MUCOSOLVAN "75 MG PROLONGED-RELEASE HARD CAPSULES" 20 CAPSULES"

Name
MUCOSOLVAN 75 mg prolonged-release hard capsules
Ambroxol


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


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 subject to be treated is a child.


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

Cases of serious skin reactions associated with ambroxol administration have been reported. If you experience a skin rash (including lesions of the mucous membranes such as the mouth, throat, nose, eyes, and genitals), stop taking Mucosolvan and contact your doctor immediately.
These reactions may be symptoms of serious skin conditions characterized by peeling skin and a severe toxic skin reaction (Stevens-Johnson syndrome and toxic epidermal necrolysis). Additionally, in the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), you may experience nonspecific flu-like symptoms, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Because of these misleading symptoms, you may be prompted to resume symptomatic treatment with cough and cold medication.

Children
Do not give this medicine to children/adolescents aged 0 to 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 following the use of 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, difficulty in digesting (dyspepsia);
rare (may affect up to 1 in 1,000 people)
- hypersensitivity reactions, skin 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 (rapidly developing swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and pruritus;
- serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis), heartburn (pyrosis).

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

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.