Bisolvon 8 mg 20 tablets

Bisolvon 8 mg 20 tablets is a mucolytic based on bromhexine hydrochloride , specifically formulated to promote the fluidification and elimination of phlegm in acute and chronic respiratory diseases . Thanks to its expectorant action, Bisolvon tablets are indicated for the treatment of productive cough and cough with phlegm , helping to reduce the viscosity of bronchial secretions and facilitating their expulsion. Each tablet contains 8 mg of bromhexine, an active ingredient recognized for its effectiveness in improving the functionality of the respiratory tract and supporting lung health.

The 20-tablet pack is a practical and convenient solution for adults and children over 12 years of age, but can also be used in children aged 6 and up, according to the doctor's instructions. Bisolvon 8 mg is particularly useful in cases of acute respiratory diseases such as bronchitis, tracheitis and colds, but also in chronic respiratory diseases where the presence of dense and persistent mucus hinders breathing. Its tablet formulation makes it easy to take and also suitable for those who prefer to avoid syrups or liquid solutions.

Thanks to its targeted action on bronchial secretion , Bisolvon 8 mg tablets is a reference cough medicine for those seeking effective treatment of catarrh and rapid relief from the symptoms of respiratory conditions. The presence of lactose among the excipients should be taken into consideration for those with specific intolerances. Choose Bisolvon 8 mg 20 tablets for reliable support in managing productive cough and to promote the natural expectoration of mucus.

ACTIVE INGREDIENTS

Active ingredients contained in Bisolvon 8 mg 20 tablets - What is the active ingredient in Bisolvon 8 mg 20 tablets?

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

EXCIPIENTS

Composition of Bisolvon 8 mg 20 tablets - What does Bisolvon 8 mg 20 tablets contain?

Lactose , corn starch, magnesium stearate.

DIRECTIONS

Therapeutic indications Bisolvon 8 mg 20 tablets - Why is Bisolvon 8 mg 20 tablets used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Bisolvon 8 mg 20 tablets - When should Bisolvon 8 mg 20 tablets not be used?

Hypersensitivity to the active substance or to 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, its use is recommended after consulting the doctor. Phenylketonuria (limited to the use of Bisolvon granules sachets). Contraindicated during breastfeeding.

DOSAGE

Quantity and method of taking Bisolvon 8 mg 20 tablets - How to take Bisolvon 8 mg 20 tablets?

The following dosages are recommended unless otherwise prescribed by your doctor: Adults and children over 12 years: 2 tablets 3 times a day. Children (6 - 12 years): 1 tablet 3 times a day. Early childhood (2 - 6 years): ½ tablet 2 times a day. DO NOT EXCEED THE RECOMMENDED DOSES.

CONSERVATION

Storage Bisolvon 8 mg 20 tablets - How to store Bisolvon 8 mg 20 tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Bisolvon 8 mg 20 tablets - About Bisolvon 8 mg 20 tablets it is important to know that:

Treatment with Bisolvon leads to increased bronchial secretion (this promotes expectoration). Do not use for prolonged treatments. In the treatment of acute respiratory conditions, consult your doctor if symptoms do not improve or worsen during therapy. Bisolvon tablets contain lactose, equivalent to 468 mg for the maximum recommended daily dose, patients with rare hereditary problems of galactose intolerance, the Lapp 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 blistering 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 early phase of Stevens Johnson syndrome or toxic epidermal necrolysis (TEN), patients may initially experience non-specific flu-like symptoms, such as fever, chills, rhinitis, cough and sore throat. Because of these misleading symptoms, symptomatic treatment with cough and cold therapy may be initiated.

INTERACTIONS

Interactions Bisolvon 8 mg 20 tablets - Which medicines or foods can modify the effect of Bisolvon 8 mg 20 tablets?

No interactions confirmed.

SIDE EFFECTS

Like all medicines, Bisolvon 8 mg 20 tablets can cause side effects - What are the side effects of Bisolvon 8 mg 20 tablets?

Frequencies are defined using 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: 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, diarrhoea and upper abdominal pain. Skin and subcutaneous tissue disorders: 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 after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Bisolvon 8 mg 20 tablets - What are the risks of Bisolvon 8 mg 20 tablets in case of overdose?

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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Bisolvon 8 mg 20 tablets.

No studies have been conducted to investigate the effects on human fertility. Based on preclinical experience there is no indication of possible effects on fertility following the use of bromhexine. There are limited data on 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 toxicological data in animals have shown excretion of bromhexine and its metabolites in breast milk. A risk to breast-fed children cannot be excluded. Bisolvon should not be used during breast-feeding.

DRIVING AND USE OF MACHINERY

Taking Bisolvon 8 mg 20 tablets before driving or using machines - Does Bisolvon 8 mg 20 tablets affect driving or using machines?

No studies on the effects of bromhexine hydrochloride on the ability to drive and use machines have been performed.