Fluibron Aerosol 20 vials 15mg/2ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Severe hepatic and/or renal alterations. First three months of pregnancy (see par. 4.6) Pediatric population The medicine is contraindicated in children under 2 years of age.

WARNINGS AND PRECAUTIONS FOR USE

Pediatric population Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children under 2 years of age (see section 4.3). Since inhaling aerosols too deeply can cause an irritating cough, you should try to inhale and exhale normally during inhalation. In particularly sensitive patients, pre-warming the inhaled product to body temperature may be recommended. For patients suffering from bronchial asthma it is advisable to use a bronchial spasmolytic before inhalation. Fluibron should be administered with caution in patients with peptic ulcers. Cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported associated with the administration of ambroxol. If symptoms or signs of progressive skin rash are present (sometimes associated with blisters or mucosal lesions), treatment with ambroxol should be stopped immediately and a doctor should be consulted. The majority of these cases can be explained by the severity of the patient's underlying disease and/or concomitant therapy. Additionally, during the early phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like prodromes such as fever, muscle aches, rhinitis, cough, and sore throat. Because of these misleading, nonspecific flu-like prodromes, symptomatic treatment with cough-and-cold medications may be instituted. Therefore, if new lesions of the skin or mucous membranes appear, it is necessary to immediately consult your doctor and discontinue treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, Fluibron should be used only after consulting your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of ambroxol metabolites generated in the liver may occur in severe renal insufficiency.

INTERACTIONS

Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been observed.

SIDE EFFECTS

At the recommended doses the medicine is normally well tolerated. The following side effects were observed during therapy with ambroxol hydrochloride, with the frequencies: Very common ≥1/10 Common ≥1/100 and <1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known not known (the frequency cannot be estimated based on available data)

Classification by systems and organs | Adverse reaction | Frequency

Immune System Disorders | Hypersensitivity reactions | Rare

Anaphylactic reactions, including anaphylactic shock, angioedema and pruritus | Not known

Nervous system disorders | Dysgeusia (e.g. impaired sense of taste) | Municipality

Headache | Rare

Respiratory, thoracic and mediastinal disorders | Hypoesthesia of the oral cavity and pharynx | Common

Bronchial obstruction | Not known

Gastrointestinal disorders | Nausea | Municipality

Vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth | Uncommon

Dry throat | Not known

Skin and subcutaneous tissue disorders | Rash, urticaria | Rare

Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis). | Not known

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa