Benzafarm

Package leaflet: Information for the user

BENZAFARM 0.25%+70% cutaneous solution

Benzalkonium chloride and ethyl alcohol
Please read all of 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 told you to do.

• 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 effects, 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 you notice worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What BENZAFARM is and what it is used for

BENZAFARM contains two active substances: benzalkonium chloride and ethyl alcohol, which belong to
a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
BENZAFARM is indicated for cleaning and disinfecting:

• intact skin or in the presence of minor superficial wounds;
• the surgical site prior to a surgical procedure.

Consult your doctor if you do not notice any improvement or if you observe a worsening of symptoms after a few days.

2. What you need to know before using BENZAFARM

Do not use BENZAFARM

• if you are allergic to benzalkonium chloride, ethanol, or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age who are predisposed to breathing problems (laryngospasm) and seizures (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZAFARM.
Apply this medicine only on the skin (for external use).
Do not inhale or swallow this medicine, as serious, even fatal, effects may occur.
Do not apply this medicine to the eyes or ears.
In addition, contact with the brain or the membranes covering the brain (meninges) should be avoided.
Do not expose yourself to sunlight or sunlamps (artificial sources of ultraviolet radiation) after applying this medicine to the skin.
Do not use this medicine for prolonged treatments.
BENZAFARM, especially if used for long periods, may cause allergic reactions (sensitization phenomena). If this occurs,
discontinue treatment and inform your doctor, who will determine appropriate therapy.
.
The product is flammable: do not expose the container to sources of heat and do not spray it onto a flame or glowing object.
Children
Due to the presence of camphor, this medicine must not be used in children under 2 years of age who are predisposed to breathing problems and seizures (See section “Do not use BENZAFARM”).
In children over 2 years of age, it should be used with great caution.
Other medicines and BENZAFARM
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
During treatment with BENZAFARM, avoid using other similar medicines (antiseptics and/or detergents).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, you may use this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
BENZAFARM contains lemon essential oil, which in turn contains linalool, citronellol, and geraniol. Linalool, citronellol, and geraniol may cause allergic reactions.

3. How to use BENZAFARM

Use BENZAFARM exactly as directed in this leaflet or as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the medicine to the affected area and the surrounding skin, using a small amount of cotton thoroughly soaked in the medicine, and rub for at least 30 seconds.
Repeat this procedure 2-3 times a day.
Do not exceed the recommended doses.
If you use more BENZAFARM 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 BENZAFARM 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), deep unconsciousness (coma), and death may occur.
In case of accidental ingestion or intake of an excessive dose of BENZAFARM, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:

• allergic reactions (intolerance) with symptoms such as burning or skin irritation;
• skin irritation and dryness, when the medicine is applied frequently.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store BENZAFARM

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.
This medicine is highly flammable.
Store in tightly closed containers, away from flames, sparks, and any source of heat.
DO NOT SMOKE.
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 BENZAFARM contains

• The active substances are benzalkonium chloride and ethyl alcohol. 100 g of brown solution contain 0.25 g of benzalkonium chloride and 70 g of 96% ethyl alcohol.
• The other components are: lemon essential oil (containing linalool, citronellol and geraniol), camphor, colourants E110, E122, E131, purified water.

Description of the appearance of BENZAFARM and contents of the pack
Bottles of 250 ml, 500 ml and 1000 ml.
Marketing Authorisation Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy

Package leaflet: information for the user

BENZAFARM 0.25%+70% cutaneous solution

Benzalkonium chloride and ethyl alcohol
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 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What BENZAFARM is and what it is used for

BENZAFARM contains two active substances: benzalkonium chloride and ethyl alcohol, which belong to
a group of medicines called antiseptics and disinfectants that reduce or inhibit the growth of bacteria.
BENZAFARM is indicated for cleaning and disinfecting:

• intact skin or in the presence of small superficial wounds;
• hands;
• the surgical site before a surgical procedure.

Consult your doctor if you do not notice any improvement or if you observe worsening of symptoms after a few days.

2. What you need to know before using BENZAFARM

Do not use BENZAFARM

• if you are allergic to benzalkonium chloride, ethyl alcohol, or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age who are prone to breathing problems (laryngospasm) and seizures (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using BENZAFARM.
Apply this medicine only on the skin (external use).
Do not inhale or swallow this medicine, as serious, even fatal, effects may occur.
Do not apply this medicine to the eyes or ears.
In addition, contact with the brain or the membranes covering the brain (meninges) should be avoided.
Do not expose yourself to sunlight or sunlamps (artificial sources of ultraviolet radiation) after applying this medicine to the skin.
Do not use this medicine for prolonged treatments.
BENZAFARM, especially if used for long periods, may cause allergic reactions (sensitization phenomena). In such cases, discontinue treatment and inform your doctor, who will determine appropriate therapy.

Children
Due to the presence of camphor, this medicine must not be used in children under 2 years of age who are prone to breathing problems and seizures (See section “Do not use BENZAFARM”).
In children over 2 years of age, it must be used with great caution.

Other medicines and BENZAFARM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
During treatment with BENZAFARM, avoid using other similar medicines (antiseptics and/or detergents).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or 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.

BENZAFARM contains lemon essential oil, which in turn contains linalool, citronellol, and geraniol. Linalool, citronellol, and geraniol may cause allergic reactions.

3. How to use BENZAFARM

Use BENZAFARM exactly as instructed 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 affected area and the surrounding skin, using a piece of cotton thoroughly soaked in the medicine, and rub for at least 30 seconds.
Repeat this procedure 2-3 times a day.
To disinfect hands, wash repeatedly with 5-6 ml of the medicine for at least 1 minute.
Do not exceed the recommended doses.

If you use more BENZAFARM 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 BENZAFARM 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), deep unconsciousness (coma), and death may occur.
In case of accidental ingestion/overdose of BENZAFARM, contact 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 will experience them.
The following side effects may occur:

• allergic reactions (intolerance) with symptoms such as burning or skin irritation;
• skin irritation and dryness, when the medicine is applied frequently.

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 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 BENZAFARM

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.
This medicine is highly flammable.
Store in tightly closed containers, away from flames, sparks, and any source of heat.
DO NOT SMOKE.
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 BENZAFARM contains

• The active substances are benzalkonium chloride and ethanol. 100 g of colourless solution contain 0.25 g of benzalkonium chloride and 70 g of 96% ethyl alcohol.
• The other components are: lemon essential oil (containing linalool, citronellol and geraniol), camphor, purified water.

Description of the appearance of BENZAFARM and contents of the pack
Bottles of 250 ml, 500 ml and 1000 ml.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy