Cetilsan

• contact with eyes, mucous membranes, and the inner part of the ear (middle ear);
• ingestion of the medicine, as it may lead to serious, sometimes fatal, consequences;
• exposing the treated area to direct sunlight after application of the product.

Package leaflet: Information for the patient
CETILSAN 0.2% Cutaneous solution
Cetylpyridinium chloride
Read all of this leaflet carefully before you start 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.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must consult a doctor if you do not feel better or if you feel worse after a short period of treatment.

What is in this leaflet

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

What CETILSAN is and what it is used for
Cetilsan is a cutaneous solution containing the active substance cetylpyridinium chloride, which acts as a disinfectant (antiseptic) against bacteria present on the skin. It is suitable for skin disinfection, including in the presence of superficial, minor wounds, excoriations, and abrasions. It can also be used for disinfection of objects.
You must talk to a doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before you use CETILSAN

Do not use CETILSAN:

• if you are allergic to the active substance 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 Cetilsan.
Use this medicine only on the external surface of the body.
During treatment with Cetilsan, avoid:

• contact of the product with eyes, mucous membranes, and the internal part of the ear (middle ear);
• ingestion of the product, because it could lead to serious consequences, sometimes fatal;
• exposing the treated skin area to direct sunlight after application. This medicine must not come into contact with the brain or meninges. Do not use this medicine for prolonged periods and inform your doctor if you do not notice an improvement in symptoms. Discontinue treatment if, during use, you observe skin reactions at the site of application (sensitization phenomena).

Children
No data are available on the use of this product in children.

Other medicines and CETILSAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use Cetilsan with caution when combined with other medicines used for washing (detergents) or disinfecting (antiseptics) the skin.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breast-feeding, use this medicine with caution.

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

This medicine contains fragrance components: anise alcohol, benzyl alcohol, benzyl salicylate, lilial, cinnamyl alcohol, geraniol, hexyl cinnamal, hydroxicitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol, and linalool.
Anise alcohol, benzyl alcohol, benzyl salicylate, lilial, cinnamyl alcohol, geraniol, hexyl cinnamal, hydroxicitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol, and linalool may cause allergic reactions.

3. How to take CETILSAN

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
For skin disinfection, clean the affected area with a cotton ball soaked in CETILSAN, or apply a few drops of the solution onto the wound and cover with a sterile gauze pad soaked in CETILSAN.
Repeat the application 2–3 times a day, if necessary.
For disinfection of objects, use undiluted CETILSAN as needed.

If you use more CETILSAN than you should
Local use of CETILSAN, especially if prolonged, may cause skin sensitization reactions.
Ingestion of CETILSAN may cause nausea, vomiting, and serious breathing difficulties (dyspnoea, cyanosis, and asphyxiation) due to paralysis of the respiratory muscles, central nervous system depression, low blood pressure (hypotension), and profound unconsciousness (coma).
The doctor will determine the most appropriate treatment based on the severity of symptoms.
In case of accidental ingestion or intake of an excessive dose of this medicine, stop treatment immediately and contact your doctor or the nearest hospital without delay.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects could occur:
Unknown frequency (frequency could not be estimated from available data)

• irritation or sensation of burning of the skin (local intolerance).

Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CETILSAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Scad.”. The expiry
date refers to the last day of that month and to the product in its original packaging and correctly
stored.
Store this medicine in its original container.
Do not throw away any medicines via wastewater. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CETILSAN contains

• The active substance is cetylpyridinium chloride. 100 ml of product contain 0.2 g of cetylpyridinium chloride.
• The other ingredients are: rose essence, purified water.

What CETILSAN looks like and contents of the pack
Bottle of 200 ml or 150 ml with nebulizer.
Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A.Sella srl
via Vicenza 67 – 36015 Schio (VI)
Last revision of the Package leaflet

• contact with eyes, mucous membranes and the inner part of the ear (middle ear);
• ingestion of the medicinal product because it may lead to serious, sometimes fatal, consequences;
• exposing the treated area to direct sunlight after application of the product.
• skin burning or irritation (local intolerance).

PACKAGE LEAFLET

Patient Information Leaflet

CETILSAN 3 mg Sugar-Free Tablets

Cetylpyridinium Chloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take 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 more information or advice, consult your pharmacist.
• If you experience any of the side effects listed in this leaflet, or any not listed, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What CETILSAN is and what it is used for

CETILSAN contains the active substance cetilpyridinium chloride, which belongs to a group of medicines called antiseptics that prevent or inhibit the growth of bacteria.
This medicine is indicated as a disinfectant for the mucous membranes of the mouth and throat.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking CETILSAN

Do not take CETILSAN:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the person who is to take this medicine is a child under 12 years of age (see section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CETILSAN.
This medicine is intended for topical use only.
Do not take this medicine for prolonged periods and inform your doctor if you do not notice an improvement in symptoms.
If you use CETILSAN for long periods of time, allergic reactions (sensitization phenomena) may occur. In this case, discontinue treatment and consult your doctor, who will determine appropriate therapy.

Children
CETILSAN is contraindicated in children under 12 years of age, unless otherwise prescribed by a doctor.

Other medicines and CETILSAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking CETILSAN, do not use other antiseptic or cleansing medicines for the mouth and throat (oral cavity).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only when clearly needed and under direct medical supervision.

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

CETILSAN contains sorbitol
This medicine contains 900 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before you (or the child) take this medicine.

3. How to take CETILSAN

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet every 3–4 hours, up to a maximum of 6 tablets per day.
Allow the tablets to dissolve slowly in the mouth.
Do not exceed the recommended daily doses.

If you take more CETILSAN than you should
Following an overdose of this medicine, the following symptoms may occur: nausea, vomiting, breathing difficulties (dyspnoea), bluish discoloration of the skin (cyanosis), suffocation sensation (asphyxia) due to paralysis of the respiratory muscles, reduced brain activity (central nervous system depression), low blood pressure (hypotension), and deep unconsciousness (coma).
Your doctor will determine the most appropriate treatment depending on the severity of the symptoms.
In case of ingestion/overdose of an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.

If you forget to take CETILSAN
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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:
Frequency not known (frequency cannot be estimated from the available data)

• temporary irritation of the gums;
• nausea, vomiting and abdominal pain;
• inflammation of the mouth (stomatitis);
• taste disturbance;
• slight change in tooth colour;
• skin irritation (allergic dermatitis);
• burning or irritation of the mouth.

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 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 CETILSAN

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 date:".
The expiry date refers to the last day of that month.
Store this medicine in its original packaging.
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 CETILSAN contains

• The active substance is cetylpyridinium chloride. Each tablet contains 3 mg of cetylpyridinium chloride.
• The other components are: peppermint flavour, eucalyptol, tragacanth gum, rice starch, magnesium stearate, mannitol, sorbitol.

Description of the appearance of CETILSAN and contents of the pack
Pack of 20 tablets.
Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A.SELLA srl, via Vicenza, 67 - 36015 Schio (VI)
Package leaflet: Information for the patient
CETILSAN 3 mg Sugar free lozenges
Cetylpyridinium chloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after a short period of treatment.

What is in this leaflet

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

What CETILSAN is and what it is used for
Cetilsan contains the active substance cetylpyridinium chloride, which is an antiseptic that prevents or blocks the growth of bacteria.
This medicine is recommended for disinfection of the mouth and throat mucous membranes.
You must talk to a doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before you take CETILSAN

Do not take CETILSAN:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if the patient is a child under 12 years of age, unless otherwise prescribed by a doctor (see the section "Children").

Warnings and precautions
Talk to your doctor or pharmacist before taking CETILSAN.
This medicine is intended only for local use.
Do not take this medicine for prolonged periods and inform your doctor if you do not experience an improvement in symptoms.
If CETILSAN is used for long periods, allergic reactions (sensitization phenomena) may occur. In such cases, discontinue treatment and consult your doctor, who will establish an appropriate therapy.

Children
CETILSAN is not intended for children under 12 years of age, unless otherwise prescribed by a doctor.

Other medicines and CETILSAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using CETILSAN, do not use any other antiseptic or detergent for the mouth and throat.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breast-feeding, take this medicine only if necessary and under the direct supervision of a doctor.

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

CETILSAN contains sorbitol
This medicine contains 900 mg of sorbitol per dosage unit. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot metabolize fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. How to take CETILSAN

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 lozenge every 3–4 hours, up to a maximum of 6 lozenges per day.
Allow the lozenge to dissolve slowly in your mouth.
Do not exceed the indicated doses.

If you take more CETILSAN than you should
In case of intake of an excessive dose of the medicine, the following symptoms may appear: nausea,
vomiting, difficulty in breathing (dyspnoea), bluish coloration of the skin (cyanosis), feeling of suffocation
(asphyxiation) due to paralysis of the respiratory muscles, reduction of brain activity (central nervous
system depression), lowering of blood pressure (hypotension) and deep state of unconsciousness (coma).
The doctor will establish the most suitable therapy for you, according to the severity of the symptoms.
In case of accidental ingestion or intake of an excessive dose of this medicine, stop the treatment
and contact immediately the doctor or the nearest hospital.

If you forget to take CETILSAN
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects could occur:
Unknown frequency (frequency cannot be estimated from available data)

• transient soreness of the gums;
• nausea, vomiting, abdominal pain;
• mouth inflammation (stomatitis);
• alteration of taste;
• slight discoloration of the teeth;
• skin irritation (allergic dermatitis);
• sensation of burning in the mouth.

Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CETILSAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Scade/Expiry date:”. The
expiry date refers to the last day of that month.
Store this medicine in its original container.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CETILSAN contains

• The active substance is cetylpyridinium chloride. Each lozenge contains 3 mg of cetylpyridinium chloride.
• The other ingredients are: essence of mint, eucalyptol, tragacanth, rice starch, magnesium stearate, mannitol, sorbitol.

What CETILSAN looks like and contents of the pack
Box containing 20 lozenges.
Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Farmaceutico A.Sella srl
via Vicenza 67 – 36015 Schio (VI)
Last revision of the Package leaflet