Eosin sodium

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

EOSIN NA 2% cutaneous solution

Eosin
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after several days of treatment.

Contents of this leaflet:

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

1. What EOSINA NA is and what it is used for

EOSINA NA is a topical solution containing the active substance eosin, a medicinal product used as a skin disinfectant.
EOSINA NA is indicated for disinfecting minor superficial wounds, abrasions, mild burns (first-degree burns), insect bites, diaper rash (erythema), and mild pressure sores (skin lesions affecting body areas subjected to prolonged pressure).
Consult a doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using EOSINA NA

Do not use EOSINA NA

• if you are allergic to eosin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using EOSINA NA.
Avoid applying the medicine near the eyes.
Avoid mixing EOSINA NA with other medicines.
While using this medicine, keep in mind that EOSINA NA stains the skin red. Stains disappear within approximately three days.
Other medicines and EOSINA NA
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
This medicine may be used during pregnancy and breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
EOSINA NA 2% contains parahydroxybenzoates (Sodium methyl p-hydroxybenzoate; Sodium propyl p-hydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to use EOSINA NA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply 1 to 2 drops daily using a clean gauze pad or pour directly onto the area to be treated; if necessary, cover with a sterile, dry dressing.
If you use more EOSINA NA than you should
In case of accidental ingestion or intake of an excessive dose of EOSINA NA, inform your doctor immediately or go to the nearest hospital.
No cases of overdose with topically applied eosin have been reported.
If you have any doubts about the use of EOSINA NA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Frequency not known (frequency cannot be estimated from the available data):

• skin irritation (contact dermatitis);
• hypersensitivity reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 EOSINA NA

Keep this medicine out of the sight and reach of children.
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 and applies to the product in its original unopened
packaging and properly stored.
EOSINA NA 2% is valid for 12 months after first opening of the container.
Store the container tightly closed in the original packaging, protected from light.
Do not dispose of any medicine 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 EOSINA NA 2% cutaneous solution contains

• The active substance is eosin. 100 g of solution contain 2 g of eosin.
• The other components are purified water, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate.

Description of the appearance of EOSINA NA and pack contents
100 g bottle of cutaneous solution.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 – Gorgonzola (MI)
Manufacturer and Responsible for Batch Release
AEFFE FARMACEUTICI S.r.l. - Via Torino, 448 - 10032 Brandizzo (TO)

PATIENT INFORMATION LEAFLET

EOSINA NA 2% cutaneous solution

Eosin
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If any adverse reactions occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after several days of treatment.

Contents of this leaflet:

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

1. What EOSINA NA is and what it is used for

EOSINA NA is a topical solution containing the active substance eosin, a medicinal product used as a skin disinfectant.
EOSINA NA is indicated for disinfecting minor superficial wounds, abrasions, mild burns (first-degree burns), insect bites, diaper rash irritations (erythema), and mild pressure sores (skin lesions affecting body areas subjected to prolonged pressure).
Consult a doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using EOSINA NA

Do not use EOSINA NA

• if you are allergic to eosin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using EOSINA NA.
Avoid applying the medicine near the eyes.
Avoid mixing EOSINA NA with other medicines.
During use of this medicine, bear in mind that EOSINA NA stains the skin red. The stains disappear in about three days.
Other medicines and EOSINA NA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
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.
This medicine may be used during pregnancy and breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
EOSINA NA 2% contains parahydroxybenzoates (Sodium methyl p-hydroxybenzoate; Sodium propyl p-hydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to use EOSINA NA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply 1 to 2 times a day, a few drops using a clean gauze, or pour directly onto the area to be treated; cover with a sterile, dry dressing if necessary.
If you use more EOSINA NA than you should
In case of accidental ingestion or intake of an excessive dose of EOSINA NA, inform your doctor immediately or go to the nearest hospital.
No cases of overdose with topically applied eosin have been reported.
If you have any doubts about the use of EOSINA NA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data):

• skin irritation (contact dermatitis);
• hypersensitivity reactions.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 EOSINA NA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of that month and to the product in its original sealed packaging stored correctly.
EOSINA NA 2% is valid for 12 months after first opening of the container.
Keep the container tightly closed in the original packaging, protected from light.
Do not dispose of any medicine 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 EOSINA NA 2% Cutaneous Solution Contains

• The active substance is eosin. 100 g of solution contain 2 g of eosin.
• The other components are purified water, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate.

Description of the Appearance of EOSINA NA and Package Contents
500 g bottle of cutaneous solution.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 - Gorgonzola (MI)
Manufacturer and Responsible for Batch Release
AEFFE FARMACEUTICI S.r.l. - Via Torino, 448 - 10032 Brandizzo (TO)