MUCOSOLVAN*20CAPS 75MG MR

MUCOSOLVAN 75 mg prolonged-release hard capsules
Ambroxol

What it is and what it is used for
Mucosolvan contains ambroxol, an active ingredient that works by dissolving phlegm and facilitating its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic bronchial and lung diseases (i.e., in the presence of cough and difficulty expelling phlegm from the bronchi due to increased or thickened secretions).

What you need to know before taking the medicine
Do not use Mucosolvan
- if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver or kidney disease;
- if the person to be treated is a child.

Warnings and precautions
Talk to your doctor or pharmacist before using Mucosolvan:
- if you have/have had stomach and/or intestinal lesions (peptic ulcer).

Severe skin reactions have been reported in association with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and seek medical attention immediately.
Such reactions could be symptoms of severe skin conditions characterized by skin peeling and severe toxic skin reactions (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis). Furthermore, in the initial phase of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN), you may experience non-specific symptoms similar to those of the flu, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, you may resume symptomatic treatment with a cough and cold therapy.

Children
Do not give this medicine to children/adolescents aged between 0 and 18 years.

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

The following side effects may occur after using Mucosolvan:
common (may affect up to 1 in 10 people)
- nausea;
uncommon (may affect up to 1 in 100 people)
- vomiting, diarrhea and abdominal pain, indigestion (dyspepsia);
rare (may affect up to 1 in 1,000 people)
- hypersensitivity reactions, rash, appearance of red spots on the skin accompanied by itching (urticaria);
not known (frequency cannot be estimated from the available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucous membranes and submucosal tissues) and itching;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis), heartburn (pyrosis).

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.

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.