Mucosolvan

Package leaflet: Information for the user

MUCOSOLVAN 60 mg granules for oral solution

Ambroxol
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use 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, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 2 weeks of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by liquefying mucus and facilitating
its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic
diseases of the bronchi and lungs (i.e. in the presence of cough and when there is difficulty in
expelling mucus from the bronchi due to increased or thickened mucus).

2. What you need to know before taking Mucosolvan

Do not take Mucosolvan

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease;
• in case of rare hereditary conditions of intolerance to one of the excipients (see section 2, “Mucosolvan granules contain sorbitol”). The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2, “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mucosolvan:

• if you have or have had stomach and/or intestinal lesions (peptic ulcer).

Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions could be symptoms of severe skin disorders characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Additionally, in the early stages of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you may experience non-specific symptoms resembling those of influenza, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold remedies might be restarted inappropriately.

Children
Do not give this medicine to children/adolescents aged between 0 and 18 years.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, following administration of ambroxol, concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased.

Mucosolvan with food and drink
You may take Mucosolvan either on an empty or full stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

• If you are in the first 3 months of pregnancy, use of Mucosolvan is not recommended (see section 2, “Do not take Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• If you are breastfeeding, use of Mucosolvan is not recommended (see section 2, “Do not take Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan oral granules contain sorbitol and sodium
This medicine contains 2.9 g of sorbitol per sachet, corresponding to 5.8 g of sorbitol per maximum daily dose, equivalent to 116 mg/kg. Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially “sodium-free”.

3. How to use Mucosolvan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 1 sachet twice daily.
Caution: Do not exceed the recommended dose without medical advice.
Dissolve the contents of one sachet of granules in about half a glass of water, tea, or fruit juice.
You may use Mucosolvan even if you have diabetes. Do not use Mucosolvan for longer than a short-term treatment (no more than 2 weeks) without consulting your doctor.
Consult your doctor if the condition recurs, if you have noticed any recent changes in its characteristics, or if symptoms worsen or do not improve.
If you take more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the missed dose.
If you stop using Mucosolvan
If you have any doubts about using 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.
The following side effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea, taste disturbance (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia);
  uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty digesting (dyspepsia), dry mouth;
  rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat;
  not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), heartburn (pyrosis).

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mucosolvan

This medicine does not require any special storage conditions.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mucosolvan contains

• The active substance is ambroxol hydrochloride 60 mg, equivalent to ambroxol 54.7 mg;
• The other components are: sorbitol (E 420), sodium saccharinate (see section 2. “Mucosolvan granules contain sorbitol and sodium”), raspberry flavour powder.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is presented as granules. It is available in packs of 20 sachets.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)
Manufacturer
Delpharm Reims S.A.S. – 10 rue Colonel Charbonneaux – 51100 Reims (France)
November 2022

Patient Information Leaflet: Information for the user

MUCOSOLVAN 15 mg/5 ml berry-flavored syrup

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leafleaflet. 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by liquefying mucus and facilitating
its elimination. Mucosolvan is used in adults and children over 2 years of age for the
treatment of secretions in acute and chronic diseases of the bronchi and lungs (i.e. in the presence of
cough and when there is difficulty in expelling mucus from the bronchi due to increased or thickened mucus).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you/your child are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if the child is under 2 years of age;
• if you/your child have a severe liver or kidney disease;
• The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2 “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you/your child have/have had stomach and/or intestinal lesions (peptic ulcer).

Severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions could be symptoms of serious skin disorders characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Furthermore, during the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you/your child may experience non-specific symptoms resembling those of influenza, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, symptomatic treatment with a cough and cold remedy might be restarted.

Children
Do not give this medicine to children under 2 years of age. Mucolytics may cause bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines. In particular, following administration of ambroxol, concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva have been shown to increase.

Mucosolvan with food and drink
You may take Mucosolvan either on an empty or full stomach.

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

Pregnancy

• If you are in the first 3 months of pregnancy, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• If you are breastfeeding, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan syrup contains propylene glycol and benzoic acid
This medicine contains:

• 52 mg of propylene glycol per single dose (10 ml) in adults and 15.6 mg of propylene glycol per single dose (3 ml) in children. This corresponds to 5.2 mg per ml.

This medicine also contains:

• 5 mg of benzoic acid per single dose (10 ml) in adults and 1.5 mg of benzoic acid per single dose (3 ml) in children. This corresponds to 0.5 mg per ml.

3. How to use Mucosolvan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 10 ml three times daily.
Children over 5 years: 3 ml four times daily.
Children from 2 to 5 years: 3 ml three times daily.
Give Mucosolvan berry-flavoured syrup to children aged between 2 and 6 years only under medical supervision.
Caution: Do not exceed the recommended doses without medical advice. You may use Mucosolvan even if you have diabetes. Do not use Mucosolvan for longer than 2 weeks without consulting your doctor.
Consult your doctor if symptoms recur frequently, if you have noticed any recent change in their characteristics, or if symptoms worsen or do not improve.

The bottle is equipped with a child-resistant closure. To open, remove the measuring cup from the cap, press down and simultaneously turn the cap in the direction of the arrow; to close, screw the cap tightly while pressing.
Each ml of syrup contains 3 mg of ambroxol hydrochloride. A double measuring cup is supplied with the pack, marked with graduations corresponding to 1.25 ml, 2.5 ml, 5 ml (conical part) and 3 ml, 7.5 ml, 10 ml, 15 ml (cylindrical part).
If you take more Mucosolvan than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the forgotten dose.
If you stop using Mucosolvan
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 gets them.
The following side effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia); uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty in digestion (dyspepsia), dry mouth; rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat; not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis), heartburn (pyrosis).

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you/your child 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 the following website:
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 Mucosolvan

This medicine does not require any special storage conditions.
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.
The shelf life after first opening the bottle is 1 year. After this period, any remaining product
should be disposed of.
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 Mucosolvan contains
100 ml of fruit-flavoured syrup contain:

• the active substance is ambroxol hydrochloride 300 mg, equivalent to ambroxol 273.6 mg;
• the other components are: benzoic acid (E 210), hydroxyethylcellulose, sucralose, mixed berry flavour, vanilla flavour, purified water.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is a fruit-flavoured syrup. It is available in a 200 ml amber glass bottle with a child-resistant closure. A double-ended dosing cup is supplied with the pack, with markings corresponding to 1.25 ml, 2.5 ml, 5 ml (conical end) and 3 ml, 7.5 ml, 10 ml, 15 ml (cylindrical end).
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Delpharm Reims S.A.S. – 10 rue Colonel Charbonneaux – 51100 Reims (France)
or
Opella Healthcare Italy S.r.l. - Viale Europa 11 - 21040 Origgio (Italy)

Patient Information Leaflet: Information for the user

MUCOSOLVAN 30 mg/5 ml syrup

Ambroxol
Please read this leaflet carefully before using this medicine as it contains important information for you.
Use 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 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 after 2 weeks of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active substance that works by liquefying mucus and facilitating
its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic
conditions of the bronchi and lungs (i.e. in the presence of cough and when there is difficulty in
expelling mucus from the bronchi due to increased or thickened secretions).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease. The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2 “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you have or have had stomach and/or intestinal disorders (peptic ulcer).

Severe skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions may be symptoms of serious skin diseases characterized by skin peeling and severe skin toxic reaction (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Additionally, during the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you may experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold remedies might be restarted inappropriately.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, after administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.

Mucosolvan with food and drink
You may take Mucosolvan either on an empty or full stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

• If you are in the first 3 months of pregnancy, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• If you are breastfeeding, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan syrup contains propylene glycol and benzoic acid
This medicine contains 29 mg of propylene glycol per single dose (5 ml), equivalent to 5.8 mg per ml. This medicine also contains 2.5 mg of benzoic acid per single dose (5 ml), equivalent to 0.5 mg per ml.

3. How to use Mucosolvan

This medicine is intended for adult patients only.
Always use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 5 ml three times daily.
Caution: Do not exceed the recommended doses without medical advice. You may use Mucosolvan even if you have diabetes. Do not use Mucosolvan for longer than 2 weeks without consulting your doctor.
Consult your doctor if symptoms recur, if you have noticed any recent changes in their characteristics, or if symptoms worsen or do not improve.

The bottle has a child-resistant closure. To open, remove the dosing cup from the cap, press down and turn the cap in the direction of the arrow; to close, screw firmly while pressing.
Each ml of syrup contains 6 mg of ambroxol hydrochloride. The package includes a double dosing cup with markings corresponding to 1.25 ml, 2.5 ml, 5 ml (conical part) and 3 ml, 7.5 ml, 10 ml, 15 ml (cylindrical part).
If you take more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the missed dose.
If you stop using Mucosolvan
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 everyone experiences them.
The following side effects may occur with the use of Mucosolvan:
Common (may affect up to 1 in 10 people)

• nausea, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia);
  Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea, and abdominal pain, difficulty in digestion (dyspepsia), dry mouth;
  Rare (may affect up to 1 in 1,000 people)

• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat;
  Not known (frequency cannot be estimated from the available data)

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and itching;

• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), heartburn (pyrosis).

These side effects are usually transient. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 Mucosolvan

This medicine does not require any special storage conditions.
Shelf life after opening the bottle: 6 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
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 Mucosolvan contains
100 ml of syrup contain:

• the active substance is ambroxol hydrochloride 600 mg, equivalent to ambroxol 547.2 mg;
• the other components are: sucralose, benzoic acid (E 210), hydroxyethylcellulose, strawberry cream flavour (containing propylene glycol (E1520)), vanilla flavour (containing propylene glycol (E 1520))), purified water.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is presented as a syrup. It is available in 100 ml and 200 ml bottles. A dual-marked dosing cup is included in the package, with graduations corresponding to 1.25 ml, 2.5 ml, 5 ml (conical part) and 3 ml, 7.5 ml, 10 ml, 15 ml (cylindrical part).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)

Manufacturer
Boehringer Ingelheim España, S.A. – Prat de la Riba 50 – 08174 Sant Cugat del Vallès (Barcelona) –
Spain

Instructions for the user: package leaflet

MUCOSOLVAN 7.5 mg/ml nebulizer solution

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use 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 after a short period of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by dissolving mucus and facilitating
its elimination. Mucosolvan is used in adults and in children for the treatment of secretions in
acute and chronic diseases of the bronchi and lungs (i.e. in the presence of cough and when there is
difficulty in expelling mucus from the bronchi due to increased or thickened secretions).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you/your child are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you/your child have a severe liver or kidney disease;
• in case of rare hereditary conditions of incompatibility with one of the excipients (see section 2, “Mucosolvan nebulizing solution contains benzalkonium chloride”). The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2, “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you/your child have/have had stomach and/or intestinal lesions (peptic ulcer).

Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis). Additionally, during the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you/your child may experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with a cough and cold remedy might be restarted.
Other medicines and Mucosolvan
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines. In particular, following administration of ambroxol, concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.
Pregnancy

• If you are in the first 3 months of pregnancy, the use of Mucosolvan is not recommended (see section 2, “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.
  Breastfeeding
• If you are breastfeeding, the use of Mucosolvan is not recommended (see section 2, “Do not use Mucosolvan”).
  Fertility
• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.
Mucosolvan nebulizing solution contains benzalkonium chloride and sodium
Mucosolvan nebulizing solution contains benzalkonium chloride, which may cause bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Mucosolvan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 5 years of age: 2–3 ml of solution 1–2 times daily.
Children under 5 years of age: 1–2 ml of solution 1–2 times daily.
Warning: Do not exceed the recommended doses without medical advice.
Mucosolvan nebulising solution can be administered using various inhalation devices.
Your doctor will advise whether this medicine should be diluted with physiological solution (saline solution). If dilution is required, it must be done in equal parts (equal amounts of medicine and physiological solution).
Do not mix Mucosolvan nebulising solution with sodium cromoglicate, a compound used to reduce asthma symptoms.
Do not mix Mucosolvan nebulising solution with other solutions if the resulting mixture has a pH greater than 6.3 (such as Emser salts), since an increase in pH may cause clouding of the solution.

Since inhalation itself may cause coughing, breathe normally during inhalation.
It is recommended to warm the solution to body temperature by holding the vial in your hands before use.
If you/your child suffer from asthma, take/give your usual bronchodilator (medicine used for the treatment of asthma) before inhalation.
Consult your doctor if the condition recurs, if you have noticed any recent changes in its characteristics, or if symptoms worsen or do not improve.
If you use more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, contact your doctor immediately or go to the nearest hospital.
If you forget to use Mucosolvan
Do not use a double dose to make up for the missed dose.
If you stop using Mucosolvan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia);
  uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty in digestion (dyspepsia), dry mouth;
  rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash (rash), appearance of red spots on the skin accompanied by itching (urticaria), dryness of the throat;
  not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), stomach burning (pyrosis).

These adverse effects are generally transient. If they occur, consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Mucosolvan

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Shelf life after opening the bottle: 12 months.
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 Mucosolvan contains
100 ml of solution contain:

• The active substance is ambroxol hydrochloride 750 mg;
• The other components are: citric acid, disodium phosphate, sodium chloride, benzalkonium chloride (see section 2. "Mucosolvan solution for nebulisation contains benzalkonium chloride and sodium"), distilled water.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is presented as a solution for nebulisation. It is available in a 40 ml bottle.
A transparent plastic measuring cup is included in the package.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)
Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli n. 103/c – 50066 Reggello (FI)
April 2022

Package leaflet: information for the user

MUCOSOLVAN 15 mg/2 ml nebulizing solution

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use 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 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 improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active substance that works by liquefying mucus and facilitating its
elimination. Mucosolvan is used in adults and in children for the treatment of secretions in acute and chronic bronchial and pulmonary diseases (i.e., in the presence of cough and when there is difficulty in expelling mucus from the bronchi due to increased or thickened secretions).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you/your child are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you/your child have severe liver or kidney disease. The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2 “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you/your child have/have had stomach and/or intestinal lesions (peptic ulcer).

Severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions may be symptoms of serious skin diseases characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Additionally, in the early stages of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you/your child may experience non-specific flu-like symptoms such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold remedies might be started again.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you/your child are taking, have recently taken or might take any other medicines. In particular, following administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

• If you are in the first 3 months of pregnancy, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• If you are breastfeeding, the use of Mucosolvan is not recommended (see section 2 “Do not use Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan nebulizing solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Mucosolvan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 5 years of age: 2–3 vials per day.
Children under 5 years of age: 1–2 vials per day.
Warning: Do not exceed the recommended doses without medical advice.
Mucosolvan nebuliser solution can be administered using various inhalation devices.
Your doctor will advise whether this medicine should be diluted with physiological saline solution.
Dilution must be performed in equal parts (the same volume of medicine and physiological saline solution).
Do not mix Mucosolvan nebuliser solution with other solutions if the resulting mixture has a pH greater than 6.3 (e.g. when using Emser salts), as an increase in pH may cause clouding of the solution.
Breakable vials, no file needed.

Since inhalation itself may cause coughing, breathe normally during the procedure.
It is recommended to warm the solution to body temperature by holding the vial between your hands before use.
If you/your child suffer(s) from asthma, take/give the usual bronchospasmolytic (medication used for the treatment of asthma) before inhalation.
Consult your doctor if symptoms occur repeatedly, if you have noticed any recent changes in their characteristics, or if symptoms worsen or do not improve.
If you use more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, contact your doctor immediately or go to the nearest hospital.
If you forget to use Mucosolvan
Do not use a double dose to make up for the missed dose.
If you stop using Mucosolvan
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.

The following side effects may occur with the use of Mucosolvan:

Common (may affect up to 1 in 10 people)

• nausea, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoaesthesia), numbness of the throat (pharyngeal hypoaesthesia);

Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea and abdominal pain, difficulty in digesting (dyspepsia), dry mouth;

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

• hypersensitivity reactions, skin rash (rash), appearance of red spots on the skin accompanied by itching (urticaria), dry throat;

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching;
• severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis), stomach burning (pyrosis).

These side effects are usually temporary. If they occur, consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mucosolvan

This medicine does not require any special storage conditions.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mucosolvan contains
Each vial contains:

• The active substance is ambroxol hydrochloride 15 mg;
• The other components are citric acid, disodium phosphate, sodium chloride (see section 2, "Mucosolvan nebulising solution contains sodium"), water for injections.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is a solution for nebulisation. It is available in packs of 6 vials of 2 ml.
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Boehringer Ingelheim Espana S.A. – San Cugat del Vallés – Barcelona (Spain)
Or
Sanofi S.r.l.
Via Valcanello 4, 03012 Anagni (FR) - Italy.

Instructions for the user: package leaflet

MUCOSOLVAN 15 mg chewable tablets

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by dissolving mucus and facilitating its elimination. Mucosolvan is used in adults and in children over 6 years of age for the treatment of secretions in acute and chronic diseases of the bronchi and lungs (i.e., in the presence of cough and difficulty in expelling mucus from the bronchi due to increased or thickened secretions).

2. What you should know before using Mucosolvan

Do not use Mucosolvan

• if you/your child are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you/your child have severe liver or kidney disease;
• in case of rare hereditary conditions of incompatibility with one of the excipients (see section 2, “Mucosolvan chewable tablets contain sorbitol”). Use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2, “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you/your child have/have had stomach and/or intestinal lesions (peptic ulcer).

Serious skin reactions have been reported following administration of ambroxol. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions could be symptoms of serious skin diseases characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Moreover, in the early phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you/your child may experience non-specific symptoms resembling those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold remedies might be restarted.

Children
Do not give this medicine to children under 6 years of age.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you/your child are taking, have recently taken or might take any other medicines. In particular, following administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.

Mucosolvan with food and drink
You may take Mucosolvan either on an empty or full stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

• If you are in the first 3 months of pregnancy, use of Mucosolvan is not recommended (see section 2, “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• Use of Mucosolvan is not recommended if you are breastfeeding (see section 2, “Do not use Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan chewable tablets contain sorbitol, maltitol and sodium
This medicine contains 420.08 mg of sorbitol per tablet, equivalent to 50.41 mg/kg per maximum recommended daily dose (6 tablets) in adults and adolescents, and 78.77 mg/kg per maximum recommended daily dose (3 tablets) in children. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before you (or your child) take this medicine.
This medicine contains maltitol. If your doctor has diagnosed you or your child with intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to use Mucosolvan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age: 2 chewable tablets three times a day.
Children between 6 and 12 years of age: 1 chewable tablet 2–3 times a day.
Warning: Do not exceed the recommended doses without medical advice.
The chewable tablet must be slowly dissolved in the mouth.
You can use Mucosolvan even if you have diabetes. Do not use Mucosolvan for longer than 2 weeks without consulting your doctor.
Consult your doctor if symptoms recur repeatedly, if you have noticed any recent changes in their characteristics, or if symptoms worsen or do not improve.
If you take more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, inform your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the forgotten chewable tablet.
If you stop using Mucosolvan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea, taste disturbance (dysgeusia), numbness of the mouth and tongue (oral hypoesthesia), numbness of the throat (pharyngeal hypoesthesia); uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty in digestion (dyspepsia), dry mouth; rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria), dry throat; not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis), burning sensation in the stomach (pyrosis).

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you/your child 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 the following website:
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 Mucosolvan

Do not store above 30°C.
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.
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 Mucosolvan Contains

• The active substance is ambroxol hydrochloride 15 mg, equivalent to ambroxol 13.7 mg;
• The other ingredients are: acacia, maltitol (E965), sorbitol (E420) (see section 2. “Mucosolvan chewable tablets contain sorbitol, maltitol and sodium”), mannitol, peppermint oil, eucalyptus oil, sodium saccharin (see section 2. “Mucosolvan chewable tablets contain sorbitol, mannitol and sodium”), liquid paraffin, purified water.

Description of the Appearance of Mucosolvan and Contents of the Pack
Mucosolvan is presented as chewable tablets. It is available in packs containing 20 or 40 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)

Manufacturer
Bolder Arzneimittel GmbH & Co. KG - Cologne (Germany)

Package leaflet: Information for the user

MUCOSOLVAN Children 30 mg Suppositories

Ambroxol
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for you.
Give this medicine to your child exactly as described in this leaflet or as directed by the
doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

1. What Mucosolvan is and what it is used for
2. What you need to know before giving Mucosolvan to your child
3. How to give Mucosolvan to your child
4. Possible side effects
5. How to store Mucosolvan
6. Contents of the pack and other information

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by dissolving mucus and facilitating its elimination. Mucosolvan is used in children over 2 years of age and weighing more than 15 kg, for the treatment of secretions in acute and chronic bronchial and pulmonary diseases (i.e. in the presence of cough and difficulty in expelling mucus from the bronchi due to increased or thickened secretions).

2. What you should know before giving Mucosolvan to the child

Do not give Mucosolvan to the child

• if he/she is allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if he/she has severe liver or kidney disease;
• if he/she is under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before giving Mucosolvan to the child:

• if the child has or has had stomach and/or intestinal lesions (peptic ulcer).

Serious skin reactions have been reported with ambroxol administration. If a skin rash occurs (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop giving Mucosolvan to the child and consult a doctor immediately.
These reactions may be symptoms of severe skin disorders characterized by skin peeling and severe skin toxicity (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Additionally, in the early stages of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), non-specific flu-like symptoms may occur, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold medicines might be restarted.
Children
Do not give this medicine to children under 2 years of age. Mucolytics may cause bronchial obstruction in children under 2 years. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.
Give this medicine to children aged between 2 and 6 years only after consulting a doctor.
Other medicines and Mucosolvan
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines. In particular, after administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.
Mucosolvan with food and drink
You may give Mucosolvan to the child either on an empty or full stomach.
Driving and using machines
Mucosolvan does not affect the ability to drive vehicles such as bicycles.

3. How to administer Mucosolvan to the child

Give this medicine to the child exactly as stated in this leaflet or as instructed by the doctor or pharmacist.
If you have any doubts, consult the doctor or pharmacist.

The recommended dose in children over 2 years of age (weighing more than 15 kg) is 1 suppository 1–2 times daily.
Administer Mucosolvan suppositories to children aged between 2 and 6 years only under medical supervision.

Warning: Do not exceed the recommended doses without medical advice.
Do not give Mucosolvan to the child for longer than 2 weeks without consulting a doctor.
Administer the medicine rectally.

Consult a doctor if symptoms recur frequently, if you have noticed any recent changes in their characteristics, or if symptoms worsen or do not improve.

If you give the child more Mucosolvan than you should
In case of accidental ingestion/overdose of Mucosolvan, contact your doctor immediately or go to the nearest hospital.

If you forget to give the child Mucosolvan
Do not give a double dose to make up for the forgotten suppository.

If you stop treatment with Mucosolvan
If you have any doubts about using 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 the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea;
  uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty in digestion (dyspepsia);
  rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash (rash), appearance of red spots on the skin accompanied by itching (urticaria);
  not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), stomach burning (pyrosis).

These side effects are generally transient. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 Mucosolvan

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not give this medicine to a child after the expiry date stated on the packaging after
Exp.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mucosolvan Children 30 mg suppositories contains

• The active substance is ambroxol hydrochloride 30 mg, equivalent to ambroxol 27.4 mg;
• The other components are: glycerol esters of saturated fatty acids.

Description of the appearance of Mucosolvan and contents of the pack
Mucosolvan is presented as suppositories for children. It is available in packs of 10 suppositories.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli n. 103/c – 50066 Reggello (FI)
April 2022

Package leaflet: information for the user

MUCOSOLVAN 75 mg prolonged-release hard capsules

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use 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 any side effects occur, including side effects not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active substance that works by breaking down mucus and facilitating its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic diseases of the bronchi and lungs (i.e. in the presence of cough and when there is difficulty in expelling mucus from the bronchi due to increased amount or thickening).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease;
• if the person to be treated is a child.

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you have or have had stomach and/or intestinal lesions (peptic ulcer).

Severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and consult your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by skin peeling and severe skin toxic reaction (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis). Furthermore, in the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you may experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with a cough and cold remedy might be restarted.
Children
Do not give this medicine to children/adolescents aged between 0 and 18 years.
Other medicines and Mucosolvan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, after administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.
Mucosolvan with food and drink
You can take Mucosolvan either on an empty or full stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy

• If you are in the first 3 months of pregnancy, the use of Mucosolvan is not recommended (see section 2. "Do not use Mucosolvan").
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.
  Breastfeeding
• If you are breastfeeding, the use of Mucosolvan is not recommended (see section 2. "Do not use Mucosolvan").
  Fertility
• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

3. How to use Mucosolvan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
1 capsule (75 mg) once daily, taken in the morning after breakfast. Warning: Do not exceed the recommended dose.
Do not open or chew the capsules; swallow them whole with plenty of water or other liquids. Do not be alarmed if you notice the capsule shell in your stools, as the active substance will have already been released.
If you do not notice any improvement, or if your symptoms worsen after 2 weeks of treatment, consult your doctor or pharmacist.
If you take more Mucosolvan than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the missed dose.
If you stop taking Mucosolvan
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 gets them.
The following side effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea; uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea, abdominal pain, difficulty in digestion (dyspepsia); rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash, appearance of red spots on the skin accompanied by itching (urticaria); not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and itching;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), heartburn (pyrosis).

These side effects are generally transient. If they occur, consult your doctor or pharmacist.
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 the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mucosolvan

Do not store above 30°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Mucosolvan contains

• the active substance is ambroxol hydrochloride 75 mg, equivalent to ambroxol 68.4 mg;
• the other components are: stearyl alcohol, carnauba wax, crospovidone, magnesium stearate; capsule shell: gelatin, titanium dioxide, yellow iron oxide, red iron oxide.

Description of the appearance of Mucosolvan and pack contents
Mucosolvan is presented as prolonged-release hard capsules. It is available in packs of
20 capsules.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Delpharm Reims S.A.S. – 10 rue Colonel Charbonneaux – 51100 Reims (France)

Package leaflet: Information for the user

MUCOSOLVAN 30 mg tablets

Ambroxol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use 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 of the side effects listed in this leaflet, or any that are not listed, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

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

1. What Mucosolvan is and what it is used for

Mucosolvan contains ambroxol, an active ingredient that works by liquefying mucus and facilitating
its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic
conditions of the bronchi and lungs (i.e. in the presence of cough and when there is difficulty in
expelling mucus from the bronchi due to increased or thickened secretions).

2. What you need to know before using Mucosolvan

Do not use Mucosolvan

• if you are allergic to ambroxol or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney disease;
• in case of rare inherited conditions of intolerance to one of the excipients (see section 2, “Mucosolvan tablets contain lactose”). The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see section 2, “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:

• if you have or have had stomach and/or intestinal lesions (peptic ulcer).

Severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions could be symptoms of serious skin diseases characterized by skin peeling and severe skin toxic reaction (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Additionally, during the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN), you may experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, symptomatic treatment with a cough and cold remedy might be restarted.

Children
Do not give this medicine to children/adolescents aged between 0 and 18 years.

Other medicines and Mucosolvan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, following administration of ambroxol, increased concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) have been observed in bronchopulmonary secretions and saliva.

Mucosolvan with food and drinks
You may take Mucosolvan either on an empty or full stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

• If you are in the first 3 months of pregnancy, use of Mucosolvan is not recommended (see section 2, “Do not use Mucosolvan”).
• Use Mucosolvan from the 4th to the 9th month of pregnancy only on medical advice.

Breastfeeding

• If you are breastfeeding, use of Mucosolvan is not recommended (see section 2, “Do not use Mucosolvan”).

Fertility

• Mucosolvan has no effect on fertility.

Driving and using machines
Mucosolvan does not affect the ability to drive or operate machinery.

Mucosolvan tablets contain lactose
Mucosolvan tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to use Mucosolvan

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 1 tablet 3 times a day.
This dosage may be reduced after 8–10 days to 1 tablet twice daily. Caution: Do not exceed the recommended doses without medical advice. Take the tablets with water or other liquids.
You can use Mucosolvan even if you have diabetes. Do not use Mucosolvan for longer than a short-term treatment (no more than 2 weeks) without consulting your doctor.
Consult your doctor if the condition recurs, if you have noticed any recent changes in its characteristics, or if symptoms worsen or do not improve.
If you take more Mucosolvan than you should
If you accidentally ingest/overdose on Mucosolvan, contact your doctor immediately or go to the nearest hospital.
If you forget to take Mucosolvan
Do not take a double dose to make up for the forgotten tablet.
If you stop using Mucosolvan
If you have any doubts about using 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.
The following side effects may occur with the use of Mucosolvan:
common (may affect up to 1 in 10 people)

• nausea; uncommon (may affect up to 1 in 100 people)
• vomiting, diarrhoea and abdominal pain, difficulty in digestion (dyspepsia); rare (may affect up to 1 in 1,000 people)
• hypersensitivity reactions, skin rash (rash), appearance of red spots on the skin accompanied by itching (urticaria); not known (frequency cannot be estimated from the available data)
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and itching;
• severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis), stomach burning (pyrosis).

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: 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 Mucosolvan

Keep this medicine below 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
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 Mucosolvan contains

• the active substance is hydrochloride ambroxol 30 mg, equivalent to ambroxol 27.4 mg;
• the other components are: lactose (see section 2. “Mucosolvan tablets contain lactose”), maize starch, colloidal silica, magnesium stearate.

Description of the appearance of Mucosolvan and package contents
Mucosolvan is available as tablets. It is supplied in packs containing 20 tablets.
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)
Manufacturer
Delpharm Reims - 10 Rue Colonel Charbonneaux - 51100 Reims (France)
April 2022