Fluibrón

Package leaflet: Information for the patient

FLUIBRON 15 mg/5 ml syrup, Adults 30 mg granules for oral suspension

Ambroxol hydrochloride
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 improvement or if you notice worsening of symptoms after a short period of time.

Contents of this leaflet:

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

1. What FLUIBRON is and what it is used for

FLUIBRON contains ambroxol, an active substance belonging to the class of mucolytics, which
works by making mucus more fluid and therefore easier to expel.
FLUIBRON is used in patients with acute respiratory tract diseases characterized by thick and viscous mucus.

2. What you need to know before taking FLUIBRON

Do not take FLUIBRON if:

• you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• you have severe liver and/or kidney disease.

Do not use FLUIBRON in children under 2 years of age.
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Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIBRON:

• if you have stomach lesions (peptic ulcer);
• if you have mild or moderate impairment of kidney function;
• during the first three months of pregnancy or if you are breastfeeding.

PAY ATTENTION:
Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including mucosal membrane lesions such as in the mouth, throat, nose, eyes, genitals), stop taking FLUIBRON and contact your doctor immediately.
Children
Do not use FLUIBRON in children under 2 years of age, as mucolytic agents may cause obstruction of the airways (bronchi).
Other medicines and FLUIBRON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. Do not take FLUIBRON during the first three months of pregnancy or while breastfeeding without first consulting your doctor.
Driving and using machines
FLUIBRON does not affect the ability to drive or operate machinery.
Excipients with known effects
FLUIBRON granules for oral suspension contain:

• sorbitol: this medicine contains 2,878.08 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told 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 are unable to metabolize fructose, speak with your doctor before taking this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
• azo dye (E110 Orange Yellow S): may cause allergic reactions.
• sodium saccharin: this medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially sodium-free.

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FLUIBRON syrup contains:

• sorbitol: this medicine contains 3,000 mg of sorbitol per 10 ml dose. Sorbitol is a source of fructose. If your doctor has told 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 are unable to metabolize fructose, speak with your doctor before taking this medicine. It may cause severe gastrointestinal problems and has a mild laxative effect.
• this medicine contains 750 mg of sorbitol per 2.5 ml dose and 1,500 mg of sorbitol per 5 ml dose. Sorbitol is a source of fructose. If your doctor has told you that the child is intolerant to certain sugars, or if the child has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before the child takes this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
• benzoic acid: this medicine contains 1.3 mg/ml of benzoic acid.

3. How to take FLUIBRON

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.

Adults
FLUIBRON granules for oral suspension
The initial dose is 1 sachet three times a day; the maintenance dose is 1 sachet twice a day.
FLUIBRON syrup
The initial dose is 10 ml of syrup three times a day, unless otherwise directed by the doctor; subsequently, 5 ml three times a day.

Children
Use only FLUIBRON syrup.
Children from 2 to 5 years of age: the dose is 2.5 ml of syrup, three times a day, unless otherwise directed by the doctor.
Children over 5 years of age: the dose is 5 ml of FLUIBRON syrup, three times a day, unless otherwise directed by the doctor.
Do not exceed the recommended doses.

Method of administration
Take FLUIBRON by mouth (oral use), as follows:
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• Granules for oral suspension: take the granules by dissolving them in water;
• Syrup: use the graduated measuring cup provided in the package, with markings at 10 ml, 5 ml and 2.5 ml, to ensure the correct dose is taken.

Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.

If you take more FLUIBRON than you should
The risk of experiencing side effects increases. In case of accidental ingestion or overdose of FLUIBRON, contact your doctor immediately or go to the nearest hospital.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking FLUIBRON immediately and contact your doctor if you experience any of the following: itching, skin rash (urticaria, cutaneous rash), swelling (angioedema) of the face, eyes, lips and/or throat with breathing difficulties due to allergy (hypersensitivity).

Inform your doctor if you notice the following:

Common side effects (may affect up to 1 in 10 people)
Altered or reduced sense of taste (dysgeusia), decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity), nausea.

Uncommon side effects (may affect up to 1 in 100 people)
Vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, dryness of the mouth.

Rare side effects (may affect up to 1 in 1,000 people)
Headache; hypersensitivity reactions; rash, urticaria.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
Airway obstruction (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching; severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. 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.
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5. How to store FLUIBRON

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the carton after the word
EXP. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging, properly stored.
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 FLUIBRON Contains
The active substance is: ambroxol hydrochloride.
FLUIBRON granules for oral suspension
Each sachet contains 30 mg of ambroxol hydrochloride.
The other components are: Orange-flavoured granulate on sorbitol (sorbitol, orange flavour, and orange yellow S (E110)), mannitol, citric acid monohydrate, glycine, arabic gum, sodium saccharin, anhydrous colloidal silica.
FLUIBRON syrup
1 ml contains 3 mg of ambroxol hydrochloride.
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The other components are: sorbitol 70% non-crystallising solution, glycerol, citric acid monohydrate, benzoic acid, sucralose, natural raspberry flavour, purified water.

Description of the Appearance of FLUIBRON and Contents of the Pack
FLUIBRON syrup is available in a 200 ml bottle equipped with a measuring spoon graduated at 10 ml, 5 ml and 2.5 ml, and a child-resistant cap.
FLUIBRON granules for oral suspension are available in packs containing 30 or 60 sachets.

Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A. - Via Palermo, 26/A – Parma
Manufacturer
Sachets: Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43- Brembate (BG)
Syrup: ZETA FARMACEUTICI S.p.A. – Via Galvani 10 - Sandrigo (VI)
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Patient information leaflet

FLUIBRON 7.5 mg/ml oral solution for oral use or nebulization

Ambroxol hydrochloride
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 improvement or if you experience worsening of symptoms after a short period of time.

Contents of this leaflet:

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

1. What FLUIBRON is and what it is used for

FLUIBRON contains ambroxol, an active ingredient belonging to the class of mucolytics, which works by making mucus more fluid and therefore easier to eliminate.
FLUIBRON is used in patients with acute and chronic respiratory tract diseases characterized by thick and viscous mucus.

2. What you need to know before taking FLUIBRON

Do not take FLUIBRON if:

• you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• you have severe liver and/or kidney disease.

Do not use FLUIBRON in children under 2 years of age.
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Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIBRON:

• if you have stomach lesions (peptic ulcer);
• if you have mild or moderate impairment of kidney function;
• during the first three months of pregnancy or if you are breastfeeding.

PAY ATTENTION:
Serious skin reactions have been reported following administration of ambroxol.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose,
eyes, genitals), stop taking FLUIBRON and consult your doctor immediately;

• if you have asthma, before inhaling FLUIBRON (using a nebulizer device), you should use your bronchodilator inhaler to avoid potential breathing difficulties.

Children
Do not use FLUIBRON in children under 2 years of age, as mucolytic agents may cause
obstruction of the airways (bronchi).
Other medicines and FLUIBRON
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not take FLUIBRON during the first three months of pregnancy or while breastfeeding
without first consulting your doctor.
Driving and using machines
FLUIBRON does not affect the ability to drive vehicles or operate machinery.
Excipients with known effects
FLUIBRON oral or nebulizer solution contains

• methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions) and, if inhaled, exceptionally bronchospasm;
• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically 'sodium-free'.

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3. How to take FLUIBRON

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.

If you are taking FLUIBRON by mouth (orally)
Adults: 2 - 4 ml (15-30 mg), 3 times a day.
Children from 2 to 5 years of age: 0.5 - 1 ml (3.75-7.5 mg), 2 - 3 times a day.
Children over 5 years of age: 1 - 2 ml (7.5-15 mg), 2 - 3 times a day.

If you are using FLUIBRON by inhalation (via a nebulizer device)
Adults: 2 - 3 ml, 1 - 2 times a day.
Children from 2 to 5 years of age: 2 ml, 1 - 2 times a day.
Children over 5 years of age: 2 - 3 ml, 1 - 2 times a day.

Method of administration
If taking FLUIBRON by mouth (orally), use the dropper and measuring device provided to measure the correct dose. Dilute the dose in a small amount of water or other liquid such as tea, milk, or fruit juice.
If using FLUIBRON by inhalation, place the prescribed dose into the vial of the "nebulizer device" and inhale the medicine normally through the mouth and/or nose. Breathing too deeply may cause coughing; to reduce this risk, it may be helpful to warm the vial containing the medicine to body temperature before nebulization.

Do not exceed the recommended doses.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their pattern.

If you take more FLUIBRON than you should
The risk of experiencing adverse effects increases. In case of accidental ingestion or overdose of FLUIBRON, contact your doctor immediately or go to the nearest hospital.

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

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking FLUIBRON immediately and contact your doctor if you experience any of the following:
itching, skin rash (urticaria, cutaneous rash), swelling (angioedema) of the face, eyes, lips and/or throat with breathing difficulties due to allergy (hypersensitivity).

Inform your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)
disturbance or loss of taste (dysgeusia), decreased sensation (hypoaesthesia) of the mouth and pharynx (oral cavity), nausea.

Uncommon side effects (may affect up to 1 in 100 people)
vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, dry mouth.

Rare side effects (may affect up to 1 in 1,000 people)
headache; hypersensitivity reactions; rash, urticaria.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
airway obstruction (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching; severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse. 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.
V.10.0_2026_02

5. How to store FLUIBRON

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging after the word
EXP. The expiry date refers to the last day of that month. This date applies to the product in its original, undamaged packaging, stored correctly.
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 FLUIBRON contains
The active substance is: ambroxol hydrochloride.
1 ml of solution contains 7.5 mg of ambroxol hydrochloride.
The other components are: sodium chloride, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
purified water.
Description of the appearance of FLUIBRON and package contents
FLUIBRON oral solution or solution for nebulization is available in a 40 ml bottle of solution equipped with a dropper and oral dosing syringe.
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A. - Via Palermo, 26/A – Parma
Manufacturer
ISTITUTO DE ANGELI S.r.l. - Loc. Prulli, 103/C - Reggello (FI)
CHIESI FARMACEUTICI S.p.A. - Officine di Parma, Via San Leonardo 96
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Package leaflet: information for the patient

FLUIBRON 15 mg/2 ml nebulizing solution

Ambroxol hydrochloride
Please read this leaflet carefully before using 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.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of time.

Contents of this leaflet:

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

1. What FLUIBRON is and what it is used for

FLUIBRON contains ambroxol, an active substance belonging to the class of mucolytics, which works by making mucus more fluid and therefore easier to eliminate.
FLUIBRON is used in patients with acute and chronic respiratory tract diseases characterized by thick and viscous mucus.

2. What you should know before taking FLUIBRON

Do not take FLUIBRON if:

• you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• you have severe liver and/or kidney disease;
• you are in the first three months of pregnancy.

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Do not use FLUIBRON in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIBRON if:

• you have stomach lesions (peptic ulcer);
• you have mild or moderate impairment of kidney function;
• you are breastfeeding.

TAKE CARE:

• Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking FLUIBRON and contact your doctor immediately;
• if you have asthma, before taking FLUIBRON by inhalation (using an aerosol device), you should use your bronchodilator inhaler to avoid possible breathing difficulties.

Children
Do not use FLUIBRON in children under 2 years of age, as mucolytics may cause obstruction of the airways (bronchi).
Other medicines and FLUIBRON
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
Do not take FLUIBRON during the first three months of pregnancy.
If you are breastfeeding, do not take FLUIBRON without first consulting your doctor.
Driving and using machines
FLUIBRON does not affect the ability to drive or operate machinery.
FLUIBRON contains: sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take FLUIBRON

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.
Adults
1 single-dose container, twice daily.
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Children
Children from 2 to 5 years of age: half or 1 single-dose container, 1–2 times daily.
Children over 5 years of age: 1 single-dose container, twice daily.
Your doctor may also instruct you to use half a container. Do not exceed the recommended doses.
Method of administration
This medicine must be nebulized (converted into very fine droplets) using an “aerosol device” equipped with mouth and/or nasal administration accessories.
Take the medicine by breathing normally through the mouth and/or nose. To take half a dose, use the graduation mark indicated on the container. The prescribed dose may be diluted by adding an equal volume of distilled water (ratio 1:1) to the nebulizer chamber.
Breathing too deeply may cause coughing; to reduce this risk, it may be helpful to warm the vial containing the medicine to body temperature before nebulization.
For correct use of this medicine, refer to the section “Instructions for use of FLUIBRON for AEROSOL” at the end of this package leaflet.
Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.
If you take more FLUIBRON than you should, the risk of experiencing adverse effects increases. In case of accidental ingestion or overdose of FLUIBRON, inform your doctor immediately or go to the nearest hospital.
If you forget to take FLUIBRON
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking FLUIBRON immediately and contact your doctor if you experience any of the following:
itching, skin rash (urticaria, skin rash), swelling (angioedema) of the face, eyes, lips and/or throat
with breathing difficulties due to allergy (hypersensitivity).
Inform your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)
taste disturbance or reduced sense of taste (dysgeusia), decreased sensitivity (hypoesthesia) of
the mouth and pharynx (oral cavity), nausea.
Uncommon side effects (may affect up to 1 in 100 people)
vomiting, diarrhoea, difficulty in digestion (dyspepsia), abdominal pain, dry mouth.
Rare side effects (may affect up to 1 in 1,000 people)
headache; hypersensitivity reactions; rash, urticaria.
Side effects with unknown frequency (frequency cannot be estimated from the available data)
airway obstruction (bronchi); dry throat; anaphylactic reactions including anaphylactic shock,
angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues),
and itching; severe skin adverse reactions (including erythema multiforme, Stevens-Johnson
syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor,
pharmacist or nurse. You can also report side effects directly via the national reporting system at
http://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 FLUIBRON

Keep this medicine out of the sight and reach of children.
Keep the single-dose containers inside the protective pouch to protect the medicine from light.
If half a dose is used, the remaining portion in the container must be stored at a temperature between 2 °C and 8 °C (in the refrigerator) and used within 12 hours of the first opening.
Do not use this medicine after the expiry date stated on the packaging after the word EXP. The expiry date refers to the last day of that month. This date applies to the product in its original unopened packaging, stored correctly.
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

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What FLUIBRON contains
The active substance is: ambroxol hydrochloride.
Each 2 ml single-dose container contains 15 mg of ambroxol hydrochloride.
The other components are: sodium chloride, water for injections.
Description of the appearance of FLUIBRON and contents of the pack
FLUIBRON nebulising solution is available in packs containing 10, 15 or 20 single-dose
containers, each containing 2 ml.
Marketing Authorization Holder
CHIESI FARMACEUTICI S.p.A. - Via Palermo, 26/A – Parma
Manufacturer
CHIESI FARMACEUTICI S.p.A. - Via San Leonardo, 96 – Parma
By scanning with a smartphone the QR code present on the outer packaging,
it is possible to access the video on the authorized instructions for use.
The same information is also available at the following URL:
https ://videoistruzioniduso.chiesi.it/F15
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INSTRUCTIONS FOR USE OF FLUIBRON FOR NEBULIZATION

Before use, carefully read the following instructions, which indicate what to do and what to
pay attention to.
To use, perform the following steps:
Figure A Bend the single-dose container in both directions.
Figure B Detach the single-dose container from the strip, first from the top and then at the center.
Figure C Open the single-dose container by rotating the tab in the direction indicated by the arrow.
Figure D By applying moderate pressure on the sides of the single-dose container, dispense the solution in the prescribed amount and transfer it into the nebulizer vial (nebulizer device).
Figure E If using half a dose, the container can be reclosed by flipping and pressing the cap.
The reclosed container must be stored in the refrigerator, at a temperature between 2 °C and 8 °C, and the remaining solution must be used within 12 hours of the first opening.

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