BISOLVON*SYRUP FL 200ML 8MG/5ML

Bisolvon Linctus 8 mg/5 ml syrup - chocolate-cherry 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 6 years and over suffering from acute and chronic respiratory diseases, with cough and phlegm production.
It acts as a mucolytic, meaning it thins the mucus deposits in the respiratory tract and thus facilitates their elimination.

What you need to know before taking the medicine
Do not take/give Bisolvon to your child:
- 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).

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 appears and worsens within 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 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 contact your doctor immediately.
Such reactions could be symptoms of severe skin diseases characterized by skin peeling and 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 early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN), you might 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, you might 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 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 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 (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and pruritus;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized 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.