FLUIMUCIL MUCOL CHILDREN 100 MG/5 ML SYRUP 1 GLASS BOTTLE OF 200 ML WITH DOSING GLASS

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


What you need to know before taking the medicine
Do not use Fluimucil Mucolitico children
- 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 the patient is a child under 2 years of age (See paragraph "Warnings and precautions");
- if you are pregnant or breast-feeding (See section "Pregnancy and breast-feeding").


Warnings and precautions
Talk to your doctor or pharmacist before using Fluimucil Mucolitico children.
Use this medicine with caution and always under the supervision of your doctor in the following cases:
- if the child suffers from a chronic inflammatory disease of the bronchi called bronchial asthma. Stop taking the medicine if, after taking it, you experience dyspnoea (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 the child is intolerant to histamine, in case of therapy with Fluimucil Mucolitico children, allergic reactions (hypersensitivity) may occur;
- if the child suffers or has suffered from a stomach or intestinal problem called peptic ulcer, especially if he is taking other medicines that cause stomach problems (gastro-lesive drugs) together with Fluimucil Mucolitico bambini.

This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and the child is unable to eliminate bronchial secretions by coughing (expectorating), contact your doctor who will indicate a method to eliminate the mucus (postural drainage or bronchoaspiration). If you smell a sulphurous odour, do not worry because this does not indicate an alteration of the preparation, but is due to N-acetylcysteine.

Laboratory tests: N-acetylcysteine ​​may interfere with some blood and urine tests (colorimetric assay for salicylates and tests for ketones). Tell your doctor that your child is taking this medicine before having any tests.

Fluimucil Mucolitico children 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 (cephalea);
- ringing in the ears (tinnitus);
- increased heart rate (tachycardia);
- vomit;
- diarrhea;
- inflammation of the mouth (stomatitis);
- abdominal pain;
- nausea;
- skin irritations (hives, 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 1000 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)
- bronchial obstruction (bronchial obstruction);
- 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.