CETILSAN 200 ML Topical solution

Зміст інструкції

1. CETILSAN 0.2% Cutaneous solution
   1. What you need to know before you take CETILSAN
   2. How to take CETILSAN
   3. Possible side effects
   4. How to store CETILSAN
   5. Contents of the pack and other information
2. CETILSAN 3 mg Sugar-Free Lozenges
   1. What is CETILSAN and what is it 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
3. CETILSAN 3 mg Sugar free lozenges
   1. What you need to know before you take CETILSAN
   2. How to take CETILSAN
   3. Possible side effects
   4. How to store CETILSAN
   5. Contents of the pack and other information

• contact with eyes, mucous membranes and the inner part of the ear (middle ear);
• ingesting the medicine as it can 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 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 have
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 is a cutaneous solution containing the active substance cetylpyridinium chloride which acts
as disinfectant (antiseptic) against the bacteria present in the skin. It is suitable for skin
disinfections, also in presence of superficial, small wounds, excoriations and abrasions. It can be use
for disinfection of objects.
You must talk to a doctor if you do not feel better or if you feel worse after few days 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).

Warnings and precautions
Talk to your doctor or pharmacist before taking CETILSAN.

Use this medicine only on the external surface of the body.
During the 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;
• expose the treated skin to direct sunlight after product use. This medicine must not come into contact with the brain and meninges. Do not take this medicine for long periods and inform your doctor if you do not perceive an improvement of the symptoms. Discontinue the treatment if during use you notice reactions on the skin where the medicine has been used (sensitization phenomena).

Children
No data are available on use of this product on 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 other medicines used for washing (detergent) or disinfecting (antiseptic) 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 taking this medicine.
If you are pregnant or breast-feeding, take this medicine with caution.

Driving and using machines
Cetilsan does not alter the ability to drive or use machinery.
This medicine contains fragrance with anise alcohol, benzyl alcohol, benzyl salicylate, lilial
cinnamyl alcohol, geraniol, hexyl cinnamal, hydroxicitronellal, hydroxymethylpentyl-
cyclohexenecarboxaldehyde, isoeugenol, linalool.
Anise alcohol, benzyl alcohol, benzyl salicylate, lilial cinnamyl alcohol, geraniol, hexyl cinnamal,
hydroxicitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol, 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, wash the affected area with a cotton ball soaked with CETILSAN, or drop a
bit of solution on the wound and apply a sterilized gauze soaked with CETILSAN.
Repeat the application 2-3 times a day, if necessary.
For disinfection of objects use pure CETILSAN, according to needs.

If you take more CETILSAN than you should
Local use of CETILSAN, especially for prolonged use, can cause sensitization reactions on the
skin.
CETILSAN ingestion can cause nausea, vomiting, serious breathing problems (dyspnoea, cyanosis
and asphyxiation), due to paralysis of the respiratory muscles, central nervous system depression,
lowering of blood pressure (hypotension) and a deep state of unconsciousness (coma).
The doctor will establish the most suitable therapy for you, according to the seriousness of the
symptoms.
In case of accidental ingestion / assumption of an excessive dose of this medicine suspend the
treatment and contact immediately the doctor or the nearest hospital.
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 arise:

Unknown frequency(frequency could not be evaluated from available data)

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

Reporting of side effects
If you get 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 into the integral package and correctly
stored.
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. 100 ml of product contain 0.2 g of cetylpyridinium chloride.
• The other ingredients are: essence of rose, 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 medicine because it can lead to serious, sometimes fatal, consequences;
• exposure of the treated area to direct sunlight after application of the product.
• burning or irritation of the skin (local intolerance).

CETILSAN 3 mg Sugar-Free Lozenges

Cetylpyridinium chloride

Read this leaflet carefully before taking this medicine as 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.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 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

1. What is CETILSAN and what is it used for

CETILSAN contains the active ingredient cetylpyridinium chloride which belongs to a group of medicines
called antiseptics that prevent or block the growth of bacteria.
This medicine is indicated as a disinfectant for the mucous membrane of the mouth and throat.
See 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 ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if the person who needs to take this medicine is a child under 12 years of age (see the “Children” section).

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

Children
CETILSAN is contraindicated in children under 12 years of age, unless otherwise prescribed by your 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 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only in cases of actual
need and under the direct supervision of your doctor.

Driving and operating machinery
This medicine does not alter 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 told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot convert fructose,
talk to your doctor before you (or the child) take this medicine.

3. How to take CETILSAN

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 lozenge every 3-4 hours, up to a maximum of 6 lozenges per day.
Dissolve the lozenges slowly in your mouth.
Do not exceed the recommended daily doses.

If you take more CETILSAN than you should
Following the intake of an excessive dose of this medicine, the following symptoms may occur:
nausea, vomiting, difficulty breathing (dyspnea), bluish discoloration of the skin (cyanosis),
feeling of suffocation (asphyxia), due to paralysis of the respiratory muscles, reduced brain activity
(depression of the central nervous system), low blood pressure (hypotension), deep
state of unconsciousness (coma).
The doctor will establish the most appropriate therapy for you, based on the severity of the symptoms.
In case of ingestion/intake of an excessive amount of this medicine, stop the treatment
and immediately consult your doctor or the nearest hospital.

If you forget to take CETILSAN
Do not take a double dose to make up for the missed 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 gets them.
The following side effects may occur:

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 CETILSAN

Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after
“Scade/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 in waste water 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

WhatCETILSANcontains

• The active ingredient is cetylpyridinium chloride. Each lozenge contains 3 mg of cetylpyridinium chloride.
• The other ingredients are: peppermint essence, eucalyptus oil, tragacanth gum, rice starch, magnesium stearate, mannitol, sorbitol.

Description of the appearance of CETILSAN and contents of the pack
Pack of 20 lozenges.

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 have 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 which prevent or
block the growth of bacteria.
This medicine is recommended as a disinfectant of 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 less than 12 years old, unless otherwise prescribed by a doctor (see the paragraph “Children”).

Warnings and precautions
Talk to the doctor or pharmacist before taking CETILSAN.
This medicine is only indicated for local use.
Do not take this medicine for long periods and inform the doctor if you do not perceive an improvement of
the symptoms.
If you take CETILSAN for long periods, allergic reactions (sensibilisation phenomena) could arise. In such
case, suspend the treatment and consult the doctor who will establish a suitable therapy.

Children
CETILSAN is not intended for children below the age of 12 years, 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 taking CETILSAN do not use any other antiseptic or detergent of 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 in case of need and under direct control of a
doctor.

Driving and using machines
Cetilsan does not alter the ability to drive or use machinery.

CETILSAN contains sorbitol
This medicine contains 900 mg of sorbitol in each dosage unit. Sorbitol is a source of fructose. If your Doctor
has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with
hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down
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, until 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 discoloration 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 seriousness of the symptoms.
In case of accidental ingestion / assumption of an excessive dose of this medicine suspend 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 arise:

Unknown frequency(frequency could not be evaluated 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);
• sense of burning of the mouth.

Reporting of side effects
If you get 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 “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