IT SHOULD BE NOTED THAT THERE IS A RISK THAT THE SUBSTANCE MAY BE TOXIC TO HUMANS

NEO BOROCILLINA FLUIDIFICANTE TOSSE "30 MG/10 ML SCIROPPOSE" – FLACONE 200 ML

active ingredients

100 ml of syrup contain: Active ingredient: Ambroxol hydrochloride 300 mg. For excipients: See paragraph 6.1

Excellent

Hydroxyetylcellulose, 70% sorbitol, glycerol, benzoic acid, propylene glycol, tartaric acid, purified water, bitter aroma.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

The drug is contraindicated in children under 2 years of age. Hypersensitivity to the active ingredient or any of the excipients. Severe liver and/or kidney alterations. Intake of the drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see par. 4.4).

Population

We recommend the following dosages unless otherwise prescribed: 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 syrup after meals. Do not exceed the recommended doses. Do not use Neo Borocillin Fluidifier Tosse for prolonged treatments.

Conservation

This medicine does not require any special condition of conservation

Warnings

Neo Borocillin Fluidifier Tosse 30 mg / 10 ml syrup contains sorbitol: patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. Ambroxol Hydrochloride should be given with caution in patients with peptic ulcer. 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). Serious skin reactions such as multiform erythema, Stevens–Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized 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. In addition, in the initial phase of Stevens–Johnson Syndrome or TEN, patients may initially experience non-specific symptoms similar to flu symptoms, such as fever, malaise, rhinitis, cough and throat pain. Due to these misleading symptoms, symptomatic treatment with cough therapy and cold is possible. In case of mild or moderate renal failure, Neo Borocillin Fluidifier Tosse can only be used after consulting your doctor. As with every medication with liver metabolism followed by kidney excretion, the accumulation of ambroxol metabolites at a liver level is predictable in the presence of severe kidney failure.

Interactions

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

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common: ≥ 1/10 Municipality: ≥ 1/100, Rare immune system disorders: Hypersensitivity reactions Not known: Anaphylactic reactions, including anaphylactic shock, angioedema and itching Diseases of the nervous system Municipality: Disgeusia Raro: Cefalea Respiratory, chest and mediastinic pathologies City: Hypoesthesia of oral cavity and Rare pharynx: Rinorrea Notable: Bronchial obstruction Gastrointestinal diseases City: Nausea Not common: Vomito, diarrhea, dyspepsia and abdominal pain, mouth dry Raro: Pirosis, stips Not known: Dry gorge Pathologies of skin and subcutaneous tissue Rare: Rash, hives, contact dermatitis Notable: Severe skin adverse reactions (including multiform erythema, Stevens–Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis) Kidney and urinary pathologies Rare: Disuria Systemic pathologies and conditions for administration Rare: Tiredness 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/responsabili.

Overdosing

So far no specific symptoms of overdose have been reported in man. 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 Fluidifier Tosse at recommended doses, and may require symptomatic treatment.

Ambroxol Hydrochloride crosses the placental barrier. Clinical data relating to exposed pregnancy are not available for ambroxol. Animal studies do not indicate direct or indirect harmful effects for pregnancy, embryo/fetal development, birth or post-natal development (see 5.3). Clinical studies and extensive clinical experience have not evidenced any harmful effects for the fetus after 28^aweek of gestation. In spite of this, normal precautions should be taken on the intake of pregnant medicines. In particular during the first trimester, Neo Borocillina Fluidifier Tosse is not recommended. The drug is secreted in breast milk. Although there are no side effects in breast-feededed children, the use of Neo Borocillin Fluidifier Tosse is not recommended during breastfeeding.

Source: Farmadati