BISOLVON "4 MG/5 ML SYRUP" STRAWBERRY FLAVOR 200 ML BOTTLE"

Name
BISOLVON Linctus 4 mg/5 ml syrup - strawberry flavour bromhexine hydrochloride


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


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Bisolvon to your child:
- if you/your child suffers from a respiratory disease that develops and worsens over a relatively short period of time (acute respiratory conditions). Consult your doctor if symptoms do not improve or worsen during treatment;
- if you are pregnant (see section 2. “Pregnancy, breastfeeding and fertility”);
- if you/your child has/has 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 the mucous membranes such as the mouth, throat, nose, eyes, and genitals), stop taking Bisolvon and contact your doctor immediately.
These reactions may be symptoms of serious skin conditions characterized by peeling skin and severe toxic skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis). Most of these reactions may be due to existing serious conditions or the concomitant use of other medications.
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 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. Mucolytics can cause bronchial obstruction in children under 2 years of age. Indeed, 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, diarrhea and upper abdominal pain;
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, mucosa and submucosal tissues) and purpura;
- 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 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.