Acetylcysteine EG: detailed information

Package leaflet: Information for the user

ACETYLCYSTEINE EG 300 mg/3 ml solution for injection and inhalation

Generic medicine
Please read this leaflet carefully before using 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, pharmacist, or nurse.
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 adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What ACETYLCYSTEINE EG is and what it is used for
What you need to know before using ACETYLCYSTEINE EG
How to use ACETYLCYSTEINE EG
Possible side effects
How to store ACETYLCYSTEINE EG
Contents of the pack and other information

1. What ACETILCISTEINA EG is and what it is used for

ACETILCISTEINA EG contains the active substance N-acetylcysteine, which belongs to a group of
medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract, and to a group
of medicines called antidotes, used to counteract the toxic effects of certain substances.
ACETILCISTEINA EG is indicated for the treatment of respiratory diseases characterized by
an increased production of thick and viscous mucus (dense and viscous hypersecretion), such as:

inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
lung alveolar disease (pulmonary emphysema);
cystic fibrosis (mucoviscidosis);
bronchiectasis.

ACETILCISTEINA EG is used as an antidote particularly in cases of:

accidental or intentional paracetamol overdose, an anti-inflammatory medicine;
urinary tract disease (uropathy) caused by chemotherapeutic agents such as ifosfamide and cyclophosphamide.

2. What you need to know before using ACETILCISTEINA EG

Do not use ACETILCISTEINA EG

if you are allergic to N-acetylcysteine or to any of the other ingredients of this medicine (listed in section 6);
if the patient is a child under 2 years of age, except when used as an antidote;
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using ACETILCISTEINA EG.
Use this medicine with caution, and always under medical supervision, in the following cases:

if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are taking other medicines together with ACETILCISTEINA EG that may cause stomach problems (gastrotoxic drugs);
if you suffer from a bronchial inflammatory disease called bronchial asthma. Inform your doctor and stop taking the medicine immediately if you experience bronchial muscle contraction (bronchospasm);
when the medicine is administered intravenously (intravenous route).

This medicine may increase bronchial mucus volume (bronchial secretions), especially when administered by aerosol, at the beginning of treatment. Therefore, if this occurs and you are unable to clear the bronchial secretions by coughing (expectorate), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
This medicine must be administered to you with particular caution and strictly following the instructions provided in section “How to use ACETILCISTEINA EG”.
Please note that:

if ACETILCISTEINA EG is administered to counteract the toxic effects of certain substances (antidotal treatment) and your body weight is less than 40 kg, excessive fluid administration may occur, leading to reduced sodium levels in the blood (hyponatremia), seizures, and death;
if ACETILCISTEINA EG is administered rapidly intravenously or in excessive amounts, the occurrence of adverse effects may increase.

This medicine may alter certain blood parameters (reduction in prothrombin index, increase in INR) when used as an antidote at the recommended dosage (see section “How to use ACETILCISTEINA EG”).
If you detect a sulfur-like odor when opening the vial, or if the solution turns pink in the opened vial or during transfer of the solution into the nebulizer device, do not be concerned, as this does not indicate degradation of the medicine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate measurement and tests for ketone detection). Inform your doctor that you are taking this medicine before undergoing such tests.
Children
ACETILCISTEINA EG must not be administered to children under 2 years of age, as it may obstruct the bronchi and impair normal breathing.
Other medicines and ACETILCISTEINA EG
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not use this medicine if you are taking cough suppressants (antitussives), as they may lead to mucus accumulation in the bronchi.
Use this medicine with caution and consult your doctor if you are taking any of the following medicines:

nitroglycerin, used for certain heart conditions. Concomitant use of this medicine with ACETILCISTEINA EG may cause a reduction in blood pressure (hypotension) and headache (cephalalgia); your doctor will monitor your blood pressure periodically;
antibiotics, medicines used to treat infections, as reduced antibiotic activity may occur. Do not mix these medicines with the solution containing ACETILCISTEINA EG.

ACETILCISTEINA EG may be used together with medicines for asthma (see section “Warnings and precautions”) and bronchial or lung diseases (bronchodilators), or medicines to increase blood pressure (vasoconstrictors).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.
Driving and using machines
There is no available information on the effects of this medicine on the ability to drive vehicles or operate machinery.
ACETILCISTEINA EG contains sodium
This medicine contains 42 mg of sodium (the main component of table salt) per vial. This corresponds to 2% of the maximum daily dietary intake recommended for an adult.

3. How to use ACETILCISTEINA EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Open the ACETILCISTEINA EG vials immediately before use. Use opened vials only if stored in the refrigerator and within a maximum of 24 hours. Do not use opened vials for intravenous administration.

If ACETILCISTEINA EG is mixed with medicines for the treatment of asthma and diseases of the bronchi and lungs (bronchodilators) or other medicines, use the solution promptly and do not store it in the refrigerator.

The dose, duration of treatment, and method of administration will be determined by your doctor according to your condition.

This medicine will be administered by a doctor or nurse in the case of intravenous injection (intravenous administration).

Intravenous administration (injection):
The recommended dose is 1 vial 1–2 times daily in adults. Your doctor will determine the duration of treatment based on your clinical response.

Treatment of accidental or intentional paracetamol poisoning:
The recommended initial dose for intravenous administration is 150 mg of N-acetylcysteine per kg of body weight, added to an equal volume of 5% glucose solution. The injection should be given over 15 minutes. Subsequently, administer 50 mg of N-acetylcysteine per kg of body weight, with 5% glucose solution, over 4 hours via infusion (intravenous infusion), followed by 100 mg of N-acetylcysteine per kg of body weight, again with 5% glucose solution, infused intravenously over 16 hours.

Administration by nebulization (aerosol):
The recommended dose is 1 vial to be nebulized, 1–2 times daily. The duration of treatment is 5–10 days. The dose and frequency may be adjusted by your doctor. Use a glass or plastic nebulizer device. For devices containing metal or rubber parts, it is necessary to wash the equipment with water immediately after use.

Administration into the trachea and bronchi:
The recommended dose is 1 vial at a time, 1–2 times daily, or as needed, administered by the chosen method (e.g., indwelling catheters, bronchoscope, etc.). Your doctor may adjust the frequency of treatments or the dose for each administration. However, the maximum daily dose of 600 mg must not be exceeded.

Ear instillations or irrigation of other body cavities:
The recommended dose is half a vial or 1 vial at a time.

If you use more ACETILCISTEINA EG than you should:
Symptoms of overdose following excessive intravenous injection are similar to, but more severe than, the undesirable effects listed in section "Possible side effects".

No cases of overdose have been reported when this medicine is administered by aerosol or bronchial route. However, after administration of an excessive dose, accumulation of mucus in the bronchi may occur, especially if the patient is unable to expel it by coughing (expectoration). Seek immediate medical advice; the doctor will recommend a method to remove the mucus (bronchoaspiration).

In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to use ACETILCISTEINA EG:
Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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 when ACETILCISTEINA EG is administered by nebuliser (inhaled use) or by endotracheobronchial route:

Frequency not known (frequency cannot be estimated from the available data)

urticaria;
rash;
itching (pruritus);
bronchial muscle constriction (bronchospasm);
vomiting;
nausea;
allergic reactions (hypersensitivity);
runny nose (rhinorrhea);
inflammation of the mouth (stomatitis);
bronchial obstruction.

The following additional side effects may occur when ACETILCISTEINA EG is administered intravenously (parenteral use):

Frequency not known (frequency cannot be estimated from the available data)

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reactions);
allergic reactions (hypersensitivity);
rapid heartbeat (tachycardia);
bronchial muscle constriction (bronchospasm);
breathing difficulties (dyspnoea);
vomiting;
nausea;
swelling due to fluid accumulation in the mouth, eyes, tongue or other parts of the body (angioedema);
urticaria;
rash;
itching (pruritus);
redness;
facial swelling (facial oedema);
decrease in blood pressure;
prolonged blood clotting time (prothrombin time).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell's syndrome) have been reported. If you experience changes in mucous membranes or skin, stop taking the medicine and consult your doctor immediately.

Additionally, a reduction in platelet aggregation (prolonged bleeding time) may occur.

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 ACETILCISTEINA EG

Keep this medicine out of the sight and reach of children.
It is recommended to open the ampoules immediately before use. Opened ampoules can only be used if stored in
the refrigerator and for a maximum of 24 hours. Ampoules stored after opening must not be used for injection.
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.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 ACETILCISTEINA EG contains

The active substance is N-acetylcysteine: 1 vial of 3 ml contains 300 mg of N-acetylcysteine.
The other components are: sodium hydroxide, edetate disodium, water for injections.

Description of the appearance of ACETILCISTEINA EG and package contents
Boxes containing 5 or 10 vials of 3 ml of injectable and nebulizable solution.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (Rome)

Package leaflet: Information for the patient

ACETILCISTEINA EG 600 mg effervescent tablets

Generic Medicine
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 ACETILCISTEINA EG is and what it is used for
What you need to know before taking ACETILCISTEINA EG
How to take ACETILCISTEINA EG
Possible side effects
How to store ACETILCISTEINA EG
Package contents and other information

1. What ACETILCISTEINA EG is and what it is used for

ACETILCISTEINA EG contains the active substance N-acetylcysteine, which belongs to a group of
medicinal products called mucolytics, used to facilitate the elimination of mucus from the respiratory tract, and to a
group of medicinal products called antidotes, used to counteract the toxic effects of certain substances.
ACETILCISTEINA EG is indicated for the treatment of respiratory diseases characterized
by an increased production of thick and viscous mucus (dense and viscous hypersecretion), such as:

inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
lung alveolar disease (pulmonary emphysema);
cystic fibrosis (mucoviscidosis);
bronchiectasis.

ACETILCISTEINA EG is used as an antidote particularly in cases of:

accidental or intentional poisoning with paracetamol, an anti-inflammatory medicinal product;
urinary tract disorders (uropathy) caused by chemotherapeutic medicinal products such as iso- and cyclophosphamide.

2. What you need to know before taking ACETILCISTEINA EG

Do not take ACETILCISTEINA EG

if you are allergic to N-acetylcysteine, to similar substances, or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding, unless specifically advised by your doctor after careful evaluation (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACETILCISTEINA EG.
Take this medicine with caution and always under medical supervision in the following cases:

if you suffer from a bronchial inflammatory disease called bronchial asthma. Inform your doctor and immediately stop taking ACETILCISTEINA EG if you experience bronchial muscle contractions (bronchospasm). Consult your doctor also if such symptoms have occurred in the past;
if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with ACETILCISTEINA EG;
if you have or have had a stomach or intestinal disorder called peptic ulcer, especially if you are concurrently taking other medicines that may cause stomach problems (gastrotoxic drugs) together with ACETILCISTEINA EG.

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to clear the bronchial secretions by coughing (expectoration), consult your doctor, who will advise you on a method to remove the mucus (postural drainage or bronchoaspiration).
If you notice a sulfur-like odor, do not be concerned, as this does not indicate deterioration of the product but is due to N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with certain blood and urine analyses (colorimetric assay for salicylate determination and tests for ketones). Inform your doctor that you are taking this medicine before undergoing such tests.
Other medicines and ACETILCISTEINA EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking:

cough suppressants (antitussives), as they may lead to mucus accumulation in the bronchi. Take this medicine with caution and consult your doctor if you are taking any of the following medicines:
activated charcoal, used to treat digestive disorders or intestinal gas (meteorism), as it may reduce the effectiveness of ACETILCISTEINA EG;
antibiotics (medicines used to treat infections) taken orally (except loracarbef), as reduced antibiotic activity may occur. Take these medicines at least two hours apart from ACETILCISTEINA EG;
nitroglycerin, used for certain heart conditions. Concomitant use of this medicine with ACETILCISTEINA EG may cause low blood pressure (hypotension) and headache (cephalalgia). In such cases, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy or while breastfeeding only if strictly necessary and under direct medical supervision.
Driving and using machines
ACETILCISTEINA EG does not affect the ability to drive or operate machinery.
ACETILCISTEINA EG effervescent tablets contain sodium
This medicine contains 193.9 mg of sodium (a main component of table salt) per tablet.
This corresponds to 9.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take ACETILCISTEINA EG

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Treatment of respiratory tract diseases:
The recommended dose is 1 tablet (600 mg) daily, preferably in the evening.
Your doctor may advise you to adjust the frequency and dosage, but without exceeding the maximum daily dose of 600 mg.
The duration of treatment in acute forms ranges from 5 to 10 days; in chronic forms, your doctor will evaluate whether to continue treatment for several months.
Treatment of accidental or intentional paracetamol poisoning:
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, administered as soon as possible and within 10 hours of paracetamol intake. Subsequently, the dose is 70 mg of N-acetylcysteine per kg of body weight every 4 hours for 1–3 days.
Treatment of urinary tract disorders (uropathy) caused by chemotherapeutic agents such as ifosfamide and cyclophosphamide:
The recommended dose is 4 g of N-acetylcysteine per day, divided into 4 doses of 1 g, in patients undergoing chemotherapy cycles with ifosfamide and cyclophosphamide, for 5 days every 28 days.

Instructions for use of ACETILCISTEINA EG
Dissolve one tablet in a glass containing some water, stirring if necessary with a teaspoon.
Take the medicine immediately after preparing the solution.
Do not mix other medicines with the ACETILCISTEINA EG solution.

If you take more ACETILCISTEINA EG than you should
Cases of overdose have not been reported. Symptoms of overdose may include nausea, vomiting, and diarrhea.
If you take too much of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take ACETILCISTEINA EG
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 everybody will experience them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

allergic reactions (hypersensitivity);
headache (cephalalgia);
ringing in the ears (tinnitus);
increased heart rate (tachycardia);
vomiting;
diarrhoea;
inflammation of the mouth (stomatitis);
abdominal pain;
nausea;
urticaria, skin rash;
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
itching (pruritus);
fever (pyrexia);
low blood pressure.

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

bronchial muscle spasms (bronchospasm);
difficulty breathing (dyspnoea);
digestive difficulties (dyspepsia).

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

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
bleeding (haemorrhage).

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

facial swelling (oedema). In very rare cases, severe skin reactions have occurred (Stevens-Johnson syndrome or Lyell's syndrome). If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your doctor. You should also consult your doctor if you experience prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 ACETYLCYSTEINE EG

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.
Store in the original packaging to protect the medicine from moisture.
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 ACETILCISTEINA EG 600 mg effervescent tablets contains

The active substance is N-acetylcysteine: 1 effervescent tablet contains 600 mg of N-acetylcysteine.
The other components are: anhydrous citric acid, sodium bicarbonate, maltodextrins, L-leucine, sodium saccharin, orange flavour.

Description of the appearance of ACETILCISTEINA EG and package contents
Carton containing 20 or 30 (15x2) effervescent tablets.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 - Milan
Manufacturer
E-Pharma Trento S.p.A. – Ravina fraction, Via Provina, 2 – 38123 Trento (TN)