AMBROTUS SCIR FL 200ML

AMBROSE

active ingredients

AMBROTUS 30 mg/10 ml bottle syrup 200 ml 100 ml of syrup contain: Active ingredient: ambroxol hydrochloride 300 mg AMBROTUS 30 mg/10 ml syrup 10 ml monodose containers A single-dose container contains: Active ingredient: ambroxol Hydrochloride 30 mg Eccipients with known effects: sorbitol, glycerol, benzoic acid, glycol propylene. For the full list of excipients, see paragraph 6.1.

Excellent

Hydroxyetylcellulose, Sorbitol 70%, Glycerol, Benzoic Acid, Amaranus Aroma, Glycol Propilene, 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 changes. • The medicinal product is contraindicated in children under 2 years of age.

Population

Population Adults: 10 ml 3 times a day (30 ml). Children from 2 to 5 years: 2.5 ml 3 times a day (7,5 ml).Children over 5 years: 5 ml 3 times a day (15 ml). It is recommended to take syrup after meals. Do not use AMBROTUS for prolonged treatments. In acute respiratory affections, contact your doctor if symptoms do not improve or worsen during treatment with Ambrotus.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Serious skin reactions such as multiform erythema, Stevens Johnson syndrome (SJS) / Toxic epidermal necrolysis (NET) and generalized acute esantelosis (AGEP) associated with ambroxol administration have been 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 reactions 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 (NET), 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 new lesions of the skin or mucous membrane occur, consult your doctor immediately and precautionally stop the treatment with ambroxol hydrochloride. In case of compromised kidney function, ambroxol hydrochloride can only be used after consulting the doctor. As with any medication with liver metabolism followed by kidney elimination, in the presence of kidney failure, it may be expected to accumulate ambroxol metabolites generated in the liver. Ambroxol 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). Important information about some excipients: This medicine contains 350 mg of sorbitol by ml. Patients with hereditary fructose intolerance should not be given this medicine. It can cause gastrointestinal problems and have a slight laxative effect. This medicine contains 2 mg of benzoic acid for ml.Questo medicine contains 30 mg of propylene glycol by ml.

Interactions

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

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, Systemic-organic classification Very common (≥1/10) Town (≥1/100 and Not common (≥1/1,000 and Rare (≥1/10.000 and Frequency not known Immune system disorders       Reactions of hypersensitivity Anaphylactic reactions, including anaphylactic shock, angioedema and itching Pathologies of skin and subcutaneous tissue       Rash, hives Severe skin adverse reactions (including multiform erythema, Stevens Johnson syndrome/ Toxic epidermal necrolysis and generalized acute exantematic pustolosis) Diseases of the nervous system   Disgeus       Gastrointestinal diseases   Nausea, oral hypoesthesia Vomito, diarrhea, dispepsia, abdominal pain, mouth dryness Dryness of the throat Pirosis Respiratory, chest and mediastinic pathologies   Phyngeal hypoesthesia     Bronchial obstruction Kidney and urinary pathologies       Disability   Systemic pathologies and conditions for administration       Tired   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 cases of errors in the administration of the medicinal product are consistent with the expected effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.

Pregnancy Ambroxol Hydrochloride crosses the placental barrier. Preclinical 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, there is no evidence of any harmful effect on the fetus after the 28th week of gestation, it is recommended to take normal precautions on taking medications in pregnancy. Especially during the first trimester it is not recommended to take ambroxol hydrochloride. Food Ambroxol Hydrochloride is excreted in breast milk. Although there are no side effects in breast-feededed children, the use of ambroxol hydrochloride is not recommended during breastfeeding. Fertility Preclinical studies have not evidenced directly or indirectly harmful effects for fertility.

Source: Farmadati