FLUIMUCIL MUCOL*SYR600MG/15ML

FLUIMUCIL MUCOLITICO 600 mg/15 ml syrup
N-acetylcysteine

What it is and what it is used for
Fluimucil Mucolitico 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 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).

What you need to know before taking the medicine
Do not take Fluimucil Mucolitico
- if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (See the "Pregnancy and breastfeeding" section).

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 an inflammatory disease of the bronchi called bronchial asthma. Immediately stop taking Fluimucil Mucolitico if you experience contraction of the bronchial muscles (bronchospasm). Consult your doctor even if such disorders have occurred in the past;
- if you are histamine intolerant, 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 with Fluimucil Mucolitico that can cause stomach problems (gastro-damaging drugs).

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

If you smell sulfur, 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 analyses (colorimetric assay for the determination of salicylates and test for determining ketones). Inform your doctor that you are taking this medicine before undergoing these 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;
- ringing in the ears (tinnitus);
- increased heart rate (tachycardia);
- vomiting;
- diarrhea;
- inflammation of the mouth (stomatitis);
- abdominal pain;
- nausea;
- urticaria, rash;
- swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema);
- itching;
- fever (pyrexia);
- reduced blood pressure.

Rare (may affect up to 1 in 1,000 people)
- bronchial muscle contractions (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)
- facial swelling (edema).

In very rare cases, severe skin reactions (Stevens-Johnson syndrome or Lyell's syndrome) have occurred. If you experience changes in your mucous membranes or skin, stop taking the medicine and contact your doctor.
Also contact your doctor if you experience a prolongation of bleeding time (reduction of 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.