FLUIMUCIL*NEBUL 20F 300MG/3ML

FLUIMUCIL 300 mg/3 ml nebuliser solution
N-acetylcysteine

What it is and what it is used for
Fluimucil 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.

Fluimucil is indicated for the treatment of respiratory diseases characterised 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);
- pathology of the pulmonary alveoli (pulmonary emphysema);
- cystic fibrosis (mucoviscidosis);
- bronchial dilations (bronchiectasis).

Consult your doctor if you do not feel better or if you feel worse after 10 days.

What you need to know before taking the medicine
Do not take Fluimucil:
- 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.

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

Take this medicine with caution and always under medical supervision in the following cases:
- if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Immediately stop taking Fluimucil if you experience bronchial muscle contraction (bronchospasm);
- if you have a history of atopy and asthma, as you may develop allergic reactions;
- if you are histamine intolerant, as you may develop allergic reactions;
- if you suffer or have suffered from a stomach or intestinal problem called peptic ulcer, especially if you are taking other medicines that cause stomach problems (gastro-damaging drugs) together with Fluimucil;

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

Allergic reactions (hypersensitivity/anaphylactoid reactions) may occur with N-acetylcysteine. Monitoring for signs of an allergic reaction may be necessary.

If you smell sulphur when opening the ampoule, or if the solution turns pink in the opened ampoule 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 analyses (colorimetric assay for salicylate determination and ketone determination test). Inform your doctor that you are taking this medicine before undergoing these tests.

Children
Fluimucil should not be administered to children under 2 years of age, as it can obstruct the bronchi and impede normal breathing.
The same warnings and precautions apply to children and adolescents as for adults.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known (cannot be estimated from the available data):
- allergic reactions (hypersensitivity);
- bronchial muscle contraction (bronchospasm);
- runny nose (rhinorrhea);
- breathing difficulties (bronchial obstruction);
- inflammation of the mouth (stomatitis);
- vomiting;
- nausea;
- urticaria;
- skin rash;
- itching.
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.
Furthermore, a reduction in platelet aggregation (prolonged bleeding time) is possible.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.