Neomedil

Package leaflet: Information for the user

NEOMEDIL 0.25%+70% cutaneous solution

Benzalkonium chloride and ethyl alcohol
Please read all of this leaflet carefully before you use 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 any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What NEOMEDIL is and what it is used for

NEOMEDIL 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.
NEOMEDIL is indicated for cleaning and disinfecting:

• intact skin or skin with minor superficial wounds;
• hands;
• the surgical site prior to surgery.

2. What you need to know before using NEOMEDIL

Do not use NEOMEDIL

• 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 predisposed to breathing problems (laryngospasm) and seizures (See section “Children”).

Warnings and precautions
Talk to your doctor or nurse before using NEOMEDIL.
Apply this medicine only on the skin (for external use only).
Do not ingest or inhale NEOMEDIL, as serious, even fatal, consequences may occur.
Do not apply this medicine to the eyes or ears.
Furthermore, 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.
NEOMEDIL, especially if used for long periods, may cause allergic reactions (sensitization). If this occurs, stop treatment and inform your doctor, who will determine appropriate therapy.
This product is flammable: do not expose the container to heat sources and do not spray near flames or hot surfaces.

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 NEOMEDIL”).
In children over 2 years of age, this medicine must be used with great caution.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before using this medicine.
This medicine may be used during pregnancy and breastfeeding.

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

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

3. How to use NEOMEDIL

This medicinal product will only be administered by a doctor or trained medical personnel.
Apply the medicinal product to the affected area and surrounding skin, using a piece of cotton moistened with a sufficient amount of the medicinal product, and rub for at least 30 seconds.
Repeat the procedure 2–3 times daily.
To disinfect the hands, wash repeatedly with 5–6 ml of the medicinal product for at least 1 minute.
Do not exceed the recommended doses.
If you use more NEOMEDIL than you should
If you do not exceed the recommended doses, there is no risk of overdose.
Accidental ingestion of this medicinal product may cause nausea and vomiting. If large amounts of NEOMEDIL are ingested, symptoms such as difficulty breathing (dyspnoea), 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 NEOMEDIL, immediately inform a 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:

• 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 NEOMEDIL

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. Contents of the pack and other information

What NEOMEDIL contains

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

Description of the appearance of NEOMEDIL and contents of the pack
Pack sizes:

• 24 bottles of 250 ml;
• 20 bottles of 500 ml;
• 12 bottles of 1 litre.

Marketing Authorisation Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy

Patient Information Leaflet: Information for the user

NEOMEDIL 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.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 NEOMEDIL is and what it is used for
2. What you need to know before using NEOMEDIL
3. How to use NEOMEDIL
4. Possible side effects
5. How to store NEOMEDIL
6. Package contents and other information

1. What NEOMEDIL is and what it is used for

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

• intact skin or skin with minor superficial wounds;
• the surgical field prior to a surgical procedure.

2. What you should know before using NEOMEDIL

Do not use NEOMEDIL

• 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 predisposed to breathing problems (laryngospasm) and seizures (See section “Children”).

Warnings and precautions
Talk to your doctor or nurse before using NEOMEDIL.
Apply this medicine only on the skin (for external use).
Do not swallow or inhale NEOMEDIL, as serious, even fatal, consequences 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.
NEOMEDIL, especially if used for long periods, may cause allergic reactions (sensitization). 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 near flames or glowing objects.
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 NEOMEDIL”).
In children over 2 years of age, this medicine should be used with great caution.
Other medicines and NEOMEDIL
Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.
During treatment with NEOMEDIL, avoid using other similar medicines (antiseptics and/or detergents).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
This medicine may be used during pregnancy and breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
NEOMEDIL contains lemon essential oil, which in turn contains linalool, citronellol and geraniol. Linalool, citronellol and geraniol may cause allergic reactions.

3. How to use NEOMEDIL

This medicine will only be administered by a doctor or trained medical personnel.
Apply the medicine to the affected area and 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 NEOMEDIL 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 NEOMEDIL 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 NEOMEDIL, immediately contact a doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine may 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 NEOMEDIL

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 NEOMEDIL 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, colouring agents E110, E122, E131, purified water.

Description of the appearance of NEOMEDIL and package contents
Pack containing 12 bottles of 1 litre each.
Marketing Authorization Holder and Manufacturer
Nuova Farmec S.r.l. - Via W. Flemming, 7 - Settimo di Pescantina (VR) - Italy