FLUIMUCIL MUCOL*30SACHETS200MGS/Z

FLUIMUCIL MUCOLITICO 200 mg granules for oral solution, sugar-free
N-Acetylcysteine

What it is and what it is used for
This medicine contains the active ingredient N-acetylcysteine, which belongs to a group of medicines called expectorants - mucolytics, used to facilitate the elimination of mucus from the respiratory tract.

Fluimucil Mucolitico is indicated for the treatment of respiratory diseases characterized by an increase in the production of thick and viscous mucus (dense and viscous hypersecretion).
Contact your doctor if you do not improve or if you feel worse after 10 days.

What you need to know before taking the medicine
Do not take Fluimucil Mucolitico
- 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 (See section Pregnancy and breastfeeding).

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

Take this medicine with caution and always under medical supervision in the following cases:
- if you suffer from a chronic inflammatory disease of the bronchi called bronchial asthma. Stop taking the medicine if, after taking it, you experience dyspnea (difficulty breathing), due to the onset of contraction of the bronchial muscles (bronchospasm). Consult your doctor even if these disorders have occurred in the past;
- if you are intolerant to histamine, in case of therapy with Fluimucil Mucolitico, allergic reactions (hypersensitivity) may occur;
- 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 (gastrolesive drugs) together with Fluimucil Mucolitico.

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 through coughing (expectorate), contact your doctor, who will indicate a method to eliminate the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur smell, do not worry as this does not indicate an alteration of the preparation, but is due to N-acetylcysteine.

Laboratory tests: N-acetylcysteine can interfere with some blood and urine tests (colorimetric assay for salicylate determination and ketone tests). Inform your doctor that you are taking this medicine before undergoing tests.

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 (cephalgia);
- ringing in the ear (tinnitus);
- increased heart rate (tachycardia);
- vomiting;
- diarrhea;
- inflammation of the mouth (stomatitis);
- abdominal pain;
- nausea;
- skin irritations (urticaria, rash);
- swelling due to fluid accumulation around the mouth and eyes (angioedema);
- itching;
- fever (pyrexia);
- reduced blood pressure.

Rare (may affect up to 1 in 1,000 people)
- contractions of the bronchial muscles (bronchospasm);
- difficulty breathing (dyspnea);
- digestive difficulties (dyspepsia).

Very rare (may affect up to 1 in 10,000 people)
- severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
- bleeding (hemorrhage).

Not known (frequency cannot be estimated from the available data)
- swelling (edema) of the face.

Talk to your doctor if you experience any of the following side effects:
- skin lesions (Stevens Johnson syndrome or Lyell's syndrome). If you experience changes in the mucous membranes or skin, stop taking the medicine;
- blood problems (reduced platelet aggregation).

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.