ESTECLIN 300 mg Kapsułka Twarda

Treść ulotki

1. ESTECLIN 300 mg hard capsules
   1. What Esteclin is and what it is used for
   2. What you need to know before you take Esteclin
   3. How to take Esteclin
   4. Possible side effects
   5. How to store Esteclin
   6. Contents of the pack and other information
2. ESTECLIN 300 mg dispersible tablets
   1. What Esteclin is and what it is used for
   2. What you need to know before you take Esteclin
   3. How to take Esteclin
   4. Possible side effects
   5. How to store Esteclin
   6. Contents of the pack and other information
3. ESTECLIN 225 mg granules for oral suspension
   1. What Esteclin is and what it is used for
   2. What you need to know before you take Esteclin
   3. How to take Esteclin
   4. Possible side effects
   5. How to store Esteclin
   6. Contents of the pack and other information
4. ESTECLIN 175 mg/5 ml powder for oral suspension
   1. What Esteclin is and what it is used for
   2. What you need to know before you take Esteclin
   3. How to take Esteclin
   4. Possible side effects
   5. How to store Esteclin
   6. Contents of the pack and other information

ESTECLIN 300 mg hard capsules

Erdosteine
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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esteclin is and what it is used for

Esteclin contains the active ingredient erdosteine. It is a mucolytic, fluidifying agent in acute and chronic conditions of the respiratory system.

2. What you need to know before you take Esteclin

Do not take Esteclin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from lesions of the stomach or intestine (active peptic ulcer);
• if you suffer from renal insufficiency with creatinine clearance <25 ml/min or severe hepatic insufficiency;
• if you are affected by cirrhosis of the liver and deficiency of the cystathionine-synthetase enzyme due to the probable interference of the product metabolites with methionine metabolism.
• if the person who is to take the medicine is a child under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Esteclin.
Children
Esteclin is contraindicated in children under 2 years of age. Mucolytics may induce
bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of
bronchial mucus is limited in this age group due to the physiological characteristics
of the airways.

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 the medicine can therefore be
usefully associated with antibiotics and bronchodilators (theophylline or beta2mimetics,
cough sedatives, etc.).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
The safety of erdosteine in human pregnancy has not been established, therefore, its
use is not recommended.
Its use during breastfeeding is also not recommended.

Effects on ability to drive and operate machinery
Esteclin does not alter the ability to drive vehicles or operate machinery.

3. How to take Esteclin

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

Adults
1 capsule 2-3 times a day, for oral use.
The capsules must be swallowed whole with a glass of water.

If you take more Esteclin than you should
With dosages higher than those recommended (1200 mg/day), sweating,
dizziness and hot flushes have been reported.
In case of accidental ingestion/intake of an excessive dose of Esteclin, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Esteclin
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Less than 1 in 1000 patients may complain of gastrointestinal side effects.
The following frequency 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 from the
available data).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
http://www.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 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 package and on the label
after “Exp”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
The possible presence of a sulfurous (sulfur) odour does not indicate alteration of the product, but is
characteristic of the Active Substance contained within it.
Store at a temperature not exceeding 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Esteclin contains
The active ingredient is erdosteine.
Each capsule contains 300 mg of Erdosteine
The other ingredients 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 of 20 capsules

Marketing Authorisation Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Distributor:
Bruschettini Srl – Via Isonzo 6, 16147 Genova

Manufacturer and batch release
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

ESTECLIN 300 mg dispersible tablets

Erdosteine
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esteclin is and what it is used for

Esteclin contains the active ingredient erdosteine. It is a mucolytic, fluidifying agent in acute and chronic conditions of the respiratory system.

2. What you need to know before you take Esteclin

Do not take Esteclin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from lesions of the stomach or intestine (active peptic ulcer);
• if you suffer from renal insufficiency with creatinine clearance <25 ml/min or severe hepatic insufficiency;
• if you are affected by hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme due to the probable interference of the product's metabolites with methionine metabolism.
• if the person who is going to take the medicine is a child under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Esteclin.

Children
Esteclin is contraindicated in children under 2 years of age. Mucolytics may induce
bronchial obstruction in children under 2 years of age. In fact, the ability to drain
bronchial mucus is limited in this age group, due to the physiological characteristics
of the airways.

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 the medicine can therefore be
usefully associated with antibiotics and bronchodilators (theophylline or beta2-mimetics,
cough sedatives, etc…).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
The safety of erdosteine in human pregnancy has not been established, therefore, its
use is not recommended.
Its use during breastfeeding is also not recommended.

Effects on ability to drive and use machines
Esteclin does not alter the ability to drive vehicles or use machines.

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 intolerance to some sugars,
contact him/her before taking this medicine.

Sunset Yellow
Sunset Yellow (E110) is a dye that can cause allergic reactions.

3. How to take Esteclin

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

Adults
1 tablet 2-3 times a day, for oral use.
The tablets must be dissolved in a glass of water. Mix with a teaspoon and drink
immediately.

If you take more Esteclin than you should
With dosages higher than those recommended (1200 mg/day), sweating,
dizziness and hot flushes have been reported.
In case of accidental ingestion/intake of an excessive dose of Esteclin, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Esteclin
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Less than 1 in 1000 patients may complain of gastrointestinal side effects.
The following frequency 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 from the
available data).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at:
http://www.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 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 package and on the label
after “Exp”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
The possible presence of a sulfurous (sulfur) odour does not indicate alteration of the product, but is
characteristic of the Active Substance contained within it.
Store at a temperature below 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Esteclin contains
The active ingredient is erdosteine.
Each tablet contains 300 mg of erdosteine
The other ingredients are lactose, microcrystalline cellulose, sucralose, sodium croscarmellose,
talc, magnesium stearate, mango flavour, Sunset Yellow (E110), povidone, colloidal silicon dioxide.

Description and contents of the pack
ESTECLIN 300 mg dispersible tablets, pack of 20 tablets

Marketing Authorisation Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Distributor:
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)

ESTECLIN 225 mg granules for oral suspension

Erdosteine
Read this leaflet carefully before you start to take 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esteclin is and what it is used for

Esteclin contains the active ingredient erdosteine. It is a mucolytic, fluidifying agent in acute and chronic conditions of the respiratory system.

2. What you need to know before you take Esteclin

Do not take Esteclin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from lesions of the stomach or intestine (active peptic ulcer);
• if you suffer from renal insufficiency with creatinine clearance <25 ml/min or severe hepatic insufficiency;
• if you are affected by hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme due to the probable interference of the product metabolites with methionine metabolism.
• if the person who has to take the medicine is a child under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Esteclin.

Children
Esteclin is contraindicated in children under 2 years of age. Mucolytics may induce
bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of
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 the medicine can therefore be
usefully associated with antibiotics and bronchodilators (theophylline or beta2mimetics,
cough sedatives, etc…).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
The safety of erdosteine in human pregnancy has not been established, therefore its
use is not recommended.
Its use during breastfeeding is also not recommended.

Effects on ability to drive and operate machinery
Esteclin does not alter the ability to drive vehicles or operate machinery.

Sucrose
If your doctor has diagnosed you with 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 following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

Adults
1 sachet 2-3 times a day, for oral use.
The contents of the sachet must be dissolved in water. Mix with a teaspoon and drink
immediately.

If you take more Esteclin than you should
With dosages higher than those recommended (1200 mg/day), sweating,
dizziness and hot flushes have been detected.
In case of accidental ingestion/intake of an excessive dose of Esteclin, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Esteclin
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Less than 1 in 1000 patients may complain of gastrointestinal side effects.
The following frequency 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 from the
available data).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at:
http://www.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 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 package and on the label
after “Exp”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
The possible presence of a sulfurous (sulfur) odour does not indicate alteration of the product, but is
characteristic of the Active Substance contained within it.
Store at a temperature below 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Esteclin contains
The active ingredient is erdosteine.
Each sachet contains 225 mg of erdosteine
The other ingredients are sucrose, malic acid, sodium starch glycolate, orange flavour,
sucralose, silicon dioxide

Description and contents of the pack
ESTECLIN 225 mg granules for oral suspension, pack of 20 sachets

Marketing Authorisation Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Distributor:
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)

ESTECLIN 175 mg/5 ml powder for oral suspension

Erdosteine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esteclin is and what it is used for

Esteclin contains the active ingredient erdosteine. It is a mucolytic, fluidifying agent in acute and chronic conditions of the respiratory system.

2. What you need to know before you take Esteclin

Do not take Esteclin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from lesions of the stomach or intestine (active peptic ulcer);
• if you suffer from renal insufficiency with creatinine clearance <25 ml/min or severe hepatic insufficiency;
• if you are affected by hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme due to the probable interference of the product metabolites with methionine metabolism;
• if the person who is to take the medicine is a child under the age of 2 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking Esteclin.

Children
Esteclin is contraindicated in children under the age of 2 years. Mucolytics may induce bronchial obstruction in children under the age of 2 years. In fact, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the airways.

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 the medicine can therefore be usefully associated with antibiotics and bronchodilators (theophylline or beta2mimetics, cough sedatives, etc.).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of erdosteine in human pregnancy has not been established, therefore its use is not recommended.
Its use during breastfeeding is also not recommended.

Effects on ability to drive and operate machinery
Esteclin does not alter the ability to drive vehicles or operate machinery.

Sucrose
If your doctor has diagnosed you with 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 following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
5 ml, twice a day, in children weighing between 15 and 19 kg; 5 ml of suspension three
times a day in children weighing between 20 and 30 kg; 10 ml of suspension twice a day in
children weighing more than 30 kg and in adults.
Add water to the bottle up to the level mark. Shake until completely dispersed 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 dosages higher than those recommended (1200 mg/day), sweating,
dizziness and hot flushes have been detected.
In case of accidental ingestion/intake of an excessive dose of Esteclin, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Esteclin
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Less than 1 in 1000 patients may complain of gastrointestinal side effects.
The following frequency 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 from the
available data).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
http://www.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 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 package and on the label
after “Exp”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
The possible presence of a sulfurous (sulfur) odour does not indicate alteration of the product, but is
characteristic of the Active Substance contained within it.
The ready-to-use suspension can be used for a maximum of 15 days if stored
in the refrigerator.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Esteclin contains
The active ingredient is erdosteine.
Each 5 ml of oral suspension contains 175 mg of erdosteine
The other ingredients are sucrose, sodium benzoate, sodium starch glycolate, orange aroma
powder, anhydrous citric acid, sucralose, aroma mask CLD nat.

Description and contents of the pack
ESTECLIN 175 mg/5 ml powder for oral suspension, 100 ml bottle

Marketing Authorisation Holder
Edmond Pharma Srl – Strada Statale dei Giovi 131 – 20037 Paderno Dugnano (MI) – Italy
Distributor for sales:
Bruschettini Srl – Via Isonzo 6, 16147 Genova

Manufacturer and batch release responsible
ZETA FARMACEUTICI SpA, Via Galvani 10, 36066 Sandrigo (VI)