FLUIBRON 0.75% ORAL OR NEBULIZED SOLUTION 40 ML BOTTLE

Name
FLUIBRON 7.5 mg/ml oral or nebulized solution
Ambroxol hydrochloride


What is it and what is it used for?
FLUIBRON contains ambroxol, an active ingredient belonging to the mucolytic class, which works by making mucus more fluid and therefore easier to eliminate.

FLUIBRON is used in patients with acute and chronic respiratory tract diseases, characterized by thick, viscous mucus.


What you need to know before taking the medicine
Do not take FLUIBRON if:
• are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
• has severe liver and/or kidney disease.

Do not use FLUIBRON in children under 2 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIBRON:
• if you have stomach lesions (peptic ulcer);
• if you have mild or moderate impairment of kidney function;
• during the first three months of pregnancy or if you are breastfeeding.

PLEASE NOTE:
Cases of serious skin reactions associated with the administration of ambroxol have been reported.
If you develop a skin rash (including lesions of mucous membranes such as the mouth, throat, nose, eyes, genitals), stop taking FLUIBRON and contact your doctor immediately;
• if you have asthma, before taking FLUIBRON by inhalation (with an aerosol device), you must use your inhaler (bronchial antispasmodic), to avoid possible breathing difficulties.

Children
Do not use FLUIBRON in children under 2 years of age, as mucolytics can cause obstruction of the airways (bronchi).


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking FLUIBRON immediately and contact your doctor if you experience any of the following conditions: itching, skin spots (hives, rash), swelling (angioedema) of the face, eyes, lips and/or throat with difficulty breathing, due to allergy (hypersensitivity).

Tell your doctor if you notice:

Common side effects (may affect up to 1 in 10 people)
alteration or decrease in the sense of taste (dysgeusia), decreased sensation (hypoesthesia) of the mouth and pharynx (oral cavity), nausea.

Uncommon side effects (may affect up to 1 in 100 people)
vomiting, diarrhea, difficulty in digestion (dyspepsia), abdominal pain, dry mouth.

Rare side effects (may affect up to 1 in 1,000 people)
headache; hypersensitivity reactions; rash, urticaria.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
airway obstruction (bronchi); dry throat; anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus; serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

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.