Broncolib

Package leaflet: Information for the patient

BRONCOLIB 2.7 g granules for oral solution

Carbocysteine lysine salt monohydrate
Equivalent medicine
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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BRONCOLIB is and what it is used for

BRONCOLIB contains the active substance carbocisteine and belongs to a group of medicines called mucolytics, which work by liquefying mucus in the respiratory tract, thus facilitating its elimination.
BRONCOLIB is indicated to help eliminate mucus (mucolytic effect) in acute and chronic respiratory tract diseases.

2. What you need to know before taking BRONCOLIB

Do not take BRONCOLIB

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a stomach or intestinal condition called gastroduodenal ulcer;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person taking this medicine is a child under 11 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCOLIB.
There are no known cases of reduced effectiveness of the medicine after prolonged treatment or dependence (need to continue taking the medicine) with the use of BRONCOLIB.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, in those with a history of gastroduodenal ulcers or in those taking medicines known to cause gastrointestinal bleeding. You must stop treatment with carbocisteine if gastrointestinal bleeding occurs.
This medicine must not be used concomitantly with cough suppressants and/or medicines that inhibit bronchial secretion.
This medicine does not affect body weight and therefore may be taken if you are on a low-calorie diet or if you have diabetes.
Children
BRONCOLIB must not be taken by children under 11 years of age (see section “Do not take BRONCOLIB”).
Other medicines and BRONCOLIB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No disturbances due to interactions with medicines used for treating upper and lower respiratory tract diseases are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take BRONCOLIB during pregnancy.
Breastfeeding
The use of BRONCOLIB is not recommended while breastfeeding, as it is unknown whether this medicine passes into breast milk.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
BRONCOLIB contains aspartame
This medicine contains 30 mg of aspartame per sachet, equivalent to 6 mg/g. 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 BRONCOLIB

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 sachet per day, unless otherwise directed by the doctor.
Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.
Instructions for use: Dissolve the contents of one sachet in about half a glass of water, stirring well.
Do not mix BRONCOLIB with other products.
If you take more BRONCOLIB than you should
In case of overdose, symptoms such as headache, nausea, vomiting, diarrhoea, stomach pain (gastralgia), skin irritations (cutaneous reactions), and altered sensory perceptions (alterations of sensory systems) may occur.
If you or someone else has accidentally taken an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take BRONCOLIB
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 will experience them.
Contact your doctor if you experience any of the following side effects:

• Skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption, skin rash, urticaria, erythema, dermatitis), possibly with spots, blisters or vesicles (exanthema, bullous exanthema/erythema), itching, swelling due to fluid accumulation around the mouth and eyes, possibly causing breathing difficulties (angioedema) (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Dizziness;
• Flushing;
• Difficulty in breathing (dyspnoea).

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 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 BRONCOLIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
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 BRONCOLIB contains

• The active substance is carbocisteine lysine salt monohydrate: 1 sachet of 5 g contains 2.7 g of carbocisteine lysine salt.
• The other components are: mannitol, anhydrous citric acid, povidone, aspartame (E951), cedar flavour, orange flavour, granular orange.

Description of the appearance of BRONCOLIB and package contents
Pack sizes containing 10 and 30 sachets of 5 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ipso Pharma S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Mipharm S.p.A. - Via B. Quaranta, 12 – 20139 Milano

Patient Information Leaflet

BRONCOLIB 90 mg/ml syrup

Carbocysteine lysine salt monohydrate
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.

• 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 listed in this leaflet, or any that are not listed, contact your doctor or pharmacist. See section 4. Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment. Contents of this leaflet:
  1. What BRONCOLIB is and what it is used for
  2. What you need to know before taking BRONCOLIB
  3. How to take BRONCOLIB
  4. Possible side effects
  5. How to store BRONCOLIB
  6. Contents of the pack and other information

1. What BRONCOLIB is and what it is used for

BRONCOLIB contains the active substance carbocisteine and belongs to a group of medicines called mucolytics, which work by liquefying mucus in the respiratory tract, thus facilitating its elimination.
BRONCOLIB is indicated to help eliminate mucus (mucolytic effect) in acute and chronic respiratory tract diseases.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking BRONCOLIB

Do not take BRONCOLIB

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a stomach or intestinal condition called gastroduodenal ulcer;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person taking this medicine is a child under 2 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCOLIB.
There are no known cases of reduced effectiveness of the medicine after prolonged treatment or dependence (need to continue taking the medicine) with the use of BRONCOLIB.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, in those with a history of gastroduodenal ulcers or in those taking medicines known to cause gastrointestinal bleeding. You must stop treatment with carbocisteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants and/or medicines that inhibit bronchial secretion.
Children
BRONCOLIB must not be administered to children under 2 years of age, as it may obstruct the bronchi and interfere with normal breathing.
Other medicines and BRONCOLIB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No disturbances due to interactions with medicines used for the treatment of upper and lower respiratory tract diseases are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not take BRONCOLIB during pregnancy.
Breastfeeding
The use of BRONCOLIB is not recommended while breastfeeding, as it is unknown whether this medicine passes into breast milk.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
BRONCOLIB contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains 6 g of sucrose (sugar) per 15 ml dose. This should be taken into account in patients with diabetes mellitus. In addition, if you take the medicine for two or more weeks, it may be harmful to the teeth.
BRONCOLIB contains methyl parahydroxybenzoate
May cause allergic reactions (including delayed-type reactions).
BRONCOLIB contains ethanol
This medicine contains 96 mg of alcohol (ethanol) in each dose (15 ml). The amount in 15 ml of this medicine is equivalent to less than 3 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 BRONCOLIB

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.
The recommended dose for adults is 15 ml, 2–3 times daily.
Use in children over 5 years of age
The recommended dose is 5 ml, 2–3 times daily.
Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml, 2–3 times daily.
Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.
If you take more BRONCOLIB than you should
In case of overdose, symptoms such as headache, nausea, vomiting, diarrhoea, stomach pain (gastralgia), skin irritations (cutaneous reactions), and altered sensory perceptions (sensory system disturbances) may occur.
If you accidentally ingest or take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take BRONCOLIB
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Contact your doctor if you experience any of the following adverse reactions:

• Skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption, skin rash, urticaria, erythema, dermatitis), possibly accompanied by spots, blisters or vesicles (exanthema, bullous exanthema/erythema), itching, swelling due to fluid accumulation around the mouth and eyes, possibly causing breathing difficulties (angioedema) (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Dizziness;
• Flushing;
• Breathing difficulties (dyspnoea), bronchial obstruction (bronchial obstruction with unknown frequency).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store BRONCOLIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The product should be used within 15 days of first opening the bottle. Any remaining product should be
discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What BRONCOLIB contains

• The active substance is carbocisteine lysine salt monohydrate: 100 ml of syrup contain 9 g of carbocisteine lysine salt.
• The other components are: methyl 4-hydroxybenzoate, sucrose, cherry flavour, ethanol (96%), purified water.

Description of the appearance of BRONCOLIB and contents of the pack
Pack containing 1 bottle of 200 ml and a graduated dosing glass.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ipso Pharma S.r.l.
Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Vamfarma S.r.l - Via Kennedy, 5 - 26833 – Comazzo (LO)

Patient Information Leaflet

BRONCOLIB 2.7 g/10 ml syrup

Carbocysteine lysine salt monohydrate
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.

• Keep this leaflet. You may need to read it again.
• If you want 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 you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What BRONCOLIB is and what it is used for

BRONCOLIB contains the active substance carbocisteine and belongs to a group of medicines called mucolytics, which work by liquefying mucus in the respiratory tract, thus facilitating its elimination.
BRONCOLIB is indicated
to facilitate the elimination of mucus (mucolytic effect) in acute and chronic diseases of the respiratory system.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking BRONCOLIB

Do not take BRONCOLIB

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a stomach or intestinal condition called gastroduodenal ulcer;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if the person taking this medicine is a child under 11 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCOLIB.
There are no known effects of reduced efficacy of the medicine after prolonged treatment or dependence (need to continue taking the medicine) with the use of BRONCOLIB.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, debilitated patients, in those with a history of gastroduodenal ulcers or in those taking medicines known to cause gastrointestinal bleeding. You must stop treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants and/or medicines that inhibit bronchial secretion.
Children
BRONCOLIB must not be administered to children under 11 years of age (see section “Do not take BRONCOLIB”).
Other medicines and BRONCOLIB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No disturbances caused by concomitant use with medicines used to treat upper and lower respiratory tract diseases (interactions) are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must not take BRONCOLIB during pregnancy.
Breastfeeding
The use of BRONCOLIB is not recommended if you are breastfeeding, as it is not known whether this medicine passes into breast milk.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
BRONCOLIB contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. In addition, if you take this medicine for two or more weeks, it may be harmful to the teeth.
BRONCOLIB contains methyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).
BRONCOLIB contains ethanol
This medicine contains 96 mg of alcohol (ethanol) per dose (10 ml). The amount in 10 ml of this medicine is equivalent to less than 3 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 BRONCOLIB

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.
The recommended dose for adults is 1 single-dose container per day. Your doctor will determine the duration of treatment and may decide to adjust the required dose and frequency of administration.
If you take more BRONCOLIB than you should
In case of overdose, symptoms such as headache, nausea, vomiting, diarrhoea, stomach pain (gastralgia), skin irritations (cutaneous reactions), and altered sensory perceptions (sensory system disturbances) may occur.
In the event of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take BRONCOLIB
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 everyone experiences them.
Contact your doctor if you experience any of the following side effects:

• Skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption, skin rash, urticaria, erythema, dermatitis), possibly with spots, blisters or vesicles (exanthema, bullous exanthema/erythema), itching, swelling due to fluid accumulation around the mouth and eyes, potentially causing breathing difficulties (angioedema) (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• Dizziness;
• Flushing;
• Difficulty breathing (dyspnoea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 BRONCOLIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 BRONCOLIB contains

• The active substance is carbocisteine lysine salt monohydrate: one 10 ml single-dose container of syrup contains 2.7 g of carbocisteine lysine salt.
• The other components are: ethanol (96%), sucrose, strawberry flavour, vanilla flavour, methyl parahydroxybenzoate, purified water.

Description of the appearance of BRONCOLIB and contents of the pack
Box containing 6 single-dose containers of 10 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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