Name
SOLMUCOL MUCOLYTIC 600 mg effervescent tablets
Acetylcysteine


What it is and what it is used for
SOLMUCOL MUCOLITICO contains acetylcysteine, an active ingredient belonging to the class of “mucolytics”, drugs that act by thinning the mucus in the respiratory tract (catarrh).

SOLMUCOL MUCOLYTIC is used to make phlegm more fluid and therefore easier to eliminate in patients with acute or long-lasting (chronic) respiratory tract diseases.


What you need to know before taking the medicine
Do not take SOLMUCOL MUCOLITIC:
• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breast-feeding unless otherwise advised by your doctor (see section “Pregnancy, breast-feeding and fertility”);
• for the treatment of respiratory tract diseases in children under 2 years of age , since mucolytics such as SOLMUCOL MUCOLITICO can create obstruction of the airways.


Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLYTIC if:
• have or have had a stomach or duodenal ulcer, especially if you are taking medicines that cause stomach problems (gastrolesives);
• has asthma;
• noted following the intake of SOLMUCOL MUCOLITICO, symptoms such as nausea, vomiting, and allergic reactions such as changes in the appearance of the skin associated with irritation or swelling of the skin (skin rash); in this case, the administration of the medicine must be suspended.

Please note:
• when you open the tube containing the tablets you may notice a very strong and pungent odor (sulphurous odor). This odor does not indicate an alteration of the medicine but is typical of the active ingredient;
• if you have difficulty clearing phlegm. Your doctor may recommend techniques to avoid the accumulation of secretions, such as postural drainage or bronchoaspiration;
• during treatment you may have difficulty breathing (bronchospasm), especially if this has happened to you on other occasions or if you have asthma. If this happens, immediately stop taking SOLMUCOL MUCOLITICO and consult your doctor.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you notice the following side effects during treatment with SOLMUCOL MUCOLITICO:

uncommon (may affect up to 1 in 100 people)
• nausea, vomiting, diarrhoea, inflammation of the mouth (stomatitis), abdominal pain;
• more or less sudden appearance of skin lesions, for example spotty or widespread changes in colour (rash), itching and hives, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (buzzing, hissing, ringing, whistling or other persistent sounds in the ears);
• increased heart rate (tachycardia), decreased blood pressure.
rare (may affect up to 1 in 1,000 people)
• indigestion (dyspepsia);
• difficulty breathing (dyspnea).

very rare (may affect up to 1 in 10,000 people)
• bleeding (hemorrhage).

not known (the frequency of which cannot be established from the available data)
• swelling (edema) of the face;
• bronchial obstruction.

Stop taking SOLMUCOL MUCOLITICO and consult your doctor immediately if you experience:
• severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson syndrome, Lyell syndrome). These side effects occur rarely;
• contraction of the bronchial muscles (bronchospasm) which manifests itself with shortness of breath, coughing, shortness of breath and wheezing;
• a prolongation of bleeding time (reduction of 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.