BISOLVON*ORAL SOL FL 40ML 2MG/ML

BISOLVON 2 mg/ml oral solution
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, thinning mucus deposits in the respiratory tract and thus facilitating their elimination.

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

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

Cases of severe 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 the mouth, throat, nose, eyes, genitals), stop taking Bisolvon and consult your doctor immediately.
These reactions could be symptoms of serious skin conditions characterised by skin peeling and a severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Most of these could be due to serious pre-existing conditions or the concomitant use of other medicines.
Furthermore, in the initial stage of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), you may experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, you may undertake symptomatic treatment with a cough and cold therapy.
Treatment with Bisolvon leads to an increase in bronchial secretion (this promotes expectoration).
Take/give Bisolvon to your child for short periods.

Children
Do not give this medicine to children under 2 years of age. Mucolytics can cause bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.
Give this medicine to children between 2 and 6 years of age only after consulting a doctor.

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, diarrhoea and pain in the upper abdomen;
rare (may affect up to 1 in 1,000 people)
- hypersensitivity reactions, rash (skin eruption), 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, mucous membranes and submucous tissues) and itching;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis);
- narrowing of the bronchi that makes breathing difficult (bronchospasm).

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.