ERYTHROMYCIN IDI

Package leaflet: Information for the user

ERITROMICINA IDI 30 mg/g gel

Generic medicine
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact 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 ERITROMICINA IDI is and what it is used for

ERITROMICINA IDI contains the active substance erythromycin, which belongs to the group of antimicrobial medicines used for the treatment of acne.
ERITROMICINA IDI 30 mg/g Gel is indicated for topical treatment of acne, particularly for papulopustular forms with predominant inflammatory component.
Consult your doctor if you do not notice any improvement or if you observe a worsening of symptoms.

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
Talk to your doctor or pharmacist before using ERITROMICINA IDI.
ERITROMICINA IDI 30 mg/g Gel is for external use only and not for ophthalmic (ocular) use.
Contact of the gel with eyes and mucous membranes must be avoided.
Use, especially if prolonged, of topical (local) products may lead to sensitization reactions. If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
As with all antibiotics, erythromycin may lead to overgrowth of microorganisms insensitive to its action, i.e. organisms resistant to erythromycin: in such cases, treatment must be discontinued and appropriate therapy initiated.
Other medicines and ERITROMICINA IDI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of other anti-acne medications, peeling agents, desquamating or abrasive agents may increase irritant effects.
Pregnancy and breastfeeding
Use only if necessary and under direct medical supervision.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Does not affect the ability to drive or use machinery.
This medicine contains 955 mg of alcohol per gram.
It may cause a burning sensation on damaged skin.

3. How to use ERITROMICINA IDI

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the medicine 1-2 times a day, as directed by the doctor, after thoroughly washing with non-alkaline soap and carefully drying the face. Treatment should be continued until clinical improvement occurs, usually from one to three months.

4. Possible side effects

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website: 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 stated on the packaging.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via 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 ERITROMICINA IDI 30 mg/g gel contains

• The active substance is erythromycin. 1 g of gel contains 30 mg of erythromycin base.
• The other components are: hydroxypropyl cellulose, ethanol.

Description of the appearance of ERITROMICINA IDI and contents of the pack
30 g tube of dermatological topical gel.
Marketing Authorization Holder and Manufacturer
IDI FARMACEUTICI S.r.l.
Via dei Castelli Romani 83/85
00071 Pomezia (RM)

Package leaflet: information for the user

ERYTHROMYCIN IDI 30 mg/g cream, mg/ml topical solution

Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ERYTHROMYCIN IDI is and what it is used for
2. What you need to know before using ERYTHROMYCIN IDI
3. How to use ERYTHROMYCIN IDI
4. Possible side effects
5. How to store ERYTHROMYCIN IDI
6. Package contents and other information

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

ERITROMICINA IDI contains the active substance erythromycin, which belongs to a group of medicines
called anti-infective agents used for the treatment of acne.
ERITROMICINA IDI is indicated for the treatment of:

• skin infections caused by susceptible microorganisms:
• pyodermitis (skin infections) of varying severity and extent, including ecthyma (characterized by blisters, vesicles, and pustules), folliculitis (inflammation of the hair follicles), furunculosis, microbial eczema (skin inflammations caused by microorganisms), secondarily infected conditions such as impetiginized dermatitis and eczema (lesions with pus and blood), infected traumatic wounds, and infected excoriations. ERITROMICINA IDI is also used for the treatment of acne, in any form and severity, as well as erythrasma (an infection mainly affecting skin folds).

ERITROMICINA IDI 30 mg/g cream is indicated for exudative, dry, and excoriated lesions.
ERITROMICINA IDI 30 mg/ml cutaneous solution is indicated for infections occurring in hairy areas (trichogenous zones).

Consult 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 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
Talk to 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, due to its alcoholic content, must not come into contact with eyes, wounds, or mucous membranes. If this occurs, rinse thoroughly with water.
Due to lack of data on the potential photosensitizing and photoallergenic effects of the product, avoid unnecessary or prolonged exposure to sunlight or UV rays during treatment.
The use, especially if prolonged, of topical skin products may lead to sensitization reactions. If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
The use of antibiotics may promote the growth of resistant organisms, i.e. organisms that do not respond to the antibacterial activity of antibiotics. If this occurs, drug administration should be discontinued.

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

Pregnancy, breast-feeding and fertility
During pregnancy and breast-feeding, this medicine should be administered only when clearly needed and under direct medical supervision.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
The use of ERITROMICINA IDI 30 mg/g cream and ERITROMICINA IDI 30 mg/ml cutaneous solution does not impair the ability to drive or 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 exactly as directed by 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 judgment, once initial therapeutic results are achieved, the number of applications may be reduced to 1–2 times per 24 hours, until complete resolution of the clinical condition.

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 and may cause redness and discomfort.
In case of accidental ingestion of an excessive dose of ERITROMICINA IDI, contact your doctor immediately or go to the nearest hospital.

If you stop treatment with 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 will experience them.
Side effects reported during treatment with erythromycin include dry skin, itching, erythema (skin irritation), desquamation, oiliness, burning sensation, and eye irritation.
Many of these reactions are due to the alcohol content and are reversible upon discontinuation of treatment or by reducing the frequency of application.
Always keep in mind the possibility of hypersensitivity reactions.
Contact your doctor immediately if you experience a severe skin reaction: red, scaly rash with formation of pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated based on the available data).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address: 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 stated on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
ERITROMICINA IDI 30 mg/ml topical solution, due to its alcohol content, must be kept away from sources of heat.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ERITROMICINA IDI contains
ERITROMICINA IDI 30 mg/g cream:

• The active substance is erythromycin. 1 g of cream contains 30 mg of erythromycin base.
• The other components are: liquid paraffin, white vaseline.

ERITROMICINA IDI 30 mg/ml cutaneous solution:

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

Description of the appearance of ERITROMICINA IDI and contents of the pack
ERITROMICINA IDI 30 mg/g cream: tube of 30 g - for cutaneous use
ERITROMICINA IDI 30 mg/ml cutaneous solution: 40 ml bottle - for cutaneous use

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