Description
Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.
Active Ingredients
10 ml of syrup contains: Active ingredient : Ambroxol hydrochloride 30 mg. Excipients with known effects: Sorbitol 5 g Benzoic acid 20 mg Propylene glycol 300 mg Glycerol 1.5 g For excipients: See section 6.1
Excipients
Hydroxyethylcellulose, sorbitol 70%, glycerol , benzoic acid , propylene glycol , tartaric acid, purified water, black cherry flavouring.
Dosage
The following dosages are recommended unless otherwise prescribed by your doctor: Adults : 10 ml (30 mg) 3 times a day. Children over 5 years: 5 ml (15 mg) 3 times a day. Children from 2 to 5 years: 2.5 ml (7.5 mg) 3 times a day. It is recommended to take the syrup after meals. Do not exceed the recommended doses. Do not use Neo Borocillina Fluidificante Tosse for prolonged treatments.
Warnings
This medicinal product contains 5 g of sorbitol per 10 ml of syrup. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet should be considered. The sorbitol content in medicinal products for oral use may modify the bioavailability of other concomitantly administered medicinal products for oral use. Patients with hereditary fructose intolerance should not be given this medicinal product. It may cause gastrointestinal problems and have a mild laxative effect. Ambroxol hydrochloride should be administered with caution in patients with peptic ulcer. 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). 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 with the administration of ambroxol. 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. Furthermore, in the early phase of Stevens-Johnson syndrome or TEN, patients may initially experience non-specific flu-like symptoms, such as fever, malaise, rhinitis, cough and sore throat. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy may be initiated. In case of mild or moderate renal insufficiency, Neo Borocillina Fluidificante Tosse can only be used after consulting a doctor. As with any medicinal product with hepatic metabolism followed by renal excretion, accumulation of ambroxol metabolites at the hepatic level is predictable in the presence of severe renal insufficiency.
Conservation
This medicinal product does not require any special storage conditions.
Contraindications
The drug is contraindicated in children under 2 years of age. Hypersensitivity to the active substance or to any of the excipients. Severe liver and/or kidney disorders. Taking the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4).
Side effects
Adverse reactions are listed below by system organ class and frequency, using the following categories: Very common: ≥ 1/10; Common: ≥ 1/100, < 1/10; Uncommon: ≥ 1/1,000, < 1/100; Rare: ≥ 1/10,000, < 1/1,000; Very rare: < 1/10,000; Not known: frequency cannot be estimated from the available data. Immune system disorders: Rare: hypersensitivity reactions; Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders : Common: dysgeusia; Rare: headache. Respiratory, thoracic and mediastinal disorders : Common: hypoaesthesia of the oral cavity and pharynx; Rare: rhinorrhoea; Not known: bronchial obstruction. Gastrointestinal disorders . Common: nausea; Uncommon: vomiting, diarrhoea, dyspepsia and abdominal pain, dry mouth; Rare: heartburn, constipation; Not known: dry throat. Skin and subcutaneous tissue disorders . Rare: rash, urticaria, contact dermatitis; Not known: serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis). Renal and urinary disorders . Rare: dysuria. General disorders and administration site conditions . Rare: fatigue. Reporting of suspected adverse reactions Reporting of 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
No specific symptoms of overdose have been reported in humans to date. The 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 adverse effects of Neo Borocillina Fluidificante Tosse at the recommended doses, and may require symptomatic treatment.
Pregnancy
Ambroxol hydrochloride crosses the placental barrier. For ambroxol, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/foetal development, parturition or postnatal development (see 5.3). Clinical studies and extensive clinical experience have not shown any harmful effects on the foetus after the 28th week of gestation. Despite this, the usual precautions for taking medicines during pregnancy should be taken. In particular during the first trimester, the intake of Neo Borocillina Fluidificante Tosse is not recommended. The drug is secreted in breast milk. Although no undesirable effects are expected in breast-fed children, the use of Neo Borocillina Fluidificante Tosse is not recommended during breast-feeding.
