Name
BISOLVON 8 mg tablets
Bromhexine hydrochloride


What it is and what it is used for
Bisolvon contains bromhexine hydrochloride.
Bisolvon is used in adults, adolescents and children aged 2 years and over suffering from acute and chronic respiratory diseases with cough and phlegm production.
It acts as a mucolytic, that is, it thins out mucus deposits in the respiratory tract and thus facilitates their elimination.


What you need to know before taking the medicine
Do not take/do not give your child Bisolvon - if you/your child is allergic to bromhexine or any of the other ingredients of this medicine (listed in section 6);
- if you are breast-feeding (see section 2. “Pregnancy, breast-feeding and fertility”);


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving your child Bisolvon:
- if you suffer from a respiratory disease that occurs and worsens over a relatively short period of time (acute respiratory conditions). Consult your doctor if your symptoms do not improve or worsen during treatment;
- if you are pregnant (see section 2. “Pregnancy, breast-feeding and fertility”);
- if you have/have had lesions of the stomach and/or intestine (gastroduodenal ulcer).

Cases of serious skin reactions associated with the administration of bromhexine hydrochloride have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Bisolvon and contact your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized by peeling skin and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Most of these could be due to serious existing diseases or the concomitant use of other drugs.
Also, 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 treated symptomatically with cough and cold medication.

Treatment with Bisolvon causes an increase in bronchial secretion (this promotes expectoration).

Take/give your child Bisolvon for short periods.

Children
Do not give this medicine to children under 2 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 following the use of Bisolvon: uncommon (may affect up to 1 in 100 people)
- nausea, vomiting, diarrhea and upper abdominal pain;
rare (may affect up to 1 in 1,000 people)
- hypersensitivity reactions, rash, urticaria (appearance of red spots on the skin); 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 purpurite;
- serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
- narrowing of the bronchi which makes breathing difficult (bronchospasm).

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

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.