BISOLVON 20CPR 8MG

BISOLVON 8 MG COMPRESENT

active ingredients

1 tablet contains: Active ingredient: bromexine hydrochloride 8 mg. Excipient with known effects: lactose. For the full list of excipients, see paragraph 6.1.

Excellent

Lactose, corn starch, magnesium stearate.

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. 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. Fenilchetonuria (limited to the use of Bisolvon granulate sachets). Contraindicated during lactation.

Population

We recommend the following dosages unless otherwise prescribed: Adults and boys over 12 years: 2 tablets 3 times a day giorno.Bambini (6 - 12 years): 1 tablet 3 times a day. Early childhood (2 - 6 years): 1⁄2 tablet 2 times a day. DON'T OVERDO IT.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Treatment with Bisolvon 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. Bisolvon tablets contain lactose, equal to 468 mg for the intake of the maximum recommended daily dose, patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency, glucose/galactosis disease, should not take this medicine. 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.

Interactions

No confirmed interaction.

Effects

The frequencies are defined according to the following convention: Very common: ≥ 1/10 Municipality: ≥ 1/100, Immune system 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 pain in the upper quadrants of the abdomen. 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