BISOLVON * LINCTUS SCIR FL 250ML

BISOLVON * LINCTUS SCIR FL 250ML

Therapeutic indications

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

Dosage and method of use

The following dosages are recommended unless otherwise prescribed: Adults: 5 - 10 ml 3 times a day. In adults, at the start of treatment, the total daily dose may need to be increased up to 48 mg divided into three times. Children over 2 years of age: 2.5 - 5 ml 3 times a day. It is recommended to take the drug after meals. The syrup can be administered to diabetics and children over 2 years, it does not contain fructose or sucrose.Do not exceed the recommended dose. To measure the appropriate dose, use the measuring cup included in the package (marked with 1.25 ml equal to 1 mg of bromhexine hydrochloride, 2.5 equal to 2 mg of bromhexine hydrochloride and 5 ml equal to 4 mg of bromhexine hydrochloride).

Contraindications

Hypersensitivity to the active substance or to any of the excipients. The drug is contraindicated in children under 2 years of age. In case of hereditary conditions which may be incompatible with one of the excipients (see 4.4). There are no absolute contraindications, but in patients with gastroduodenal ulcer, its use is recommended after consulting your doctor. Contraindicated during lactation (see section 4.6).

Side effects

Frequencies are defined according to the following convention: Very common: ≥ 1/10 Common: ≥ 1/100, 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.Skin and subcutaneous tissue disorders.Rare: rash, hives; Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

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 over the course of therapy. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with administration of bromhexine hydrochloride. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with bromhexine hydrochloride should be discontinued immediately and a physician consulted. Most of these reactions could be explained by the severity of underlying disease or other medications taken at the same time. Also in the early stages of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific flu-like symptoms such as fever, chills, rhinitis, cough and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (see section 4.3). The medicine contains liquid maltitol: the maximum recommended daily dose of Bisolvon 4 mg / 5ml contains 15 g of maltitol (30 g in case of increased daily dose in adults at the start of treatment), patients with rare problems of fructose intolerance do not need to take this medicine. This medicine may have a mild laxative effect.

Pregnancy and breastfeeding

No studies have been conducted to investigate the effects on human fertility. Based on preclinical experience there are no indications of possible effects on fertility following the use of bromhexine. There are limited data from the use of bromhexine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Bisolvon during pregnancy. It is not known whether bromhexine and its metabolites pass into human milk. Available pharmacodynamic and toxicology data in animals have shown excretion of bromhexine and its metabolites in breast milk. A risk to breastfed babies cannot be excluded. Bisolvon should not be used during breastfeeding.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No clinically relevant interactions with other medicinal products have been reported.

Overdose

Until now, no specific symptoms of overdose have ever been reported in humans. In reported cases of accidental overdose and / or medication errors, the symptoms observed correspond to the known side effects of Bisolvon at recommended dosages, and symptomatic treatment may be required.

Active principles

5 ml of syrup contain: Active ingredient:bromhexine hydrochloride4 mg (equivalent tobromhexine3.65 mg). Excipient with known effect: maltitol. For the full list of excipients, see section 6.1.

Excipients

Benzoic acid,liquid maltitol, sucralose, chocolate flavor, cherry flavor, levomenthol, purified water.