SOLMUCOL MUCOLITIC*30TAB600MG

SOLMUCOL MUCOLITICO 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 thin respiratory mucus (phlegm).

SOLMUCOL MUCOLITICO is used to make phlegm more fluid and thus easier to eliminate in patients with acute or chronic respiratory diseases.

What you need to know before taking the medicine
Do not take SOLMUCOL MUCOLITICO:
• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding unless otherwise advised by your doctor (see section "Pregnancy, breastfeeding and fertility");
• for the treatment of respiratory diseases in children under 2 years of age, as mucolytics such as SOLMUCOL MUCOLITICO can cause airway obstruction.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOLMUCOL MUCOLITICO if:
• you have or have had a stomach or duodenal ulcer, especially if you are taking medications that cause stomach problems (gastrolesive drugs);
• you have asthma;
• you notice, after taking SOLMUCOL MUCOLITICO, symptoms such as nausea, vomiting, and allergic reactions such as changes in skin appearance associated with skin irritation or swelling (skin rash); in this case, the administration of the medicine should be discontinued.

Pay attention:
• when opening the tube containing the tablets, you may notice a very strong and pungent odor (sulfurous odor). This odor does not indicate an alteration of the medicine but is characteristic of the active ingredient;
• if you have difficulty eliminating phlegm. Your doctor may recommend some techniques to prevent the accumulation of secretions, such as postural drainage or bronchoaspiration;
• during treatment, you may experience breathing difficulties (bronchospasm), especially if you have experienced it on other occasions or if you have asthma. If this occurs, immediately stop treatment with SOLMUCOL MUCOLITICO and consult your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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, diarrhea, inflammation of the mouth (stomatitis), abdominal pain;
• more or less sudden appearance of skin lesions, for example, patchy or widespread color changes (rash), itching and urticaria, possible signs of allergy;
• swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing (angioedema);
• headache, fever;
• tinnitus (ringing, whistling, buzzing, hissing 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 (dyspnoea).

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

not known (frequency cannot be estimated 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, exfoliation and/or blistering (e.g., Steven-Johnson Syndrome, Lyell's Syndrome). These side effects occur rarely;
• contraction of the bronchial muscles (bronchospasm) which manifests as shortness of breath, cough, wheezing and gasping;
• a prolongation of bleeding time (reduced platelet aggregation)

Reporting of side effects
If you get any side effects, including those 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.