Fluibron dry cough

Package leaflet: Information for the user

FLUIBRON DRY COUGH 30 mg/5 ml syrup

Levodropropizine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet:

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

1. What Fluibron Dry Cough is and what it is used for

Fluibron Dry Cough is a medicinal product containing levodropropizine.
Fluibron Dry Cough is indicated for the treatment of cough.

2. What you need to know before using Fluibron Dry Cough

Do not use Fluibron Dry Cough if:

• you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from excessive mucus production by the bronchi (bronchorrhea);
• you have a respiratory disease whose problems are due to structural and/or functional defects in part of the cells lining the respiratory mucosa: the cilia (Kartagener syndrome, ciliary dyskinesia);
• you are pregnant;
• you are breastfeeding;

Fluibron Dry Cough must not be administered to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluibron Dry Cough.
In particular, consult your doctor if you have severe kidney function impairment (severe renal insufficiency).
If you are elderly
If you are elderly, take this medicine with caution and under medical supervision.
Children and adolescents
This medicine is indicated for children with a body weight of at least 10 kg.
Fluibron Dry Cough must not be administered to children under 2 years of age.
This medicine may cause drowsiness. Therefore, be cautious if you intend to drive or operate machinery (see section "Driving and using machines").
Other medicines and Fluibron Dry Cough
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that induce physical and mental relaxation (sedatives).

Fluibron Dry Cough with food, drinks and alcohol
Take this medicine preferably away from meals (see section "How to use Fluibron Dry Cough").
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fluibron Dry Cough if you are pregnant or intend to become pregnant.
Do not take Fluibron Dry Cough if you are breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive or operate machinery. However, since this medicine may cause drowsiness (see section "Possible side effects"), you should exercise caution when driving or operating machinery.
Fluibron Dry Cough contains:
Sucrose:
if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. Contains 10.5 g of sucrose per 30 ml dose. This should be taken into account in patients with diabetes mellitus.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
Sodium: contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to use Fluibron Dry Cough

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 10 ml of syrup up to 3 times daily, at intervals of at least 6 hours.
Children and adolescents
Up to 3 times daily according to the following scheme:
Amount of syrup to give to the child
Weight (kg)
10-20 3 ml
20-30 5 ml
Instructions for use
Take the syrup preferably away from meals.
To measure the dose, use the dosing cup provided inside the package, which has markings corresponding to 3 - 5 and 10 ml.
The bottle has a child-resistant cap. To open, press down firmly on the cap while turning it counterclockwise until it opens.
Duration of treatment
You should continue treatment until coughing stops or as directed by your doctor.
However, if coughing persists after 2 weeks of treatment, stop taking the medicine and consult your doctor.
Cough is a symptom, and the underlying cause should be investigated and treated.
If you take more Fluibron Dry Cough than you should
In case of accidental ingestion or overdose of Fluibron Dry Cough, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluibron Dry Cough
Do not take a double dose to make up for the missed dose.
If you stop using Fluibron Dry Cough
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 will experience them.
Following the instructions contained in this leaflet reduces the risk of side effects.
The adverse reactions observed, all very rare (may affect up to 1 in 10,000 people), are as follows:
skin reactions (urticaria),
skin redness (erythema),
skin rash (exanthema),
itching (pruritus),
swelling of the face, eyes, lips, tongue, and throat, possibly causing breathing or swallowing difficulties (angioedema),
gastric and abdominal pain,
nausea,
vomiting,
diarrhea,
inflammation of the mouth (glossitis and aphthous stomatitis),
allergic reactions, even severe ones (anaphylactoid reactions),
general malaise,
fluid accumulation (generalized edema),
fainting (syncope),
weakness (asthenia),
dizziness,
vertigo,
tremors,
altered sensation in limbs or other body parts (paraesthesia),
awareness of heartbeat (palpitations),
increased heart rate (tachycardia),
low blood pressure (hypotension),
alteration of heart rhythm (atrial bigeminy),
nervousness,
drowsiness,
feeling of depersonalization,
difficulty breathing (dyspnea),
cough,
fluid accumulation in the lungs (respiratory tract edema),
weakness (asthenia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/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 Dry Cough

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
After first opening the bottle, use the product within 6 weeks.
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 Cough Syrup Dry contains

• The active substance is: levodropropizine. The other ingredients are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavour, purified water.

Description of the appearance of Fluibron Cough Syrup Dry and package contents
Fluibron Cough Syrup Dry is a syrup presented in a 200 ml dark glass bottle,
graduated dosing cup and child-resistant plastic cap.
Marketing Authorization Holder
Chiesi Italia S.p.A. Via Giacomo Chiesi, 1 - 43122 Parma
Manufacturer
Doppel Farmaceutici S.r.l. Via Martiri delle Foibe, 1 - 29016 Cortemaggiore - Piacenza
Marco Viti Farmaceutici S.p.A. Via Tarantelli, 13/15 – 22076 Mozzate - Como

Package leaflet: Information for the user

FLUIBRON COUGH 60 mg/ml oral drops, solution

Levodropropizine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet:

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

1. What Fluibron Dry Cough is and what it is used for

Fluibron Dry Cough is a medicinal product containing levodropropizine.
Fluibron Dry Cough is indicated for the treatment of cough.

2. What you need to know before using Fluibron Cough Suppressant

Do not use Fluibron Cough Suppressant if:

• you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6);
• you have excessive mucus production by the bronchi (bronchorrhea);
• you suffer from a respiratory disease caused by structural and/or functional defects in the cilia, which are part of the cells lining the respiratory mucosa (Kartagener syndrome, ciliary dyskinesia);
• you are pregnant;
• you are breastfeeding;

Fluibron Cough Suppressant must not be administered to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluibron Cough Suppressant.
In particular, consult your doctor if you have severe impairment of kidney function (severe renal failure).
If you are elderly
If you are elderly, take this medicine with caution and under medical supervision.
Children and adolescents
This medicine is indicated for children with a body weight of at least 7 kg.
Fluibron Cough Suppressant must not be administered to children under 2 years of age.
This medicine may cause drowsiness. Therefore, exercise caution if you intend to drive or operate machinery (see section “Driving and use of machines”).
Other medicines and Fluibron Cough Suppressant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines that induce physical and mental relaxation (sedatives).

Fluibron Cough Suppressant with food, drinks and alcohol
Take this medicine preferably away from meals (see section “How to use Fluibron Cough Suppressant”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fluibron Cough Suppressant if you are breastfeeding.
Driving and use of machines
No studies on the ability to drive or use machinery have been conducted. However, since this medicine may cause drowsiness (see section "Possible side effects"), you should exercise caution when driving or operating machinery.
Fluibron Cough Suppressant contains methyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).
Fluibron Cough Suppressant contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Fluibron Dry Cough

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 20 drops (corresponding to 60 mg), taken up to 3 times daily at intervals of at least 6 hours, or as directed by the doctor.
Children and adolescents
Up to 3 times daily at intervals of at least 6 hours, according to the following scheme:
Number of drops per administration  Weight (kg)
7–10  3
11–13  4
14–16  5
17–19  6
20–22  7
23–25  8
26–28  9
29–31  10
32–34  11
35–37  12
38–40  13
41–43  14
44–46  15
Over 46  20
The doctor may, at his or her discretion, double the doses indicated above. The doctor may increase the dose up to a maximum of 20 drops three times daily.
Instructions for use
The drops should preferably be diluted in half a glass of water and taken away from meals.
The bottle has a child-resistant cap. To open, press down firmly on the cap while turning it counterclockwise until it opens. To dispense the drops, gently press on the container.
Duration of treatment
You should continue treatment until coughing stops or as prescribed by your doctor. However, if coughing persists after 2 weeks of treatment, stop taking the medicine and consult your doctor. Coughing is a symptom and its underlying cause should be investigated and treated.
If you take more Fluibron Dry Cough than you should
In case of accidental ingestion or overdose of Fluibron Dry Cough, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fluibron Dry Cough
Do not take a double dose to make up for the missed dose.
If you stop using Fluibron Dry Cough
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 will experience them.
The adverse reactions reported, all very rare (may affect up to 1 in 10,000 people), are as follows:
skin reactions (urticaria),
skin redness (erythema),
skin rash (exanthema),
itching (pruritus),
swelling of the face, eyes, lips, tongue, and throat, possibly causing breathing or swallowing difficulties (angioedema),
gastric and abdominal pain,
nausea,
vomiting,
diarrhea,
inflammation of the mouth (glossitis and aphthous stomatitis),
allergic reactions, even severe ones (anaphylactoid reactions),
general malaise,
fluid accumulation (generalized edema),
fainting (syncope),
weakness (asthenia),
dizziness,
vertigo,
tremors,
altered sensation in limbs or other body parts (paresthesia),
awareness of heartbeat (palpitations),
increased heart rate (tachycardia),
low blood pressure (hypotension),
changes in heart rhythm (atrial bigeminy),
nervousness,
drowsiness,
feelings of depersonalization,
difficulty breathing (dyspnea),
cough,
fluid accumulation in the lungs (pulmonary edema).

Following the instructions contained in this leaflet reduces the risk of side effects.

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 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 Tosse Secca

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
After first opening the bottle, use the product within 21 weeks.
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 Tosse Secca contains

• The active substance is: levodropropizine.
  The other components are: propylene glycol, xylitol, sodium saccharinate, methyl parahydroxybenzoate, forest fruit flavour, anise flavour, anhydrous citric acid, purified water.

Description of the appearance of Fluibron Tosse Secca and contents of the pack
It is presented as a solution contained in a 30 ml white bottle,
equipped with a dropper and a child-resistant cap made of plastic material.
Marketing Authorization Holder
Chiesi Italia S.p.A. Via Giacomo Chiesi, 1 - 43122 Parma
Manufacturer
Doppel Farmaceutici S.r.l. Via Martiri delle Foibe 129016 Cortemaggiore - Piacenza