FLUIBRON OS NEBUL FL40ML 0,75%

FLUIBRON

active ingredients

Fluibron Children 15 mg granulated oral suspension A bag contains: Active ingredient: Ambroxol hydrochloride 15 mg Orange granulate on sorbitol 1499,0 mg (sorbitol: about 96%; Nitrogen (E110 yellow orange S): approx. 0.02%-0,03%); Sodium saccharin 2.5 mg. Fluibron 7.5 mg/ml oral solution or to nebulize 100 ml of solution contain: Active ingredient: Ambroxol hydrochloride 750 mg P-hydroxybenzoate 135 mg; Propile p-hydroxybenzoato 15 mg; Sodium Chloride 767 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Oral Solution or Nebulization: Sodium chloride, p-hydroxybenzoate, p-hydroxybenzoate, purified water. Granulated oral suspension Children: Orange granulate on sorbitol (sorbitol, orange aroma, orange yellow (E110)), Mannitol, Citric acid monohydrate, Glycine, Arabic rubber, Sodium saccharin, colloidal silica anidra.

Therapeutic indications

Fluibron is indicated in the treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Severe liver and/or kidney alterations. Pediatric population The medicinal product is contraindicated in children under 2 years of age.

Population

Bus. Children aged 5 years: 1 child bag 2-3 times a day depending on age, dissolved in water. Oral Solution or Nebulization: For inhalation: Adults and children over five years: 2-3 ml, 1-2 times a day. Children from two to five years: 2 ml, 1-2 times a day. The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in ratio 1:1. Orally: Adults: 2-4 ml (15-30 mg) 3 times a day. Children over five years: 1-2 ml (7,5-15 mg) 2-3 times a day. Children aged 2 to 5 years: 1/2-1 ml (3,75-7,5 mg) 2-3 times a day. 1 ml= 7.5 mg. Dilute drops in little water, tea, milk or juice

Conservation

This medicine does not require any special condition for conservation.

Warnings

Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Fluibron should be administered with caution in patients carrying peptic ulcer. Because in the too deep intake of aerosols it can develop coughs from irritation, it must be sought during inhalation to inhale and exhale normally. Particularly sensitive patients can recommend a preheating of inhalation at body temperature. For patients with bronchial asthma it is appropriate to resort to a bronchial spasmolytic before inhalation. Cases of severe skin reactions such as multiform erythema, Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. Most of these cases can be explained by the severity of the underlying disease of the patient and/or concomitant therapy. In addition, during the initial phase of Stevens-Johnson's or TEN's syndrome, patients may charge unspecified flu-like prodromas such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading aspecific symil-fluid prodromas, a symptomatic treatment with cough and cold medicines can be established. Therefore, if new lesions of the skin or mucous membranes occur, you must immediately consult your doctor and precautionally stop the treatment with ambroxol hydrochloride. In the presence of mild or moderate kidney failure, Fluibron must be used only after consulting the doctor. As with any medication with liver metabolism followed by renal elimination, in case of severe renal failure, an accumulation of ambroxol metabolites generated in the liver may occur. Warnings related to some Fluibron excipients. FLUIBRON oral granulate contains: . sorbitol: this medicine contains 1.439,04 mg sorbitol per sachet. Sorbitol is a source of fructose. This medicine should not be administered to patients suffering from rare hereditary problems of fructose intolerance. It can cause gastrointestinal problems and have a slight laxative effect. e sodium saccharin: this medicine contains less than 1mmol (23mg) sodium per bag, i.e. it is essentially without sodium; azoic dye (E110 yellow orange S): can cause allergic reactions. FLUIBRON oral solution or nebulizing contains: so sodium: this medicine contains less than 1mmol (23mg) of sodium per dose, i.e. it is essentially without sodium; benzoate para-hydroxy: can cause allergic reactions (also delayed) and, exceptionally, bronchospasm.

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No interactions with other medicines have been observed.

Effects

The medicinal product is normally well tolerated at recommended doses. During therapy with ambroxol hydrochloride the undesirable effects reported below, with the frequencies: Very common ≥1/10; Common ≥1/100 and Classification for systems and organs Action against Frequency Immunity System Disorders Reactions of hypersensitivity Rare Anaphylactic reactions, including anaphylactic shock, angioedema and itching Notable Diseases of the nervous system Disgeusia (e.g. alteration of the sense of taste) Town Cefa Rare Respiratory, chest and mediastinic pathologies Hypoesthesia of the oral cable and pharynx Town Bronchial obstruction Notable Gastrointestinal diseases Nausea Town Vomito, diarrhea, dispepsia and abdominal pain, dry mouth Not common Dry gorge Notable Pathologies of skin and subcutaneous tissue Rash, hives Rare Severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Notable Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

You don't know cases of overdose with Fluibron. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of the medicinal product are consistent with the expected effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment. Keep in mind that the patient has not ingested other medicines at the same time.

Ambroxol Hydrochloride crosses the placental barrier. Animal studies showed no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy showed no evidence of harmful effects on the fetus. However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. In particular, during the first quarter, the use of Fluibron is not recommended. Ambroxol Hydrochloride is secreted in breast milk. Although there are no undesirable effects on infants, the use of Fluibron is not recommended in nursing mothers.

Source: Farmadati