Esteclin
Italy
Table of Contents
Package leaflet
ESTECLIN 300 mg hard capsules
Erdosteine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Esteclin is and what it is used for
- What you need to know before taking Esteclin
- How to take Esteclin
- Possible side effects
- How to store Esteclin
- Contents of the pack and other information
1. What Esteclin is and what it is used for
Esteclin contains the active substance erdosteine. It is a mucolytic agent, used to liquefy mucus in acute and chronic respiratory tract disorders.
2. What you need to know before taking Esteclin
Do not take Esteclin
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if you have stomach or intestinal lesions (active peptic ulcer);
- if you have renal failure with creatinine clearance <25 ml/min or severe hepatic impairment;
- if you have hepatic cirrhosis and cystathionine synthase deficiency, due to the probable interference of the product's metabolites with methionine metabolism;
- if the person to be treated is a child under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esteclin.
Children
Esteclin is contraindicated in 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 Esteclin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other drugs have been reported, therefore this medicine may be usefully combined with antibiotics and bronchodilators (theophylline derivatives or beta2-mimetics), antitussive agents, etc.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of erdosteine during human pregnancy has not been established; therefore, its use is not recommended.
Likewise, its use during breastfeeding is not recommended.
Effects on ability to drive vehicles and use machinery
Esteclin does not affect the ability to drive vehicles or operate machinery.
3. How to take Esteclin
Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Adults
1 capsule 2-3 times daily, for oral use.
The capsules must be swallowed whole with a glass of water.
If you take more Esteclin than you should
With doses higher than recommended (1200 mg/day), sweating,
dizziness and hot flushes have been reported.
In case of accidental ingestion or overdose of Esteclin, contact your doctor immediately or go to the nearest hospital.
If you forget to take Esteclin
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Fewer than 1 in 1000 patients may report gastrointestinal side effects.
The frequency listed below is described using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated based on available data).
| Nervous system disorders Very rare lhh | Headache |
| Respiratory, thoracic and mediastinal disorders Very rare Frequency not known ll | Difficulty breathing Bronchial obstruction |
| Gastrointestinal disorders Very rare llll | Taste alteration, nausea, vomiting, diarrhea, epigastric pain |
| Skin and subcutaneous tissue disorders Very rare | Urticaria, erythema, eczema |
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions
directly through the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse
reactions, you can help provide more information on the safety of this medicine.
5. How to store Esteclin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the product stored in its original, undamaged packaging and kept under the recommended storage conditions.
The possible presence of a sulfurous (sulfur-like) odour does not indicate any deterioration of the product, but is characteristic of the Active Substance it contains.
Store below 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Esteclin contains
The active substance is erdosteine.
Each capsule contains 300 mg of Erdosteine.
The other components are povidone, microcrystalline cellulose, magnesium stearate, gelatin,
titanium dioxide (E 171), yellow iron oxide (E 172), indigotine (E 132).
Description and contents of the pack
ESTECLIN 300 mg hard capsules, pack containing 20 capsules.
Marketing Authorization Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Distributor for sale:
Bruschettini Srl – Via Isonzo 6, 16147 Genoa
Manufacturer and batch release responsible
EDMOND PHARMA S.r.l. – Strada Statale dei Giovi 131 – Paderno Dugnano (MI)
FAMAR S.p.A - Via Zambeletti, 25 – 20021 Baranzate (MI)
RECIPHARM FONTAINE S.A.S. - Rue des Prés Potets – 21121 Fontaine-les-Dijon - France
Package leaflet
ESTECLIN 300 mg dispersible tablets
Erdosteine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Esteclin is and what it is used for
- What you need to know before taking Esteclin
- How to take Esteclin
- Possible side effects
- How to store Esteclin
- Package contents and other information
1. What Esteclin is and what it is used for
Esteclin contains the active substance erdosteine. It is a mucolytic agent, used to fluidify mucus in acute and chronic respiratory tract disorders.
2. What you need to know before taking Esteclin
Do not take Esteclin
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if you have stomach or intestinal lesions (active peptic ulcer);
- if you have renal impairment with creatinine clearance <25 ml/min or severe hepatic impairment;
- if you have liver cirrhosis and cystathionine synthase deficiency, due to the probable interference of the product's metabolites with methionine metabolism;
- if the person to take the medicine is a child under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esteclin.
Children
Esteclin is contraindicated in 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 Esteclin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other drugs have been reported, therefore Esteclin can be usefully combined with antibiotics and bronchodilators (xanthines or beta2-mimetics), cough suppressants, etc.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of erdosteine during human pregnancy has not been established; therefore, its use is not recommended during pregnancy.
Likewise, its use during breastfeeding is not recommended.
Effects on ability to drive vehicles and use machinery
Esteclin does not impair the ability to drive vehicles or operate machinery.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.
Lactose
Lactose is a sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Sunset Yellow
Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
3. How to take Esteclin
Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Adults
1 tablet 2-3 times daily, for oral use.
The tablets must be dissolved in a glass of water. Stir with a teaspoon and drink
immediately.
If you take more Esteclin than you should
When taken in doses higher than recommended (1200 mg/day), sweating,
dizziness, and hot flushes have been reported.
In case of accidental ingestion/overdose of Esteclin, contact your doctor immediately or go to the nearest hospital.
If you forget to take Esteclin
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Less than 1 in 1,000 patients may experience gastrointestinal adverse reactions.
The frequency categories listed below are described using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
| Nervous system disorders Very rare lhh | Headache |
| Respiratory, thoracic and mediastinal disorders Very rare Frequency not known ll | Difficulty breathing Bronchial obstruction |
| Gastrointestinal disorders Very rare llll | Altered taste, nausea, vomiting, diarrhea, epigastric pain |
| Skin and subcutaneous tissue disorders Very rare | Urticaria, erythema, eczema |
Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions
directly through the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse
reactions, you can help provide more information on the safety of this medicine.
5. How to store Esteclin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging, correctly stored.
The possible presence of a sulfurous (sulfur-like) odour does not indicate deterioration of the product, but is characteristic of the Active Substance contained therein.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Esteclin contains
The active substance is erdosteine.
Each tablet contains 300 mg of erdosteine.
The other components are lactose, microcrystalline cellulose, sucralose, sodium croscarmellose,
talc, magnesium stearate, mango flavour, Sunset Yellow (E110), povidone, colloidal silicon dioxide.
Description and content of the container
ESTECLIN 300 mg dispersible tablets, box containing 20 tablets
Marketing Authorization Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Selling Authorization Licensee:
Bruschettini Srl – Via Isonzo 6, 16147 Genova
Manufacturer and batch release responsible
EDMOND PHARMA S.r.l. – Strada Statale dei Giovi 131 – Paderno Dugnano (MI)
Package leaflet
ESTECLIN 225 mg granules for oral suspension
Erdosteine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Esteclin is and what it is used for
- What you need to know before taking Esteclin
- How to take Esteclin
- Possible side effects
- How to store Esteclin
- Contents of the pack and other information
1. What Esteclin is and what it is used for
Esteclin contains the active substance erdosteine. It is a mucolytic agent, used to fluidify secretions in acute and chronic respiratory tract disorders.
2. What you need to know before taking Esteclin
Do not take Esteclin
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if you have stomach or intestinal lesions (active peptic ulcer);
- if you have renal insufficiency with creatinine clearance <25 ml/min or severe hepatic insufficiency;
- if you have liver cirrhosis and cystathionine-synthase deficiency, due to the probable interference of the product's metabolites with methionine metabolism;
- if the person to be treated is a child under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esteclin.
Children
Esteclin is contraindicated in children under 2 years of age. Mucolytic agents 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 Esteclin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other drugs have been reported, and therefore this medicine can be usefully combined with antibiotics and bronchodilators (xanthines or beta2-mimetics), antitussive sedatives, etc.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of erdosteine during human pregnancy has not been established; therefore, its use is not recommended.
Likewise, its use during breastfeeding is not recommended.
Effects on ability to drive vehicles and use machinery
Esteclin does not impair the ability to drive vehicles or operate machinery.
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per single dose, i.e. it is essentially 'sodium-free'.
3. How to take Esteclin
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults
1 sachet 2-3 times daily, for oral use.
The contents of the sachet must be dissolved in water. Stir with a teaspoon and drink immediately.
If you take more Esteclin than you should
With doses higher than recommended (1200 mg/day), sweating, dizziness, and hot flushes have been reported.
In case of accidental ingestion/overdose of Esteclin, contact your doctor immediately or go to the nearest hospital.
If you forget to take Esteclin
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Fewer than 1 in 1,000 patients may experience gastrointestinal side effects.
The frequencies listed below are described using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated based on available data).
| Nervous system disorders Very rare lhh | Headache |
| Respiratory, thoracic and mediastinal disorders Very rare Frequency not known ll | Dyspnoea, bronchial obstruction |
| Gastrointestinal disorders Very rare llll | Altered taste, nausea, vomiting, diarrhoea, epigastric pain |
| Skin and subcutaneous tissue disorders Very rare | Urticaria, erythema, eczema |
Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions
directly through the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse
reactions, you can help provide more information on the safety of this medicine.
5. How to store Esteclin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and label after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the product stored in its original intact packaging and properly stored.
The possible presence of a sulfurous (sulfur-like) odour does not indicate deterioration of the product, but is characteristic of the Active Substance contained in it.
Store below 25 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Esteclin contains
The active substance is erdosteine.
Each sachet contains 225 mg of erdosteine.
The other components are sucrose, malic acid, sodium starch glycolate, orange flavour,
sucralose, silicon dioxide.
Description and content of the container
ESTECLIN 225 mg granules for oral suspension, pack containing 20 sachets.
Marketing Authorization Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Selling concessionaire:
Bruschettini Srl – Via Isonzo 6, 16147 Genova
Manufacturer and batch release responsible
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG)
EDMOND PHARMA S.r.l. – Strada Statale dei Giovi 131 – Paderno Dugnano (MI)
Package leaflet
ESTECLIN 175 mg/5 ml powder for oral suspension
Erdosteine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Esteclin is and what it is used for
- What you need to know before taking Esteclin
- How to take Esteclin
- Possible side effects
- How to store Esteclin
- Contents of the pack and other information
1. What Esteclin is and what it is used for
Esteclin contains the active substance erdosteine. It is a mucolytic agent, helping to fluidify mucus in acute and chronic respiratory tract disorders.
2. What you need to know before taking Esteclin
Do not take Esteclin
- if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6);
- if you have stomach or intestinal lesions (active peptic ulcer);
- if you have renal failure with creatinine clearance <25 ml/min or severe hepatic impairment;
- if you have hepatic cirrhosis and cystathionine synthase deficiency due to the probable interference of the product's metabolites with methionine metabolism;
- if the person to take the medicine is a child under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esteclin.
Children
Esteclin is contraindicated in 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 Esteclin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No negative interactions with other drugs have been reported, and therefore this medicine can be usefully combined with antibiotics and bronchodilators (xanthines or beta2-mimetics), cough sedatives, etc.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of erdosteine during human pregnancy has not been established; therefore, its use is not recommended.
Likewise, its use during breastfeeding is not recommended.
Effects on ability to drive vehicles and use machinery
Esteclin does not affect the ability to drive vehicles or operate machinery.
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml, i.e. it is essentially ‘sodium-free’.
Sodium benzoate (E211)
This medicine contains 10 mg of benzoate salt per 5 ml dose, equivalent to 2 mg/ml of volume.
3. How to take Esteclin
Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
5 ml, twice daily, in children weighing between 15 and 19 kg; 5 ml of suspension three
times daily in children weighing between 20 and 30 kg; 10 ml of suspension twice daily in
children weighing more than 30 kg and in adults.
Add water to the bottle up to the level mark. Shake until complete dispersion is achieved and,
if necessary, add more water again up to the level mark, shaking again.
Always shake before use.
If you take more Esteclin than you should
With doses higher than recommended (1200 mg/day), sweating, dizziness, and hot flushes have been reported.
In case of accidental ingestion/overdose of Esteclin, contact your doctor immediately or go to the nearest hospital.
If you forget to take Esteclin
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Fewer than 1 in 1000 patients may experience gastrointestinal side effects.
The frequency categories below are described using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
| Nervous system disorders very rare lhh | Headache |
| Respiratory, thoracic and mediastinal disorders very rare frequency not known | Difficulty breathing Bronchial obstruction |
| Gastrointestinal disorders very rare llll | Taste disturbance, nausea, vomiting, diarrhea, epigastric pain |
| Skin and subcutaneous tissue disorders very rare | Urticaria, erythema, eczema |
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions
directly through the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse
reactions, you can help provide more information on the safety of this medicine.
5. How to store Esteclin
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 carton and label after "Exp". The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging and stored correctly.
The possible presence of a sulfurous (sulfur-like) odour does not indicate deterioration of the product, but is characteristic of the Active Substance it contains.
The ready-to-use suspension can be used for a maximum of 15 days if stored in the refrigerator.
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 Esteclin contains
The active substance is erdosteine.
Each 5 ml of oral suspension contains 175 mg of erdosteine.
The other components are sucrose, sodium benzoate, sodium amidoglycolate, orange flavouring powder, anhydrous citric acid, sucralose, aroma mask CLD nat.
Description and content of the pack
ESTECLIN 175 mg/5 ml powder for oral suspension, 100 ml bottle.
Marketing Authorization Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Marketing Authorization Holder's Licensee:
Bruschettini Srl – Via Isonzo 6, 16147 Genoa
Manufacturer and batch release responsible
ZETA FARMACEUTICI SpA, Via Galvani 10, 36066 Sandrigo (VI)