AMBROX NEBUL FL50ML 7,5

AMBROX ANGELINI 7,5 MG/ML SOLVED BY NEBULZATION

active ingredients

AMBROX ANGELINI 7.5 mg/ml Nebulizing solution 100 ml of solution contain 750 mg of ambroxol hydrochloride. Excipient(s) with known effects: metabisulphite sodium, methyl parahydroxybenzoate, propile parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Metile parahydroxybenzoate - propile parahydroxybenzoa - sodium metabisulfite - monohydrate citric acid - sodium hydroxide - purified water.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Severe liver and/or kidney alterations. Intake of the medicinal product is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see paragraph 4.4).

Population

Population Adults and children over 5 years: 2-3 ml solution 1-2 times a day. Children under 5 years: 2 ml solution 1-2 times a day. How to administer As in the deep breathing of aerosol can subtract cough, you must try to breathe normally during inhalation. It is recommended to heat the solution up to the body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. Do not use ambroxol for prolonged treatments.

Conservation

DO NOT CONSERVATE HIGHLIGHTS AT 25°C

Warnings

Ambroxol should be given with caution in patients with peptic ulcer. Cases of severe skin reactions such as multiform erythema, Steven-Jhonson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute (AGEP) stemming from ambroxol were reported. Most of these could be explained by the severity of underlying diseases or other concomitant drugs. In addition, in the initial phase of Stevens Johnson's syndrome or toxic epidermal necrolysis (TEN), patients may initially experience non-specific symptoms similar to flu symptoms, such as fever, chills, rhinitis, cough and throat pain. Due to these misleading symptoms, symptomatic treatment with cough and cold therapy is possible. 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 should be consulted by your doctor. If new skin or mucosa lesions occur, consult your doctor immediately and precautionally stop treatment with ambroxol hydrochloride. In case of mild or moderate kidney failure, Ambroxolo Angelini can only be used after consulting the doctor. As with each metabolized drug through the liver and eliminated by renal means, you can have an accumulation of ambroxol metabolites generated in the liver in the presence of severe kidney failure (see paragraph 4.3). Ambroxolo Angelini contains: - sodium metabisulfite: this medicine contains metabisulphite sodium that can rarely cause serious reactions of hypersensitivity and bronchospasm; - methyl parahydroxybenzoate and propile parahydroxybenzoate: this medicine contains parahydroxybenzoates that can cause allergic reactions (also delayed) and, exceptionally, bronchospasm; - sodio: This medicine contains less than 1 mmol (23 mg) of sodium per dose (3 ml), i.e. essentially ‘without sodium’.

Interactions

AMBROX ANGELINI, generally does not interfere with other drugs.

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common (≥1/10) Common (≥1/100, Rare immune system disorders: hypersensitivity reactions. Notable: anaphylactic reactions including anaphylactic shock, angioedema and itching. Pathologies of skin and subcutaneous tissue Raro: rash, hives Notable: severe skin adverse reactions (including multiform erythema, Steven-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Diseases of the nervous system Municipality: disgeusia (modification of taste) Gastrointestinal pathologies, respiratory, thoracic and mediastinic Common: nausea, pharyngeal hypoesthesia and oral Not common: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth Not known: dry throat, pyrosis. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 medicinal products are consistent with the expected adverse effects of Ambroxolo Angelini at recommended doses and may require symptomatic treatment.

Pregnancy

Ambroxol Hydrochloride crosses the placental barrier. Animal studies have not evidenced directly or indirectly harmful effects for pregnancy, embryo/fetal development, birth or postnatal development. Despite preclinical studies and extensive clinical experience, no harmful effects after 28^a week of gestation, it is recommended to take the normal precautions on taking medications during pregnancy. Especially during the first trimester, Ambroxolo Angelini is not recommended.

Food

Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects in breast-feededed children, the use of Ambroxolo Angelini is not recommended during breastfeeding.

Source: Farmadati