FLUIMUCIL MUCOL*SYR 100MG/5ML

FLUIMUCIL MUCOLITICO 100 mg/5 ml syrup
N-acetylcysteine

What it is and what it is used for
This medicine contains the active substance 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 increased production of thick and viscous mucus (dense and viscous hypersecretion). Consult your doctor if your condition does not improve or worsens after 10 days.

What you need to know before taking the medicine
Do not take Fluimucil Mucolitico
- if you are allergic to N-acetylcysteine, similar substances or any of the other ingredients of this medicine (listed in paragraph 6);
- if the patient is a child under 2 years of age (See paragraph "Children");
- if you are pregnant or breastfeeding (See paragraph "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 bronchial muscle contraction (bronchospasm). Consult your doctor even if these disorders have occurred in the past;
- if you are histamine intolerant, allergic reactions (hypersensitivity) may occur during treatment with Fluimucil Mucolitico;
- 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 clear bronchial secretions by coughing (expectorate), contact your doctor who will suggest a method for eliminating the mucus (postural drainage or bronchoaspiration).

If you notice a sulfur smell, do not worry because 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 the determination of salicylates and tests to determine ketones). Inform your doctor that you are taking this medicine before undergoing any tests.

Children
Fluimucil Mucolitico should not be administered to children under 2 years of age for the treatment of respiratory problems because it can obstruct the bronchi and prevent normal breathing.

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 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)
- contraction of 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)
- bronchial obstruction;
- facial swelling (edema).

Contact 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.