Neoxinal

Package leaflet: Information for the user

NEOXINAL 0.05% cutaneous solution

Chlorhexidine gluconate
Please read all of 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 nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What NEOXINAL is and what it is used for

NEOXINAL contains the active substance chlorhexidine gluconate, which belongs to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
NEOXINAL is indicated for cleaning and disinfecting the skin, even when lesions (wounds, burns) are present.

2. What you need to know before using NEOXINAL

Do not use NEOXINAL

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

Warnings and precautions
Talk to your doctor or nurse before using NEOXINAL.
This medicine is for topical use only (external use on the skin).
Avoid using this medicine for prolonged periods, as allergic reactions (hypersensitivity reactions) may occur if NEOXINAL is used for a long time. In such cases, discontinue treatment and consult your doctor, who will determine appropriate therapy.
Do not swallow this medicine, as serious, even fatal, consequences may occur.
Do not apply this medicine to the eyes or inside the ear.
In addition, contact with the brain or the membranes covering the brain (meninges) should be avoided.
Before applying a dressing (occlusive-type dressings) to areas of the body treated with NEOXINAL, ensure that no excess of the medicine remains in that area.

Children
Use with caution in newborns, especially those born prematurely. NEOXINAL may cause chemical burns.
If this medicine is used to disinfect the surgical site or medical devices, the doctor or nurse must avoid:

• contact of their skin with materials impregnated with this medicine before proceeding with the procedure;
• the use of excessive amounts and accumulation in skin folds or under the body.

Other medicines and NEOXINAL
Inform your doctor or nurse if you are using, have recently used, or might use any other medicines.
During treatment with NEOXINAL, avoid using other similar medicines (antiseptics and/or detergents).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
This medicine can be used during pregnancy and while breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use NEOXINAL

This medicinal product will only be used by a doctor or specialized personnel.
Wipe the skin with cotton thoroughly soaked in NEOXINAL.
If necessary, repeat the procedure up to a maximum of 3–4 times a day.
Do not exceed the recommended doses.
If you use more NEOXINAL than you should
There are no known cases of overdose.
In case of accidental ingestion/ingestion of an excessive dose of NEOXINAL, inform your doctor immediately or go to the nearest hospital.

4. Possible side effects

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

• burning or irritation of the skin (intolerance). These effects are usually transient, without consequences, and do not require treatment modifications;
• burns (chemical burns) in newborns.

Reporting of side effects
If you experience any side effect, 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 the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEOXINAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NEOXINAL contains

• The active substance is chlorhexidine gluconate. 100 g of solution contain 0.05 g of chlorhexidine gluconate.
• The other components are: 96% ethyl alcohol, isopropyl alcohol and purified water.

Description of the appearance of NEOXINAL and contents of the pack
Pack containing 400 sachets of 25 ml of solution.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy

Package leaflet: information for the user

NEOXINAL 0.05% cutaneous solution

Chlorhexidine gluconate
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 you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact 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 NEOXINAL is and what it is used for
2. What you need to know before using NEOXINAL
3. How to use NEOXINAL
4. Possible side effects
5. How to store NEOXINAL
6. Package contents and other information

1. What NEOXINAL is and what it is used for

NEOXINAL contains the active substance chlorhexidine gluconate, which belongs to a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
NEOXINAL is indicated for cleaning and disinfecting the skin, even when lesions (wounds, burns) are present.
Consult your doctor if you do not feel better or if you feel worse after several days of treatment.

2. What you need to know before using NEOXINAL

Do not use NEOXINAL

• if you are allergic to chlorhexidine gluconate 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 NEOXINAL.
This medicine is for external use on the skin only.
Avoid using this medicine for prolonged periods, as prolonged use of NEOXINAL may lead to allergic reactions (hypersensitivity phenomena). In such cases, discontinue treatment and consult your doctor, who will determine appropriate therapy.
Do not swallow this medicine, as serious, even fatal, consequences may occur.
Do not apply this medicine to the eyes or inside the ear.
Before applying a dressing (occlusive-type dressings) to areas of the body treated with NEOXINAL, ensure that no excess medicine remains in the area.

Children
Use with caution in newborns, especially those born prematurely. NEOXINAL may cause chemical burns.

Other medicines and NEOXINAL
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
During treatment with NEOXINAL, avoid using other similar medicines (antiseptics and/or detergents).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use this medicine during pregnancy and while breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use NEOXINAL

Use NEOXINAL exactly as instructed in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Wipe the skin with cotton wool thoroughly soaked in NEOXINAL.
If necessary, repeat the procedure up to a maximum of 3–4 times daily.
Do not exceed the recommended doses without first consulting your doctor.
If you use more NEOXINAL than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of a large amount of NEOXINAL, inform your doctor immediately or go to the nearest hospital.

4. Possible side effects

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

• burning or irritation of the skin (intolerance). These effects are usually transient, without consequences, and do not require treatment modification;
• chemical burns (chemical burns) in newborns.

Reporting of side effects
If you experience any side effect, 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 the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEOXINAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
Store in the original packaging.
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 NEOXINAL contains

• The active substance is chlorhexidine gluconate. 100 g of solution contain 0.05 g of chlorhexidine gluconate.
• The other components are: ethyl alcohol 96%, isopropyl alcohol, and purified water.

Description of the appearance of NEOXINAL and contents of the pack
Pack containing 10 sachets of 25 ml of solution.
Marketing Authorisation Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy