Package leaflet: Information for the user

CLOREXIFARM 0.05% cutaneous solution in single-dose container

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 would like further information or advice, please consult your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

What CLOREXIFARM is and what it is used for
What you need to know before using CLOREXIFARM
How to use CLOREXIFARM
Possible side effects
How to store CLOREXIFARM
Contents of the pack and other information

1. What CLOREXIFARM is and what it is used for

CLOREXIFARM contains the active substance chlorhexidine gluconate, which belongs to a group of
medicines called antiseptics and disinfectants that reduce or inhibit bacterial growth.
CLOREXIFARM 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 a few days.

2. What you need to know before using CLOREXIFARM

Do not use CLOREXIFARM

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 CLOREXIFARM.
This medicine is for topical use only (external use on the skin).
Avoid prolonged use of this medicine, as allergic reactions (hypersensitivity reactions) may occur with long-term use of CLOREXIFARM. If this happens, stop 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 inside the ear canal.
CLOREXIFARM must not come into contact with the eyes due to the risk of visual damage. If contact occurs, rinse immediately and thoroughly with water. If eye irritation, redness, pain or visual disturbance occurs, seek immediate medical advice.
Serious cases of permanent corneal injury (damage to the surface of the eye) have been reported following accidental exposure of similar products to the eye during surgical procedures in patients under general anesthesia (induced deep sleep). Such injuries may require corneal transplantation.
Before applying a dressing (particularly occlusive dressings) to areas of skin treated with CLOREXIFARM, ensure that no excess product remains in the area.

Children
Use with caution in newborns, especially premature infants. CLOREXIFARM may cause chemical burns.

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

Pregnancy and breastfeeding
If you are pregnant, think you might 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

Use CLOREXIFARM exactly as directed in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply CLOREXIFARM to the skin by dabbing with cotton wool or sterile gauze thoroughly soaked in CLOREXIFARM.
If necessary, repeat the procedure up to 3–4 times a day.
Do not exceed the recommended doses without first consulting your doctor.
If you use more CLOREXIFARM than you should
Cases of overdose are not known.
In case of accidental ingestion or overdose, immediately inform your doctor 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 changes in treatment;
chemical burns in newborns;
corneal trauma (damage to the surface of the eye) and permanent eye damage, including permanent vision impairment (following accidental exposure of the eyes during surgical procedures on the head, face, and neck) in patients under general anaesthesia (induced deep sleep).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://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

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 "Expiry".
This medicine does not require any special storage conditions.
Store in the original packaging.
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 CLOREXIFARM 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 CLOREXIFARM and package contents
Sterile clear solution
Pack size: 1 single-dose sachet containing 25 ml.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy