FLUIMUCIL 300 mg /3 Ml Injectable Solution

Зміст інструкції

1. FLUIMUCIL 300 mg/3 ml injectable solution and for nebulizer and for instillation
   1. What Fluimucil is and what it is used for
   2. What you need to know before you take Fluimucil
   3. How to take Fluimucil
   4. Possible side effects
   5. How to store Fluimucil
   6. Package contents and other information
2. FLUIMUCIL 300 mg/3 ml solution for nebulizer
   1. What Fluimucil is and what it is used for
   2. What you need to know before taking Fluimucil
   3. How to take Fluimucil
   4. Possible side effects
   5. How to store Fluimucil
   6. Contents of the pack and other information
3. FLUIMUCIL 300 mg/3 ml solution for nebulizer
   1. What Fluimucil is and what it is used for
   2. What you need to know before taking Fluimucil
   3. How to use Fluimucil
   4. Possible side effects
   5. How to store Fluimucil
   6. Contents of the pack and other information
4. FLUIMUCIL 600 mg effervescent tablets
   1. What is Fluimucil and what is it used for
   2. What you need to know before taking Fluimucil
   3. How to take Fluimucil
   4. Possible side effects
   5. How to store Fluimucil
   6. Contents of the pack and other information
5. FLUIMUCIL 600 mg granules for oral solution
   1. What is Fluimucil and what is it used for
   2. What you need to know before taking Fluimucil
   3. How to take Fluimucil
   4. Possible side effects
   5. How to store Fluimucil
   6. Contents of the pack and other information

FLUIMUCIL 300 mg/3 ml injectable solution and for nebulizer and for instillation

endotracheobronchial
N-acetylcysteine

Read this leaflet carefully before taking this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fluimucil is and what it is used for

Fluimucil contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called
mucolytics, used to facilitate the elimination of mucus from the respiratory tract and to a group of medicines
called antidotes used to counteract the toxic effect of certain substances.
Fluimucil is indicated for the treatment of diseases of the respiratory system characterized by an increase
in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• disease of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilations (bronchiectasis).

Fluimucil is used as an antidote in particular for:

• accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
• disease affecting the urinary tract (uropathy) caused by chemotherapeutic drugs such as iso and cyclophosphamide

2. What you need to know before you take Fluimucil

Do not take Fluimucil

• if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in section 6), unless it is used as an antidote;
• if the patient is a child under 2 years of age, unless it is used as an antidote.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma, immediately stop taking Fluimucil if you experience bronchospasm (contraction of the bronchial muscles);
• If you have previously suffered from atopy and asthma, as you may develop allergic reactions;
• If you are intolerant to histamine as you may develop allergic reactions;
• if you suffer from or have suffered from a problem with your stomach or intestines called a peptic ulcer, especially if you are taking other medicines with Fluimucil that can cause problems with your stomach (gastrolesive drugs).

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially if
administered by aerosol, at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate
the bronchial secretions through coughing (expectorate), consult your doctor who will indicate a method for
removing the mucus (postural drainage or bronchoaspiration).
Allergic (hypersensitivity/anaphylactoid) reactions may occur with N-acetylcysteine. Monitoring
for signs of an allergic reaction may be necessary.
This medicine must be administered to you with particular caution and strictly following the
instructions given in the section “How to take Fluimucil”.
Keep in mind that:

• administration of Fluimucil to counteract the toxic effect of certain substances (antidotal treatment) has in very rare cases caused death;
• if Fluimucil is to be administered to counteract the toxic effect of certain substances (antidotal treatment) in people with a body weight of less than 40 kg, an excessive administration of fluids may occur with a consequent reduction of sodium in the blood (hyponatremia), convulsions and death;
• if Fluimucil is administered intravenously rapidly or in excessive quantities, it may increase the occurrence of undesirable effects.

This medicine may alter some blood parameters (reduction of prothrombin index, increase
of INR) when used as an antidote at the indicated dosage.
If you notice a sulfurous odor when opening the vial, or the solution turns pink in the open vial or
when transferring the solution to the aerosol device, do not worry, as this does not indicate
alteration of the medicine.

Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric
determination for the determination of salicylates and tests to determine ketones). Inform your doctor that you are
taking this medicine before undergoing these tests.

Children
Fluimucil should not be administered to children under 2 years of age, as it may obstruct the
bronchi and prevent normal breathing.
The same warnings and precautions as for adults apply to children and adolescents.

Other medicines and Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take this medicine if you are taking cough medicines (antitussives), as they may lead
to an accumulation of mucus inside the bronchi.
Use this medicine with caution and consult your doctor if you are taking any of the following medicines:

• nitroglycerin, used for some heart conditions. The use of this medicine together with Fluimucil may cause a reduction in blood pressure (hypotension) and headache;
• antibiotics, medicines used to treat infections. Do not mix these medicines with the solution containing Fluimucil.

You can use Fluimucil together with medicines for the treatment of asthma (see section “Warnings and
precautions”) and diseases of the bronchi and lungs (bronchodilators) or medicines to increase
blood pressure (vasoconstrictors).

Pregnancy, breastfeeding and fertility
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.
Pregnancy
Take this medicine if you are pregnant only if strictly necessary and under the direct control of
your doctor.
Breastfeeding
The use of Fluimucil should be avoided if you are breastfeeding. Ask your doctor for advice before stopping
breastfeeding and/or starting/stopping therapy with Fluimucil.
Fertility
There are no data available on the effect of Fluimucil on fertility.

Driving and operating machinery
There is no information available on the effect on the ability to drive vehicles or operate machinery.

Fluimucil contains sodium
This medicine contains 43 mg (1.9 mmol) of sodium (the main component of table salt) per vial.
This is equivalent to 2.15% of the maximum recommended daily intake of sodium for an adult.

3. How to take Fluimucil

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Open the vials of Fluimucil at the time of use. Use the opened vials only if stored in the refrigerator and for a
maximum of 24 hours. Do not use the vials stored open for intravenous administration.
If Fluimucil is mixed with medicines for the treatment of asthma and diseases of the bronchi and lungs (bronchodilators) or other medicines, use the solution briefly and do not store it, the dose, the
duration of treatment and the method of administration will be established by the doctor based on your
conditions.
This medicine will be administered to you by a doctor or a nurse in case of intravenous injection
(intravenous administration).

Administration via injection (intravenous):
Treatment of accidental or intentional poisoning from paracetamol:
Fluimucil will be administered to you slowly into a vein via intravenous infusion. The medicine will be
administered in a hospital setting by a doctor or a nurse who will prepare the infusion. If you have any doubts
consult your doctor or nurse.

Administration via aerosol
The recommended dose is 1 vial to be nebulized, 1-2 times a day. The duration of treatment is 5-10
days.
The dose and frequency of the drug may be modified by the doctor.
Use a glass or plastic nebulizer and for devices that have metal or rubber parts it is
necessary to wash the devices with water immediately after use.

Administration into the bronchi
The recommended dose is 1 vial at a time 1-2 times a day or as needed to be administered
using the chosen methods (permanent probes, bronchoscope, etc.).

Administrations or ear washes or other body cavities
The recommended dose is half or 1 vial at a time.
How to open the vial:

Figure 1 Figure 2

• Hold the lower part of the vial firmly with one hand and place the index finger of the other hand in the recess of the vial as shown in figure 1;
• exert pressure with the thumb placed above the point as shown in figure 2.

If you take more Fluimucil than you should
The symptoms of an overdose following an intravenous injection of an excessive dose are similar, but more serious,
to the undesirable effects listed in the paragraph “Possible side effects”.
However, no cases of overdose have been reported when this medicine is administered by aerosol or bronchial route. However, following the administration of an excessive dose of this
medicine, an accumulation of mucus in the bronchi may occur, especially if the patient is unable to
eliminate it by coughing (expectorating). Seek immediate medical attention, which will indicate a method for
removing the mucus (bronchoaspiration).
In case of ingestion/taking an excessive dose of this medicine, immediately warn
the doctor or go to the nearest hospital

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when Fluimucil is administered by aerosol (inhalation use) or via endotracheobronchial route:

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

• urticaria;
• skin rash;
• pruritus;
• bronchial muscle contraction (bronchospasm);
• vomiting;
• nausea;
• allergic reactions (hypersensitivity);
• runny nose (rhinorrhea);
• inflammation of the mouth (stomatitis).
• Bronchial obstruction.

The following side effects may occur when Fluimucil is administered intravenously (parenteral use):

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

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• allergic reactions (hypersensitivity);
• fast heartbeat (tachycardia);
• bronchial muscle contraction (bronchospasm);
• difficulty breathing (dyspnea);
• vomiting;
• nausea;
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• urticaria;
• skin rash;
• pruritus;
• redness;
• swelling (edema) of the face;
• decrease in blood pressure;
• increased time required for blood to clot (prothrombin time).

In very rare cases, severe skin reactions (Stevens Johnson syndrome or Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your doctor.
Furthermore, a reduction in platelet aggregation (prolongation of bleeding time) is possible.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, 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 Fluimucil

Keep this medicine out of the sight and reach of children.
It is recommended to open the vials at the time of use. Opened vials can only be used if stored in
the refrigerator and for a maximum of 24 hours. Opened vials should not be used for injection.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. The expiry
date refers to the last day of that month. The expiry date indicated refers to the product in
intact packaging and correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil contains

• The active ingredient is N-acetylcysteine: 1 vial of 3 ml contains 300 mg of N-acetylcysteine.
• The other ingredients are: sodium hydroxide, disodium edetate, water for injections.

Description of the appearance of Fluimucil and package contents
Pack of 5 or 10 vials of 3 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
ZAMBON ITALIA s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - via della Chimica, 9 - Vicenza
Biologici Italia Laboratories S.r.l. – via Filippo Serpero, 2 – 20060 Masate (MI)
The following information is intended exclusively for healthcare professionals.

Treatment of accidental or intentional paracetamol poisoning:
For the therapeutic success of an antidote treatment for paracetamol poisoning, the period that
elapses between the intake of excessive paracetamol and the start of therapy is essential.
Therapy should be started from the ingestion of paracetamol and within 8 hours. In the case of
administration of acetylcysteine during the 15 hours following a paracetamol overdose, therapy is
generally ineffective, although there is evidence in the literature of successful treatments after 16-24 hours
from the intake of paracetamol.
Administration must be by intravenous infusion.
The infusion must be carried out slowly to reduce the risk of adverse effects.
The following dosage regimen is recommended.

Patients with a body weight greater than 40 Kg
Initial dose: 150 mg/kg in 200 ml of solution over 60 minutes.
Second dose: 50 mg/kg in 500 ml over 4 hours
Third dose: 100 mg/kg in 1000 ml over 16 hours

Patients with a body weight between 20 and 40 Kg
Initial dose: 150 mg/kg in 100 ml of solution over 60 minutes.
Second dose: 50 mg/kg in 250 ml over 4 hours
Third dose: 100 mg/kg in 500 ml over 16 hours

Patients with a body weight less than 20 Kg
Initial dose: 150 mg/kg in 3 ml/kg of solution over 60 minutes.
Second dose: 50 mg/kg in 7 ml/kg over 4 hours
Third dose: 100 mg/kg in 14 ml/kg over 16 hours
The solution must be compatible (5% dextrose solution, 0.45% sodium chloride solution or water for
injections).

FLUIMUCIL 300 mg/3 ml solution for nebulizer

N-acetylcysteine

Read this leaflet carefully before you start to take 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 you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after 10 days.

Contents of this leaflet:

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

1. What Fluimucil is and what it is used for

Fluimucil contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called
mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil is indicated for the treatment of diseases of the respiratory system characterized by an increase
in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• pathology of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilation (bronchiectasis).

Consult your doctor if you do not feel better or if you feel worse after 10 days.

2. What you need to know before taking Fluimucil

Do not take Fluimucil

• if you are allergic to N-acetylcysteine, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking Fluimucil immediately if you experience bronchospasm (contraction of the bronchial muscles).
• If you have previously suffered from atopy and asthma as you may develop allergic reactions;
• If you are intolerant to histamine as you may develop allergic reactions;
• if you suffer from or have suffered from a problem with your stomach or intestines called a peptic ulcer, especially if you are taking other medicines with Fluimucil that cause problems with your stomach (gastrolesive drugs);

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially
at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the bronchial secretions (expectorate) through coughing, consult your doctor who will indicate a method for eliminating mucus (postural drainage or bronchoaspiration).
Allergic (hypersensitivity/anaphylactoid) reactions may occur with N-acetylcysteine. Monitoring
for signs of an allergic reaction may be necessary.
If you notice a sulfur odor when opening the vial, or the solution turns pink in the open vial or
when transferring the solution to the aerosol device, do not worry as this does not indicate
alteration of the medicine.

Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests for determining ketones). Tell your doctor that you are
taking this medicine before undergoing these tests.

Children
Fluimucil should not be administered to children under 2 years of age, as it may obstruct the
bronchi and prevent normal breathing.
The same warnings and precautions as those reported for adults apply to children and adolescents.

Other medicines and Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take this medicine if you are taking:

• cough medicines (antitussives), as they may lead to an accumulation of mucus inside the bronchi.

Avoid taking at the same time:

• medicines that can decrease the volume of bronchial secretions (anticholinergics), as they may have an effect opposite to that of Fluimucil.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

• nitroglycerin, used for some heart conditions. The use of this medicine together with Fluimucil may cause a decrease in blood pressure (hypotension) and headache;
• medicines used for the treatment of infections (antibiotics). Do not mix these medicines with the solution containing Fluimucil. You can take Fluimucil together with medicines for the treatment of asthma (see the “Warnings and precautions” section) and lung diseases (bronchodilators) or medicines to increase blood pressure (vasoconstrictors).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Take this medicine if you are pregnant only if strictly necessary and under the direct supervision of
your doctor.
Breastfeeding
The use of Fluimucil should be avoided if you are breastfeeding. Ask your doctor for advice before stopping
breastfeeding and/or starting/stopping therapy with Fluimucil.
Fertility
No data are available on the effect of Fluimucil on fertility.

Driving and using machines
No information is available on the influence of this medicine on the ability to drive vehicles or to
use machines.

3. How to take Fluimucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose to be nebulized is 1 vial, 1-2 times a day. The duration of treatment is 5-10 days.
The dose and frequency of the medicine may be modified by the doctor. Use a glass
or plastic nebulizer and for devices that have metal or rubber parts, it is necessary to wash the devices with
water immediately after use.
Use open vials only if stored in the refrigerator and for a maximum of 24 hours.
If Fluimucil is mixed with medicines for the treatment of asthma and diseases of the bronchi and lungs (bronchodilators) or other medicines, use the solution shortly and do not store it.
How to open the vial:

Figure 1 Figure 2

• Hold the lower part of the vial firmly with one hand and place the index finger of the other hand in the recess of the vial as shown in figure 1;
• exert pressure with the thumb placed above the point as shown in figure 2.

If you take more Fluimucil than you should
No cases of overdose have been reported, however, following the administration of an
excessive dose of this medicine, an accumulation of mucus in the bronchi may occur, especially if the patient
is unable to eliminate it by coughing (expectorating). Seek immediate medical attention, which will indicate
a method for eliminating the mucus (bronchoaspiration).
In case of ingestion/taking an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take Fluimucil
Do not take a double dose to make up for the missed dose.
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.

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

• allergic reactions (hypersensitivity);
• constriction of the bronchial muscles (bronchospasm);
• runny nose (rhinorrhea);
• difficulty breathing (bronchial obstruction);
• inflammation of the mouth (stomatitis);
• vomiting;
• nausea;
• urticaria;
• skin rash;
• itching. In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell's syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your doctor. Furthermore, a reduction in platelet aggregation (prolongation of bleeding time) is possible.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Fluimucil

Keep this medicine out of the sight and reach of children.
Opened vials can only be used if stored in a refrigerator and for a maximum of 24 hours.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. The expiry
date refers to the last day of that month. The expiry date indicated refers to the product in
intact packaging correctly stored.
Do not dispose of any medicine in 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 Fluimucil contains

• The active ingredient is N-acetylcysteine: 1 vial of 3 ml contains 300 mg of N-acetylcysteine.
• The other ingredients are: sodium hydroxide, disodium edetate, water for injections.

Description of the appearance of Fluimucil and contents of the pack
One pack contains 6, 10 or 20 vials of 3 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - via della Chimica, 9 - Vicenza
Biologici Italia Laboratories S.r.l. – via Filippo Serpero, 2 – 20060 Masate (MI)

FLUIMUCIL 300 mg/3 ml solution for nebulizer

N-acetylcysteine

Read this leaflet carefully before you start to take 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 doctor or pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse after 10 days.

Contents of this leaflet:

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

1. What Fluimucil is and what it is used for

Fluimucil contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called
mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil is indicated for the treatment of respiratory diseases characterized by an increase
in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• lung alveolar pathology (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilations (bronchiectasis).

See your doctor if you do not feel better or if you feel worse after 10 days.

2. What you need to know before taking Fluimucil

Do not take Fluimucil

• if you are allergic to N-acetylcysteine, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking Fluimucil immediately if you experience bronchospasm (contraction of the bronchial muscles);
• if you have had atopy and asthma in the past, as you may develop allergic reactions;
• if you are intolerant to histamine as you may develop allergic reactions;
• if you suffer from or have suffered from a problem with your stomach or intestines called a peptic ulcer, especially if you are taking other medicines with Fluimucil that cause problems with your stomach (gastrolesive drugs).

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially
at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the bronchial
secretions by coughing (expectorating), consult your doctor who will indicate a method for eliminating the mucus (postural drainage or bronchoaspiration).
Allergic (hypersensitivity/anaphylactoid) reactions can occur with N-acetylcysteine. Monitoring
for signs of an allergic reaction may be necessary.
If you notice a smell of sulfur when opening the vial, or the solution turns pink in the open vial or
when transferring the solution to the aerosol device, do not worry as this does not indicate
alteration of the medicine.

Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric
dosage for the determination of salicylates and tests to determine ketones). Tell your doctor that you
are taking this medicine before undergoing these tests.

Children
Fluimucil should not be given to children under 2 years of age, as it may obstruct the
bronchi and prevent normal breathing.
The same warnings and precautions as for adults apply to children and adolescents.

Other medicines and Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take this medicine if you are taking:

• cough medicines (antitussives), as they can lead to an accumulation of mucus inside the bronchi.

Avoid taking at the same time:

• medicines that can decrease the volume of bronchial secretions (anticholinergics), as they can have an effect opposite to that of Fluimucil.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

• nitroglycerin, used for some heart conditions. The use of this medicine together with Fluimucil may cause a decrease in blood pressure (hypotension) and headache;
• medicines used for the treatment of infections (antibiotics). Do not mix these medicines with the solution containing Fluimucil. You can take Fluimucil together with medicines for the treatment of asthma (see the “Warnings and precautions” section) and bronchial and lung diseases (bronchodilators) or medicines to increase blood pressure (vasoconstrictors).

Pregnancy, breastfeeding and fertility
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.
Pregnancy
Take this medicine if you are pregnant only if strictly necessary and under the direct control of
your doctor.
Breastfeeding
The use of Fluimucil should be avoided if you are breastfeeding. Ask your doctor for advice before stopping
breastfeeding and/or starting/stopping therapy with Fluimucil.
Fertility
No data are available on the effect of Fluimucil on fertility.

Driving and operating machinery
There is no information available on the influence of this medicine on the ability to drive vehicles or
operate machinery.

3. How to use Fluimucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose to be nebulized is 1 vial, 1-2 times a day. The duration of treatment is 5-10 days.
The dose and frequency of the medicine can be modified by the doctor. Use a glass
or plastic nebulizer and for devices that have metal or rubber parts, it is necessary to wash the devices with
water immediately after use.
Use open vials only if stored in the refrigerator and for a maximum of 24 hours.
If Fluimucil is mixed with medicines for the treatment of asthma and diseases of the bronchi and lungs (bronchodilators) or other medicines, use the solution briefly and do not store it.

If you take more Fluimucil than you should
No cases of overdose have been reported, however, following the administration of an
excessive dose of this medicine, an accumulation of mucus in the bronchi may occur, especially if the patient
is unable to eliminate it through coughing (expectoration). Seek immediate medical attention, which will indicate
a method for eliminating the mucus (bronchoaspiration).
In case of ingestion/taking an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take Fluimucil
Do not take a double dose to make up for a missed dose.
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.

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

• allergic reactions (hypersensitivity);
• bronchial muscle contraction (bronchospasm);
• runny nose (rhinorrhea);
• difficulty breathing (bronchial obstruction);
• inflammation of the mouth (stomatitis);
• vomiting;
• nausea;
• urticaria;
• skin rash;
• itching.

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell's syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your
doctor.
Furthermore, a reduction in platelet aggregation (prolongation of bleeding time) is possible.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Fluimucil

Keep this medicine out of the sight and reach of children.
Once the inner aluminum sachet is opened, the vials of Fluimucil must be used within 7 days.
Opened vials can only be used if stored in a refrigerator and for a maximum of 24 hours.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. The expiry
date refers to the last day of that month. The expiry date indicated refers to the product in
intact packaging correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fluimucil contains

• The active ingredient is N-acetylcysteine: 1 vial of 3 ml contains 300 mg of N-acetylcysteine.
• The other ingredients are: sodium hydroxide, disodium edetate, water for injections.

Description of the appearance of Fluimucil and contents of the pack
Box of 2 sachets. Each sachet contains 5 plastic vials of 3 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
Genetic S.p.A. - Contrada Canfora z.i. – Fisciano (SA)

FLUIMUCIL 600 mg effervescent tablets

N-acetylcysteine

Read this leaflet carefully before taking this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Fluimucil and what is it used for

Fluimucil contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called
mucolytics, used to facilitate the elimination of mucus from the respiratory tract and to a group of medicines
called antidotes used to counteract the toxic effect of certain substances.
Fluimucil is indicated for the treatment of diseases of the respiratory system characterized by an increase
in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• pathology of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilations (bronchiectasis).

Fluimucil is used as an antidote in particular for

• accidental or voluntary poisoning with paracetamol, an anti-inflammatory medicine;
• pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs such as ifosfamide and cyclophosphamide.

2. What you need to know before taking Fluimucil

Do not take Fluimucil

• if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding unless after careful evaluation by your doctor (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking Fluimucil immediately if you have bronchospasm (contraction of the bronchial muscles). Also consult your doctor if such disorders have occurred in the past;
• if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur when taking Fluimucil;
• if you suffer from or have suffered from a problem with your stomach or intestines called peptic ulcer, especially if you are taking other medicines with Fluimucil that can cause problems with your stomach (gastrolesive drugs).

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially
at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the bronchial
secretions by coughing (expectorating), consult your doctor who will indicate a method for eliminating the mucus (postural drainage or bronchoaspiration).
If you notice a sulfur odor, do not worry because this does not indicate alteration of the preparation, but is
due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Tell your doctor that you are
taking this medicine before undergoing these tests.

Other medicines and Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take this medicine if you are taking:

• cough medicines (antitussives), because they can lead to an accumulation of mucus inside the bronchi.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

• activated charcoal used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it may reduce the effectiveness of Fluimucil;
• medicines used to treat infections (antibiotics) taken orally (with the exception of loracarbef). Take these medicines at least two hours apart from Fluimucil;
• nitroglycerin, used for some heart conditions. The use of this medicine at the same time as Fluimucil may cause a decrease in blood pressure (hypotension) and headache. In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if strictly
necessary and under the direct supervision of your doctor.

Driving and using machines
Fluimucil does not affect the ability to drive vehicles and operate machinery.

Fluimucil contains sodium
This medicine contains 156.9 mg of sodium (the main component of table salt) in each
tablet. This is equivalent to 7.9% of the recommended daily intake with the diet of an
adult.

Fluimucil containsaspartame
This medicine contains 20 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be
harmful if you have phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine
because the body cannot eliminate it properly.

Fluimucil contains glucose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Fluimucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Treatment of diseases of the respiratory system:
The recommended dose is 1 tablet (600 mg) per day, preferably in the evening. Your doctor may
advise you to modify the frequency and dose of administrations but without exceeding the maximum
daily dose of 600 mg.
The duration of therapy in acute forms ranges from 5 to 10 days and in chronic forms, the doctor will evaluate whether
to continue therapy for a few months.

Treatment of accidental or voluntary poisoning with paracetamol:
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, to be administered as
soon as possible, within 10 hours of taking paracetamol. Subsequently, the dose is 70 mg of N-
acetylcysteine per kg of body weight at intervals of 4 hours for 1-3 days.

Treatment of pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs
such as ifosfamide and cyclophosphamide.
The recommended dose is 4 g of N-acetylcysteine per day to be divided into 4 doses of 1 g, in patients
undergoing a chemotherapy cycle with ifosfamide and cyclophosphamide for 5 days every 28 days.

Instructions for use of Fluimucil
Dissolve one tablet in a glass containing a little water, stirring if necessary with a teaspoon.
Do not mix other drugs with the Fluimucil solution.
To facilitate the removal of the tablet, it is recommended to tear open the blister using the
side notches as shown in the figure.

If you take more Fluimucilthan you should
No cases of overdose have been reported. Symptoms of overdose may include nausea, vomiting and
diarrhea.
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Fluimucil
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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 may occur:

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache;
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• urticaria, skin rash;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• itching;
• fever (pyrexia);
• low blood pressure.

Rare(may affect up to 1 in 1,000 people)

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive difficulties (dyspepsia).

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• bleeding (haemorrhage).

Not known(frequency cannot be estimated from available data)

• swelling (oedema) of the face.

In very rare cases, severe skin reactions (Stevens Johnson syndrome or Lyell syndrome) have occurred. If you experience changes to the mucous membranes or skin, stop taking the medicine and consult your doctor.
Also consult your doctor if you experience a prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Fluimucil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Fluimucil contains

• The active ingredient is N-acetylcysteine: 1 effervescent tablet contains 600 mg of N-acetylcysteine.
• The other ingredients are: sodium bicarbonate, anhydrous citric acid, lemon flavour (containing glucose), aspartame.

Description of the appearance of Fluimucil and contents of the pack
Fluimucil 600 mg effervescent tablets in aluminium-polyethylene blisters. Pack of 30 or 60 tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
ZAMBON ITALIA s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A.- Via della Chimica, 9 - Vicenza

FLUIMUCIL 600 mg granules for oral solution

N-acetylcysteine

Read this leaflet carefully before taking this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Fluimucil and what is it used for

Fluimucil contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called
mucolytics, used to facilitate the elimination of mucus from the respiratory tract and to a group of medicines
called antidotes used to counteract the toxic effect of certain substances.
Fluimucil is indicated for the treatment of diseases of the respiratory system characterized by an increase
in the production of thick and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• pathology of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilation (bronchiectasis).

Fluimucil is used as an antidote in particular for

• accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
• pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs such as ifosfamide and cyclophosphamide.

2. What you need to know before taking Fluimucil

Do not take Fluimucil

• if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding unless after careful evaluation by your doctor (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking Fluimucil immediately if you have bronchospasm (contraction of the bronchial muscles). Also consult your doctor if these disorders have occurred in the past;
• if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur when taking Fluimucil;
• if you suffer from or have suffered from a problem with your stomach or intestines called peptic ulcer, especially if you are taking other medicines with Fluimucil that can cause problems with your stomach (gastrolesive drugs).

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially
at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the bronchial
secretions (expectorate) through coughing, consult your doctor who will indicate a method for eliminating the mucus (postural drainage or bronchoaspiration).
If you notice a sulfurous odor, do not worry because this does not indicate alteration of the preparation, but is
due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Tell your doctor that you are
taking this medicine before undergoing these tests.

Other medicines and Fluimucil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take this medicine if you are taking:

• cough medicines (antitussives), because they can lead to an accumulation of mucus inside the bronchi.

Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

• activated charcoal used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it may reduce the effectiveness of Fluimucil;
• medicines used to treat infections (antibiotics) taken orally (with the exception of loracarbef). Take these medicines two hours apart from Fluimucil;
• nitroglycerin, used for some heart disorders. The use of this medicine together with Fluimucil may cause a decrease in blood pressure (hypotension) and headache. In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if strictly
necessary and under the direct supervision of your doctor.

Driving and using machines
Fluimucil does not affect the ability to drive vehicles and use machinery.

Fluimucil contains sorbitol
Fluimucil contains 2025 mg of Sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has
told you that you are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a
rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before
taking this medicine.

Fluimucil containsaspartame
This medicine contains 75 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be
harmful if you have phenylketonuria, a rare genetic disease that causes a buildup of phenylalanine
because the body cannot eliminate it properly.

Fluimucil contains glucose and lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact them before taking
this medicine.

3. How to take Fluimucil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Treatment of respiratory diseases:
The recommended dose is 1 sachet (600 mg) per day, preferably in the evening. Your doctor may advise
you to modify the frequency or dose of administrations but without exceeding the maximum daily
dose of 600 mg.
The duration of therapy in acute forms ranges from 5 to 10 days and in chronic forms, the doctor will evaluate whether
to continue therapy for a few months.

Treatment of accidental or voluntary poisoning with paracetamol:
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, to be administered as
soon as possible, within 10 hours of taking paracetamol. Subsequently, the dose is 70 mg of N-
acetylcysteine per kg of body weight at intervals of 4 hours for 1-3 days.

Treatment of pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs
such as ifosfamide and cyclophosphamide.
The recommended dose is 4 g of N-acetylcysteine per day to be divided into 4 doses of 1 g, in patients
undergoing a chemotherapy cycle with ifosfamide and cyclophosphamide for 5 days every 28 days.

Instructions for use of Fluimucil:Dissolve the contents of the sachet in a glass containing a little
water, stirring if necessary with a teaspoon.
Do not mix other medicines with the Fluimucil solution.

If you take more Fluimucilthan you should
No cases of overdose have been reported. Symptoms of overdose may include nausea, vomiting and
diarrhea.
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Fluimucil
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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 may occur:

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache;
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• urticaria, skin rash;
• swelling of the face, lips, mouth, tongue or throat which can cause difficulty swallowing or breathing (angioedema);
• itching;
• fever (pyrexia);
• low blood pressure.

Rare(may affect up to 1 in 1,000 people)

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive difficulties (dyspepsia).

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• bleeding (haemorrhage).

Not known(frequency cannot be estimated from available data)

• swelling (oedema) of the face.

In very rare cases, severe skin reactions (Stevens Johnson syndrome or Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your
doctor.
Also consult your doctor if you experience a prolonged bleeding time (reduced
platelet aggregation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Fluimucil

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 packaging. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in 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 Fluimucil contains

• The active ingredient is N-acetylcysteine: 1 sachet contains 600 mg of N-acetylcysteine.
• The other ingredients are: aspartame, orange flavour (containing glucose and lactose), sorbitol

Description of the appearance of Fluimucil and contents of the pack
Fluimucil 600 mg granules for oral solutionin paper-aluminium-polyethylene sachets.
Pack of 20, 30 and 60 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ZAMBON ITALIA s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
ZAMBON S.p.A. - Via della Chimica 9 - 36100 Vicenza