TUSSEVAL MUCOLITICAL STRUCTURE 250ML

TUSSEVAL MUCOLITICAL 4 MG/5 ML SCIROPPOSE

active ingredients

5 ml contain: bromexine hydrochloride 4 mg, equivalent to bromexin 3,65 mg Excipients with known effects: sorbitol, ethanol, benzoic acid, sodium carmellose and hydroxide sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Tartaric acid, benzoic acid, sodium carmellose, glycerol, liquid sorbitol, ethanol (96%), all fruits aroma, sodium hydroxide, purified water.

Therapeutic indications

TUSSEVAL MUCOLITICAL is indicated in the treatment of secretion turbes in acute and chronic respiratory affections in adults and children over 2 years of age.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. There are no absolute contraindications, but in patients with gastroduodenal ulcer, it is recommended to use it after consulting the doctor. Contraindicated during nursing (see par. 4.6). The drug is contraindicated in children under 2 years of age.

Population

Population We recommend the following dosages unless otherwise prescribed: Adults: 5-10 ml 3 times a day (=24 mg die) In adults, at the beginning of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided into three times. Pediatric population Children over 2 years: 2.5 - 5 ml 3 times a day (= 12 mg die) Method of administration It is recommended to take the drug after meals. Do not exceed the recommended doses. To measure the appropriate dose use the dosing glass inserted in the package (with 2,5 ml notches equal to 2 mg of bromexine hydrochloride, 5 ml equal to 4 mg of bromexine hydrochloride and 10 ml equal to 8 mg of bromexine hydrochloride).

Conservation

This medicine does not require any special condition of conservation.

Warnings

Treatment with TUSSEVAL MUCOLITICO involves an increase in bronchial secretion (this promotes expectation). Do not use for protracted treatments. In treating acute respiratory conditions, consult your doctor if symptoms do not improve or worsen during therapy. Cases of severe skin reactions such as multiform erythema, StevensJohnson 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 bromexine hydrochloride should be stopped immediately and a doctor should be consulted. Most of these reactions could be explained by the severity of underlying diseases or other medications taken simultaneously. 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. - TUSSEVAL MUCOLITICAL contains 4 g of sorbitol per dose equivalent to 10 ml, which are equivalent to 400 mg/ml. Sorbitol is a source of fructose. In case of intolerance to certain sugars, or in case of diagnosis of hereditary intolerance to fructose, a rare genetic disease for which patients fail to transform fructose, speak with the doctor before you (or the child) take this medicine. Patients with hereditary fructose intolerance should not be given this medicine. It can cause gastrointestinal problems and have a slight laxative effect. - TUSSEVAL MUCOLITICAL contains 290 mg alcohol (ethanol) in 10 ml, which are equivalent to 29 mg/ml. The quantity in 10 ml of this medicine is equivalent to less than 0.5 ml of beer or 1.25 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. - TUSSEVAL MUCOLITICAL contains 20 mg of benzoic acid per dose equivalent to 2 ml/ml. - TUSSEVAL MUCOLITICAL contains less than 1 mmol (23 mg) of sodium for 10 ml, i.e. essentially “without sodium”. Pediatric population 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

Clinical interactions with other medicines have not been reported.

Effects

The frequencies are defined according to the following convention: Very common: ≥ 1/10; Common: ≥ 1/100, Immune disorders. Rare: hypersensitivity reactions; Notable: anaphylactic reactions, including anaphylactic shock, angioedema and itching. Respiratory, thoracic and mediastinic pathologies. Notable: bronchospasm. Gastrointestinal disease. Not common: nausea, vomiting, diarrhea and superior abdominal pain. Pathologies of skin and subcutaneous tissue. Rare: rash, hives; Notable: severe skin adverse reactions (including multiform erythema, StevensJohnson syndrome/toxic epidermal necrolysis and generalized acute acute exantematic pustolosis). 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 reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse

Overdosing

No specific overdose symptoms have ever been reported. In reported cases of accidental overdose and/or drug intake errors, observed symptoms correspond to the known side effects of TUSSEVAL MUCOLITICAL to recommended dosages, and symptomatic treatment may be required.

Pregnancy

There are limited data on the use of bromexin in pregnant women. Animal studies show no direct or indirect harmful effects on reproductive toxicity. As a precautionary measure, it is preferable to avoid using TUSSEVAL MUCOLITICAL during pregnancy.

Food

It is not known if bromexin and its metabolites pass into human milk. The pharmacodynamic and toxicology data available on animals showed the excretion of bromexin and its metabolites in breast milk. A risk for breast-feededed children cannot be excluded. TUSSEVAL MUCOLITICO should not be used during lactation.

Fertility

Studies have not been conducted to investigate the effects on human fertility. Based on the preclinical experience there are no indications of possible effects on fertility as a result of the use of bromexin.