BISOLVON*SYRUP FL 200ML STRAWBERRY

BISOLVON Linctus 4 mg/5 ml syrup - strawberry flavour 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 above suffering from acute and chronic respiratory diseases, with cough and phlegm production.
It acts as a mucolytic, thinning mucus deposits in the airways and thus facilitating their elimination.

What you need to know before taking the medicine
Do not take/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 breastfeeding (see section 2. "Pregnancy, breastfeeding and fertility");
- if the child is under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving your child Bisolvon:
- if you/your child suffers from a respiratory disease that appears 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/your child has/has had stomach and/or intestinal lesions (gastroduodenal ulcer).

Cases of severe skin reactions associated with bromhexine hydrochloride administration have been reported. If you develop a skin rash (including mucosal lesions such as mouth, throat, nose, eyes, genitals), stop taking Bisolvon and consult your doctor immediately.
Such reactions could be symptoms of serious skin diseases characterized 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 diseases or the simultaneous use of other medicines.
Furthermore, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), you may experience non-specific flu-like symptoms, 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 secretions (this promotes expectoration).

Take/give your child Bisolvon 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 airways.

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 submucosal tissues) and itching;
- severe 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 generally transient. 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.