Name
FLUIMUCIL MUCOLYTIC 600 mg granules for oral solution
N-acetylcysteine
What is it and what is it for?
Fluimucil Mucolitico contains the active substance N-acetylcysteine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the airways.
Fluimucil Mucolitico is indicated for the treatment of respiratory tract diseases characterised by increased production of thick, viscous mucus (thick, 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 section 6);
- if you are pregnant or breast-feeding unless carefully evaluated by your doctor (See the section “Pregnancy and breast-feeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil Mucolitico.
Take this medicine with caution and always under the supervision of your doctor in the following cases:
- if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking Fluimucil Mucolitico immediately if you experience contraction of the bronchial muscles (bronchospasm). Consult your doctor if you have had such problems in the past;
- if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur in case of therapy 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 can cause stomach problems (gastro-damaging drugs) together with Fluimucil Mucolitico.
This medicine may 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 (sputum), consult your doctor who will indicate a method for clearing the mucus (postural drainage or bronchoaspiration).
If you smell a sulfurous odor, do not worry because this does not indicate any alteration of the preparation, but is due to the N-acetylcysteine.
Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric assays for salicylates and tests for ketones). Tell 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 (cephalalgia);
- ringing in the ears (tinnitus);
- increased heart rate (tachycardia);
- vomit;
- diarrhea;
- 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)
- 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 (the frequency of which cannot be established based on the available data)
- swelling (edema) of the face.
In very rare cases, serious skin reactions (Stevens-Johnson syndrome or Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the medicine and contact your doctor.
Also, tell your doctor if you experience prolonged bleeding time (reduced platelet aggregation).
Reporting of side effects
If you experience 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.