Fluibron*30tabs 30mg

NAME
FLUIBRON

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Ambroxol hydrochloride.

EXCIPIENTS
Tablets: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate Syrup: 70% non-crystallizable sorbitol solution, glycerol, citric acid monohydrate, sucralose, benzoic acid, natural raspberry flavoring, purified water. >> Granules for oral suspension. Adults: sorbitol, mannitol, orange flavor, citric acid monohydrate, glycine, gum arabic, sodium saccharin, colloidal anhydrous silica, orange yellow S (E 110).

INDICATIONS
The medicine is indicated in the treatment of acute respiratory diseases characterized by thick and viscous hypersecretion.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; severe hepatic and / or renal disorders. Pediatric population: the drug is contraindicated in children younger than 2 years.

DOSAGE
>> Tablets. Adults: at first 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: initially 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 old: 5 ml 3 times a day. At the beginning of the treatment the dose can be increased or even doubled in the opinion of the doctor. 10 ml = 30 mg. The enclosed measuring cup has graduated marks at 10ml, 5ml and 2.5ml. >> Sachets. Adults: at first 1 sachet. Adults 3 times a day, in maintenance therapy 2 sachets Adults a day, dissolved in water.

STORAGE
This medicinal product does not require any special storage conditions.

WARNINGS
Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the 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 younger 'less than 2 years. The drug should be administered with caution in patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol should be stopped immediately and a physician consulted. Most of these cases can be explained by the severity of the patient's underlying disease and / or by concomitant therapy. In addition, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience nonspecific flu-like prodromes such as fever, body aches, rhinitis, cough, and sore throat. Because of these misleading nonspecific flu-like prodromes, symptomatic treatment with cough and cold medicines is possible. Therefore, if new lesions of the skin or mucous membranes occur, it is necessary to consult your doctor immediately and to stop the treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency, the medicinal product should only be used after consulting your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of the metabolites of ambroxol generated in the liver may occur in severe renal insufficiency. The tablets contain lactose. The granules formulations for oral suspension and in syrup contain sorbitol.

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 undesirable effects have been observed during therapy with ambroxol hydrochloride, with 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. Disorders of the Immune System. Rare: hypersensitivity reactions'; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders. Common: dysgeusia (eg, altered sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders. Common: hypoesthesia of the oral cavity and pharynx; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth; not known: dry throat. Skin and subcutaneous tissue disorders. Rare: rash, hives; not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). The reporting of suspected 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.

PREGNANCY AND BREASTFEEDING
Ambroxol hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal / fetal 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 to observe the usual precautions regarding the use of medicines during pregnancy. Particularly during the first trimester, the use of the medicine is not recommended. Ambroxol hydrochloride is secreted in breast milk. Although undesirable effects on infants are not expected, the use of the drug is not recommended in nursing mothers.