Bisolvon 8 mg 20 tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Bisolvon is indicated in the treatment of secretion disorders in acute and chronic respiratory diseases.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. In case of hereditary conditions which may be incompatible with one of the excipients (see 4.4). There are no absolute contraindications, but its use is recommended in patients with gastroduodenal ulcers after consulting the doctor. Phenylketonuria (limited to the use of Bisolvon granule sachets). Contraindicated during breastfeeding.

WARNINGS AND PRECAUTIONS FOR USE

Treatment with Bisolvon involves an increase in bronchial secretion (this promotes expectoration). Do not use for prolonged treatments. When 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 maximum recommended daily dose. Patients suffering from rare hereditary problems of galactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome should not take this medicine. Cases of serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the administration of bromhexine hydrochloride. If symptoms or signs of progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, treatment with bromhexine 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 medications. Furthermore, in the initial phase of Stevens Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience non-specific symptoms similar to those of the flu, such as fever, chills, rhinitis, cough and sore throat. Because of these misleading symptoms, symptomatic treatment with cough and cold therapy may be undertaken.

INTERACTIONS

No confirmed interactions.

SIDE EFFECTS

Frequencies are defined according to the following convention: Very common: ≥ 1/10 Common: ≥ 1/100, < 1/10 Uncommon: ≥ 1/1,000, < 1/100 Rare: ≥ 1/10,000, < 1/1,000 Very rare: < 1/10,000 Not known: the frequency cannot be estimated from the available data. Immune system disorders. Rare: hypersensitivity reactions; Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Respiratory, thoracic and mediastinal disorders. Not known: bronchospasm. Gastrointestinal disorders. Uncommon: nausea, vomiting, diarrhea and upper abdominal pain. Pathologies of the skin and subcutaneous tissue. Rare: rash, urticaria; Not known: serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.