ACETILCISTEINA 600 mg Effervescent Tablet

Зміст інструкції

1. ACETILCISTEINA EG 300 mg/3 ml injectable solution and for nebulizer
   1. What is ACETILCISTEINA EG and what is it used for
   2. What you need to know before using ACETILCISTEINA EG
   3. How to use ACETILCISTEINA EG
   4. Possible side effects
   5. How to store ACETILCISTEINA EG
   6. Contents of the pack and other information
2. ACETILCISTEINA EG 600 mg effervescent tablets
   1. What is ACETILCISTEINA EG and what is it used for
   2. What you need to know before taking ACETILCISTEINA EG
   3. How to take ACETILCISTEINA EG
   4. Possible side effects
   5. How to store ACETILCISTEINA EG
   6. Contents of the pack and other information

ACETILCISTEINA EG 300 mg/3 ml injectable solution and for nebulizer

Generic medicine

Read this leaflet carefully before using 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, pharmacist or nurse.
• 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 any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

ACETILCISTEINA EG contains the active ingredient 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 effect of certain substances.
ACETILCISTEINA EG is indicated for the treatment of respiratory diseases characterized by
increased production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• pathology of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• bronchial dilations (bronchiectasis).

ACETILCISTEINA EG is used as an antidote in particular for:

• accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
• pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs such as iso- 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, unless used as an antidote;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding” section).

Warnings and precautions
Talk to your doctor or pharmacist before using ACETILCISTEINA EG.

Use with cautionthis medicine and always under the control of your doctor in the following cases:

• if you suffer from or have suffered from a stomach or intestinal problem called peptic ulcer, especially if you are taking other medicines with ACETILCISTEINA EG that can cause stomach problems (gastrolesive drugs);
• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Inform your doctor and immediately stop taking the medicine if you have bronchial muscle contraction (bronchospasm);
• in the case of administering the medicine intravenously (via intravenous administration).

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially if
administered by aerosol, at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate
the bronchial secretions through coughing (expectorate), consult your doctor who will indicate a method for
eliminating the mucus (postural drainage or bronchoaspiration).

This medicine must be administered to you with particularcaution and strictly following the
instructions reported in the “How to use ACETILCISTEINA EG” section.
Keep in mind that:

• if ACETILCISTEINA EG is to be administered to counteract the toxic effect of certain substances (antidotal treatment) and you have a body weight of less than 40 Kg. In this case, an excessive administration of fluids may occur with a consequent reduction of sodium in the blood (hyponatremia), convulsions and death;
• if ACETILCISTEINA EG is administered intravenously quickly or in excessive quantities, it may increase the occurrence of undesirable effects.

This medicine may alter some blood parameters (reduction of the prothrombin index, increase
of the INR) when used as an antidote with its recommended dosage (see “How
to use ACETILCISTEINA EG” section).
If you notice a sulfur odor when opening the vial, or the solution turns pink in the open vial or when
transferring the solution to the aerosol device, do not worry as this does not indicate alteration
of the medicine.

Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Inform your doctor that you are
taking this medicine before undergoing these tests.

Children
ACETILCISTEINA EG should not be administered to children under 2 years of age, as it may
obstruct the bronchi and prevent normal breathing.

Other medicines and ACETILCISTEINA EG
Tell 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 medicines(antitussives), as they may lead to
an accumulation of mucus inside the bronchi.
Use this medicine with caution and consult your doctor if you are taking any of the following medicines:

• nitroglycerin, used for some heart disorders. The use of this medicine together with ACETILCISTEINA EG may cause a reduction in blood pressure (hypotension) and headache; your doctor will check your blood pressure periodically;
• antibiotics, medicines used for the treatment of infections, as a reduced activity of the antibiotic may occur. Do not mix these medicines with the solution containing ACETILCISTEINA EG.

You can use ACETILCISTEINA EG together with medicines for the treatment of asthma (see “Warnings and precautions” section) and bronchial and lung diseases (bronchodilators) or medicines for
increasing blood pressure (vasoconstrictors).

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.
Use this medicine if you are pregnant or breastfeeding only if strictly necessary and under the
direct control of your doctor.

Driving and operating machinery
No information is available to establish the effect 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
is equivalent to 2% of the maximum recommended daily intake with the diet of an adult.

3. How to use ACETILCISTEINA EG

Use this medicine following exactly the instructions of the doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Open the vials of ACETILCISTEINA EG at the time of use. Use the opened vials only if stored in
refrigerator and for a maximum of 24 hours. Do not use the vials stored open 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 quickly and do not
store it in the refrigerator.
The dose, the duration of treatment and the method of administration will be established by the doctor based on
your conditions.
This medicine will be administered by a doctor or a nurse in case of injection into a vein
(intravenous administration).

Administration via injection (intravenous):
The recommended dose is 1 vial 1-2 times a day in adults. The doctor will establish the duration of treatment
based on your clinical response.

Treatment of accidental or intentional poisoning with paracetamol:
The initial recommended 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 performed in 15
minutes. Subsequently the dose is 50 mg of N-acetylcysteine per kg of body weight, with 5% glucose solution, to be administered in 4 hours via infusion (infusion), followed by a dose of 100 mg of N-
acetylcysteine per kg of body weight, always with 5% glucose solution, to be infused intravenously in 16 hours.

Administration by aerosol
The recommended dose is 1 vial to be nebulized, 1-2 times a day. The duration of treatment is 5-10 days.
The dose and frequency of the drug may be modified by the doctor. Use a glass or plastic aerosol device and for devices that have metal or rubber parts, it is necessary to wash the devices with water immediately after use.

Administration in the trachea and bronchi
The recommended dose is 1 vial at a time 1-2 times a day or as needed to be administered
using the chosen methods (permanent probes, bronchoscope, etc.). The doctor may modify the frequency
of treatments or the dose for each treatment. However, the maximum dose of 600
mg per day must not be exceeded.

Administrations or ear washes or 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
The symptoms of an overdose following an intravenous injection of an excessive dose are similar, but more serious,
to the undesirable effects listed in the paragraph ”Possible side effects”.
However, no cases of overdose have been reported when this medicine is administered by
aerosol or bronchial route. However, following the administration of an excessive dose of this
medicine, an accumulation of mucus in the bronchi may occur, especially if the patient is unable to
eliminate it by coughing (expectorating). Seek immediate medical attention, who will indicate a method for
removing the mucus (bronchoaspiration).
In case of ingestion/taking an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to use ACETILCISTEINA EG
Do not use a double dose to make up for a missed dose.
If you have any doubts 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 gets them.
The following side effects can occur when ACETILCISTEINA EG is administered
by aerosol (inhalation use) or via endotracheobronchial route:

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

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

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

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

• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• allergic reactions (hypersensitivity);
• fast heartbeat (tachycardia);
• contraction of bronchial muscles (bronchospasm);
• difficulty breathing (dyspnea);
• vomiting;
• nausea;
• swelling, due to fluid retention, of the mouth, eyes, tongue or other parts of the body (angioedema);
• urticaria;
• skin rash;
• pruritus;
• redness;
• swelling (edema) of the face;
• decrease in blood pressure;
• increased time required for blood to clot (prothrombin time).

In very rare cases, severe skin reactions (Stevens Johnson syndrome or Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and consult your
doctor.
Furthermore, a reduction in platelet aggregation (prolongation of bleeding time) is possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 vials at the time of use. Opened vials can only be used if stored in
a refrigerator and for a maximum of 24 hours. Opened vials should not be used for injection.
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.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACETILCISTEINA EG contains

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

Description of the appearance of ACETILCISTEINA EG and contents of the pack
Boxes of 5 or 10 vials of 3 ml injectable and nebulizable solution.

Marketing Authorisation Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan

Manufacturer
Esseti Farmaceutici S.r.l.- Via Campobello, 15 - 00071 Pomezia (Rome)

ACETILCISTEINA EG 600 mg effervescent tablets

Generic Medicine

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

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

ACETILCISTEINA EG contains the active ingredient 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 effect of certain substances.
ACETILCISTEINA EG is indicated for the treatment of diseases of the respiratory system characterized
by an increase in the production of dense and viscous mucus (dense and viscous hypersecretion) such as:

• inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
• pathology of the pulmonary alveoli (pulmonary emphysema);
• cystic fibrosis (mucoviscidosis);
• dilatation of the bronchi (bronchiectasis).

ACETILCISTEINA EG is used as an antidote in particular for:

• accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
• pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs 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 components of this medicine (listed in section 6);
• if you are pregnant or breastfeeding unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking ACETILCISTEINA EG.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Inform your doctor and immediately stop taking ACETILCISTEINA EG if you have contractions of the muscles

bronchial (bronchospasm). Also consult your doctor if these disorders have occurred in the past;

• if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur when taking ACETILCISTEINA EG;
• if you suffer from or have suffered from a problem with your stomach or intestines called a peptic ulcer, especially if you are taking other medicines that can cause stomach problems (gastrolesive 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 eliminate the bronchial secretions (expectorate) through coughing, consult your doctor who will indicate a method for eliminating mucus (postural drainage or bronchoaspiration).
If you notice a sulfurous odor, do not worry because this does not indicate alteration of the preparation, but is
due to N-acetylcysteine.

Laboratory tests: N-acetylcysteine can interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones) (). Inform your doctor that you are
taking this medicine before undergoing these tests.

Other medicines and ACETILCISTEINA EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take this medicine if you are taking:

• cough medicines (antitussives), because they can lead to an accumulation of mucus inside 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 to eliminate intestinal gas (flatulence), because it can reduce the effectiveness of ACETILCISTEINA EG;
• medicines used for the treatment of infections (antibiotics) taken orally (with the exception of loracarbef), as a reduced activity of the antibiotic may occur. Take these medicines at least two hours apart from ACETILCISTEINA EG;
• nitroglycerin, used for some heart disorders. The use of this medicine together with ACETILCISTEINA EG may cause a decrease in blood pressure (hypotension) and headache (cephalalgia). In this case, your doctor will monitor you closely.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if strictly
necessary and under the direct control of your doctor.

Driving and operating machinery
ACETILCISTEINA EG does not affect the ability to drive vehicles and operate machinery.

ACETILCISTEINA EG effervescent tablets contains sodium
This medicine contains 193.9mg of sodium (the main component of table salt) per tablet.
This is equivalent to 9.7% of the recommended maximum daily intake in the diet of an adult.

3. How to take ACETILCISTEINA EG

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

Treatment of respiratory system diseases:
The recommended dose is 1 tablet (600 mg) per day, preferably in the evening.
Your doctor may advise you to modify the frequency and dose of administrations but without exceeding the
maximum daily dose of 600 mg.
The duration of therapy in acute forms ranges from 5 to 10 days and in chronic forms the doctor will evaluate whether
to continue therapy for a few months.

Treatment of accidental or intentional poisoning with paracetamol:
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, to be administered as
soon as possible and in any case within 10 hours of taking paracetamol. Subsequently the dose is 70 mg of
N-acetylcysteine per kg of body weight at intervals of 4 hours for 1-3 days.

Treatment of pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs
such as iso- and cyclophosphamide:
The recommended dose is 4 g of N-acetylcysteine per day, to be divided into 4 doses of 1 g, in patients
undergoing a chemotherapy cycle with iso- and cyclophosphamide for 5 days every 28 days.
Instructions for use of ACETILCISTEINA EG
Dissolve one tablet in a glass containing a little 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 EGthan you should
No cases of overdose have been reported. The symptoms of an overdose may be nausea, vomiting and
diarrhea.
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity);
• headache;
• 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 swallowing or breathing (angioedema);
• itching;
• fever (pyrexia);
• low blood pressure.

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

• bronchial muscle contractions (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)

• swelling (oedema) of the face. In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell’s syndrome) have occurred. If you experience changes to the mucous membranes or skin, stop taking the medicine and consult your doctor. Also consult your doctor if you experience a prolonged bleeding time (reduced platelet aggregation).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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.
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.
Store in the original packaging to protect the medicine from moisture.
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 ACETILCISTEINA EG 600 mg effervescent tablets contain

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

Description of the appearance of ACETILCISTEINA EG and contents of the pack
Pack containing 20 or 30 (15x2) effervescent tablets.

Marketing Authorisation Holder
EG S.p.A. – Via Pavia, 6 – 20136 - Milano

Manufacturer
E-Pharma Trento S.p.A. – Frazione Ravina Via Provina, 2 – 38123 Trento (TN)