FLUIBRON 60 mg /Ml Oral Drops, Solution

Содержание инструкции

1. FLUIBRON TOSSE SECCA 30 mg/5 ml syrup
   1. What is Fluibron Tossa Secca and what is it used for
   2. What you need to know before you use Fluibron Tossa Secca
   3. How to use Fluibron Tossa Secca
   4. Possible side effects
   5. How to store Fluibron Tosse Secca
   6. Package contents and other information
2. FLUIBRON TOSSE SECCA 60 mg/ml oral drops, solution
   1. What is Fluibron Dry Cough and what is it used for
   2. What you need to know before you use Fluibron Dry Cough
   3. How to use Fluibron Tossa Secca
   4. Possible side effects
   5. How to store Fluibron Tosse Secca
   6. Contents of the pack and other information

FLUIBRON TOSSE SECCA 30 mg/5 ml syrup

Levodropropizine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 2 weeks.

Contents of this leaflet:

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

1. What is Fluibron Tossa Secca and what is it used for

Fluibron Tosse Secca is a medicine based on levodropropizine.
Fluibron Tosse Secca is indicated in the treatment of cough.

2. What you need to know before you use Fluibron Tossa Secca

Do not use Fluibron Tossa Secca 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 suffer from a respiratory disease whose problems are due to defects in the structure and/or function of cells lining the respiratory mucous membranes: the cilia (Kartagener syndrome, ciliary dyskinesia);
• you are pregnant;
• you are breastfeeding;

Fluibron Tosse Seccashould not be administered to children under 2 yearsof age.
Warnings and precautions
Talk to your doctor or pharmacist before using Fluibron Tosse Secca .
In particular, talk to your doctor if you suffer from severe kidney function impairment (severe renal insufficiency).

If you are elderly
If you are elderly, take this medicine with caution and under the supervision of your doctor.

Children and adolescents
This medicine is indicated for children weighing 10 kg or more.

Fluibron Tosse Seccashould not be administered to children under 2 yearsof age.
This medicine may cause drowsiness. Therefore, be careful if you intend to drive vehicles or
operate machinery (see section “Driving and using machines”).

Other medicines and Fluibron Tossa Secca
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking:

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

Fluibron Tossa Secca with food, drinks and alcohol
Take this medicine preferably away from meals (see section “How to use Fluibron Tosse
Secca”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Fluibron Tossa Secca if you are pregnant or if you wish to become pregnant.

Do nottake Fluibron Tossa Secca if you are breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and/or use machines. However, since
this medicine can cause drowsiness (see section "Possible side effects"), you should be careful if you intend to drive vehicles or operate machinery.

Fluibron Tossa Secca contains:
Sucrose:
if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine. It contains 10.5 g of sucrose per 30 ml dose. This should be taken into consideration in people affected
by 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. it is essentially “sodium-free”.

3. How to use Fluibron Tossa Secca

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

Adults
The recommended dose is 10 ml of syrup up to 3 times a day at intervals of at least 6 hours.

Children and adolescents
Up to 3 times a day according to the following scheme:

Weight (kg)

Amount of syrup to give to the

child
10-20 3 ml
20-30 5 ml

Instructions for use
Take the syrup preferably away from meals.
To dose the syrup, use the measuring cup found inside the package with markings
corresponding to 3 - 5 and 10 ml.
The bottle has a childproof closure. To open, press down on the cap firmly and simultaneously turn
counterclockwise until it opens.

Duration of treatment
You should continue treatment until the cough disappears or as prescribed by your doctor.
However, if after 2 weeks of therapy you still have a cough, stop the treatment and consult your
doctor. In fact, a cough is a symptom and the cause should be investigated and treated.

If you use more Fluibron Tosse Secca than you should
In case of ingestion/accidental intake of an excessive dose of Fluibron Tosse Secca, immediately notify your
doctor or go to the nearest hospital.

If you forget to take Fluibron Tosse Secca
Do not use a double dose to make up for a missed dose.

If you stop taking Fluibron Tosse Secca
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 adverse reactions observed, all with very rare frequency (may affect up to 1 in 10,000 people)
are as follows:
reactions at the skin level (urticaria),
redness of the skin (erythema),
skin rash (exanthem),
itching,
appearance of swelling of the face, eyes, lips, tongue and throat with possible difficulty in
breathing and swallowing (angioedema),
gastric and abdominal pain,
nausea,
vomiting,
diarrhea,
inflammation of the mouth (glossitis and aphthous stomatitis),
allergic reactions, including severe ones (anaphylactoid reactions),
general malaise,
fluid accumulation (generalized edema),
fainting (syncope),
weakness (asthenia),
dizziness,
vertigo,
tremors,
alteration of the sensitivity of the limbs or other parts of the body (paresthesia),
perception of the heartbeat (palpitations),
increased heart rate (tachycardia),
low blood pressure (hypotension),
alteration of the heart rhythm (atrial bigeminy),
nervousness,
drowsiness,
feeling of detachment.
Difficulty breathing (dyspnea),
cough,
fluid accumulation in the lungs (edema of the respiratory tract),
weakness (asthenia).

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after Scad. The expiry date
refers to the last day of that month.
Store at a temperature below 25°C
After the first opening of the bottle, use the product within 6 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment

6. Package contents and other information

What Fluibron Tosse Secca contains

• the active ingredient is: levodropropizine the other components are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavour, purified water.

Description of the appearance of Fluibron Tosse Secca and package contents
Fluibron Tosse Secca is presented as a syrup contained in a dark glass bottle containing 200 ml of syrup,
graduated measuring cup and a cap with child-resistant closure made of plastic.

Marketing Authorisation 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

FLUIBRON TOSSE SECCA 60 mg/ml oral drops, solution

Levodropropizine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

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

Contents of this leaflet:

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

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

Fluibron Dry Cough is a medicine based on levodropropizine.
Fluibron Dry Cough is indicated in the treatment of cough.

2. What you need to know before you use 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 suffer from a respiratory disease whose problems are due to defects in the structure and/or function of cells that line the respiratory mucous membranes: the cilia (Kartagener syndrome, ciliary dyskinesia);
• you are pregnant;
• you are breastfeeding;

Fluibron Dry Coughshould not be administered to children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before using Fluibron Dry Cough .
In particular, consult your doctor if you suffer from severe impairment of kidney function (severe renal insufficiency).

If you are elderly
If you are elderly, take this medicine with caution and under the supervision of your doctor.

Children and adolescents
This medicine is indicated for children weighing 7 kg or more.

Fluibron Dry Coughshould not be administered to children under 2 years of age.
This medicine may cause drowsiness. Therefore, be careful if you intend to drive vehicles or
operate machinery (see section “Driving and using machines”).

Other medicines and Fluibron Dry Cough
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell 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, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Fluibron Dry Cough if you are breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and/or operate machinery. However, since
this medicine can cause drowsiness (see section “Possible side effects”), you should be careful if you intend to drive vehicles or operate machinery.

Fluibron Dry Cough contains methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).
Fluibron Dry Cough contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Fluibron Tossa Secca

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

Adults
The recommended dose is 20 drops (corresponding to 60 mg) to be taken up to 3 times a day at intervals of
at least 6 hours or as directed by your doctor.

Children and adolescents
Up to 3 times a day at intervals of at least 6 hours according to the following scheme:

Weight (kg)

Number of drops per

administration

Weight (kg)

Number of drops per

administration
7-10 3 29-31 10
11-13 4 32-34 11
14-16 5 35-37 12
17-19 6 38-40 13
20-22 7 41-43 14
23-25 8 44-46 15
26-28 9 Greater than 46 20
The doctor, according to his/her judgment, may double the doses reported above. The doctor may increase the
dose up to a maximum of 20 drops three times a day.

Instructions for use
The drops should preferably be diluted in half a glass of water and taken between meals.
The bottle has a child-resistant closure. To open, press down firmly on the cap and simultaneously
turn counterclockwise until it opens. To dispense the drops, press lightly on the container.

Duration of treatment
You should continue the treatment until the cough disappears or as prescribed by your doctor.
However, if you still have a cough after 2 weeks of therapy, stop the treatment and consult your
doctor. In fact, cough is a symptom and the cause should be investigated and treated.

If you use more Fluibron Tosse Secca than you should
In case of ingestion/accidental intake of an excessive dose of Fluibron Tosse Secca, immediately
inform your doctor or go to the nearest hospital.

If you forget to take Fluibron Tosse Secca
Do not use a double dose to make up for a missed dose.

If you stop taking Fluibron Tosse Secca
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The adverse reactions observed, all with very rare frequency (may affect up to 1 in 10,000 people)
are as follows:
reactions at the skin level (urticaria),
redness of the skin (erythema),
skin rash (exanthema),
itching,
appearance of swelling of the face, eyes, lips, tongue and throat with possible difficulty in
breathing and swallowing (angioedema),
gastric and abdominal pain,
nausea,
vomiting,
diarrhea,
inflammations of the mouth (glossitis and aphthous stomatitis),
allergic reactions, including severe ones (anaphylactoid reactions),
general malaise,
fluid retention (generalized edema),
fainting (syncope),
weakness (asthenia),
dizziness,
vertigo,
tremors,
alteration of the sensitivity of the limbs or other parts of the body (paresthesia),
perception of the heartbeat (palpitations),
increased heart rate (tachycardia),
low blood pressure (hypotension),
alteration of the heart rhythm (atrial bigeminy),
nervousness,
drowsiness,
feeling of depersonalization.
difficulty breathing (dyspnea),
cough,
fluid accumulation in the lungs (edema of the respiratory tract).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa . .
By reporting side effects you can help to 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 which is reported on the pack after Exp. The expiry date
refers to the last day of that month.
Store at a temperature below 25°C
After the first opening of the bottle, use the product within 21 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Fluibron Tosse Secca contains

• the active ingredient is: levodropropizine the other components are: propylene glycol, xylitol, sodium saccharin, 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 white 30 ml bottle,
equipped with a dropper and a child-resistant closure cap made of plastic.

Marketing Authorisation 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