Package leaflet: Information for the user

MUCOFRIN 300 mg/3 ml solution for injection and for nebuliser

N-acetylcysteine
Generic Medicine
Please read all of this leaflet carefully before you start 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 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT MUCOFRIN IS AND WHAT IT IS USED FOR

Mucofrin contains the active substance N-Acetylcysteine, which belongs to a group of medicines
called mucolytics, used to facilitate the removal of mucus from the respiratory tract, and to a group
of medicines called antidotes, used to counteract the toxic effects of certain substances.
Mucofrin is indicated in the treatment of respiratory diseases characterized by 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 alveoli pathology (pulmonary emphysema);
cystic fibrosis (mucoviscidosis);
bronchiectasis.

Mucofrin is used as an antidote particularly for:

accidental or intentional paracetamol poisoning, a pain-relieving and antipyretic medicine.
urinary tract disorders (uropathies) caused by chemotherapeutic medicines such as ifosfamide and cyclophosphamide.

2. WHAT YOU NEED TO KNOW BEFORE USING MUCOFRIN

Do not take Mucofrin
if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in
section 6), except when used as an antidote in paracetamol poisoning;

- if the patient is a child under 2 years of age, except when used as an antidote in paracetamol poisoning.

Warnings and precautions
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Talk to your doctor or pharmacist before taking Mucofrin. 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. Discontinue Mucofrin immediately if you experience bronchial muscle contraction (bronchospasm);
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 (gastrolesive drugs);
- If you have previously suffered from atopy and asthma, as you may develop allergic reactions;
- If you are histamine intolerant, as you may develop allergic reactions;

This medicine may increase the volume of bronchial mucus (bronchial secretions),
especially when administered by nebulization, at the beginning of treatment. Therefore, if this occurs and
you are unable to clear bronchial secretions by coughing (expectoration), consult your doctor,
who will advise you on an appropriate method to remove mucus (postural drainage or bronchoaspiration).
Allergic reactions (hypersensitivity/anaphylactoid reactions) may occur with acetylcysteine. Monitoring
for signs of an allergic reaction may be necessary.
This medicine should be administered with particular caution and strictly according to the instructions
provided in section “How to take Mucofrin”.
Please note that:

administration of Mucofrin to counteract the toxic effects of certain substances (antidotal treatment) has very rarely caused death;
if Mucofrin is administered to counteract the toxic effects of certain substances (antidotal treatment) in individuals weighing less than 40 kg, excessive fluid administration may occur, leading to reduced sodium levels in the blood (hyponatremia), seizures, and death;
if Mucofrin is administered intravenously too rapidly 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.
If you notice a sulfur-like odor upon opening the vial, or if the solution turns pink in the opened vial
or when transferring the solution to the nebulizer device, do not be concerned, as this does not
indicate any deterioration of the medicine.
Laboratory tests: acetylcysteine may interfere with certain blood and urine analyses
(colorimetric assay for salicylate determination and ketone detection tests). Inform
your doctor that you are taking this medicine before undergoing such tests.
Children
Mucofrin must not be administered to children under 2 years of age, as it may obstruct the
bronchi and impair normal breathing.
The same warnings and precautions applicable to adults also apply to children and adolescents.
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Other medicines and Mucofrin
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 using 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. Concurrent use of this medicine with Mucofrin may cause low blood pressure (hypotension) and headache (cephalalgia);
antibiotics, medicines used to treat infections. Do not mix these medicines with the solution containing Mucofrin.

Mucofrin may be used together with medicines for the treatment of asthma (see section
“Warnings and precautions”) and bronchial or lung diseases (bronchodilators), or
medicines to increase blood pressure (vasoconstrictors).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Take this medicine during pregnancy only if strictly necessary and under direct medical supervision.
Breastfeeding
The use of Mucofrin should be avoided during breastfeeding. Consult your doctor before deciding whether to discontinue
breastfeeding and/or starting/discontinuing treatment with Mucofrin.
Fertility
No data are available on the effect of Mucofrin on fertility.
Driving and use of machinery:
There is no information available to determine the effect on the ability to drive vehicles or
operate machinery.
Mucofrin contains sodium
This medicine contains 40.62 mg (1.76 mmol) of sodium (a key component of table
salt) per vial. This corresponds to 2% of the maximum daily recommended dietary intake for an
adult. This should be taken into account in individuals with impaired renal function or those
following a low-sodium diet.

3. HOW TO TAKE MUCOFRIN

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Open the MUCOFRIN vial immediately before use. Use opened vials only if stored in the refrigerator and for no longer than 24 hours. Do not use vials that have been opened and stored for intravenous administration.
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If MUCOFRIN is mixed with medicines for the treatment of asthma and bronchial or lung diseases (bronchodilators) or other medicines, use the solution promptly and do not store it. The dose, duration of treatment, and route 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 (endovenous administration).

Administration by intravenous injection:
Treatment of accidental or intentional paracetamol poisoning:
Mucofrin will be administered slowly into a vein by intravenous infusion. The medicine will be administered in a hospital setting by a doctor or nurse who will prepare the infusion. If you have any doubts, consult your doctor or nurse.

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 of the medicine may be adjusted by your doctor.
Use a nebulizer made of glass or plastic. For devices containing metal or rubber parts, it is necessary to wash the equipment with water immediately after use.

Administration into the bronchi:
The recommended dose is 1 vial at a time, 1–2 times daily, or according to clinical need, administered via the chosen method (indwelling catheters, bronchoscope, etc.).

Administration for ear irrigation or irrigation of other body cavities:
The recommended dose is half or one entire vial at a time.

How to open the vial:
Firmly hold the lower part of the vial in one hand and place the index finger of the other hand in the indentation of the vial, applying pressure with the thumb.

If you use more Mucofrin than you should:
Symptoms of overdose following excessive intravenous injection are similar but more severe than the undesirable effects listed in section “Possible side effects”. Cases of overdose have not 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 clear it by coughing (expectoration). Seek immediate medical advice; your doctor will recommend a method to remove the mucus (bronchoaspiration).
In case of ingestion or intake of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur when MUCOFRIN is administered via aerosol (inhalation use) or by endotracheobronchial route:
Frequency not known (frequency cannot be estimated from the available data)

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

The following adverse reactions may occur when MUCOFRIN is administered intravenously (parenteral use):
Frequency not known (frequency cannot be estimated from the available data)

severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
allergic reactions (hypersensitivity);
rapid heartbeat (tachycardia);
bronchial muscle contraction (bronchospasm);
breathing difficulty (dyspnea);
vomiting;
nausea;
swelling due to fluid accumulation around the mouth and eyes (angioedema);
urticaria;
skin rash;
pruritus;
redness;
facial swelling (facial edema);
decrease in blood pressure;
prolonged blood clotting time (prothrombin time).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell syndrome) have been reported. If you experience changes in mucous membranes or skin, stop taking the medicine and consult your doctor. Additionally, a reduction in platelet aggregation (prolonged bleeding time) is possible.
Reporting of adverse reactions
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If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
https://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 MUCOFRIN

Keep this medicine out of the sight and reach of children.
It is recommended to open the vials immediately before use. Opened vials may only be used if
stored in the refrigerator and for a maximum of 24 hours. Opened vials 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.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

The active substance is N-Acetylcysteine: 1 vial of 3 ml contains 300 mg of N-Acetylcysteine.
The other components are: sodium hydroxide, sodium edetate, water for injections.
Description of the appearance of MUCOFRIN and package contents
Box of 5 vials of 3 ml each.
Marketing Authorization Holder
MavenPharma S.r.l.
Via Stefano Jacini, 68 - 00191 Rome
MANUFACTURER
Esseti Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia (Rome)
This leaflet was last approved
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