NeoXinal alcoholic

Package leaflet: Information for the user

NEOXINAL ALCOLICO 0.5% + 70% cutaneous solution

Chlorhexidine gluconate and ethyl alcohol
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 nurse.
• If you experience 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 ALCOLICO is and what it is used for
2. What you need to know before using NEOXINAL ALCOLICO
3. How to use NEOXINAL ALCOLICO
4. Possible side effects
5. How to store NEOXINAL ALCOLICO
6. Contents of the pack and other information

1. What NEOXINAL ALCOLICO is and what it is used for

NEOXINAL ALCOLICO contains two active substances: chlorhexidine gluconate and ethyl alcohol, which belong to a group of medicines called antiseptics. These medicines work by disinfecting the skin.
NEOXINAL ALCOLICO is indicated for cleaning and disinfecting:

• the skin, both intact and in the presence of minor superficial wounds;
• the hands prior to surgical procedures.

2. What you need to know before using NEOXINAL ALCOLICO

Do not use NEOXINAL ALCOLICO:

• if you are allergic to chlorhexidine, to similar substances, to alcohol, or to any of the other ingredients of this medicine (listed in section 6).
• Warnings and precautions Consult your doctor or nurse before using NEOXINAL ALCOLICO.

This medicine is for topical use only (external use on the skin).
This medicine is toxic to the eyes, brain and its surrounding membranes (meninges), spinal cord, and inner ear. Therefore, avoid contact of this medicine with these areas of the body.
Accidental ingestion or inhalation may cause serious adverse effects, including death.
Avoid prolonged use of this medicine, as prolonged use of NEOXINAL ALCOLICO may lead to allergic reactions (sensitization phenomena).
Do not expose treated areas to sunlight after application.
Surgical field and medical device disinfection
The doctor or nurse must avoid:

• contact of your skin with materials impregnated with this medicine before surgery;
• using excessive amounts and accumulation in skin folds or under the body.

Before applying an occlusive dressing to areas of the body treated with NEOXINAL ALCOLICO, ensure that no excess of the medicine remains in the area.
Children
Use with caution in newborns, especially premature infants. NEOXINAL ALCOLICO may cause chemical burns.
Other medicines and NEOXINAL ALCOLICO
Inform your doctor or nurse if you are using, have recently used, or might use any other medicines.
During treatment with NEOXINAL ALCOLICO, avoid using other antiseptics or detergents.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or nurse for advice 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 ALCOLICO

This medicinal product will be used only by a doctor or trained personnel.
Use for skin disinfection
Apply this medicinal product undiluted (pure) to disinfect skin or wounds, using cotton or gauze soaked in NEOXINAL ALCOLICO, rubbing for at least 30 seconds.
Repeat the procedure 2–3 times a day.
Use for hand disinfection
To disinfect hands before a surgical procedure, wash repeatedly with 5–6 ml of the product for at least one minute.
Do not exceed the recommended doses.
Do not use excessive amounts of the product and avoid accumulation of the solution in skin folds or underneath the patient’s body, or dripping onto bed sheets or other materials in close contact. When applying occlusive dressings to areas previously exposed to Neoxinal Alcolico, take particular care to ensure that no excess product remains before applying the dressing.
If you use more NEOXINAL ALCOLICO than you should
There is no risk of overdose if you do not exceed the recommended doses.
Ingestion or inhalation may cause serious adverse effects, including death.
In case of ingestion or accidental intake of an excessive dose of NEOXINAL ALCOLICO, inform a 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):

• burns (chemical burns) in newborns;
• burning and irritation of the skin (intolerance);
• if you use this medicine frequently, skin irritation and dryness may occur.

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 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 NEOXINAL ALCOHOLIC

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 below 30°C, in the original packaging, to protect the product from light. This medicine is highly flammable.
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. Package contents and other information

What NEOXINAL ALCOLICO contains

• The active substances are chlorhexidine gluconate and ethyl alcohol. 100 g of solution contain 0.5 g of chlorhexidine digluconate and 70 g of 96% ethyl alcohol.
• The other component is: purified water.

Description of the appearance of NEOXINAL ALCOLICO and package contents
24 bottles of 250 ml, 12 bottles of 250 ml, 20 bottles of 500 ml, 10 bottles of 500 ml, 12 bottles of
1 litre, 6 bottles of 1 litre of solution.
Marketing Authorization Holder
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy
Manufacturer
Nuova Farmec S.r.l. - Via W. Fleming 7, Industrial Zone - 37026 Settimo di Pescantina (VR) - Italy