MUCOSOLVAN*20LOZENGES 15MG

MUCOSOLVAN 15 mg chewable lozenges
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 and children over 6 years of age for the treatment of secretions in acute and chronic bronchial and pulmonary diseases (i.e., in the presence of cough and in case of difficulty expelling phlegm from the bronchi due to increased or thickened mucus).

What you need to know before taking the medicine
Do not use Mucosolvan
- if you/your child are allergic to ambroxol or any of the other ingredients of this medicine (listed in paragraph 6);
- if you/your child have severe liver or kidney disease;
- in case of rare hereditary conditions of incompatibility with one of the excipients (see paragraph 2. "Mucosolvan chewable lozenges contain sorbitol").

The use of Mucosolvan during the first trimester of pregnancy and during breastfeeding is not recommended (see paragraph 2 "Pregnancy, breastfeeding and fertility").

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

Cases of severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately.
Such reactions could be symptoms of severe skin conditions characterized by skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).

Furthermore, in the early stages of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN), you/your child 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, a symptomatic treatment with cough and cold therapy may be started again.

Children
Do not give this medicine to children under 6 years of age.

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, altered taste (dysgeusia), numbness of the mouth and tongue (oral hypoesthesia), numbness of the throat (pharyngeal hypoesthesia);
uncommon (may affect up to 1 in 100 people)
- vomiting, diarrhea and abdominal pain, indigestion (dyspepsia), dry mouth;
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), dry throat;
not known (frequency cannot be estimated from the available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucous membranes and submucous 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 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.