Mucotreis

Package leaflet: Information for the patient

MUCOTREIS 0.3 g powder for oral solution

Carbocisteine
Please read all of 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 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 a few days.

Contents of this leaflet:

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

1. What MUCOTREIS is and what it is used for

MUCOTREIS contains carbocisteine, a mucolytic agent used to facilitate the elimination of mucus in acute and chronic respiratory tract diseases.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you should know before taking MUCOTREIS

Do not take MUCOTREIS

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had a stomach or intestinal lesion (gastroduodenal ulcer).
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”). Do not administer MUCOTREIS to children under 2 years of age (see section “Children”).

Warnings and Precautions
Talk to your doctor or pharmacist before taking MUCOTREIS.
During the first few days of treatment, you may experience an increase in mucus secretion, which then
rapidly decreases.
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 medications known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants (antitussives).
Children
MUCOTREIS must not be used in children under 2 years of age, as it may cause bronchial obstruction due to their limited ability to clear excess mucus (see section “Do not take MUCOTREIS”).
Other medicines and MUCOTREIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known.
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 MUCOTREIS during pregnancy or breastfeeding (see section 2).
Driving and using machines
This medicine has no known effect on the ability to drive vehicles or use machinery.
MUCOTREIS 0.3 g powder for oral solution contains

• sucrose: If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may be harmful to teeth.
• 42.3 mg of sodium (the main component of table salt) per sachet. This corresponds to 2.11% of the maximum daily recommended dietary intake for an adult.

3. How to take MUCOTREIS

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
MUCOTREIS 0.3 g powder for oral solution:
Adults: The recommended dose is 1 sachet 3 or 4 times daily.
Children over 2 years of age: The recommended dose is 1 or half a sachet 1 or 2 times daily.
Do not exceed the recommended doses.

If you take more MUCOTREIS than you should
Cases of overdose are not known. If you take an excessive dose of this medicine, you may experience stomach and intestinal problems.
In case of overdose, discontinue the medicine.

If you forget to take MUCOTREIS
Do not take a double dose to make up for the forgotten 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 will experience them.
The following side effects may occur with unknown frequency (frequency cannot be determined from the available data):

• bronchial obstruction,
• stomach pain (gastralgia), nausea, diarrhea,
• gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy),
• dizziness,
• skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic cutaneous eruption (in such cases, discontinue treatment and consult your doctor to initiate 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 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 MUCOTREIS

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 this medicine below 25°C. Keep in the original packaging to protect the medicine from moisture.

6. Package contents and other information

What MUCOTREIS 0.3 g powder for oral solution contains

• The active substance is carbocisteine. Each sachet contains 0.3 g of carbocisteine. The other ingredients are: sodium bicarbonate, citric acid, colloidal silicon dioxide, apricot flavour, sucrose, sodium saccharin.

Description of the appearance of MUCOTREIS and the contents of the pack
MUCOTREIS 0.3 g powder for oral solution is available in packs of 30 sachets.
Marketing Authorization Holder
ITC FARMA s.r.l., via Pier Luigi Nervi 164, 04100 Latina (LT), Italy
Manufacturer
ITC FARMA s.r.l., via Pontina 5 Km 29, 00071 Pomezia (RM), Italy

Patient Information Leaflet

MUCOTREIS 1.5 g granules for oral suspension

Carbocysteine
Please read this leaflet carefully before taking this medicine as 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.

• 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.
• Contact your doctor if you do not notice any improvement or if you observe a worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What MUCOTREIS is and what it is used for

MUCOTREIS 1.5 g granules for oral suspension contains carbocisteine, a mucolytic agent, used
in adults to facilitate the elimination of mucus in acute and chronic respiratory tract diseases.
Consult your doctor if you do not feel better or feel worse after a few days.

2. What you need to know before taking MUCOTREIS

Do not take MUCOTREIS

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had a stomach or intestinal lesion (gastroduodenal ulcer);
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and Precautions
Talk to your doctor or pharmacist before taking MUCOTREIS.
During the first days of treatment, an increase in mucus secretion may occur, which then rapidly decreases.
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 patients taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocysteine if gastrointestinal bleeding occurs.
This medicine must not be used in combination with cough suppressants (antitussives).

Other medicines and MUCOTREIS
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.
No interactions are known.

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 MUCOTREIS during pregnancy and breastfeeding (see section 2).

Driving and using machines
This medicine has no known effect on the ability to drive vehicles or operate machinery.

MUCOTREIS 1.5 g granules for oral suspension contains

• sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine. It may be harmful to teeth.
• 165.6 mg of sodium (main component of table salt) per sachet. This corresponds to 8.28% of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

3. How to take MUCOTREIS

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
MUCOTREIS 1.5 g granules for oral suspension is indicated only for adult populations.
The recommended dose is one sachet twice daily, in the morning and evening.
Duration of treatment:
For acute respiratory problems: 8–10 days. For chronic conditions and recurrences: 10 days to 3 weeks, repeated several times per year.
Instructions for use:
Dissolve the contents of one sachet in half a glass of water and mix with a teaspoon.
Do not exceed the recommended doses.
If you take more MUCOTREIS than you should
Cases of overdose have not been reported. If you take an excessive amount of this medicine, you may experience stomach and intestinal problems.
In case of overdose, discontinue the medicine.
If you forget to take MUCOTREIS
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.
The following adverse reactions may occur at an unknown frequency (frequency cannot be estimated
from the available data):

• bronchial obstruction,
• stomach pain (gastralgia), nausea, diarrhea,
• gastrointestinal bleeding (in such cases, discontinue treatment and consult a doctor to establish appropriate therapy),
• dizziness,
• skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic cutaneous eruption (in such cases, discontinue treatment and consult a 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 MUCOTREIS

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 this medicine below 25°C. Keep in the original packaging to protect the medicine from moisture.

6. Package contents and other information

What MUCOTREIS 1.5 g granules for oral suspension contains

• The active substance is carbocisteine. Each sachet contains 1.5 g of carbocisteine.
• The other components are: sodium bicarbonate, citric acid, colloidal silica, apricot flavoring, sucrose, sodium saccharin.

Description of the appearance of MUCOTREIS and contents of the pack
MUCOTREIS 1.5 g granules for oral suspension is available in packs of 20 sachets.
Marketing Authorization Holder
ITC FARMA s.r.l., via Pier Luigi Nervi 164, 04100 Latina (LT), Italy
Manufacturer
ITC FARMA s.r.l., via Pontina 5 Km 29, 00071 Pomezia (RM), Italy

Patient information leaflet

MUCOTREIS 20 mg/ml children's 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 you.

• Keep this leaflet. You may need to read it again.
• If you would like further 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 a few days.

Contents of this leaflet:

1. What MUCOTREIS is and what it is used for
2. What you need to know before taking MUCOTREIS
3. How to take MUCOTREIS
4. Possible side effects
5. How to store MUCOTREIS
6. Package contents and other information

1. What MUCOTREIS is and what it is used for

MUCOTREIS 20 mg/ml paediatric syrup contains carbocisteine, a mucolytic agent used to facilitate the removal of mucus in acute and chronic respiratory tract diseases.
Consult your doctor if you do not feel better or feel worse after a few days.

2. What you need to know before taking MUCOTREIS

Do not take MUCOTREIS

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had a stomach or intestinal lesion (gastroduodenal ulcer);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”). Do not administer MUCOTREIS to children under 2 years of age (see section “Children”).

Warnings and Precautions
Talk to your doctor or pharmacist before taking MUCOTREIS.
During the first days of treatment, an increase in mucus secretion may occur, which subsequently decreases rapidly.
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 medications 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 (antitussives).

Children
MUCOTREIS must not be used in children under 2 years of age, as it may cause bronchial obstruction due to their limited ability to clear excess mucus (see section “Do not take MUCOTREIS”).

Other medicines and MUCOTREIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
Do not take MUCOTREIS during pregnancy and breastfeeding (see section 2).

Driving and using machines
No effects of this medicine on the ability to drive vehicles or operate machinery are known.

MUCOTREIS 20 mg/ml paediatric syrup contains

• Sucrose: If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine. It may be harmful to teeth.
• Methyl parahydroxybenzoate: May cause allergic reactions (including delayed reactions).
• Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per teaspoon, i.e., essentially ‘sodium-free’.

3. How to take MUCOTREIS

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Children aged between 2 and 5 years: the recommended dose is 1 teaspoonful 1-2 times daily.
Children over 5 years of age: the recommended dose is 1 teaspoonful 2-3 times daily, depending on age.
Do not exceed the recommended doses.

If you take more MUCOTREIS than you should
Cases of overdose have not been reported. If you take an excessive dose of this medicine, you may experience stomach and intestinal problems.
In case of overdose, discontinue the medicine.

If you forget to take MUCOTREIS
Do not take a double dose to make up for the forgotten 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.
The following side effects may occur with unknown frequency (frequency cannot be determined from the available data):

• bronchial obstruction,
• stomach pain (gastralgia), nausea, diarrhoea,
• gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy),
• dizziness,
• skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic cutaneous eruption (in such cases, discontinue treatment and consult your doctor to initiate 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 may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store MUCOTREIS

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 this medicine below 25°C. Keep in the original packaging to protect the medicine from moisture.

6. Package contents and other information

What MUCOTREIS 20 mg/ml paediatric syrup contains

• The active substance is carbocisteine. Each 1 ml of syrup contains 20 mg of carbocisteine.
• The other ingredients are: sodium hydroxide, methyl parahydroxybenzoate, sodium chloride, caramel flavour, sucrose, sweet orange essence, purified water.

Description of the appearance of MUCOTREIS and contents of the pack
MUCOTREIS 20 mg/ml paediatric syrup is available in a pack containing 1 bottle of 150 ml.

Marketing Authorization Holder
ITC FARMA s.r.l., via Pier Luigi Nervi 164, 04100 Latina (LT), Italy
Manufacturer
ITC FARMA s.r.l., via Pontina 5 Km 29, 00071 Pomezia (RM), Italy

Patient Information Leaflet

MUCOTREIS 50 mg/ml syrup for adults

Carbocysteine
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.

• 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 a few days.

Contents of this leaflet:

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

1. What MUCOTREIS is and what it is used for

MUCOTREIS 50 mg/ml syrup for adults contains carbocisteine, a mucolytic agent used to facilitate mucus elimination in acute and chronic respiratory tract diseases.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking MUCOTREIS

Do not take MUCOTREIS

• if you are allergic to carbocysteine or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had a stomach or intestinal lesion (gastroduodenal ulcer);
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and Precautions
Talk to your doctor or pharmacist before taking MUCOTREIS.
During the first days of treatment, an increase in mucus secretion may occur, which then rapidly decreases.
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 must not be used in combination with cough suppressants (antitussives).

Other medicines and MUCOTREIS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MUCOTREIS during pregnancy and breastfeeding (see section 2).

Driving and using machines
This medicine has no known effect on the ability to drive vehicles or operate machinery.

MUCOTREIS 50 mg/ml syrup for adults contains

• Sucrose If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may be harmful to teeth.
• Sodium This medicine contains 111 mg of sodium (the main component of table salt) per tablespoon. This is equivalent to approximately 6% of the maximum recommended daily dietary intake for an adult.
• Methyl parahydroxybenzoate May cause allergic reactions (including delayed-type reactions).

3. How to take MUCOTREIS

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
MUCOTREIS 50 mg/ml syrup for adults is indicated only for adult populations.
The recommended dose is 2–3 tablespoons per day. Your doctor may prescribe a higher dose depending on your health condition.
Duration of treatment:

• For acute respiratory problems: 8 to 10 days;
• For chronic conditions and recurrences: 10 days to 3 weeks, several times per year.

Do not exceed the recommended doses.
If you take more MUCOTREIS than you should
Overdose cases have not been reported. If you take an excessive dose of this medicine, you may experience stomach and intestinal problems.
In case of overdose, discontinue the medicine.
If you forget to take MUCOTREIS
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 experiences them.
The following side effects may occur with unknown frequency (frequency cannot be estimated from the available data):

• Bronchial obstruction,
• Stomach pain (gastralgia), nausea, diarrhoea,
• Gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to establish appropriate therapy),
• Dizziness,
• Skin irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic cutaneous eruption) (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, consult 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 MUCOTREIS

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 this medicine below 25°C. Keep in the original packaging to protect the medicine from moisture.

6. Package contents and other information

What MUCOTREIS 50 mg/ml syrup for adults contains

• The active substance is carbocisteine. 1 ml of syrup contains 50 mg of carbocisteine.
• The other components are: sodium hydroxide, methyl parahydroxybenzoate, sodium chloride, caramel flavour, sucrose, sweet orange essence, purified water.

Description of the appearance of MUCOTREIS and contents of the pack
MUCOTREIS 50 mg/ml syrup for adults is available in a pack containing 1 bottle of 150 ml.
Marketing Authorization Holder
ITC FARMA s.r.l., via Pier Luigi Nervi 164, 04100 Latina (LT), Italy
Manufacturer
ITC FARMA s.r.l., via Pontina 5 Km 29, 00071 Pomezia (RM), Italy