Fluibron Aerosol 20 vials 15mg/2ml

INDICATIONS

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

ACTIVE INGREDIENTS

100 ml of sterile solution contains: Active ingredient: Ambroxol hydrochloride 750 mg. A single-dose container contains 15 mg of ambroxol hydrochloride. For the full list of excipients, see section 6.1.

EXCIPIENTS

Sodium chloride, water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Dosage Pediatric population FLUIBRON must not be used in children under 2 years of age due to safety concerns (paragraph 4.8). Adults and children over 5 years of age: one single-dose container, 2 times a day. Children aged 2 to 5 years: half a container or a single-dose container, 1-2 times a day. Do not exceed the recommended doses. Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. Method of administration The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1:1. To use, carry out the following operations: 1) Flex the single-dose container in both directions. 2) Detach the single-dose container from the strip first at the top and then in the center. 3) Open the single-dose container by rotating the flap in the direction indicated by the arrow. 4) By exerting moderate pressure on the walls of the single-dose container, release the medicine in the prescribed quantity and introduce it into the nebulizer ampoule. 5) If half the dose is used, the container can be closed as indicated in the information leaflet. The closed container must be stored at a temperature between 2°C and 8°C (in the refrigerator) and the remaining quantity must be used within 12 hours of first opening.

CONSERVATION

Single-dose containers must be stored inside the protective bag, protected from light. If half the dose is used, the closed container should be stored at a temperature between 2°C and 8°C (in the refrigerator) and used within 12 hours.

WARNINGS

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)

Immune System Disorders - Adverse reaction: Hypersensitivity reactions. Frequency: Rare.

Immune System Disorders - Adverse Reaction: Anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Frequency: Not known.

Nervous system disorders - Adverse reaction: Dysgeusia (e.g. alteration of the sense of taste). Frequency: Common.

Nervous system disorders - Adverse reaction: Headache. Frequency: Rare.

Respiratory, thoracic and mediastinal disorders - Adverse reaction: Hypoesthesia of the oral cavity and pharynx. Frequency: Common.

Respiratory, thoracic and mediastinal disorders - Adverse reaction: Bronchial obstruction. Frequency: Not known.

Gastrointestinal disorders - Adverse reaction: Nausea. Frequency: Common.

Gastrointestinal disorders - Adverse reaction: Vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth. Frequency: Uncommon.

Gastrointestinal disorders - Adverse reaction: Dry throat. Frequency: Not known.

Skin and subcutaneous tissue disorders - Adverse reaction: Rash, urticaria. Frequency: Rare.

Skin and subcutaneous tissue disorders - Adverse reaction: Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Frequency: 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

OVERDOSE

There are no known cases of overdose with Fluibron for inhalation use. The symptoms observed in cases of accidental overdose and/or in cases of errors in administration of the medicinal product are consistent with the expected side effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.

PREGNANCY AND BREASTFEEDING

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic/foetal development, parturition or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy have shown no evidence of harmful effects on the fetus. However, it is recommended that you observe the usual precautions regarding the use of medicines during pregnancy. Particularly during the first trimester, the use of Fluibron is not recommended. Ambroxol hydrochloride is secreted into breast milk. Although no side effects on infants are expected, the use of Fluibron is not recommended in breastfeeding mothers.

EFFECTS ON DRIVING ABILITY

There is no evidence of effects on the ability to drive or use machines.