BRONCOLIB 2.7 G Granules for oral solution

NAMEOFTHEMEDICINE
BRONCOLIB 90 mg/ml syrup
Carbocisteine lysine salt

WHAT IT IS
Cough and cold preparations; expectorants excluding combinations with
cough suppressants, mucolytics.

WHY IT IS USED
Broncolib 90 mg/ml syrup is used as a mucolytic, fluidifying agent in acute and chronic
respiratory tract conditions.

WHEN IT MUST NOT BE USED
Hypersensitivity to the active ingredient or to any of the excipients.
The product should not be administered to patients with gastroduodenal ulcer.
Do not administer during confirmed or suspected pregnancy and during breastfeeding (see paragraph
“What to do during pregnancy and breastfeeding”).
Paediatric patients: the drug should not be administered to children under 2 years of age.

PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.

WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE
MEDICINE

Inform your doctor or pharmacist if you have recently taken any other medicines, even

those without a prescription.
Controlled clinical studies have not revealed interactions with the most common drugs used in the
treatment of upper and lower respiratory tract conditions or with food and laboratory tests.

IT IS IMPORTANT TO KNOW THAT
Mucolytics can cause bronchial obstruction in children under 2 years of age.
In fact, the drainage capacity of bronchial mucus is limited in this age group, due to the
physiological characteristics of the respiratory tract.
They should therefore not be used in children under 2 years of age (see paragraph
“When it must not be used”).

When it can only be used after consulting a doctor
Patients who have previously suffered from gastroduodenal ulcer should consult their doctor
before taking Broncolib 90 mg/ml syrup.

What to do during pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.
Although the active ingredient has not been shown to be teratogenic or mutagenic and has not shown
negative effects on reproductive function in animals, Broncolib should not be administered during
pregnancy (see paragraph "When it must not be used"). Since no data are available regarding the passage of
carbocisteine lysine salt monohydrate into breast milk, use during breastfeeding is contraindicated (see paragraph
"When it must not be used").
Use should also be avoided if you suspect you are pregnant or wish to plan a
pregnancy.

Effects on the ability to drive and operate machinery
Broncolib 90 mg/ml syrup does not alter the ability to drive vehicles or operate machinery.

Important information on some excipients
Sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
If used chronically (i.e. for two weeks or more), Broncolib may be harmful to your teeth
(promotes the formation of dental caries).

Alcohol
This medicinal product contains 0.65 vol. % of ethanol (ethyl alcohol); each dose (15 ml) contains an amount equal to 100 mg which is equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful to subjects with alcohol problems.
The alcohol content of this medicinal product should be considered before using it in
children and in high-risk categories such as subjects with liver disease or epilepsy.
For those who play sports, the use of medicines containing ethyl alcohol can determine
positive results in doping tests in relation to the concentration limits of alcohol indicated by some
sports federations.
The medicine contains methyl para-hydroxybenzoate, known for its ability to cause urticaria.
In general, para-hydroxybenzoates can cause allergic reactions (possibly delayed), such as contact dermatitis and rarely immediate reactions with manifestation of
urticaria and bronchospasm.

HOW TO USE THIS MEDICINE

Q

Adults:15 ml 2-3 times a day or as prescribed by your doctor

Children:over 5 years: 5 ml 2-3 times a day or as prescribed by your doctor
from 2 to 5 years: 2.5 ml 2-3 times a day or as prescribed by your doctor
Caution: do not exceed the indicated doses.

Q
2-3 times a day.
Consult your doctor if the disorder recurs or if you notice any recent change in its characteristics.
Caution: use only for short periods of treatment.
Carbocisteine lysine salt monohydrate can also be used for prolonged periods, in which case it is advisable to follow the doctor's advice.

How
The package includes a graduated measuring cup.
To open the package, you must press firmly on the cap and rotate it simultaneously in
an anti-clockwise direction.

WHATTODOIFYOUHAVETAKENTOOMUCHMEDICINE
The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia,
skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform
gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/intake of an excessive dose of BRONCOLIB, immediately

inform your doctor or go to the nearest hospital.

If you have any doubts about the use of BRONCOLIB 90 mg/ml syrup, ask your doctor or

pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, Broncolib 90 mg/ml syrup can cause side effects, although not

everyone will experience them.
The undesirable effects that may occur with Broncolib, classified by systems and organs
(SOC), are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema,
bullous exanthema/erythema, pruritus, angioedema, dermatitis.

Gastrointestinal disorders:abdominal pain, nausea, vomiting, diarrhea.

Nervous system disorders:dizziness.

Vascular disorders:flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea, bronchial obstruction (frequency not
known).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or
pharmacist. Side effects can also be reported directly through the national reporting system at the address:

www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps to
provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
The validity period after first opening the bottle is 15 days (write the date of first
opening in the appropriate space on the packaging).
Medicines should not be thrown down the drain or into household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

It is important to always have information about the medicine available, so keep both

COMPOSITION
100 ml of syrup contains:

Active ingredient: carbocisteine lysine salt monohydrate equivalent to 9 g of carbocisteine lysine salt

Excipients:methyl para-hydroxybenzoate, sucrose, cherry aroma, ethyl alcohol, purified water.

PHARMACEUTICAL FORM AND CONTENT
Syrup
Bottle of 200 ml

AUTHORISATION HOLDER
Ipso Pharma S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)

MANUFACTURER
Francia Farmaceutici – Industria Farmaco Biologica S.r.l
Via Dei Pestagalli, 7
20138 Milano

OF THE MEDICINE

NAMEOFTHEMEDICINE
BRONCOLIB 2.7 g/10 ml syrup
Carbocisteine lysine salt

WHAT IT IS
Cough and cold preparations; expectorants excluding combinations with
cough suppressants, mucolytics.

WHY IT IS USED
Broncolib 2.7 g/10 ml syrup is used as a mucolytic, fluidifying agent in acute and chronic
respiratory tract conditions.

WHEN IT MUST NOT BE USED
Hypersensitivity to the active ingredient or to any of the excipients.
The product should not be administered to patients with gastroduodenal ulcer.
Do not administer during confirmed or suspected pregnancy and during breastfeeding (see paragraph
“What to do during pregnancy and breastfeeding”).
Paediatric patients: the drug should not be administered to paediatric patients under
11 years of age.

PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.

WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE
MEDICINE

Inform your doctor or pharmacist if you have recently taken any other medicines, even

those without a prescription.
Controlled clinical studies have not revealed interactions with the most common drugs used in the
treatment of upper and lower respiratory tract conditions or with food and laboratory tests.

IT IS IMPORTANT TO KNOW THAT
When it can only be used after consulting a doctor
Patients who have previously suffered from gastroduodenal ulcer should consult their doctor
before taking Broncolib 2.7 g/10 ml syrup.

What to do during pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.
Although the active ingredient has not been shown to be teratogenic or mutagenic and has not shown
negative effects on reproductive function in animals, Broncolib should not be administered during
pregnancy (see paragraph "When it must not be used"). Since no data are available regarding the passage of
carbocisteine lysine salt monohydrate into breast milk, use during breastfeeding is contraindicated (see paragraph
"When it must not be used").
Use should also be avoided if you suspect you are pregnant or wish to plan a
pregnancy.

Effects on the ability to drive and operate machinery
Broncolib 2.7 g/10 ml syrup does not alter the ability to drive vehicles or operate machinery.

Important information on some excipients
Sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
If used chronically (i.e. for two weeks or more), BRONCOLIB may be harmful to your teeth
(promotes the formation of dental caries).

Alcohol
This medicinal product contains 1 vol. % of ethanol (ethyl alcohol) each dose contains an amount equal to 100 mg which is equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful to individuals who have problems with alcoholism.
The alcoholic content of this medicinal product must be considered before using it in children and in high-risk categories such as individuals affected by liver disease or epilepsy.
For those who engage in sports, the use of medicines containing ethyl alcohol can determine positive results in doping tests in relation to the limits of blood alcohol concentration indicated by some sports federations.
The medicine contains methyl parahydroxybenzoate,known for its ability to cause urticaria. In general, parahydroxybenzoates can cause allergic reactions (possibly delayed), such as contact dermatitis and rarely immediate reactions with manifestations of urticaria and bronchospasm.

HOW TO USE THIS MEDICINE

Q
One single-dose container per day.
Considering the pharmacokinetic characteristics and high tolerability, the recommended dosage can also be maintained in patients with renal and hepatic insufficiency.
Caution: do not exceed the indicated doses.

Q
Once a day, at any time of the day.
Broncolib 2.7 g/10 ml syrup, thanks to its innovative packaging, ensures precision in dosage, hygiene, practicality and ease of administration and is particularly indicated in acute conditions for which short-term treatment is planned.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.
Caution: use only for short periods of treatment.
Carbocisteine lysine salt monohydrate can also be used for prolonged periods, in which case it is advisable to follow the doctor's instructions.

How
Separate the single single-dose container following the dotted line (fig.1), slowly lift the covering film of the container (fig. 2) and swallow the contents (fig.3).

WHATTODOIFYOUHAVETAKENTOOMUCHMEDICINE
The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/administration of an excessive dose of Broncolib 2.7 g/10 ml

syrup, immediately notify your doctor or go to the nearest hospital.

If you have any doubts about the use of Broncolib 2.7 g/10 ml syrup, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, Broncolib 2.7 g/10 ml syrup can cause side effects, although

not all people will experience them.
The side effects that can occur with Broncolib, classified by systems and organs (SOC), are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis.

Gastrointestinal disorders:abdominal pain, nausea, vomiting, diarrhea.

Nervous system disorders:dizziness.

Vascular disorders:flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at the address:

www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects helps to provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

It is important to always have information about the medicine available, therefore keep both

COMPOSITION
One single-dose container of 10 ml of 27% syrup contains:

Active ingredient:carbocisteine lysine salt monohydrate equivalent to 2.7 g of carbocisteine lysine salt.

Excipients:ethyl alcohol (96%), sucrose, strawberry aroma, vanilla aroma, methyl parahydroxybenzoate, purified water.

PHARMACEUTICAL FORM AND CONTENT
Syrup
Pack of 6 single-dose containers of 10 ml.

MARKETING AUTHORISATION HOLDER
Ipso Pharma S.r.l. -Via San Rocco, 6 – 85033 Episcopia (PZ)

PRODUCER
Francia Farmaceutici – Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milano

OF THE MEDICINE