Solmucol mucolytic

Patient Information Leaflet

SOLMUCOL MUCOLYTIC 100 mg granules for oral solution, 200 mg granules for oral solution

Acetylcysteine
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 advised.

• 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 your symptoms worsen.

Contents of this leaflet

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

1. What SOLMUCOL MUCOLYTIC is and what it is used for

SOLMUCOL MUCOLYTIC contains acetylcysteine, an active substance belonging to the class of
"mucolytics", drugs that work by liquefying mucus in the respiratory tract (phlegm).
SOLMUCOL MUCOLYTIC is used to make phlegm more fluid and therefore easier to eliminate in patients suffering from respiratory tract diseases, either acute or chronic.

2. What you need to know before taking SOLMUCOL MUCOLITIC

Do not take SOLMUCOL MUCOLITIC:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding, unless otherwise directed by your doctor (see section “Pregnancy, breastfeeding and fertility”);
• for the treatment of respiratory tract diseases in children under 2 years of age, since mucolytics such as SOLMUCOL MUCOLITIC may cause obstruction of the airways.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLITIC if:

• you have or have had a stomach or duodenal ulcer, especially if you are taking medicines that may cause stomach problems (gastrolesive agents);
• you have asthma;
• after taking SOLMUCOL MUCOLITIC, you experience symptoms such as nausea, vomiting, or allergic reactions such as skin changes associated with irritation or swelling of the skin (cutaneous rash); in such cases, administration of the medicine must be discontinued.

Take care:

• when opening the sachet, you may notice a very strong, pungent odor (sulfurous odor). This odor does not indicate deterioration of the medicine but is characteristic of the active substance;
• if you have difficulty eliminating phlegm. Your doctor may recommend certain techniques to prevent accumulation of secretions, such as postural drainage or bronchoaspiration;
• during treatment, you may experience breathing difficulties (bronchospasm), especially if you have experienced this before or if you have asthma. If this occurs, stop treatment with SOLMUCOL MUCOLITIC immediately and consult your doctor.

Other medicines and SOLMUCOL MUCOLITIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using:

• nitroglycerin, a medicine used for heart diseases. Taking this medicine together with SOLMUCOL MUCOLITIC may cause a reduction in blood pressure (hypotension) and the onset of headache (cephalalgia). In this case, your doctor will monitor you closely;
• medicines used to treat infections (antibiotics). Avoid taking SOLMUCOL MUCOLITIC at the same time as antibiotics; take the two medicines separately, leaving an interval of at least two hours;
• activated charcoal, used to treat digestive disorders or to reduce intestinal gas (meteorism), as it may reduce the effectiveness of SOLMUCOL MUCOLITIC.

Do not take SOLMUCOL MUCOLITIC together with:

• medicines that reduce secretions (e.g. anticholinergic drugs);
• medicines that suppress cough (antitussives), as they may lead to mucus accumulation in the bronchi.

SOLMUCOL MUCOLITIC may affect the results of certain blood and urine tests, such as the colorimetric assay method for salicylate determination or the test for detecting ketones in urine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, do not take this medicine unless specifically instructed by your doctor.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
There is no available information to determine whether SOLMUCOL MUCOLITIC impairs the ability to drive vehicles or operate machinery.

3. How to take SOLMUCOL 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.
Adults
The recommended dose is 200 mg (1 sachet of 200 mg or 2 sachets of 100 mg), to be taken 2–3 times a day for 5–10 days.
Use in children
Children over 2 years of age: 100 mg (1 sachet of 100 mg), to be taken 2 to 4 times a day (depending on age), for 5–10 days.
In case of respiratory tract diseases that have been present for a long time (chronic respiratory conditions), treatment should continue for several months, according to your doctor's instructions.
The maximum dose is 600 mg per day. Do not exceed the recommended doses. Consult your doctor if you do not notice any improvement or if symptoms worsen.
Instructions for use
Take SOLMUCOL MUCOLYTIC orally. Empty the contents of the sachet into half a glass of water and stir until completely dissolved.
Do not mix other medicines into the SOLMUCOL MUCOLYTIC solution.
If you take more SOLMUCOL MUCOLYTIC than you should
In case of overdose, you may experience nausea, vomiting, and diarrhoea. If an excessive dose is accidentally ingested, consult a doctor or go to the nearest hospital, as appropriate measures may be required.
If you forget to take SOLMUCOL MUCOLYTIC
Do not take a double dose to make up for a missed dose.
If you have any questions 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.
Inform your doctor if you experience any of the following side effects during treatment with SOLMUCOL MUCOLYTIC:

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting, diarrhoea, inflammation of the mouth (stomatitis), abdominal pain;
• more or less sudden appearance of skin lesions, such as discoloured spots or widespread rash, itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, buzzing, or other persistent noises in the ears);
• increased heart rate (tachycardia), decreased blood pressure.

Rare (may affect up to 1 in 1,000 people)

• indigestion (dyspepsia);
• difficulty breathing (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)

• bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

• facial swelling (facial oedema);
• bronchial obstruction.

Stop taking SOLMUCOL MUCOLYTIC and contact your doctor immediately if you experience:

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson Syndrome, Lyell's Syndrome). These side effects occur rarely;
• bronchial muscle contraction (bronchospasm), manifesting as breathlessness, cough, shortness of breath and wheezing;
• prolonged bleeding time (reduced platelet aggregation).

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: http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLMUCOL MUCOLYTIC

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 SOLMUCOL MUCOLYTIC contains
The active substance is: acetylcysteine.
Each 100 mg and 200 mg sachet of granules contains: 100 mg and 200 mg of acetylcysteine.
The other components are: xylitol, sodium saccharin, anhydrous colloidal silica, orange flavour (the orange flavour consists of orange essential oil without terpenes, arabic gum, maltodextrin).

Description of the appearance of SOLMUCOL MUCOLYTIC and contents of the pack
SOLMUCOL MUCOLYTIC 100 mg granules for oral solution is available in packs containing 10 sachets.
SOLMUCOL MUCOLYTIC 200 mg granules for oral solution is available in packs containing 30 sachets.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2 - 26900 Lodi (LO)

Patient information leaflet

SOLMUCOL MUCOLYTIC 100 mg orodispersible tablets, 200 mg orodispersible tablets

Acetylcysteine
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 of the 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 your symptoms worsen.

Contents of this leaflet

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

1. What SOLMUCOL MUCOLYTIC is and what it is used for

SOLMUCOL MUCOLYTIC contains acetylcysteine, an active substance belonging to the class of
"mucolytics", drugs that work by liquefying mucus in the respiratory tract (phlegm).
SOLMUCOL MUCOLYTIC is used to make phlegm more fluid and therefore easier to eliminate in patients suffering from respiratory tract diseases, either acute or long-lasting (chronic).

2. What you need to know before taking SOLMUCOL MUCOLITICO

Do not take SOLMUCOL MUCOLITICO:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding, unless otherwise directed by your doctor (see section “Pregnancy, breastfeeding and fertility”);
• for the treatment of respiratory tract diseases in children under 2 years of age, as mucolytics such as SOLMUCOL MUCOLITICO may cause obstruction of the airways.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLITICO if:

• you have or have had a stomach or duodenal ulcer, especially if you are taking medicines that can cause stomach problems (gastrolesive drugs);
• you have asthma;
• you experience, after taking SOLMUCOL MUCOLITICO, symptoms such as nausea, vomiting, or allergic reactions such as changes in skin appearance associated with irritation or swelling of the skin (cutaneous rash); in such cases, administration of the medicine must be discontinued.

Be careful:

• when opening the tablet, you may notice a very strong, pungent odour (sulfurous odour). This odour does not indicate that the medicine is spoiled, but is characteristic of the active substance;
• if you have difficulty in eliminating phlegm. Your doctor may recommend certain techniques to prevent accumulation of secretions, such as postural drainage or bronchial suction;
• during treatment you may experience breathing difficulties (bronchospasm), particularly if this has occurred previously or if you have asthma. If this occurs, stop treatment with SOLMUCOL MUCOLITICO immediately and consult your doctor.

Other medicines and SOLMUCOL MUCOLITICO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using:

• nitroglycerin, a medicine used for heart diseases. Taking this medicine together with SOLMUCOL MUCOLITICO may cause a reduction in blood pressure (hypotension) and the onset of headache (cephalalgia). In this case, your doctor will monitor you closely;
• medicines used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLITICO at the same time as antibiotics; take the two medicines separately, leaving an interval of at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (meteorism), as it may reduce the effectiveness of SOLMUCOL MUCOLITICO.

Do not take SOLMUCOL MUCOLITICO together with:

• medicines that reduce secretions (e.g. anticholinergic drugs);
• medicines that suppress cough (antitussives), as they may lead to accumulation of mucus within the bronchi.

SOLMUCOL MUCOLITICO may affect the results of certain blood and urine tests,
such as the colorimetric assay method for salicylate determination or the test for
urinary ketone determination.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, do not take this
medicine unless specifically instructed by your doctor.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before
taking this medicine.

Driving and using machines
There is no available information to determine whether SOLMUCOL MUCOLITICO impairs the
ability to drive vehicles or operate machinery.

Information on certain excipients
SOLMUCOL MUCOLITICO 100 mg orodispersible tablets contain:

• sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

SOLMUCOL MUCOLITICO 200 mg orodispersible tablets contain:

• sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• aspartame. This medicine contains a source of phenylalanine. It may be harmful to you if you have phenylketonuria.

3. How to take SOLMUCOL 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.

Adults
The recommended dose is 200 mg (1 tablet of 200 mg or 2 tablets of 100 mg), taken 2–3 times daily for 5–10 days.

Use in children
Children over 2 years of age: 100 mg (1 tablet of 100 mg), 2 to 4 times daily (according to age), for 5–10 days.

In case of long-standing respiratory tract diseases (chronic respiratory conditions), treatment may need to continue for several months, according to your doctor's instructions.

The maximum daily dose is 600 mg. Do not exceed the recommended doses. Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Instructions for use
Take SOLMUCOL MUCOLITICO by mouth. Allow the tablet to dissolve slowly in the mouth without chewing.

If you take more SOLMUCOL MUCOLITICO than you should
In case of overdose, you may experience nausea, vomiting, and diarrhoea. If you accidentally ingest or take an excessive dose of SOLMUCOL MUCOLITICO, consult your doctor or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to take SOLMUCOL 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 everyone experiences them.
Inform your doctor if you experience any of the following side effects while taking SOLMUCOL MUCOLYTIC:

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting, diarrhoea, inflammation of the mouth (stomatitis), abdominal pain;
• sudden or gradual appearance of skin lesions, such as discoloured spots or widespread rash, itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, buzzing, whistling, or other persistent noises in the ears);
• increased heart rate (tachycardia), decreased blood pressure.

Rare (may affect up to 1 in 1,000 people)

• indigestion (dyspepsia);
• difficulty breathing (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)

• bleeding (haemorrhage).

Not known (frequency cannot be estimated from available data)

• facial swelling (oedema);
• bronchial obstruction.

Stop taking SOLMUCOL MUCOLYTIC and contact your doctor immediately if you experience:

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson Syndrome, Lyell's Syndrome). These side effects occur rarely;
• bronchial muscle constriction (bronchospasm) causing breathlessness, cough, shortness of breath and wheezing;
• prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects
If you experience any side effects, 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:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLMUCOL MUCOLYTIC

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What SOLMUCOL MUCOLYTIC contains
The active substance is: acetylcysteine.
SOLMUCOL MUCOLYTIC 100 mg effervescent tablets
Each 100 mg effervescent tablet contains: 100 mg of acetylcysteine.
The other components are: sodium bicarbonate, potassium bicarbonate, sorbitol, xylitol,
magnesium stearate, orange flavour (the orange flavour consists of terpene-free orange essential oil,
arabic gum and maltodextrin).
SOLMUCOL MUCOLYTIC 200 mg effervescent tablets
Each 200 mg effervescent tablet contains: 200 mg of acetylcysteine.
The other components are: sodium bicarbonate, potassium bicarbonate, sorbitol, xylitol,
magnesium stearate, anhydrous colloidal silica, aspartame and lemon flavour.

Description of the appearance of SOLMUCOL MUCOLYTIC and pack contents
SOLMUCOL MUCOLYTIC 100 mg effervescent tablets are available in a pack containing 24 effervescent tablets.
SOLMUCOL MUCOLYTIC 200 mg effervescent tablets are available in a pack containing 24 effervescent tablets.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2 - 26900 Lodi (LO)

Patient information leaflet

SOLMUCOL MUCOLYTIC 100 mg/5 ml oral syrup, tropical and apricot, strawberry and raspberry flavour

Acetylcysteine
Please read this entire 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 your symptoms worsen.

Contents of this leaflet

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

1. What SOLMUCOL MUCOLYTIC is and what it is used for

SOLMUCOL MUCOLYTIC contains acetylcysteine, an active substance belonging to the class of "mucolytics", drugs that work by liquefying mucus in the respiratory tract (sputum).
SOLMUCOL MUCOLYTIC is used to make sputum more fluid and therefore easier to eliminate in patients suffering from respiratory tract diseases, either acute or chronic.

2. What you need to know before taking SOLMUCOL MUCOLYTIC

Do not take SOLMUCOL MUCOLYTIC:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding, unless otherwise directed by your doctor (see section “Pregnancy, breastfeeding and fertility”);
• for the treatment of respiratory tract diseases in children under 2 years of age, since mucolytics such as SOLMUCOL MUCOLYTIC may cause obstruction of the airways.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLYTIC if:

• you have or have had a stomach or duodenal ulcer, especially if you are taking medicines that may cause stomach problems (gastrolesive agents);
• you have asthma;
• you experience after taking SOLMUCOL MUCOLYTIC symptoms such as nausea, vomiting, or allergic reactions such as skin changes associated with irritation or swelling of the skin (cutaneous rash); in this case, administration of the medicine must be discontinued.

Take care:

• when opening the bottle, you may notice a strong, pungent odor (sulfurous odor). This odor does not indicate deterioration of the medicine but is characteristic of the active substance;
• if you have difficulty eliminating phlegm. Your doctor may recommend certain techniques to prevent accumulation of secretions, for example postural drainage or bronchoaspiration;
• during treatment you may experience breathing difficulties (bronchospasm), especially if this has occurred before on other occasions or if you have asthma. If this happens, stop treatment with SOLMUCOL MUCOLYTIC immediately and consult your doctor.

Other medicines and SOLMUCOL MUCOLYTIC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using:

• nitroglycerin, a medicine used for heart diseases. Using this medicine together with SOLMUCOL MUCOLYTIC may cause a reduction in blood pressure (hypotension) and the onset of headache (cephalalgia). In this case, your doctor will monitor you closely;
• medicines used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLYTIC at the same time as antibiotics; take the two medicines separately, leaving an interval of at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (meteorism), as it may reduce the effectiveness of SOLMUCOL MUCOLYTIC.

Do not take SOLMUCOL MUCOLYTIC together with:

• medicines that reduce secretions (e.g. anticholinergic drugs);
• medicines that suppress cough (antitussives), as they may lead to accumulation of mucus inside the bronchi.

SOLMUCOL MUCOLYTIC may affect the results of certain blood and urine tests,
such as the colorimetric assay method for salicylate measurement or the test for
urinary ketone detection.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, do not take this
medicine unless specifically instructed by your doctor.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before
taking this medicine.
Driving and using machines
There is no available information to determine whether SOLMUCOL MUCOLYTIC impairs the
ability to drive vehicles or operate machinery.
Information about certain excipients
SOLMUCOL MUCOLYTIC 100 mg/5 ml syrup contains:

• maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take SOLMUCOL MUCOLYTIC

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.

Adults
The recommended dose is 10 ml of syrup (equivalent to 200 mg), 2–3 times daily for 5–10 days.

Use in children
Children over 2 years of age: 5 ml of syrup (equivalent to 100 mg), 2 to 4 times daily (depending on age), for 5–10 days.

In case of long-standing respiratory tract diseases (chronic respiratory conditions), treatment should continue for several months, according to your doctor's instructions.

The maximum dose is 30 ml of syrup (equivalent to 600 mg) per day. Do not exceed the recommended doses. Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Instructions for use
Take SOLMUCOL MUCOLYTIC orally.

To reconstitute the syrup:

• Tear the security seal and screw the cap clockwise until the powder drops into the bottle;
• Shake vigorously until the powder is completely dissolved and a homogeneous solution is obtained;
• To take the syrup, unscrew the cap and pour the dose into the measuring cup provided in the package. Then, carefully rescrew the cap.

Do not mix other medicines with the syrup.

If you take more SOLMUCOL MUCOLYTIC than you should
In case of overdose, you may experience nausea, vomiting, and diarrhoea. If an excessive dose of SOLMUCOL MUCOLYTIC is accidentally ingested or taken, consult your doctor or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to take SOLMUCOL 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.
Inform your doctor if you experience any of the following side effects while taking SOLMUCOL MUCOLYTIC:

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting, diarrhoea, inflammation of the mouth (stomatitis), abdominal pain;
• sudden or gradual appearance of skin lesions, such as discoloured spots or widespread rash, itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, buzzing, whistling or other persistent noises in the ears);
• increased heart rate (tachycardia), decrease in blood pressure.

Rare (may affect up to 1 in 1,000 people)

• indigestion (dyspepsia);
• difficulty in breathing (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)

• bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

• swelling (oedema) of the face;
• bronchial obstruction.

Stop taking SOLMUCOL MUCOLYTIC and consult your doctor immediately if you experience:

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson Syndrome, Lyell's Syndrome). These side effects occur rarely;
• bronchial muscle contraction (bronchospasm) causing breathlessness, cough, shortness of breath and wheezing;
• prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects
If you get any side effects, 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: http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLMUCOL MUCOLYTIC

Keep this medicine out of the sight and reach of children.
Store below 25°C. Once reconstituted and opened, the syrup must be used within 20 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 SOLMUCOL MUCOLYTIC contains
The active substance is: acetylcysteine.
SOLMUCOL MUCOLYTIC 100 mg/5 ml tropical and apricot flavoured syrup
Each 5 ml of syrup contains: 100 mg of acetylcysteine.
The other components are: sodium citrate, sodium benzoate (E211), potassium sorbate (E202), sodium edetate, tropical flavouring, apricot flavouring, maltitol syrup, purified water.
SOLMUCOL MUCOLYTIC 100 mg/5 ml strawberry and raspberry flavoured syrup
Each 5 ml of syrup contains: 100 mg of acetylcysteine.
The other components are: sodium citrate, sodium benzoate (E211), potassium sorbate (E202), sodium edetate, strawberry flavouring, raspberry flavouring, maltitol syrup, purified water.

Description of the appearance of SOLMUCOL MUCOLYTIC and contents of the pack
SOLMUCOL MUCOLYTIC 100 mg/5 ml tropical and apricot flavoured syrup is available in a 180 ml bottle, supplied with a dosing cup.
SOLMUCOL MUCOLYTIC 100 mg/5 ml strawberry and raspberry flavoured syrup is available in a 90 ml bottle, supplied with a dosing cup.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2 - 26900 Lodi (LO)

Package leaflet: information for the patient

SOLMUCOL MUCOLYTIC 600 mg effervescent tablets

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

Contents of this leaflet

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

1. What SOLMUCOL MUCOLYTIC is and what it is used for

SOLMUCOL MUCOLYTIC contains acetylcysteine, an active substance belonging to the class of "mucolytics", drugs that work by liquefying mucus in the respiratory tract (phlegm).
SOLMUCOL MUCOLYTIC is used to make phlegm more fluid and therefore easier to eliminate in patients suffering from acute respiratory tract diseases or those that are long-lasting (chronic).

2. What you need to know before taking SOLMUCOL MUCOLYTIC

Do not take SOLMUCOL MUCOLYTIC:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding, unless otherwise directed by your doctor (see section “Pregnancy, breastfeeding and fertility”);
• for the treatment of respiratory tract diseases in children under 2 years of age, since mucolytics such as SOLMUCOL MUCOLYTIC may cause obstruction of the airways.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLYTIC if:

• you have or have had a stomach or duodenal ulcer, especially if you are taking medicines that may cause stomach problems (gastrolesive drugs);
• you have asthma;
• after taking SOLMUCOL MUCOLYTIC, you experience symptoms such as nausea, vomiting, or allergic reactions such as changes in skin appearance associated with irritation or swelling of the skin (cutaneous rash); in such cases, administration of the medicine must be discontinued.

Take care:

• when opening the tube containing the tablets, you may notice a very strong, pungent odor (sulfurous odor). This odor does not indicate deterioration of the medicine but is characteristic of the active substance;
• if you have difficulty eliminating phlegm. Your doctor may recommend certain techniques to prevent accumulation of secretions, such as postural drainage or bronchoaspiration;
• during treatment, you may experience breathing difficulties (bronchospasm), especially if this has occurred previously or if you have asthma. If this happens, stop treatment with SOLMUCOL MUCOLYTIC immediately and consult your doctor.

Other medicines and SOLMUCOL MUCOLYTIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are using:

• nitroglycerin, a medicine used for heart conditions. Taking this medicine together with SOLMUCOL MUCOLYTIC may cause a drop in blood pressure (hypotension) and headache (cephalalgia). In such cases, your doctor will monitor you closely;
• medicines used to treat infections (antibiotics). Avoid taking SOLMUCOL MUCOLYTIC at the same time as antibiotics; take the two medicines separately, leaving an interval of at least two hours;
• activated charcoal, used to treat digestive disorders or to reduce intestinal gas (flatulence), as it may reduce the effectiveness of SOLMUCOL MUCOLYTIC.

Do not take SOLMUCOL MUCOLYTIC together with:

• medicines that reduce secretions (e.g. anticholinergic drugs);
• medicines that suppress cough (antitussives), as they may lead to mucus accumulation in the bronchi.

SOLMUCOL MUCOLYTIC may affect the results of certain blood and urine tests, such as the colorimetric assay method for salicylate determination or the test for detecting ketones in urine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, do not take this medicine unless specifically instructed by your doctor.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
There is no available information to determine whether SOLMUCOL MUCOLYTIC impairs the ability to drive vehicles or operate machinery.

Information about certain excipients
SOLMUCOL MUCOLYTIC 600 mg effervescent tablets contain:

• approximately 194 mg of sodium per dose. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.

3. How to take SOLMUCOL MUCOLITICO

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults
The recommended dose is 600 mg once daily, preferably in the evening, for 5–10 days.
Use in children
Children over 2 years of age: consult your doctor or pharmacist, as lower doses of SOLMUCOL MUCOLITICO are available and suitable for these patients.
In case of long-standing respiratory tract diseases (chronic respiratory conditions), treatment may need to continue for several months, according to your doctor's instructions.
The maximum dose is 600 mg per day. Do not exceed the recommended doses. Consult your doctor if you do not notice any improvement or if symptoms worsen.
Instructions for use
Take SOLMUCOL MUCOLITICO orally. Let one tablet dissolve in half a glass of water, stirring if necessary with a teaspoon.
If you take more SOLMUCOL MUCOLITICO than you should
In case of overdose, you may experience nausea, vomiting, and diarrhoea. If you accidentally ingest/absorb an excessive dose of SOLMUCOL MUCOLITICO, consult your doctor or go to the nearest hospital immediately, as appropriate measures may be required.
If you forget to take SOLMUCOL MUCOLITICO
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.
Inform your doctor if you notice any of the following side effects during treatment with SOLMUCOL MUCOLYTIC:

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting, diarrhoea, mouth inflammation (stomatitis), abdominal pain;
• more or less sudden appearance of skin lesions, for example discoloured spots or widespread rash, itching and urticaria, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, buzzing, whistling, hissing or other persistent sounds in the ears);
• increased heart rate (tachycardia), decreased blood pressure.

Rare (may affect up to 1 in 1,000 people)

• indigestion (dyspepsia);
• breathing difficulty (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)

• bleeding (haemorrhage).

Not known (frequency cannot be estimated from the available data)

• facial swelling (oedema);
• bronchial obstruction.

Stop taking SOLMUCOL MUCOLYTIC and consult your doctor immediately if you experience:

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blister formation (e.g. Stevens-Johnson Syndrome, Lyell’s Syndrome). These side effects occur rarely;
• bronchial muscle contraction (bronchospasm) causing breathlessness, cough, shortness of breath and wheezing;
• prolonged bleeding time (reduced platelet aggregation).

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:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLMUCOL MUCOLYTIC

Keep this medicine out of the sight and reach of children.
No special temperature conditions are required for storage. Keep the tube tightly closed to protect it from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 SOLMUCOL MUCOLITIC contains
The active substance is: acetylcysteine.
SOLMUCOL MUCOLITIC 600 mg effervescent tablets
Each 600 mg effervescent tablet contains: 600 mg of acetylcysteine.
The other components are: citric acid, maltodextrin, sodium bicarbonate, leucine, sodium saccharin and orange flavour.

Description of the appearance of SOLMUCOL MUCOLITIC and pack contents
SOLMUCOL MUCOLITIC is available in a carton containing 2 tubes of 15 tablets each.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2 - 26900 Lodi (LO)

Manufacturer
E-Pharma Trento S.p.A. Frazione Ravina, Via Provina, 2, 38123 - Trento TN - Italy