SOLMUCOL 600 mg Effervescent Tablet

Зміст інструкції

1. SOLMUCOL MUCOLITIC 100 mg granules for oral solution, 200 mg granules for oral solution
   1. What is SOLMUCOL MUCOLITIC and what is it used for
   2. What you need to know before taking SOLMUCOL MUCOLITIC
   3. How to take SOLMUCOL MUCOLITICO
   4. Possible side effects
   5. How to store SOLMUCOL MUCOLITICO
   6. Contents of the pack and other information
2. SOLMUCOL MUCOLITIC 100 mg orodispersible tablets, 200 mg orodispersible tablets
   1. What is SOLMUCOL MUCOLITIC and what is it used for?
   2. What you need to know before taking SOLMUCOL MUCOLITIC
   3. How to take SOLMUCOL MUCOLITICO
   4. Possible side effects
   5. How to store SOLMUCOL MUCOLITICO
   6. Contents of the pack and other information
3. SOLMUCOL MUCOLITIC 100 mg/5 ml syrup tropical and apricot flavour, strawberry and raspberry
   1. What is SOLMUCOL MUCOLITIC and what is it used for
   2. What you need to know before taking SOLMUCOL MUCOLITIC
   3. How to take SOLMUCOL MUCOLITICO
   4. Possible side effects
   5. How to store SOLMUCOL MUCOLITICO
   6. Contents of the pack and other information
4. SOLMUCOL MUCOLITICO 600 mg effervescent tablets
   1. What is SOLMUCOL MUCOLITIC and what is it used for
   2. What you need to know before taking SOLMUCOL MUCOLITIC
   3. How to take SOLMUCOL MUCOLITICO
   4. Possible side effects
   5. How to store SOLMUCOL MUCOLITICO
   6. Contents of the pack and other information

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

Acetylcysteine

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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet

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

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

SOLMUCOL MUCOLITIC contains acetylcysteine, an active ingredient belonging to the class of “mucolytics”, drugs that work by fluidifying the mucus of the respiratory tract (phlegm).
SOLMUCOL MUCOLITIC is used to make phlegm more fluid and therefore more easily
removable in patients who have respiratory diseasesacute or chronic (long-lasting).

2. What you need to know before taking SOLMUCOL MUCOLITIC

Do not take SOLMUCOL MUCOLITIC:

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

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 drugs that cause stomach problems (gastrolesive);
• you have asthma;
• you notice, following taking SOLMUCOL MUCOLITIC, symptoms such as nausea, vomiting, and allergic reactions such as changes in skin appearance associated with irritation or swelling of the skin (skin rash); the administration of the medicine in this case must be suspended.

Pay attention:

• when opening the sachet you may notice a very strong and pungent odor (sulfurous odor). This odor does not indicate alteration of the medicine but is characteristic of the active ingredient;
• if you have difficulty eliminating phlegm. Your doctor may advise you on some techniques to avoid the accumulation of secretions, for example postural drainage or bronchoaspiration;
• during treatment you may experience difficulty breathing (bronchospasm), especially if it has happened to you on other occasions or if you have asthma. If this should happen, immediately stop therapy with SOLMUCOL MUCOLITIC and consult your doctor.

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

• nitroglycerin, a drug used in heart disease. The use of this medicine together with SOLMUCOL MUCOLITIC may cause a decrease in blood pressure (hypotension) and the onset of headache. In this case, your doctor will monitor you closely;
• drugs used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLITIC at the same time as antibiotics; take the two medicines separately, waiting for an interval of at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it can reduce the effectiveness of SOLMUCOL MUCOLITIC.

Do not take SOLMUCOL MUCOLITIC together with:

• drugs that decrease secretions (e.g. anticholinergic drugs);
• cough suppressants (antitussives), because they can lead to an accumulation of mucus inside the bronchi.

SOLMUCOL MUCOLITIC may affect the results of some blood and urine tests, such as
the colorimetric dosage method for the determination of salicylates or the test for
determination of ketones in urine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding with breast milk, do not take this medicine
unless specifically indicated by your doctor.
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.

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

3. How to take SOLMUCOL MUCOLITICO

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask 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 diseases that last a long time (chronic respiratory disease forms), you should continue therapy for several months, as directed by your doctor.
The maximum dose is 600 mg per day. Do not exceed the recommended doses. See your doctor if you do
not notice any improvement or if your symptoms worsen.
Method of administration
Take SOLMUCOL MUCOLITICO orally, pour the contents of the sachet into half a glass of
water and stir until completely dissolved.
Do not mix other medicines into the SOLMUCOL MUCOLITICO solution.

If you take more SOLMUCOL MUCOLITICO than you should
In case of overdose, you may experience nausea, vomiting and diarrhea. In case of
accidental ingestion/intake of 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 a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor if you notice the following side effects during treatment with SOLMUCOL MUCOLITICO:

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, for example, patchy or widespread colour changes (rash), itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, whistling, buzzing, hissing or other persistent sounds in the ears);
• increased heart rate (tachycardia), decreases in blood pressure.

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

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

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

• bleeding (haemorrhage).

not known(the frequency of which cannot be estimated based on available data)

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

Stop taking SOLMUCOL MUCOLITICO and consult your doctor immediately ifyou 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 are rare;
• contraction of the bronchial muscles (bronchospasm) which manifests with shortness of breath, cough, shortness of breath and wheezing;
• a prolongation of bleeding time (reduction of platelet aggregation).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
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 MUCOLITICO

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 MUCOLITICO contains
The active ingredient is: acetylcysteine.
Each sachet of 100 and 200 mg granules contains: 100 and 200 mg of acetylcysteine.
The other ingredients are: xylitol, sodium saccharin, anhydrous colloidal silica, orange flavour (the orange flavour is composed of orange essential oil without terpenes, gum arabic, maltodextrin).

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

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

SOLMUCOL MUCOLITIC 100 mg orodispersible tablets, 200 mg orodispersible tablets

Acetylcysteine

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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet

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

1. What is SOLMUCOL MUCOLITIC and what is it used for?

SOLMUCOL MUCOLITIC contains acetylcysteine, an active ingredient belonging to the class of “mucolytics”, drugs that work by fluidifying the mucus of the respiratory tract (phlegm).
SOLMUCOL MUCOLITIC is used to make phlegm more fluid and therefore more easily
removable in patients who have respiratory diseasesacute or chronic (long-lasting).

2. What you need to know before taking SOLMUCOL MUCOLITIC

Do not take SOLMUCOL MUCOLITIC:

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

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 drugs that cause stomach problems (gastrolesive);
• you have asthma;
• you notice, following the intake of SOLMUCOL MUCOLITIC, symptoms such as nausea, vomiting, and allergic reactions such as changes in skin appearance associated with irritation or swelling of the skin (skin rash); the administration of the medicine in this case must be suspended.

Pay attention:

• when you open the tablet you may notice a very strong and pungent odor (sulfurous odor). This odor does not indicate alteration of the medicine but is characteristic of the active ingredient;
• if you have difficulty eliminating phlegm. Your doctor may advise you on some techniques to avoid the accumulation of secretions, for example postural drainage or bronchoaspiration;
• during treatment you may experience difficulty breathing (bronchospasm), especially if it has happened to you on other occasions or if you have asthma. If this should happen, immediately stop therapy with SOLMUCOL MUCOLITIC and consult your doctor.

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

• nitroglycerin, a drug used in heart disease. The use of this medicine together with SOLMUCOL MUCOLITIC can cause a decrease in blood pressure (hypotension) and the onset of headache. In this case, your doctor will monitor you closely;
• drugs used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLITIC at the same time as antibiotics; take the two medicines separately, waiting at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it can reduce the effectiveness of SOLMUCOL MUCOLITIC.

Do not take SOLMUCOL MUCOLITIC together with:

• drugs that decrease secretions (e.g. anticholinergic drugs);
• cough suppressants (antitussives), because they can lead to an accumulation of mucus inside the bronchi.

SOLMUCOL MUCOLITIC may affect the results of some blood and urine tests,
such as the colorimetric dosage method for the determination of salicylates or the test for
determining ketones in the urine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding with breast milk, do not take this
medicine unless specifically indicated by your doctor.
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.

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

Information on some excipients
SOLMUCOL MUCOLITIC 100 mg orodispersible tablets contains:

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

SOLMUCOL MUCOLITIC 200 mg orodispersible tablets contains:

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

3. How to take SOLMUCOL MUCOLITICO

Take this medicine following exactly the instructions in this leaflet or as indicated 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), to be taken 2-3 times a day, for 5-10 days.

Use in children

Children over 2 years of age: 100 mg (1 tablet of 100 mg), 2 to 4 times a day
(depending on age), for 5-10 days.
In case of respiratory diseases that last a long time (chronic respiratory disease forms), you should continue therapy for several months, as directed by
your doctor.
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 your symptoms worsen.
Method of use
Take SOLMUCOL MUCOLITICO orally, allowing the tablet to dissolve slowly in your mouth
without chewing.

If you take more SOLMUCOL MUCOLITICO than you should
In case of overdose, you may experience nausea, vomiting and diarrhea. In case of
accidental ingestion/administration of 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 a 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.
Inform your doctor if you experience any of the following side effects during treatment with SOLMUCOL MUCOLITICO:

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, for example, patchy or widespread colour changes (rash), itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, whistling, buzzing, 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);
• 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)

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

Stop taking SOLMUCOL MUCOLITICO 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 are rare;
• contraction of the bronchial muscles (bronchospasm) which manifests with shortness of breath, cough, shortness of breath and wheezing;
• a prolongation of bleeding time (reduction of platelet aggregation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 MUCOLITICO

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 MUCOLITICO contains
The active ingredient is: acetylcysteine.
SOLMUCOL MUCOLITICO 100 mg orodispersible tablets
Each 100 mg orodispersible tablet contains: 100 mg of acetylcysteine.
The other ingredients are: sodium bicarbonate, potassium bicarbonate, sorbitol, xylitol,
magnesium stearate, orange flavour (the orange flavour is composed of orange essential oil
without terpenes, gum arabic and maltodextrin).
SOLMUCOL MUCOLITICO 200 mg orodispersible tablets
Each 200 mg orodispersible tablet contains: 200 mg of acetylcysteine.
The other ingredients are: sodium bicarbonate, potassium bicarbonate, sorbitol, xylitol,
magnesium stearate, anhydrous colloidal silica, aspartame and lemon flavour.

Description of the appearance of SOLMUCOL MUCOLITICO and contents of the pack
SOLMUCOL MUCOLITICO 100 mg orodispersible tablets is available in packs containing
24 orodispersible tablets.
SOLMUCOL MUCOLITICO 200 mg orodispersible tablets is available in packs containing
24 orodispersible tablets.

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

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

Acetylcysteine

Read this leaflet carefully before you start 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if you feel worse.

Contents of this leaflet

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

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

SOLMUCOL MUCOLITIC contains acetylcysteine, an active ingredient belonging to the class of “mucolytics”, drugs that work by fluidifying the mucus of the respiratory tract (catarrh).
SOLMUCOL MUCOLITIC is used to make the catarrh more fluid and therefore more easily
removable in patients who have respiratory diseasesacute or chronic (long-lasting).

2. What you need to know before taking SOLMUCOL MUCOLITIC

Do not take SOLMUCOL MUCOLITIC:

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

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 medications that cause stomach problems (gastrolesive);
• you have asthma;
• you experience symptoms such as nausea, vomiting, and allergic reactions such as changes in skin appearance associated with irritation or swelling of the skin (skin rash) following taking SOLMUCOL MUCOLITIC; the medicine should be discontinued in this case.

Pay attention:

• when opening the bottle you may notice a very strong and pungent odor (sulfurous odor). This odor does not indicate alteration of the medicine but is characteristic of the active ingredient;
• if you have difficulty clearing the catarrh. Your doctor may advise you on techniques to avoid the accumulation of secretions, for example postural drainage or bronchoaspiration;
• during treatment you may experience difficulty breathing (bronchospasm), especially if it has happened to you on other occasions or if you have asthma. If this should happen, immediately stop therapy with SOLMUCOL MUCOLITIC and consult your doctor.

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

• nitroglycerin, a medicine used for heart disease. The use of this medicine together with SOLMUCOL MUCOLITIC may cause a decrease in blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely;
• medicines used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLITIC at the same time as antibiotics; take the two medicines separately, waiting at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it can reduce the effectiveness of SOLMUCOL MUCOLITIC.

Do not take SOLMUCOL MUCOLITIC together with:

• medicines that decrease secretions (e.g. anticholinergic drugs);
• cough suppressants (antitussives), because they can lead to an accumulation of mucus in the bronchi.

SOLMUCOL MUCOLITIC may affect the results of some blood and urine tests,
such as the colorimetric method for determining salicylates or the test for
determining ketones in the urine.

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

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

Information on some excipients
SOLMUCOL MUCOLITIC 100 mg/5 ml syrup contains:

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

3. How to take SOLMUCOL MUCOLITICO

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

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

Use in children

Children over 2 years of age: 5 ml of syrup (equivalent to 100 mg), from 2 to 4 times a day
(depending on age), for 5-10 days.
In case of respiratory diseases that last a long time (chronic respiratory disease forms), you should continue therapy for several months, as directed by your doctor.
The maximum dose is 30 ml of syrup (equivalent to 600 mg) per day. Do not exceed the recommended doses. If you do not notice improvements or if your symptoms worsen, consult your doctor.

Method of use
Take SOLMUCOL MUCOLITICO orally.
To reconstitute the syrup:

• tear off the guarantee seal and screw the cap clockwise until the powder falls 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 found in the package. Then, carefully screw the cap back on.

Do not mix other medicines into the syrup.

If you take more SOLMUCOL MUCOLITICO than you should
In case of overdose, you may experience nausea, vomiting and diarrhoea. In case of
accidental ingestion/administration of 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 a missed dose.
If you have any questions about using this medicine, ask 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 the following side effects during treatment with SOLMUCOL MUCOLITICO:

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, for example, patchy or widespread colour changes (rash), itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, whistling, buzzing, hissing or other persistent sounds in the ears);
• increased heart rate (tachycardia), decreases in blood pressure.

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

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

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

• bleeding (haemorrhage).

not known(frequency cannot be estimated from available data)

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

Stop taking SOLMUCOL MUCOLITICO and consult your doctor immediately ifyou experience:

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson syndrome, Lyell syndrome). These side effects are rare;
• contraction of the bronchial muscles (bronchospasm) which manifests with shortness of breath, cough, wheezing and gasping;
• a prolongation of bleeding time (reduction of platelet aggregation).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 MUCOLITICO

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

Description of the appearance of SOLMUCOL MUCOLITICO and contents of the pack
SOLMUCOL MUCOLITICO 100 mg/ 5 ml syrup tropical and apricot flavour is available in a bottle
of 180 ml, equipped with a measuring cup.
SOLMUCOL MUCOLITICO 100 mg/ 5 ml syrup strawberry and raspberry flavour is available in a bottle
of 90 ml, equipped with a measuring cup.

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

SOLMUCOL MUCOLITICO 600 mg effervescent tablets

Acetylcysteine
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 told you to.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet

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

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

SOLMUCOL MUCOLITIC contains acetylcysteine, an active ingredient belonging to the class of “mucolytics”, drugs that work by fluidifying the mucus of the respiratory tract (catarrh).
SOLMUCOL MUCOLITIC is used to make the catarrh more fluid and therefore more easily
removable in patients who have acute or long-lasting (chronic) respiratory diseases.

2. What you need to know before taking SOLMUCOL MUCOLITIC

Do not take SOLMUCOL MUCOLITIC:

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

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

• you have or have had a stomach or duodenal ulcer, especially if you are taking medications that cause stomach problems (gastrolesive);
• you have asthma;
• you experience symptoms such as nausea, vomiting, and allergic reactions such as changes in skin appearance associated with skin irritation or swelling (skin rash) following taking SOLMUCOL MUCOLITIC; the administration of the medicine should be discontinued in this case.

Pay attention:

• when you open the tube containing the tablets, you may notice a very strong and pungent odor (sulfurous odor). This odor does not indicate alteration of the medicine but is characteristic of the active ingredient;
• if you have difficulty eliminating catarrh. Your doctor may advise you on some techniques to avoid the accumulation of secretions, for example postural drainage or bronchoaspiration;
• during treatment you may experience difficulty breathing (bronchospasm), especially if it has happened to you on other occasions or if you have asthma. If this should happen, immediately stop therapy with SOLMUCOL MUCOLITIC and consult your doctor.

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

• nitroglycerin, a drug used for heart disease. The use of this medicine together with SOLMUCOL MUCOLITIC may cause a decrease in blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely;
• medicines used against infections (antibiotics). Avoid taking SOLMUCOL MUCOLITIC at the same time as antibiotics; take the two medicines separately, waiting at least two hours;
• activated charcoal, used to treat digestive disorders or to eliminate intestinal gas (flatulence), because it may reduce the effectiveness of SOLMUCOL MUCOLITIC.

Do not take SOLMUCOL MUCOLITIC together with:

• medicines that decrease secretions (e.g. anticholinergic drugs);
• cough suppressants (antitussives), because they can lead to an accumulation of mucus inside the bronchi.

SOLMUCOL MUCOLITIC may affect the results of some blood and urine tests, such as
the colorimetric dosage method for the determination of salicylates or the test for
the determination of ketones in the urine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding with breast milk, do not take this medicine
unless specifically indicated by your doctor.
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and operating machinery
No information is available to establish whether SOLMUCOL MUCOLITIC impairs
the ability to drive vehicles and operate machinery.
Information on some excipients
SOLMUCOL MUCOLITIC 600 mg effervescent tablets contains:

• approximately 194 mg of sodium per dose. This should be taken into consideration in people with reduced kidney function or who are following a low-sodium diet.

3. How to take SOLMUCOL MUCOLITICO

Take this medicine following exactly as indicated 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 600 mg, 1 time a day, preferably in the evening, for 5-10 days.
Use in children

Children over 2 years of age: ask your doctor or pharmacist for advice, as
lower dosages of SOLMUCOL MUCOLITICO are available for use in such patients.
In case of respiratory diseases that last a long time (chronic respiratory disease
forms), you should continue the therapy for several months, as directed by your doctor.
The maximum dose is 600 mg per day. Do not exceed the recommended doses. See your doctor if you
do not notice any improvement or if you notice a worsening of symptoms.
Method of use
Take SOLMUCOL MUCOLITICO orally, allowing one tablet to 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 diarrhea. In case of
accidental ingestion/intake of 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 a missed dose.
If you have any further questions on the use of this medicine, ask 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 during treatment with SOLMUCOL MUCOLITICO:
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, for example patchy or widespread colour changes (rash), itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, whistling, buzzing, hissing or other persistent noises in the ears);
• increased heart rate (tachycardia), decreases in blood pressure.

rare (may affect up to 1 in 1,000)

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

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

• bleeding (haemorrhage).

not known (frequency cannot be estimated from available data)

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

Stop taking SOLMUCOL MUCOLITICO 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 are rare;
• contraction of the bronchial muscles (bronchospasm) which manifests with shortness of breath, cough, wheezing and gasping;
• a prolongation of bleeding time (reduction of platelet aggregation)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 MUCOLITICO

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 humidity.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 MUCOLITICO contains
The active ingredient is: acetylcysteine.
SOLMUCOL MUCOLITICO 600 mg effervescent tablets
Each 600 mg effervescent tablet contains: 600 mg of acetylcysteine.
The other ingredients are: citric acid, maltodextrin, sodium bicarbonate, leucine, sodium saccharin
and orange flavour
Description of the appearance of SOLMUCOL MUCOLITICO and contents of the pack
SOLMUCOL MUCOLITICO is available in a carton containing 2 tubes of 15 tablets each.
Marketing Authorisation 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