Lisomucil cough mucolytic

Package leaflet: Information for the patient

LISOMUCIL COUGH MUCOLYTIC 750 mg/15 ml syrup with sugar, sugar-free

Carbocisteine
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 told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• 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 5 days.

Contents of this leaflet:

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

1. What LISOMUCIL cough mucolytic is and what it is used for

This medicinal product contains the active substance carbocisteine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
LISOMUCIL COUGH MUCOLYTIC is indicated for the treatment of respiratory tract diseases characterized by cough and phlegm in adults.
Consult your doctor if you do not feel better or feel worse after 5 days.

2. What you should know before taking LISOMUCIL cough expectorant

Do not take LISOMUCIL cough expectorant

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal condition known as active gastroduodenal ulcer;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

LISOMUCIL COUGH EXPECTORANT is contraindicated in children and adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before taking LISOMUCIL COUGH EXPECTORANT.

If, in addition to cough, you develop fever and/or breathing difficulties, consult your doctor, who will determine the appropriate treatment.

Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in patients 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 should not be used in combination with cough suppressants (antitussives).

For those engaged in sports: the use of medicines containing ethyl alcohol, including LISOMUCIL COUGH EXPECTORANT sugar-containing syrup, may lead to a positive result in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.

Other medicines and LISOMUCIL COUGH EXPECTORANT

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions with medicines used to treat upper and lower respiratory tract diseases are known.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

You must not take LISOMUCIL COUGH EXPECTORANT during pregnancy and breastfeeding.

Driving and using machines

LISOMUCIL COUGH EXPECTORANT does not affect the ability to drive or operate machinery.

LISOMUCIL COUGH EXPECTORANT sugar-containing syrup contains sucrose, methyl parahydroxybenzoate, sodium and ethanol (alcohol)

This medicine contains 6 g of sucrose per 15 ml of syrup (1 dosing cup or 1 tablespoon). This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

This medicine contains less than 1 mmol (23 mg) of sodium per 15 ml dose, i.e. essentially "sodium-free".

This medicine contains 200 mg of alcohol (ethanol) per 15 ml dose (one dosing cup or one tablespoon), equivalent to 4 mg/kg per 15 ml dose of syrup. The amount of ethanol in 15 ml of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

LISOMUCIL COUGH EXPECTORANT sugar-free syrup contains methyl parahydroxybenzoate and sodium.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

This medicine contains 90 mg of sodium (main component of table salt) per 15 ml dose (1 dose), and 270 mg of sodium for the daily dose of 3 tablespoons. This corresponds to 4.5% and 13.5%, respectively, of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

3. How to take LISOMUCIL COUGH MUCOLYTIC

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Instructions for use: To open the bottle, press down on the cap and unscrew it. Screw it back on to close. The package includes a dosing cup with markings indicating the volume in ml.
Take the product undiluted, regardless of meals.
The recommended dose for adults is 15 ml (1 dosing cup or 1 tablespoon), 3 times daily at 8-hour intervals.
Do not exceed the recommended doses without medical advice.
The maximum recommended duration of treatment is 5 days. Consult your doctor if you do not notice any improvement or if symptoms worsen after 5 days. Longer-term treatment may be carried out, according to the doctor's judgment.

If you take more LISOMUCIL COUGH MUCOLYTIC than you should
In case of overdose, symptoms such as headache, nausea, diarrhea, and stomach pain (gastralgia) may occur.
If you accidentally ingest or take an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.

If you forget to take LISOMUCIL COUGH MUCOLYTIC
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 gets them.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):
upper abdominal pain, nausea, diarrhoea.
Frequency not known (cannot be estimated from the available data):

• severe allergic reactions (anaphylactic, allergic skin rashes, drug-induced fixed eruption);
• skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption, skin rash). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• epigastric discomfort;
• vomiting;
• gastrointestinal bleeding. (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy).

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

5. How to store LISOMUCIL TOSSE MUCOLITICO

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.
LISOMUCIL TOSSE MUCOLITICO syrup with sugar: Store below 25°C.
LISOMUCIL TOSSE MUCOLITICO sugar-free syrup: 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 no longer used. This will help protect the environment.

6. Pack contents and other information

What LISOMUCIL TOSSE MUCOLITICO syrup with sugar contains

• The active substance is carbocisteine: each 1 ml of syrup contains 50 mg of carbocisteine.
• Other components: sucrose, methyl 4-hydroxybenzoate (E218), caramel powder, aromatic elixir (ethanol 82%), cinnamon flavour, sodium hydroxide, purified water.

What LISOMUCIL TOSSE MUCOLITICO sugar-free syrup contains

• The active substance is carbocisteine: each 1 ml of syrup contains 50 mg of carbocisteine.
• Other components: glycerol, hydroxyethylcellulose, sodium saccharin, sodium methyl 4-hydroxybenzoate, caramel powder, flavouring, sodium hydroxide, purified water.

Description of the appearance of LISOMUCIL TOSSE MUCOLITICO and contents of the pack
Pack containing 1 bottle of 200 ml and a dosing spoon.
The bottle has a child-resistant closure to make opening difficult for children.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturers
Sugar-free syrup
Unither Liquid Manufacturing – Colomiers (France)
A. Nattermann & Cie GmbH – Cologne (Germany)
Syrup with sugar
Unither Liquid Manufacturing – Colomiers (France)
A. Nattermann & Cie GmbH – Cologne (Germany)
Package leaflet: information for the patient

LISOMUCIL COUGH MUCOLYTIC 100 mg/5 ml syrup with sugar, mg/5 ml sugar-free syrup

Carbocysteine
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.

• 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.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What LISOMUCIL TOSSE MUCOLITICO is and what it is used for

This medicinal product contains the active substance carbocisteine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
LISOMUCIL TOSSE MUCOLITICO syrup with sugar is indicated for the treatment of cough in acute and chronic respiratory tract diseases.
LISOMUCIL TOSSE MUCOLITICO sugar-free syrup is indicated for the treatment of cough in acute and chronic respiratory tract diseases, particularly in cases of low-sugar and low-calorie (hypocaloric) diets or diets with a normal calorie intake (normocaloric).
Consult your doctor if you do not feel better or feel worse after 5 days.

2. What you need to know before taking LISOMUCIL COUGH MUCOLYTIC

Do not take LISOMUCIL COUGH MUCOLYTIC

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal condition called active gastroduodenal ulcer;
• during 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 LISOMUCIL COUGH MUCOLYTIC.
If, in addition to cough, you develop fever and/or difficulty breathing, consult your doctor, who will determine the appropriate treatment.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, 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 should not be used in combination with cough suppressants (antitussives).

Children
LISOMUCIL COUGH MUCOLYTIC must not be administered to children under 2 years of age for respiratory problems, as it may obstruct the bronchi and interfere with normal breathing.

Other medicines and LISOMUCIL COUGH MUCOLYTIC
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 diseases of the upper and lower respiratory tract are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
LISOMUCIL COUGH MUCOLYTIC must not be taken during pregnancy or while breastfeeding.

Driving and using machines
LISOMUCIL COUGH MUCOLYTIC does not affect the ability to drive or operate machinery.

LISOMUCIL COUGH MUCOLYTIC syrup with sugar contains sucrose, methyl
parahydroxybenzoate, carmine red, and sodium.
This medicine contains 3.5 g of sucrose per 5 ml of syrup (1 teaspoon). A daily dose of 3 teaspoons per day (15 ml of syrup) provides 10.5 g of sucrose, while a daily dose of 2 teaspoons per day (10 ml of syrup) provides 7 g of sucrose. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains carmine red A, which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per teaspoon (5 ml), i.e., essentially “sodium-free”.

LISOMUCIL COUGH MUCOLYTIC sugar-free syrup contains liquid maltitol, methyl
parahydroxybenzoate, carmine red, and sodium.
This medicine contains liquid maltitol. If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains carmine red A, which may cause allergic reactions.
This medicine contains 13.4 mg of sodium per teaspoon (5 ml). A daily dose of 3 teaspoons per day (15 ml of syrup) contains 40 mg of sodium, while a daily dose of 2 teaspoons (10 ml of syrup) contains 26.8 mg of sodium. This corresponds to 2% and 1.34% respectively of the maximum daily intake recommended by the WHO, which is 2 g of sodium per adult.

3. How to take LISOMUCIL TOSSE MUCOLITICO

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.

Use in children over 5 years of age
The recommended dose is 1 measuring teaspoon 2–3 times daily.

Use in children from 2 to 5 years of age
The recommended dose is half a measuring teaspoon / 1 measuring teaspoon, twice daily.

The maximum recommended duration of treatment is 5 days. Consult your doctor if you do not notice any improvement or if symptoms worsen after 5 days. Treatment for longer periods may be carried out, according to the doctor's judgment.

The package includes a measuring spoon with markings corresponding to 2.5 ml and 5 ml.

If you take more LISOMUCIL TOSSE MUCOLITICO than you should
In case of overdose, symptoms such as headache, nausea, diarrhea, and stomach pain (gastralgia) may occur.
If an excessive dose of this medicine is accidentally ingested, contact your doctor immediately or go to the nearest hospital.

If you forget to take LISOMUCIL TOSSE MUCOLITICO
Do not take a double dose to make up for the forgotten 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 gets them.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

• upper abdominal pain, nausea, diarrhoea.

Frequency not known (frequency cannot be estimated from the available data):

• severe allergic reactions (anaphylactic reactions, allergic skin rashes, fixed drug eruptions);
• skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme; toxic skin eruptions, skin rash). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy).
• breathing difficulty due to bronchial obstruction (bronchial obstruction). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy);
• epigastric discomfort;
• vomiting;
• gastrointestinal bleeding. (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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.

5. How to store LISOMUCIL TOSSE MUCOLITICO

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 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer used. This will help protect the environment.

6. Package contents and other information

What LISOMUCIL TOSSE MUCOLITICO 100 mg/5 ml syrup with sugar contains

• The active substance is carbocisteine: each 1 ml of syrup contains 20 mg of carbocisteine.
• The other components are: sucrose, methyl parahydroxybenzoate, vanillin, carmine red A (E124), raspberry flavour, cherry flavour, sodium hydroxide, purified water.

What LISOMUCIL TOSSE MUCOLITICO 100 mg/5 ml sugar-free syrup contains

• The active substance is carbocisteine: each 1 ml of syrup contains 20 mg of carbocisteine.
• The other components are: hydroxyethylcellulose, sodium saccharin, liquid maltitol, sodium methyl parahydroxybenzoate (E128), carmine red A (E124), cherry-raspberry flavour, sodium hydroxide, purified water.

Description of the appearance of LISOMUCIL TOSSE MUCOLITICO and the contents of the pack
LISOMUCIL TOSSE MUCOLITICO 100 mg/5 ml syrup with sugar: Pack containing 1 bottle of 200 ml. The bottle has a child-resistant closure to make opening difficult for children.
LISOMUCIL TOSSE MUCOLITICO 100 mg/5 ml sugar-free syrup: Pack containing 1 bottle of 125 ml. The bottle has a child-resistant closure to make opening difficult for children.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturers
Unither Liquid Manufacturing – Colomiers (France)
A. Nattermann & Cie. GmbH – Cologne (Germany)

Package leaflet: Information for the patient

LISOMUCIL cough mucolytic 1.5 g effervescent tablets

Carbocysteine
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.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What LISOMUCIL Cough Mucolytic is and what it is used for

This medicinal product contains the active substance carbocisteine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
LISOMUCIL Cough Mucolytic is indicated for the treatment of productive cough in acute and chronic respiratory tract diseases in adults.
Consult your doctor if you do not feel better or feel worse after 5 days.

2. What you need to know before taking LISOMUCIL cough expectorant

Do not take LISOMUCIL cough expectorant

• 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 active gastroduodenal ulcer;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);

LISOMUCIL COUGH EXPECTORANT is contraindicated in children and adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking LISOMUCIL cough expectorant.
If, in addition to cough, you develop fever and/or difficulty breathing, consult your doctor, who will determine the appropriate treatment.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in those with a history of gastroduodenal ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding. This medicine should not be used concomitantly with cough suppressants (antitussives).

Other medicines and LISOMUCIL cough expectorant
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other commonly used medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take LISOMUCIL cough expectorant during pregnancy and breastfeeding.

Driving and using machines
LISOMUCIL cough expectorant does not impair the ability to drive vehicles or operate machinery.

LISOMUCIL cough expectorant contains sorbitol and sodium
LISOMUCIL cough expectorant contains 380 mg of sorbitol per effervescent tablet and 760 mg of sorbitol per daily dose of 2 effervescent tablets, equivalent to 7.6 mg/kg/day and 15.2 mg/kg/day, respectively. Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with an intolerance,
LISOMUCIL cough expectorant contains 317.4 mg of sodium (the main component of table salt) per effervescent tablet and 634.8 mg of sodium per daily dose of 2 effervescent tablets. This corresponds to 15.87% and 31.74%, respectively, of the maximum daily intake recommended by the WHO, which is 2 g of sodium per adult.

3. How to take LISOMUCIL cough mucolytic

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.
Instructions for use: dissolve one effervescent tablet in half a glass of still (non-carbonated) water.
The recommended dose for adults at the beginning of treatment is 2 effervescent tablets per day (one in the morning and one in the evening), later reducing to 1 effervescent tablet per day.
The maximum recommended duration of treatment is 5 days. Contact your doctor if you do not notice any improvement or if your symptoms worsen after 5 days. Treatment for longer periods may be carried out according to the doctor's judgment.
If you take more LISOMUCIL cough mucolytic than you should
In case of overdose, symptoms such as headache, nausea, diarrhoea and stomach pain (gastralgia) may occur.
If you or someone else accidentally takes an excessive dose of this medicine, contact a doctor immediately or go to the nearest hospital.
If you forget to take LISOMUCIL cough mucolytic
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 get them.
Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

• severe allergic reactions (anaphylactic reactions, allergic skin rashes, drug-induced fixed eruption);
• skin irritations and skin disorders (Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme, toxic skin eruption). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.)
• abdominal pain (gastralgia), epigastric discomfort, nausea, diarrhoea;
• vomiting;
• gastrointestinal bleeding. (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.)

In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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.

5. How to store LISOMUCIL cough mucolytic

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.
Keep in the original packaging to protect the medicine from moisture.
Use this medicine within 1 month of first opening.
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 LISOMUCIL tosse mucolitico contains

• The active substance is carbocisteine: 1 effervescent tablet contains 1.5 g of carbocisteine.
• The other components are: sodium bicarbonate, anhydrous citric acid, sorbitol (E420), anhydrous sodium carbonate, acesulfame potassium, lemon flavour, orange flavour, polysorbate 20, simethicone emulsion.

Description of the appearance of LISOMUCIL tosse mucolitico and contents of the pack
Tube containing 20 effervescent tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
E-Pharma Trento S.p.A. - Ravina (TN)
Package leaflet: information for the patient

LISOMUCIL COUGH MUCOLYTIC 1.5 g granules for oral suspension

Carbocysteine
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.

• 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.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What LISOMUCIL TOSSE MUCOLITICO is and what it is used for

This medicine contains the active substance carbocisteine, which belongs to a group of medicines called mucolytics, used to help eliminate mucus from the respiratory tract.
LISOMUCIL TOSSE MUCOLITICO is indicated for the treatment of productive cough with mucus in acute and chronic respiratory tract diseases in adults.
Consult your doctor if you do not feel better or feel worse after 5 days.

2. What you need to know before taking LISOMUCIL COUGH MUCOLYTIC

Do not take LISOMUCIL COUGH MUCOLYTIC

• 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 active gastroduodenal ulcer;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if you have a genetic disorder characterized by impaired metabolism of certain amino acids, called phenylketonuria.

LISOMUCIL COUGH MUCOLYTIC is contraindicated in children and adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking LISOMUCIL COUGH MUCOLYTIC.
If, in addition to cough, you develop fever and/or difficulty breathing, consult your doctor, who will determine the appropriate treatment.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in those with a history of gastroduodenal ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine if gastrointestinal bleeding occurs. This medicine must not be used concomitantly with cough suppressants.
Use this medicine only for short-term treatment and consult your doctor if you do not notice improvement after 5 days of taking the medicine.
Other medicines and LISOMUCIL COUGH MUCOLYTIC
Inform 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, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take LISOMUCIL COUGH MUCOLYTIC during pregnancy and breastfeeding.
Driving and using machines
LISOMUCIL COUGH MUCOLYTIC does not affect the ability to drive or operate machinery.
LISOMUCIL COUGH MUCOLYTIC contains aspartame, sucrose and sorbitol
This medicine contains 10 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains 429.7 mg of sorbitol per sachet and 859.4 mg of sorbitol for the daily dose of 2 sachets, equivalent to 8.59 mg/kg/day and 17.19 mg/kg/day, respectively. 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 cannot metabolize fructose, speak with your doctor before taking this medicine.
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take LISOMUCIL TOSSE MUCOLITICO

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.
Instructions for use: dissolve the contents of one sachet in half a glass of still (non-carbonated) water.
The recommended dose for adults at the beginning of treatment is 2 sachets per day (one in the morning and one in the evening), then reduce to 1 sachet per day.
The maximum recommended duration of treatment is 5 days. Contact your doctor if you do not notice any improvement or if your symptoms worsen after 5 days. Treatment for longer periods may be carried out according to the doctor's judgment.

If you take more LISOMUCIL TOSSE MUCOLITICO than you should
In case of overdose, symptoms such as headache, nausea, diarrhoea, and stomach pain (gastralgia) 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 LISOMUCIL TOSSE MUCOLITICO
Do not take a double dose to make up for the missed dose.
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.
Contact your doctor if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

• upper abdominal pain, nausea, diarrhoea.

Frequency not known (frequency cannot be estimated from the available data):

• severe allergic reactions (anaphylactic reactions, allergic skin rashes, drug-induced fixed eruption);
• skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption; skin rash). (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.)
• epigastric discomfort;
• vomiting;
• gastrointestinal bleeding. (In such cases, discontinue treatment and consult your doctor to establish appropriate therapy.)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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.

5. How to store LISOMUCIL TOSSE MUCOLITICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store below 25 °C.
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 LISOMUCIL COUGH MUCOLYTIC contains

• The active substance is carbocisteine: 1 sachet contains 1.5 g of carbocisteine.
• The other components are: sorbitol (E 420), sucrose monopalmitate, mandarin flavour, hypromellose 3 cp, aspartame (E 951), orange yellow S dye.

Description of the appearance of LISOMUCIL COUGH MUCOLYTIC and contents of the pack
Pack containing 20 sachets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturers
Sanofi Winthrop Industrie - Avenue du Marechal Juin, 196 - 45200 - Amilly - France
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG) - Italy
Sanofi-aventis Sp. z.o.o. - Lubeska Street, 52 - 35-233 - Rzeszów – Poland