Package leaflet: Information for the user

BENALCON 0.175 cutaneous solution

Benzalkonium chloride
Please read 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 told you to.

Keep this leaflet. You may need to read it again.
If you want 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 any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What BENALCON is and what it is used for

BENALCON contains the active substance benzalkonium chloride, which belongs to a group of medicines called antiseptics and disinfectants that reduce or block the growth of bacteria.
BENALCON is indicated for cleaning and disinfecting intact skin as well as minor superficial wounds.
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 BENALCON

Do not use BENALCON

if you are allergic to benzalkonium chloride 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 BENALCON.
This medicine is for external use on the skin only.
Do not apply BENALCON to the eyes or into the middle ear, or onto mucous membranes (the lining of certain organs and canals communicating with the outside). Furthermore, this medicine must not come into contact with the brain or the membranes covering the brain (meninges).
BENALCON must not be swallowed or inhaled, as serious, even fatal, consequences may occur.
After applying this medicine to the skin, avoid exposure to sunlight or sunlamps (artificial sources of ultraviolet radiation).
Do not use this medicine for prolonged treatments.
If you use BENALCON, especially for long periods, allergic reactions (sensitization phenomena) may occur. In such cases, stop treatment and inform your doctor, who will determine appropriate therapy.

Other medicines and BENALCON
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
During treatment with BENALCON, avoid using similar medicines (disinfectants or detergents) at the same time.

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 if you are pregnant or breastfeeding.

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

Important information about some excipients
Benalcon contains bergamot essence, which in turn contains geraniol, citral, limonene, and linalool.
Geraniol, citral, limonene, and linalool may cause allergic reactions.

3. How to use BENALCON

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 the medicine to the skin using a small piece of cotton, gauze, or compresses. You may use the medicine up to 2 times a day.
Do not dilute the medicine and do not exceed the recommended doses without consulting your doctor.
Use this medicine only for short treatment periods.

If you use more BENALCON than you should
If you do not exceed the recommended doses, there is no risk of overdose.
Accidental ingestion of this medicine may cause nausea and vomiting. If large amounts of BENALCON are ingested, symptoms such as difficulty breathing (dyspnea), bluish discoloration of the skin (cyanosis), sensation of suffocation (asphyxia) due to respiratory muscle paralysis, reduced brain activity (central nervous system depression), low blood pressure (hypotension), and deep unconsciousness (coma) may occur.
The lethal dose in humans is approximately 1–3 g.
In case of accidental ingestion/overdose of BENALCON, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Burning or irritation of the skin (intolerance) may occur. These symptoms generally do not require changes to the treatment.
Following the instructions contained in this leaflet reduces the risk of side effects.
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 via the national reporting system at 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 BENALCON

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 the medicine in a tightly closed container, protected from light and heat.
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 BENALCON contains

The active substance is benzalkonium chloride. 100 ml of solution contain 0.175 g of benzalkonium chloride.
The other components are: bergamot-based essence (containing geraniol, citral, limonene, linalool), deionized water.

Description of the appearance of BENALCON and contents of the pack
BENALCON is available in 200 ml or 1000 ml bottles.
Marketing Authorization Holder
Nuova Farmec S.r.l. – Via Flemming 7, 37026 Settimo di Pescantina (VR) - Italy
Manufacturer
Nuova Farmec S.r.l. - Via W. Fleming 7, Zona industriale - 37026 Settimo di Pescantina (VR) – Italy