatment of acne and in particular for those papulopustular forms with a dominant inflammatory component.
Consult your doctor if you do not notice any improvement or if your symptoms worsen .

2. What you need to know before using ERITROMICINA IDI

Do not use ERITROMICINA IDI

• if you are allergic to erythromycin or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other antibiotics belonging to the macrolide family.

Warnings and precautions
Consult your doctor or pharmacist before using ERITROMICINA IDI.
ERITROMINICINA IDI 30 mg/g Gel is for external use only and not for ophthalmic (eye) use.
Avoid contact of the gel with eyes and mucous membranes.
The use, especially if prolonged, of topical (local) products can lead to sensitization phenomena. In this case, discontinue treatment and consult your doctor to adopt appropriate therapy.
As with all antibiotics, erythromycin can determine an overgrowth of insensitive microorganisms, i.e. those resistant to the action of erythromycin: in this case, treatment should be discontinued and appropriate therapy instituted.

Other medicines and ERITROMICINA IDI
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of other anti-acne drugs, peels, exfoliating or abrasive agents, may cause accumulation of the irritant effect.

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

Driving and operating machinery
It does not impair the ability to drive vehicles and operate machinery.
This medicine contains 955 mg of alcohol per g.
May cause a burning sensation on damaged skin

3. How to use ERITROMICINA IDI

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Apply the medicine 1-2 times a day, according to the doctor's judgement, after thorough washing with
non-alkaline soap and after drying your face well. The treatment should be continued until
clinical improvement, on average from one to three months.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will
experience them.
During use of the drug, local intolerance and a feeling of dryness of the skin may occur,
related to the treated areas.
Contact your doctor immediately if you experience a severe skin reaction: red and
scaly rash with the formation of pustules and blisters (pustular exanthematous reaction). The frequency of this reaction
is unknown (cannot be assessed based on available data).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ERITROMICINA IDI 30 mg/g gel

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.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not dispose of any medicine in waste water 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 ERITROMICINA IDI 30 mg/g gel contains

• The active ingredient is erythromycin. 1 g of gel contains 30 mg of erythromycin base.
• The other ingredients are: hydroxypropyl cellulose, ethyl alcohol.

Description of the appearance of ERITROMICINA IDI and contents of the pack
Tube containing 30 g of gel for topical dermatological use

Marketing authorisation holder and manufacturer
IDI FARMACEUTICI S.r.l.
Via dei Castelli Romani 83/85
00071 Pomezia (RM)

ERITROMICINA IDI 30 mg/g cream, mg/ml cutaneous solution

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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ERITROMICINA IDI and what is it used for

ERITROMICINA IDI contains the active ingredient erythromycin which belongs to the group of antimicrobial medicines for the treatment of acne.
ERITROMICINA IDI is indicated for the treatment of:

• skin infections caused by sensitive germs:
• pyodermas (skin infections) of varying severity and extent, including ecthyma (which manifests with blisters, vesicles and pustules), folliculitis (inflammation of the hair follicles), furunculosis, microbial eczemas (skin inflammations caused by microbes), secondarily infected forms, such as dermatitis and impetiginized eczemas (scratches with pus and blood), traumatic lesions and infected abrasions. ERITROMICINA IDI is also used for the treatment of acne, in any form and severity, as well as erythrasma (infection that predominantly affects the skin folds).

ERITROMICINA IDI 30 mg/g cream is indicated in exudative forms, in dry and excoriated forms.
ERITROMICINA IDI 30 mg/ml cutaneous solution is indicated for infections that occur in
pilose areas (covered with downy hair).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using ERITROMICINA IDI

Do not use ERITROMICINA IDI

• if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other antibiotics belonging to the macrolide family.

Warnings and precautions
Consult your doctor or pharmacist before using ERITROMICINA IDI.
ERITROMICINA IDI 30 mg/g cream is for external use only.
ERITROMICINA IDI 30 mg/ml cutaneous solution is for external use only and, given its alcoholic component,
should not come into contact with eyes, wounds and mucous membranes. If this should happen, wash thoroughly
with water.
Due to the lack of data on the potential photosensitizing and photoallergenizing properties of the product, avoid, during use,
unnecessary or prolonged exposure to sunlight or UV rays.
The use, especially if prolonged, of topical products can lead to sensitization phenomena. In
such cases, discontinue treatment and consult your doctor to adopt appropriate therapy.
The use of antibiotic agents may be associated with the growth of resistant organisms, i.e. those that do not respond
to the antibacterial activity of antibiotics. If this happens, the administration of the drug must be
interrupted.

Other medicines and ERITROMICINA IDI
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of agents containing alcohol, such as for example peeling agents and medicated soaps,
may cause a cumulative irritating effect.
Topical erythromycin and clindamycin (for local use) should not be used simultaneously
due to their antagonism.

Pregnancy, breastfeeding and fertility
In case of pregnancy and breastfeeding, this medicine should only be administered in cases of actual necessity
under the direct control of the doctor.
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.

Driving and operating machinery
The use of ERITROMICINA IDI 30 mg/g cream and ERITROMICINA IDI 30 mg/ml cutaneous solution does not
alter the ability to drive vehicles and operate machinery.

ERITROMICINA IDI 30 mg/ml cutaneous solution
This medicine contains 354 mg of alcohol per ml.
It may cause a burning sensation on damaged skin

3. How to use ERITROMICINA IDI

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Apply the medicine 2-3 times a day. According to the doctor's judgement, upon achieving the first
therapeutic results, the number of applications may be reduced to 1-2 times in 24 hours, until complete
resolution of the clinical picture.

If you use more ERITROMICINA IDI than you should
ERITROMICINA IDI 30 mg/g cream and ERITROMICINA IDI 30 mg/ml cutaneous solution are for external use
only.
Excessive application of the product does not lead to better or faster results while it may cause
redness and discomfort.
In case of accidental intake of an excessive dose of ERITROMICINA IDI, immediately notify
your doctor or go to the nearest hospital.

If you stop taking ERITROMICINA IDI
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.
The side effects reported during treatment with erythromycin have been dry skin, itching,
erythema (skin irritation), scaling, greasiness, burning sensation, eye irritation.
Many of these reactions occur due to alcohol and are reversible with discontinuation of treatment
or with a reduction in the frequency of application.
Always keep in mind the possible occurrence of hypersensitivity reactions.
Contact your doctor immediately if you experience a severe skin reaction: a red and
scaly rash with the formation of pustules and blisters (pustular exanthematous rash). The frequency of this reaction
is unknown (cannot be estimated based on available data).

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/content/come-segnalare-una-
sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ERITROMICINA IDI

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.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
ERITROMICINA IDI 30 mg/ml cutaneous solution, given the alcohol content present in the product, must be
kept away from sources of heat.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ERITROMICINA IDI contains

ERITROMICINA IDI 30 mg/g cream:

• The active ingredient is erythromycin. 1 g of cream contains 30 mg of erythromycin base.
• The other ingredients are: liquid paraffin, white soft paraffin.

ERITROMICINA IDI 30 mg/ml cutaneous solution:

• The active ingredient is erythromycin. 1 ml of cutaneous solution contains 30 mg of erythromycin base.
• The other ingredients are: caprylic/capric triglyceride, absolute ethyl alcohol.

Description of the appearance of ERITROMICINA IDI and contents of the pack

ERITROMICINA IDI 30 mg/g cream:tube containing 30 g - for cutaneous use

ERITROMICINA IDI 30 mg/ml cutaneous solution:bottle containing 40 ml - for cutaneous use

Marketing Authorisation Holder and Manufacturer
IDI FARMACEUTICI S.r.l.
Via dei Castelli Romani 83/85
00071 Pomezia (RM)