Fluibron 15mg/5ml syrup 200ml

Fluibron 15mg/5ml syrup is a mucolytic drug based on Ambroxol hydrochloride , indicated for the treatment of acute and chronic respiratory diseases characterized by excessive production of thick and viscous mucus. Thanks to its fluidifying and secretolytic action, it helps dissolve and promote the elimination of phlegm, improving breathing and reducing cough.

Fluibron is indicated for the treatment of respiratory diseases that cause excessive mucus production, including:

• Acute and chronic bronchitis .
• Tracheitis and laryngitis with thick catarrh.
• Pharyngitis and sinusitis with mucous secretions.
• Obstructive pulmonary conditions requiring mucolytic action.

ACTIVE INGREDIENTS

Active ingredients contained in Fluibron 15mg/5ml syrup 200ml - What is the active ingredient in Fluibron 15mg/5ml syrup 200ml?

Fluibron 15 mg/5 ml syrup 5 ml of syrup contain: Active ingredient: ambroxol hydrochloride 15 mg. Excipients: Sorbitol 1.5 g; Benzoic acid 6.5 mg. Fluibron Adults 30 mg granules for oral suspension One sachet contains: Active ingredient: ambroxol hydrochloride 30 mg. Excipients: Orange granules on sorbitol 2998.0 mg (sorbitol: approximately 96%; Azo dye (E110 orange yellow S): approximately 0.02%-0.03%); Sodium saccharin 5 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Fluibron 15mg/5ml syrup 200ml - What does Fluibron 15mg/5ml syrup 200ml contain?

Syrup : Sorbitol 70% non-crystallizing solution, Glycerol, Citric acid monohydrate, Sucralose, Benzoic acid, Natural raspberry flavor, Purified water. Granules for oral suspension Adults : Orange flavor granules on sorbitol (sorbitol, orange flavor, orange yellow (E110)), Mannitol, Citric acid monohydrate, Glycine, Gum arabic, Sodium saccharin, Colloidal anhydrous silica.

DIRECTIONS

Therapeutic indications Fluibron 15mg/5ml syrup 200ml - Why is Fluibron 15mg/5ml syrup 200ml used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Fluibron 15mg/5ml syrup 200ml - When should Fluibron 15mg/5ml syrup 200ml not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Severe hepatic and/or renal impairment. Paediatric population The medicinal product is contraindicated in children under 2 years of age.

DOSAGE

Quantity and method of taking Fluibron 15mg/5ml syrup 200ml - How to take Fluibron 15mg/5ml syrup 200ml?

Syrup: Adults: initially 10 ml 3 times a day, subsequently 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 treatment the dose can be increased or even doubled at the discretion of the doctor. 10 ml = 30 mg. The enclosed measuring cup has graduations at 10 ml, 5 ml and 2.5 ml. Sachets Adults: initially 1 Adult sachet 3 times a day, in maintenance therapy 2 Adult sachets per day, dissolved in water.

CONSERVATION

Storage Fluibron 15mg/5ml syrup 200ml - How is Fluibron 15mg/5ml syrup 200ml stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Fluibron 15mg/5ml syrup 200ml - About Fluibron 15mg/5ml syrup 200ml it is important to know that:

Mucolytics may induce bronchial obstruction in children under 2 years of age. In fact, the capacity for bronchial mucus drainage is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (see section 4.3). Fluibron should be administered with caution in patients with peptic ulcer. Cases 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 have been reported. If symptoms or signs of progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, treatment with ambroxol should be stopped immediately and a doctor should be consulted. Most of these cases can be explained by the severity of the patient's underlying disease and/or concomitant therapy. Furthermore, during the initial phase of Stevens-Johnson syndrome or TEN, patients may experience non-specific flu-like prodromes such as fever, muscle aches, rhinitis, cough and sore throat. Due to these misleading non-specific flu-like prodromes, symptomatic treatment with cough and cold medicines may be initiated. Therefore, if new skin or mucosal lesions appear, it is necessary to consult a doctor immediately 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 a doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, in case of severe renal insufficiency, accumulation of ambroxol metabolites generated in the liver may occur. Warnings relating to some of the excipients of Fluibron FLUIBRON granules for oral suspension contain: • sorbitol: this medicine contains 2,878.08 mg of sorbitol per sachet. Sorbitol is a source of fructose. This medicine should not be administered to patients with rare hereditary problems of fructose intolerance. It may cause gastrointestinal problems and have a mild laxative effect. • saccharin sodium: this medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e. it is essentially sodium-free. • azo colouring (E110 orange yellow S): may cause allergic reactions. FLUIBRON syrup contains: • sorbitol: this medicine contains 3,000 mg of sorbitol per 10 ml dose. Sorbitol is a source of fructose. This medicine should not be administered to patients with rare hereditary problems of fructose intolerance. It may cause gastrointestinal problems and have a mild laxative effect. This medicinal product contains 750 mg sorbitol per 2.5 ml dose and 1,500 mg sorbitol per 5 ml dose. Sorbitol is a source of fructose. This medicinal product should not be given to patients with rare hereditary problems of fructose intolerance. It may cause gastrointestinal problems and have a mild laxative effect. • benzoic acid: this medicinal product contains 1.3 mg/ml benzoic acid.

INTERACTIONS

Interactions Fluibron 15mg/5ml syrup 200ml - Which medicines or foods can modify the effect of Fluibron 15mg/5ml syrup 200ml?

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

Like all medicines, Fluibron 15mg/5ml syrup 200ml can cause side effects - What are the side effects of Fluibron 15mg/5ml syrup 200ml?

At the recommended doses the medicine is normally well tolerated. During therapy with ambroxol hydrochloride the following undesirable effects have been observed, with the following 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 (frequency cannot be estimated from the available data).

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “ https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.

OVERDOSE

Overdose Fluibron 15mg/5ml syrup 200ml - What are the risks of Fluibron 15mg/5ml syrup 200ml in case of overdose?

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.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Fluibron 15mg/5ml syrup 200ml

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 not shown any evidence of harmful effects on the foetus. However, it is recommended to observe the usual precautions regarding the use of medicinal products during pregnancy. In particular, during the first trimester, the use of Fluibron is not recommended. Ambroxol hydrochloride is secreted in breast milk. Although no undesirable effects on infants are expected, the use of Fluibron is not recommended in nursing mothers.

DRIVING AND USE OF MACHINERY

Taking Fluibron 15mg/5ml syrup 200ml before driving or using machinery - Does Fluibron 15mg/5ml syrup 200ml affect driving or using machinery?

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