FLUIBRON SCIR 200ML 15MG/5ML

FLUIBRON

active ingredients

Fluibron 30 mg tablets One tablet contains: Active ingredient: ambroxol Hydrochloride 30 mg Eccipients: Lactose monohydrate 48 mg Carbossimetilamido sodium 5 mg Fluibron 15 mg/5 ml syrup 5 ml of syrup contain: Active ingredient: ambroxol hydrochloride 15 mg Eccipients: Sorbitol 1.5 g Benzoic Acid 6.5 mg Fluibron Adults 30 mg granulated oral suspension A bag contains: Active ingredient: ambroxol Hydrochloride 30 mg Eccipients: Sorbitol 2696,5 mg Sodium saccharin 5 mg Nitrogen colorant (E110 yellow orange S) 1.5 mg For full list of excipients, see paragraph 6.1.

Excellent

Tables: Lactose monohydrate, Cellulosa microcrystalline, Carbossimetilamido sodium (type A), Silice colloidal anidra, Magnesium stearate. Syrup: Sorbitol 70% non crystallized solution, Glicerol, Citric acid monohydrate, Sucralose, Benzoic acid, Natural raspberry aroma, Purified water. Granulated oral suspension Adults: Sorbitol, Mannitol, Orange Aroma, Monohydrate Citric Acid, Glycine, Arab Rubber, Sodium Saccarin, Anidra colloidal Silice, Orange Yellow S (E 110).

Therapeutic indications

Fluibron is indicated in the treatment of acute respiratory diseases characterized by dense and viscous hypersecretion.

Contraindications

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

Population

Tablets: Adults: at the beginning 1 tablet 3 times a day, in maintenance therapy 1 tablet 2 times a day. It is recommended to take the tablets after meals with a little liquid. Syrup: Adults: at the beginning 10 ml 3 times a day, then 5 ml 3 times a day. Children from two to five years: 2.5 ml 3 times a day; over five years: 5 ml 3 times a day. At the beginning of the treatment the dose may be increased or even doubled to the doctor's judgment. 10 ml = 30 mg. The accluso misurino contains graduated heels of 10 ml, 5 ml and 2,5 ml. Adult sachets: at the beginning 1 adult sachet 3 times a day, in the maintenance therapy 2 adult sachets per day, dissolved in water.

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. 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 tablets contains: • lactose: patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose mal absorption, should not take this medicine; • sodium: this medicine contains less than 1mmol (23mg) of sodium per tablet, i.e. it is essentially without sodium. FLUIBRON oral granulate contains: • sorbitol: this medicine contains 2.696,5 mg sorbitol per bag. Sorbitol is a source of fructose. If your doctor told you that you are intolerant to some sugars, or if you have a diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak to your doctor before you take this medicine. It can cause gastrointestinal problems and have a slight laxative effect. sodium saccharin: this medicine contains less than 1mmol (23mg) of sodium per bag, i.e. it is essentially without sodium. • azoic dye (E110 yellow orange S): can cause allergic reactions. FLUIBRON syrup contains: • sorbitol: this medicine contains 3,000 mg of sorbitol per dose of 10 ml. Sorbitol is a source of fructose. If your doctor told you that you are intolerant to some sugars, or if you have a diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak to your doctor before you take this medicine. It can cause gastrointestinal problems and have a slight laxative effect. this medicine contains 750 mg of sorbitol per dose of 2.5 ml and 1,500 mg of sorbitol per dose of 5 ml. Sorbitol is a source of fructose. If the doctor told you that the child is intolerant to some sugars, or if he has a diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak to the doctor before the child takes this medicine. It can cause gastrointestinal problems and have a slight laxative effect. • benzoic acid: this medicine contains 1,3mg/ml of benzoic acid.

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 Municipality ≥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's 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 “www.agenziafarmaco.gov.it/it/content/come-segnalare-una-sospetta-reazione-avversa”.

Overdosing

There are no known cases of overdose with Fluibron.The symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of the medicine are consistent with the expected side effects of ambroxol hydrochloride at the 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