BISOLVON*20TAB 8MG

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 from 2 years of age suffering from acute and chronic respiratory diseases with cough and mucus production.
It acts as a mucolytic, meaning it thins the mucus deposits in the respiratory tract, thus facilitating 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 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 suffer from a respiratory tract disease that develops and worsens over a relatively short period (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 bromhexine hydrochloride administration 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 consult a doctor immediately.
These 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 severe 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, it is possible that you may undertake symptomatic treatment with a cough and cold therapy.

Treatment with Bisolvon results in an increase in bronchial secretions (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.

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, 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 itching;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
- narrowing of the bronchi making 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.