FLUIMUCIL MUCOL*OS 10SACHETS600MG

FLUIMUCIL MUCOLITICO 600 mg granules for oral solution
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 characterised 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 to any of the other ingredients of this medicine (listed in paragraph 6);
- if you are pregnant or breastfeeding, unless after careful medical evaluation (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 an inflammatory disease of the bronchi called bronchial asthma. Immediately stop taking Fluimucil Mucolitico if you experience constriction 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 can 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 by coughing (expectorate), contact your doctor, who will indicate a method for eliminating mucus (postural drainage or bronchoaspiration).

If you notice a sulfur smell, do not worry because this does not indicate 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 tests to determine 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 ear (tinnitus);
- increased heart rate (tachycardia);
- vomiting;
- diarrhoea;
- inflammation of the mouth (stomatitis);
- abdominal pain;
- nausea;
- hives, skin rash;
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
- itching;
- fever (pyrexia);
- reduced blood pressure.

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

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

Not known (frequency cannot be estimated from the available data)
- facial swelling (oedema).

In very rare cases, severe skin reactions have occurred (Stevens Johnson syndrome or Lyell's syndrome). 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.