CLOREXIFARM ALCOLICO

Package leaflet: Information for the user

CLOREXIFARM ALCOLICO 0.5% + 70% cutaneous solution

Chlorhexidine gluconate and ethyl alcohol
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact 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 CLOREXIFARM ALCOLICO is and what it is used for
2. What you need to know before using CLOREXIFARM ALCOLICO
3. How to use CLOREXIFARM ALCOLICO
4. Possible side effects
5. How to store CLOREXIFARM ALCOLICO
6. Contents of the pack and other information

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

CLOREXIFARM 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.
CLOREXIFARM ALCOLICO is indicated for cleaning and disinfecting:

• the skin, even if lesions (wounds, burns) are present;
• the hands before surgical procedures.

Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using CLOREXIFARM ALCOLICO

Do not use CLOREXIFARM ALCOLICO:

• if you are allergic to chlorhexidine, to similar substances, or to alcohol.

Warnings and precautions
Talk to your doctor or pharmacist before using CLOREXIFARM ALCOLICO.
This medicine is for use on the skin only (external use).
Avoid using this medicine for prolonged periods, as prolonged use of CLOREXIFARM ALCOLICO may lead to allergic reactions (sensitization phenomena).
This medicine is toxic to the eyes, brain, the membranes covering it (meninges), and the inner ear. Therefore, avoid contact of this medicine with these areas of the body.
Children
Use with caution in newborns, especially those born prematurely. CLOREXIFARM ALCOLICO may cause chemical burns.
Other medicines and CLOREXIFARM ALCOLICO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
During treatment with CLOREXIFARM ALCOLICO, avoid using other antiseptics or detergents.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are 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 CLOREXIFARM ALCOLICO

Use CLOREXIFARM ALCOLICO exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use for skin disinfection
Apply this medicinal product undiluted (pure) to disinfect the skin or wounds, using cotton or a gauze pad soaked in CLOREXIFARM ALCOLICO, and rub 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 them 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 that may be in close contact. When applying occlusive dressings to areas previously exposed to Clorexifarm Alcolico, take particular care to ensure that no excess product remains before applying the dressing.
If you use more CLOREXIFARM ALCOLICO than you should
If you do not exceed the recommended doses, there is no risk of overdose.
Accidental ingestion or inhalation may cause serious adverse effects, including death.
In case of accidental ingestion or intake of an excessive dose of CLOREXIFARM ALCOLICO, inform a doctor immediately or go to the nearest hospital.
Symptoms of overdose are not known.

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):

• skin irritation in newborns, such as burning sensations (chemical burns)
• burning or irritation of the skin (intolerance); these effects have no consequences and do not require changes in treatment;
• 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 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 CLOREXIFARM 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 CLOREXIFARM ALCOLICO contains

• The active substances are chlorhexidine gluconate and ethanol. 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 CLOREXIFARM ALCOLICO and package contents
Bottles of 250 ml, 500 ml or 1000 ml 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