FLUIBRON*SYR 200ML 15MG/5ML

FLUIBRON 15 mg/5 ml syrup
FLUIBRON Adults 30 mg granules for oral suspension
Ambroxol hydrochloride

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

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

What you need to know before taking the medicine
Do not take FLUIBRON if:
• you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
• you have 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 kidney dysfunction;
• during the first three months of pregnancy or if you are breastfeeding.

PAY ATTENTION:

Cases of severe skin reactions associated with ambroxol administration have been reported. If you develop a skin rash (including mucosal membrane lesions such as mouth, throat, nose, eyes, genitals), stop taking FLUIBRON and contact your doctor immediately.

Children
Do not use FLUIBRON in children under 2 years of age, as mucolytics can cause airway obstruction (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: itching, skin spots (hives, skin rash), swelling (angioedema) of the face, eyes, lips and/or throat with difficulty breathing, due to allergy (hypersensitivity).

Inform your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)
altered or decreased sense of taste (dysgeusia), decreased sensitivity (hypoesthesia) of the mouth and pharynx (oral cavity), nausea.

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

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

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, 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).

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.