BISOLVON OS SOL FL 40ML 2MG/ML

BISOLVON 2 MG/ML

active ingredients

1 ml or 15 drops contain: Active ingredient: bromexine hydrochloride 2 mg (equivalent to bromexin 1.82 mg). Excipient with known effects: methyl-para-hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Tartaric acid, methyl-para-hydroxybenzoate, distilled water.

Therapeutic indications

Bisolvon is indicated in the treatment of secretion turbs in acute and chronic respiratory affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. The drug is contraindicated in children under 2 years of age. In case of hereditary conditions that may be incompatible with one of the excipients (see 4.4). 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 paragraph 4.6).

Population

We recommend the following dosage except different prescription: Adults and boys over 12 years: 8 ml 3 times a day. Average population in pediatrics: Children (2 - 6 years): 20-40 drops 3 times a day. Children (6 - 12 years): 2-4 ml 3 times a day. In children between 2 and 6 years it is necessary to follow exactly the prescription of the doctor. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Methyl-para-hydroxybenzoate contained in the medicinal product may cause allergic reactions (also delayed). Do not use for protracted treatments. In treating acute respiratory conditions, consult your doctor if symptoms do not improve or worsen during therapy. Treatment with Bisolvon involves an increase in bronchial secretion (this promotes expectation). For the use of Bisolvon 2 mg/ml oral solution in children between 2 and 6 years consult your doctor before use. Cases of severe 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 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 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. 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 Municipality: ≥ 1/100, Immune system disorders: Rare: hypersensitivity reactions Not known: anaphylactic reactions, including anaphylactic shock, angioedema and itching. Respiratory, chest and mediastinic pathologies: Notable: bronchospasmo Gastrointestinal diseases: 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, Stevens-Johnson syndrome/ Toxic epidermal necrolysis and generalized 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 national reporting system at the address http://www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Until now, specific overdose symptoms have never been reported in man. In reported cases of accidental overdose and/or drug intake errors, observed symptoms correspond to the well-known side effects of Bisolvon to recommended dosages, and symptomatic treatment may be required.

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. There are limited data on the use of bromexin in pregnant women. Animal studies indicate no direct or indirect harmful effects on reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Bisolvon during pregnancy. 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. Bisolvon should not be used during feeding.

Source: Farmadati