AMBROXOLO EG FL 200ML 15MG/5ML

AMBROXOLE AND SYRUP

active ingredients

AMBROXOLO EG 15 mg/5 ml syrup - 200 ml bottle: 100 ml syrup contain: Active ingredient: ambroxol hydrochloride 300 mg AMBROXOLO EG 30 mg/10 ml syrup - monodose containers of 10 ml: Each single-dose container contains: Active ingredient: ambroxol hydrochloride 30 mg. Excipients with known effects: sorbitol 70% solution; glycerol For the full list of excipients, see paragraph 6.1

Excellent

Hydroxyethylcellulose; 70% solution sorbitol; glycerol; benzoic acid; bitter aroma; propylenglycol; tartaric acid; 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 listed in paragraph 6.1. Severe liver and/or kidney alterations. The drug is contraindicated in children under 2 years of age. The use of the product is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients of the product (see paragraph 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 use ambroxol for protracted treatments.

Conservation

This medicine does not require any special condition for conservation

Warnings

AMBROXOLO EG contains: - sorbitol: patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine. - glycerol: can cause headaches, gastric disorders and diarrhea. Ambroxol should be given with caution in patients with peptic ulcer. Cases of severe skin reactions such as multiform erythema, Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute 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. Most of these severe injuries of the skin could be explained by the severity of underlying diseases or other concomitant drugs. In addition, in the initial phase of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific symptoms similar to those of flu, such as fever, soreness, rhinitis, cough and throat. Due to these misleading influenza symptoms, symptomatic treatment with cough and cold therapy can be undertaken. In case of mild or moderate renal failure, AMBROXOLO EG can only be used after consulting the doctor. As in the case of any medication subject to liver metabolism and subsequent renal elimination, the accumulation of ambroxol metabolites in the liver is foreseeable in the presence of severe kidney failure. 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).

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No unfavorable interaction with other clinically relevant drugs has been reported.

Effects

The desired effects listed by frequency are reported using the following convention: Very common (≥1/10); common (≥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 (e.g. Alterations of taste sense) Rare: cephalea Respiratory, chest and mediastinic pathologies Common: hypoesthesia of the oral cable and the Raro pharynx: restoration Notable: bronchial obstruction Gastrointestinal diseases Municipality: nausea Not common: vomiting, diarrhea, dyspepsia and abdominal pain, dryness of the Rare bundles: pyrosis, stips Not known: dry throat Pathologies of skin and subcutaneous tissue Rare: rash, hives, contact dermatitis Not known: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic toxic epidermal necrolysis and generalized acute urstolosis). Kidney and urinary pathologies Rare: disuria Systemic pathologies and conditions for administration Rare: fatigue 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 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 reports of errors in the administration of medicinal products are consistent with the expected adverse effects of AMBROXOLO EG at recommended doses and may require symptomatic treatment.

Pregnancy Ambroxol Hydrochloride crosses the placental barrier. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see paragraph 5.3). Despite preclinical studies and extensive clinical experience, there is no evidence of any harmful effect after the 28th week of gestation, it is recommended to take normal precautions on taking pregnant drugs. Specially during the first trimester is not recommended to take Ambroxolo EG. It is necessary to be prudent in prescribing the medicine to pregnant women. In pregnancy drugs should only be prescribed if the expected benefit for the mother is considered greater than the risk for the fetus. All drugs should be avoided, if possible, during the first trimester of pregnancy. Breasting Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects on breast-feededed children, the use of AMBROXOLO EG is not recommended in nursing mothers.

Source: Farmadati