Fluimucil mucolytic

Patient Information Leaflet

FLUIMUCIL MUCOLYTIC children

100 mg/5 ml syrup
Acetylcysteine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Fluimucil Mucolytic Children is and what it is used for

This medicinal product contains the active substance N-acetylcysteine, which belongs to a group of medicines called expectorants – mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic Children is indicated for the treatment of respiratory tract diseases characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you should know before taking Fluimucil Mucolytic for children

Do not use Fluimucil Mucolytic for children

• if you are allergic to acetylcysteine, to similar substances, 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 (See section “Warnings and precautions”);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Fluimucil Mucolytic for children.
Use this medicine with caution and always under medical supervision in the following cases:

• if the child suffers from a chronic inflammatory bronchial disease called bronchial asthma. Discontinue administration of the medicine if, after taking it, shortness of breath (dyspnea) occurs due to bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if the child is histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic for children;
• if the child has or has had a stomach or intestinal problem called peptic ulcer, especially if the child is taking other medicines that cause stomach problems (gastrolesive drugs) together with Fluimucil Mucolytic for children. This medicine may increase the volume of bronchial mucus (bronchial secretions), particularly at the beginning of treatment. Therefore, if this occurs and the child is unable to expel bronchial secretions by coughing (expectoration), consult your doctor, who will recommend a method to remove the mucus (postural drainage or bronchoaspiration). If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to acetylcysteine.

Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate measurement and ketone tests). Inform your doctor that the child is taking this medicine before undergoing any laboratory tests.
Fluimucil Mucolytic for children must not be administered to children under 2 years of age for the treatment of respiratory problems, as it may obstruct the bronchi and impair normal breathing.

Other medicines and Fluimucil Mucolytic for children
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.
Do not use this medicine if the child is taking:

• cough suppressants (antitussives), as they may lead to mucus accumulation in the bronchi. Use this medicine with caution and consult your doctor if the child is taking any of the following medicines:
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (meteorism), as it may reduce the effectiveness of Fluimucil Mucolytic for children;
• antibiotics (medicines used to treat infections) taken orally (except loracarbef). Take these medicines at least two hours apart from Fluimucil Mucolytic for children;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic for children may cause low blood pressure (hypotension) and headache (cephalalgia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
Fluimucil Mucolytic for children does not affect the ability to drive or operate machinery.

Fluimucil Mucolytic for children syrup contains sodium benzoate
This medicine contains 7.5 mg per 5 ml dose.

Fluimucil Mucolytic for children syrup contains sodium
This medicine contains 19.1 mg of sodium (a main component of table salt) per 5 ml dose. This corresponds to 0.9% of the maximum daily recommended dietary intake for an adult.

Fluimucil Mucolytic for children syrup contains methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).

Fluimucil Mucolytic for children syrup contains propylene glycol
The raspberry flavor of the syrup contains 9.9 mg of propylene glycol per 5 ml dose.

Fluimucil Mucolytic for children syrup contains ethanol
The raspberry flavor of the syrup contains 2 mg of alcohol (ethanol) per 5 ml dose.
This amount in a single dose of the medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Fluimucil Mucolytic for children

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use:
Shake well before use. Once opened, the syrup is valid for 15 days.
Recommended doses:
Use in children over 2 years of age
The recommended dose is 1 measuring cup (5 ml) of syrup, equivalent to 100 mg of N-acetylcysteine, 2 to 4 times daily according to age.
The duration of treatment is 5–10 days.
Consult your doctor if the condition occurs frequently or if you notice any changes in symptoms.
If you take more Fluimucil Mucolytic for children than you should
Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you or someone else has taken an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic for children
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalaea);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure.

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

• bronchial muscle contractions (bronchospasm);
• breathing difficulties (dyspnoea);
• digestive problems (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 the available data)

• blockage of the bronchi (bronchial obstruction);
• facial swelling (facial oedema).

Contact your doctor if you experience any of the following side effects:

• skin lesions (Stevens-Johnson syndrome or Lyell syndrome). If you notice changes in the mucous membranes or skin, stop taking this medicine;
• blood disorders (reduced platelet aggregation).

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: 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 Mucolytic for children

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Once opened, the syrup remains valid for 15 days when stored under normal environmental conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic for Children contains

• The active substance is N-acetylcysteine: 5 ml of syrup contain 100 mg of N-acetylcysteine.
• The other components are: methyl parahydroxybenzoate, sodium benzoate, disodium edetate, sodium carboxymethylcellulose, sodium cyclamate, sucralose, raspberry flavour (containing propylene glycol and ethanol), sodium saccharinate, sodium hydroxide, purified water.

Description of the appearance of Fluimucil Mucolytic for Children and contents of the pack
Fluimucil Mucolytic for Children 100 mg/5 ml syrup comes in a 200 ml amber glass bottle containing syrup, with a polypropylene dosing cup.
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

Package leaflet: information for the patient

FLUIMUCIL MUCOLYTIC

100 mg oral granules for oral solution
Acetylcysteine
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 need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

1. What Fluimucil Mucolytic is and what it is used for
2. What you need to know before taking Fluimucil Mucolytic
3. How to take Fluimucil Mucolytic
4. Possible side effects
5. How to store Fluimucil Mucolytic
6. Package contents and other information

1. What Fluimucil Mucolytic is and what it is used for

This medicinal product contains the active substance N-acetylcysteine, which belongs to a group of medicines
called expectorants - mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by
an increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you should know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, 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 (See section “Children”);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

• if you suffer from a chronic inflammatory bronchial disease called bronchial asthma. Discontinue use of the medicine if, after taking it, you experience dyspnea (difficulty breathing) due to contraction of bronchial muscles (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal condition called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic drugs). This medicine may increase the volume of bronchial mucus (bronchial secretions), particularly at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the secretions by coughing (expectoration), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
  If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the product but is due to acetylcysteine.
  Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and ketone tests). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Children
Fluimucil Mucolytic must not be administered to children under 2 years of age for the treatment of respiratory problems, as it may obstruct the bronchi and impair normal breathing.

Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (flatulence), as it may reduce the effectiveness of Fluimucil Mucolytic;
• antibiotics taken orally (except loracarbef) used to treat infections. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.

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

Fluimucil Mucolytic oral granules for solution contain sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Fluimucil Mucolytic oral granules for solution contain sunset yellow (E110)
It may cause allergic reactions.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
This produces a pleasant-tasting solution that can be drunk directly from the glass or, in the case of young children over 2 years of age, administered in teaspoonfuls or via a feeding bottle. The solution should be taken immediately after preparation.
Adults
The recommended dose of Fluimucil Mucolytic oral granules is 2 sachets of 100 mg, 2–3 times daily.
Use in children over 2 years of age
The recommended dose is 1 sachet of 100 mg, 2–4 times daily, depending on age.
The duration of treatment is 5–10 days.
Consult your doctor if symptoms occur frequently or if you notice changes in their presentation.
If you take more Fluimucil Mucolytic than you should
No cases of overdose have been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you have taken or ingested too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the forgotten dose.
If you have any 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 will experience them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching;
• fever (pyrexia);
• low blood pressure.
  Rare (may affect up to 1 in 1,000 people)
• bronchial muscle contractions (bronchospasm);
• breathing difficulties (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 the available data)
• bronchial obstruction (bronchial occlusion);
• facial swelling (facial oedema).
  Contact your doctor if you experience any of the following side effects:
• skin lesions (Stevens-Johnson syndrome or Lyell's syndrome). If you experience changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood disorders (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: each sachet contains 100 mg of N-acetylcysteine.
• The other components are: orange juice granules, orange flavour, saccharin, sunset yellow (E 110), sucrose.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 100 mg, granules for oral solution: carton containing 30 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

Patient information leaflet: information for the patient

FLUIMUCIL MUCOLYTIC

100 mg oral granules for oral solution, sugar-free
Acetylcysteine
Please read this entire 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 instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement, or if your symptoms worsen after 10 days.

Contents of this leaflet:

1. What Fluimucil Mucolytic is and what it is used for
2. What you need to know before taking Fluimucil Mucolytic
3. How to take Fluimucil Mucolytic
4. Possible side effects
5. How to store Fluimucil Mucolytic
6. Package contents and other information

1. What Fluimucil Mucolytic is and what it is used for

This medicine contains the active substance N-acetylcysteine, which belongs to a group of medicines called expectorants - mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory diseases characterised by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you should know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, 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 (See section “Children”);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

• if you suffer from a chronic inflammatory disease of the bronchi called bronchial asthma. Discontinue taking the medicine if, after taking it, you experience dyspnea (difficulty breathing) due to bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal condition called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic 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 expel the bronchial secretions by coughing (expectoration), consult your doctor, who will recommend a method to remove the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Children
Fluimucil Mucolytic must not be administered to children under 2 years of age for the treatment of respiratory problems, as it may obstruct the bronchi and impair normal breathing.

Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (flatulence), as it may reduce the effectiveness of Fluimucil Mucolytic;
• antibiotics taken orally (except loracarbef) used to treat infections. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are 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 if strictly necessary and under direct medical supervision.

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

Fluimucil Mucolytic oral granules contain sorbitol
This medicine contains 775 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has informed you that you or your child has an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before taking this medicine.
In children weighing less than 22 kg, this medicine at the maximum dose (4 sachets) may cause gastrointestinal disturbances and have a mild laxative effect.

Fluimucil Mucolytic oral granules contain aspartame
This medicine contains 25 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Instructions for use Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
This produces a pleasant-tasting solution which can be drunk directly from the glass or, in the case of young children over 2 years of age, administered in teaspoonfuls or via a feeding bottle. The solution should be taken immediately after preparation.
Adults
The recommended dose of Fluimucil Mucolytic 100 mg oral granules without sugar is 2 sachets of 100 mg, 2–3 times daily.
Use in children over 2 years of age
The recommended dose is 1 sachet of 100 mg, 2–4 times daily, depending on age.
The duration of treatment is 5–10 days.
Consult your doctor if the condition occurs frequently or if you notice any changes in its presentation.
If you take more Fluimucil Mucolytic than you should
Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you have taken or ingested too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching;
• fever (pyrexia);
• reduced blood pressure.
  Rare (may affect up to 1 in 1,000 people)
• bronchial muscle contractions (bronchospasm);
• difficulty in 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 the available data)
• bronchial obstruction (bronchial occlusion);
• facial swelling (facial oedema).
  Contact your doctor if you experience any of the following side effects:
• skin lesions (Stevens-Johnson syndrome or Lyell’s syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood disorders (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website:

www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: 1 sachet contains 100 mg of N-acetylcysteine.
• The other components are: sorbitol, aspartame, orange flavour.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 100 mg oral solution granules, sugar-free: carton containing 30 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Package leaflet: information for the patient

FLUIMUCIL MUCOLYTIC

200 mg granules for oral solution, sugar-free
Acetylcysteine

Please read this leaflet carefully before taking this medicine because it contains important information for you.
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Fluimucil Mucolytic is and what it is used for

This medicine contains the active substance N-acetylcysteine, which belongs to a group of medicines
called expectorants - mucolytics, used to help eliminate mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by
increased production of thick and viscous mucus (viscous, dense hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you should know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);

• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

• if you suffer from a chronic inflammatory disease of the bronchi called bronchial asthma. Discontinue use of the medicine if, after taking it, you experience dyspnea (difficulty breathing), due to contraction of the bronchial muscles (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;

• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;

• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic 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 expel the secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product, but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylates and ketone tests). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.

Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (flatulence), as it may reduce the effectiveness of Fluimucil Mucolytic;
• oral antibiotics (antibacterial agents), except loracarbef. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concomitant use of this medicine with Fluimucil Mucolytic may cause a reduction in blood pressure (hypotension) and headache (cephalalgia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.

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

Fluimucil Mucolytic contains sorbitol
This medicine contains 675 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has informed you 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 cannot properly metabolize fructose, speak with your doctor before taking this medicine.

Fluimucil Mucolytic contains aspartame
This medicine contains 25 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to properly eliminate it.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
This produces a pleasant-tasting solution which should be taken immediately after preparation.
Adults
The recommended dose of Fluimucil Mucolytic 200 mg oral granules for solution without sugar is 1 sachet of 200 mg, 2-3 times daily.
The duration of treatment is 5–10 days.
Consult your doctor if symptoms occur frequently or if you notice changes in their pattern.
If you take more Fluimucil Mucolytic than you should
Symptoms of overdose may include nausea, vomiting and diarrhoea.
If you have taken an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the missed dose.
If you have any 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 may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure. Rare (may affect up to 1 in 1,000 people)
• bronchial muscle contractions (bronchospasm);
• difficulty in 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 the available data)
• facial swelling (facial oedema). Contact your doctor if you experience any of the following side effects:
• skin lesions (Stevens-Johnson syndrome or Lyell's syndrome). If you develop changes in the mucous membranes or skin, stop taking this medicine immediately;
• blood disorders (reduced platelet aggregation). Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: each sachet contains 200 mg of N-acetylcysteine.
• The other components are: sorbitol, aspartame, orange flavour.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 200 mg oral solution granules, sugar-free: carton containing 30 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Package leaflet: information for the patient

FLUIMUCIL MUCOLYTIC

200 mg oral granules for oral solution
Acetylcysteine
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 need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

1. What Fluimucil Mucolytic is and what it is used for
2. What you need to know before taking Fluimucil Mucolytic
3. How to take Fluimucil Mucolytic
4. Possible side effects
5. How to store Fluimucil Mucolytic
6. Package contents and other information

1. What Fluimucil Mucolytic is and what it is used for

This medicinal product contains the active substance N-acetylcysteine, which belongs to a group of
medicines called expectorants - mucolytics, used to facilitate the removal of mucus from the
respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by
increased production of thick and viscous mucus (viscous and dense hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

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

• if you suffer from a chronic inflammatory disease of the bronchi called bronchial asthma. Discontinue use of the medicine if you experience dyspnea (difficulty breathing) after taking it, due to bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are concurrently taking other medicines with gastric irritant effects (gastrolesive drugs) together with Fluimucil Mucolytic.

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 clear
secretions by coughing (expectoration), consult your doctor, who will advise you on an appropriate
method to remove mucus (postural drainage or bronchoaspiration).
If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the product,
but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses
(colourimetric assay for salicylate determination and tests for ketones).
Inform your doctor that you are taking this medicine before undergoing any laboratory tests.
Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (meteorism), as it may reduce the effectiveness of Fluimucil Mucolytic;
• medicines used to treat infections (antibiotics) taken by mouth (except loracarbef). Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalaea).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
seek advice from your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
Fluimucil Mucolytic does not affect the ability to drive or operate machinery.
Fluimucil Mucolytic granules for oral solution contains glucose, lactose, and sucrose
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.
Fluimucil Mucolytic granules for oral solution contains sunset yellow (E110)
May cause allergic reactions.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as stated in this leaflet or according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.

Instructions for use

Dissolve the contents of the sachet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
A pleasant solution is obtained, which should be taken immediately after preparation.
Adults
The recommended dose of Fluimucil Mucolytic granules for oral solution is 1 sachet of 200 mg, 2–3 times a day.
The duration of treatment is 5–10 days.
Consult your doctor if the condition occurs frequently or if you notice any changes in its symptoms.
If you take more Fluimucil Mucolytic than you should
Symptoms of an overdose may include nausea, vomiting, and diarrhoea.
In case of ingestion/absorption of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the forgotten 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.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalaea);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure.

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

• bronchial muscle contractions (bronchospasm);
• breathing difficulties (dyspnoea);
• digestive problems (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 the available data)

• facial swelling (oedema).

Contact your doctor if you experience any of the following side effects:

• skin lesions (Stevens-Johnson syndrome or Lyell’s syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood disorders (reduced platelet aggregation).

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: 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 Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: each sachet contains 200 mg of N-acetylcysteine.
• The other components are: orange juice granules (containing sucrose), orange flavour (containing glucose and lactose), saccharin, sunset yellow E110, sucrose.

Description of the appearance of Fluimucil Mucolytic and the contents of the pack
Fluimucil Mucolytic 200 mg oral solution granules: carton pack containing 30 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

Patient information leaflet

FLUIMUCIL MUCOLYTIC

200 mg effervescent tablets
Acetylcysteine
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.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Fluimucil Mucolytic is and what it is used for

This medicine contains the active substance N-acetylcysteine, which belongs to a group of medicines
called expectorants - mucolytics, used to help eliminate mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterised by
an increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);

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

• if you suffer from a chronic inflammatory bronchial disease called bronchial asthma. Discontinue taking the medicine if, after taking it, you experience dyspnea (difficulty breathing), due to bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are concurrently taking other medicines that cause stomach problems (gastrolesive drugs) together with Fluimucil Mucolytic. 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 expel the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.
Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (meteorism), as it may reduce the effectiveness of Fluimucil Mucolytic;
• antibiotics (medicines used to treat infections) taken orally (except loracarbef). Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
Fluimucil Mucolytic does not affect the ability to drive or operate machinery.
Fluimucil Mucolytic effervescent tablets contain sorbitol
This medicine contains 221 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has informed you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before taking this medicine.
Fluimucil Mucolytic effervescent tablets contain sodium
This medicine contains 26.9 mg of sodium (a main component of table salt) per dose. This corresponds to 1.3% of the maximum recommended daily dietary intake for an adult.
Fluimucil Mucolytic effervescent tablets contain aspartame
This medicine contains 10 mg of aspartame per dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to properly eliminate it.

3. How to take Fluimucil Mucolytic

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.
Instructions for use of Fluimucil Mucolytic
Keep the tablet in the mouth until it has completely dissolved.
Adults
The recommended dose of Fluimucil Mucolytic orodispersible tablets is 1 tablet of 200 mg, 2–3 times daily.
The duration of treatment is 5–10 days.
Consult your doctor if symptoms occur frequently or if you notice changes in their presentation.
If you take more Fluimucil Mucolytic than you should
Symptoms of overdose may include nausea, vomiting and diarrhoea.
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• 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 the available data)
• facial swelling (facial oedema). Contact your doctor if you experience any of the following side effects:
• skin lesions (Stevens-Johnson syndrome or Lyell's syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood disorders (reduced platelet aggregation). Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
  You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
  By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: each tablet contains 200 mg of N-acetylcysteine.
• The other components are: anhydrous citric acid, sorbitol, mannitol, polyethylene glycol 6000, povidone, sodium bicarbonate, lemon flavour, mandarin flavour, aspartame, magnesium stearate, microcrystalline cellulose.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 200 mg orodispersible tablets: cardboard box containing 20 or 30 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 – 36100 Vicenza
FLUIMUCIL MUCOLYTIC 600 mg granules for oral solution
N-acetylcysteine
Please 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 10 days.

Contents of this leaflet:

1. What Fluimucil Mucolytic is and what it is used for
2. What you need to know before taking Fluimucil Mucolytic
3. How to take Fluimucil Mucolytic
4. Possible side effects
5. How to store Fluimucil Mucolytic
6. Package contents and other information

1. What Fluimucil Mucolytic is and what it is used for

Fluimucil Mucolytic contains the active substance N-acetylcysteine, which belongs to a group of
medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to N-acetylcysteine or to 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 Mucolytic.
Take this medicine with caution and always under medical supervision in the following cases:

• if you suffer from a bronchial inflammatory disease called bronchial asthma. Immediately stop taking Fluimucil Mucolytic if you experience bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic 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 clear the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the product but is due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests to detect ketones). Inform your doctor that you are taking this medicine before undergoing such tests.

Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (flatulence), as it may reduce the effectiveness of Fluimucil Mucolytic;
• antibiotics taken orally (except loracarbef) used to treat infections. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or breastfeeding only if strictly necessary and under direct medical supervision.

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

Fluimucil Mucolytic contains sorbitol
This medicine contains 2,274.12 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has informed you 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 taking this medicine.

Fluimucil Mucolytic contains aspartame
This medicine contains 75 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body's inability to properly eliminate it.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment of respiratory tract diseases:
The recommended dose is 1 sachet (600 mg) per day, preferably in the evening. Your doctor may advise you to adjust the frequency or dose of administration, but the maximum daily dose of 600 mg must not be exceeded.
The duration of treatment ranges from 5 to 10 days.
Instructions for using Fluimucil Mucolytic:
Dissolve the contents of the sachet in a glass of water, stirring with a teaspoon if necessary.
Do not mix other medicines with the Fluimucil Mucolytic solution.
If you take more Fluimucil Mucolytic than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you have taken or ingested more than the recommended dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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:

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• 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 in 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 in 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 the available data)

• facial swelling (facial oedema).

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 prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: each sachet contains 600 mg of N-acetylcysteine.
• Other components: aspartame, orange flavour, sorbitol

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 600 mg granules for oral solution in aluminium-paper-polyethylene sachets.
Pack containing 10 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

Patient Information Leaflet: Information for the Patient

FLUIMUCIL MUCOLYTIC 600 mg/15 ml syrup

Acetylcysteine
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 to do.
Contents of this leaflet:

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

1. What Fluimucil Mucolytic is and what it is used for

Fluimucil Mucolytic contains the active substance N-acetylcysteine, which belongs to a group of
medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to N-acetylcysteine or to 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 Mucolytic.
Take this medicine with caution and always under medical supervision in the following cases:

• if you suffer from a bronchial inflammatory disease called bronchial asthma. Immediately stop taking Fluimucil Mucolytic if you experience bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic 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 (expectoration), consult your doctor, who will advise you on a method
to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the product,
but is due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses
(colourimetric assay for salicylate determination and tests for ketones). Inform
your doctor that you are taking this medicine before undergoing such tests.
Other medicines and Fluimucil Mucolytic
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
It is recommended not to mix other drugs with the Fluimucil Mucolytic solution.
Do not take this medicine if you are taking:

• cough suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (meteorism), as it may reduce the effectiveness of Fluimucil Mucolytic;
• medicines used to treat infections (antibiotics) taken by mouth (except loracarbef). Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concurrent use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.
Driving and using machines
Fluimucil Mucolytic does not affect the ability to drive vehicles or operate machinery.
Fluimucil Mucolytic contains sorbitol
This medicine contains 1.26 g of sorbitol in 15 ml. Sorbitol is a source of fructose. If your doctor
has informed you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Fluimucil Mucolytic contains sodium
This medicine contains 98.31 mg of sodium (a main component of table salt) in 15 ml.
This corresponds to 4.9% of the maximum daily recommended dietary intake for an adult.
Fluimucil Mucolytic contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate
These may cause allergic reactions (including delayed reactions).
Fluimucil Mucolytic contains propylene glycol
This medicine contains 168 mg of propylene glycol in 15 ml, equivalent to 11.2 mg/ml.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment of respiratory tract diseases
The recommended dose is 1 measuring cup of 15 ml (600 mg) per day, preferably in the evening.
Your doctor may advise you to adjust the frequency or dose of administration, but without exceeding the maximum daily dose of 600 mg.
The duration of treatment ranges from 5 to 10 days.
Do not mix other medicines with the Fluimucil Mucolytic solution.
If you take more Fluimucil Mucolytic than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you take or swallow too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the missed dose.
If you have any 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 everyone experiences them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• hives, 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 the available data)

• facial swelling (oedema).

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.
You should also consult your doctor if you experience prolonged bleeding time (reduced platelet aggregation).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The product is valid for 15 days after first opening (enter the date of first opening in the designated space on the carton).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic 600 mg/15 ml syrup contains

• The active substance is N-acetylcysteine: 15 ml of syrup contain 600 mg of N-acetylcysteine.
• The other components are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, disodium edetate, carmellose, sodium saccharin, grenadine flavour, strawberry flavour, sorbitol, sodium hydroxide, purified water.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
One pack of Fluimucil Mucolytic 600 mg/15 ml syrup contains an amber glass bottle
of 200 ml and a 15 ml dosing cup.

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

Package leaflet: Information for the patient

FLUIMUCIL MUCOLYTIC 600 mg effervescent tablets

Acetylcysteine
Please 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Fluimucil Mucolytic is and what it is used for

Fluimucil Mucolytic contains the active substance N-acetylcysteine, which belongs to a group of
medicinal products called mucolytics, used to facilitate the elimination of mucus from the respiratory tract, and to a group of medicinal products called antidotes, used to counteract the toxic effects of certain substances.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterized by increased production of thick and viscous mucus (dense and viscous hypersecretion).

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to N-acetylcysteine or to 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 Mucolytic.
Take this medicine with caution and always under medical supervision in the following cases:

• if you suffer from a bronchial inflammatory disease called bronchial asthma. Immediately stop taking Fluimucil Mucolytic if you experience bronchial muscle contraction (bronchospasm). Consult your doctor also if such symptoms occurred in the past;
• if you are histamine-intolerant, allergic-type reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that may cause stomach problems (gastrotoxic 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 clear
the bronchial secretions by coughing (expectoration), consult your doctor, who will recommend a method
to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulphur-like odour, do not be concerned, as this does not indicate deterioration of the product,
but is due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses
(colourimetric assay for salicylates and tests to detect ketones). Inform
your doctor that you are taking this medicine before undergoing such tests.
Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to accumulation of mucus in 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 intestinal gas (meteorism), as it may reduce the effectiveness of Fluimucil Mucolytic;
• antibiotics taken orally (except loracarbef) used to treat infections. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Taking this medicine together with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.
Driving and using machines
Fluimucil Mucolytic does not affect the ability to drive or operate machinery.
Fluimucil Mucolytic contains sodium
This medicine contains 156.9 mg of sodium (the main component of table salt) per dose.
This corresponds to 7.8% of the maximum daily recommended dietary intake for an adult.
Fluimucil Mucolytic contains aspartame
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 disorder causing
accumulation of phenylalanine because the body cannot properly eliminate it.
Fluimucil contains glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking
this medicine.

3. How to take Fluimucil Mucolytic

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
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 administration, but the maximum daily dose of 600 mg must not be exceeded.
The duration of treatment ranges from 5 to 10 days.

Instructions for use of Fluimucil Mucolytic
Dissolve one tablet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
Do not mix other medicines with the Fluimucil Mucolytic solution.
To facilitate removal of the tablet, it is recommended to open the blister pack by tearing along the side notches, as shown in the figure.

If you take more Fluimucil Mucolytic than you should
No cases of overdose have been reported. Symptoms of overdose may include nausea, vomiting, and diarrhoea.
If you have taken or ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take Fluimucil Mucolytic
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• 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 in swallowing or breathing (angioedema);
• itching (pruritus);
• fever (pyrexia);
• low blood pressure.

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

• bronchial muscle contractions (bronchospasm);
• difficulty in breathing (dyspnoea);
• digestive problems (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 the available data)

• facial swelling (facial oedema).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell’s syndrome) have been reported. 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 prolonged bleeding time (reduced platelet aggregation).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

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

Description of the appearance of Fluimucil Mucolytic and package contents
Fluimucil Mucolytic 600 mg effervescent tablets in aluminium-polyethylene blisters. Box of 10 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ZAMBON ITALIA s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)
Manufacturer
ZAMBON S.p.A. - Via della Chimica, 9 - Vicenza

Patient information leaflet

FLUIMUCIL MUCOLYTIC

200 mg effervescent tablets
N-Acetylcysteine
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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Fluimucil Mucolytic is and what it is used for

This medicinal product contains the active substance N-acetylcysteine, which belongs to a group of medicines called expectorants - mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
Fluimucil Mucolytic is indicated for the treatment of respiratory tract diseases characterised by increased production of thick and viscous mucus (dense and viscous hypersecretion).
Consult your doctor if you do not improve or feel worse after 10 days.

2. What you need to know before taking Fluimucil Mucolytic

Do not take Fluimucil Mucolytic

• if you are allergic to acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

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

• if you suffer from a chronic inflammatory disease of the bronchi called bronchial asthma. Discontinue use of the medicine if you experience dyspnea (difficulty breathing) after taking it, due to contraction of the bronchial muscles (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
• if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolytic;
• if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with Fluimucil Mucolytic that can cause stomach problems (gastrotoxic 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 clear the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur-like odour, do not be alarmed, as this does not indicate deterioration of the product but is due to acetylcysteine.
Laboratory tests: Acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylates and tests to detect ketones). Inform your doctor that you are taking this medicine before undergoing any laboratory tests.
Other medicines and Fluimucil Mucolytic
Inform 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 suppressants (antitussives), as they may lead to mucus accumulation in 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 intestinal gas (flatulence), as it may reduce the effectiveness of Fluimucil Mucolytic;
• medicines used to treat infections (antibiotics) taken by mouth, except loracarbef. Take these medicines at least two hours apart from Fluimucil Mucolytic;
• nitroglycerin, used for certain heart conditions. Concomitant use of this medicine with Fluimucil Mucolytic may cause low blood pressure (hypotension) and headache (cephalalgia).
• Pregnancy and breastfeeding If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. If you are pregnant or breastfeeding, take this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
Fluimucil Mucolytic does not affect the ability to drive or operate machinery.
Fluimucil Mucolytic effervescent tablets contain sodium
This medicine contains 156.9 mg of sodium (the main component of table salt) per dose. This corresponds to 7.8% of the maximum daily recommended dietary intake for an adult.
Fluimucil Mucolytic effervescent tablets contain aspartame
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 disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Fluimucil Mucolytic

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.
Instructions for use
Dissolve one effervescent tablet in a glass containing a small amount of water, stirring if necessary with a teaspoon.
This produces a pleasant-tasting solution which should be taken immediately after preparation.
To facilitate removal of the tablet, it is recommended to open the blister pack by tearing at the side notches, as shown in the figure.

Adults
The recommended dose of Fluimucil Mucolytic effervescent tablets
is 1 effervescent tablet of 200 mg, 2–3 times daily.
The duration of treatment is 5–10 days.
Consult your doctor if symptoms occur frequently or if you notice any changes in their presentation.
If you take more Fluimucil Mucolytic than you should
Symptoms of overdose may include nausea, vomiting, and diarrhoea.
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluimucil Mucolytic
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 everyone experiences them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache (cephalalgia);
• ringing in the ears (tinnitus);
• increased heart rate (tachycardia);
• vomiting;
• diarrhoea;
• inflammation of the mouth (stomatitis);
• abdominal pain;
• nausea;
• skin irritations (urticaria, rash);
• swelling due to fluid accumulation around the mouth and eyes (angioedema);
• itching (pruritus);
• fever (pyrexia);
• reduced arterial pressure.

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

• bronchial muscle contractions (bronchospasm);
• difficulty breathing (dyspnoea);
• digestive problems (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 the available data)

• facial swelling (facial oedema).

Contact your doctor if you experience any of the following side effects:

• skin lesions (Stevens-Johnson syndrome or Lyell's syndrome). If you notice changes in the mucous membranes or skin, stop taking the medicine immediately;
• blood-related problems (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluimucil Mucolytic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fluimucil Mucolytic contains

• The active substance is N-acetylcysteine: one effervescent tablet contains 200 mg of N-acetylcysteine.
• The other components are: sodium bicarbonate, anhydrous citric acid, lemon flavour, aspartame.

Description of the appearance of Fluimucil Mucolytic and contents of the pack
Fluimucil Mucolytic 200 mg effervescent tablets: carton pack containing 20 or 30 effervescent tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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