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Bisolvon Linctus Mucolytic Bromhexine Syrup 250 ml

€12.90
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021004041
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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 prevalence of underlying diseases or other drugs taken at the same time. Also in the early stage 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. Because of these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. Mucolytics can induce bronchial obstruction in children younger than 2 years. 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 younger 'less than 2 years. The medicine contains liquid maltitol: the maximum recommended daily dose 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 should not take this medicine. This medicine can 'have a mild laxative effect.
PHARMACOTHERAPEUTIC CATEGORY
Mucolytics.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. The drug is contraindicated in children younger than 2 years. In case of hereditary conditions which may be incompatible with one of the excipients. There are no absolute contraindications, but in patients with gastroduodenal ulcer, its use is recommended after consulting your doctor. Contraindicated during lactation.
NAME
BISOLVON LINCTUS 4 MG / 5 ML CHOCOLATE-CHERRY FLAVOR SYRUP
EXCIPIENTS
Benzoic acid, liquid maltitol, sucralose, chocolate flavor, aromaciliegia, levomentol, purified water.
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. Disorders of the immune system. 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). Report any suspected adverse reactions via the national reporting system.
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 use 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. It should not be used during breastfeeding.
INDICATIONS
Treatment of secretion disorders in acute and chronic respiratory diseases.
INTERACTIONS
No clinically relevant interactions with other medicinal products have been reported.
DOSAGE
The following dosages are recommended unless otherwise prescribed. Adults: 5 - 10 ml 3 times a day. In adults, at the start of treatment, it may be necessary to increase the total daily dose up to 48 mg divided in three times. Children older than 2 years: 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 glass doser 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).
ACTIVE PRINCIPLES
5 ml of syrup contain: bromhexine hydrochloride 4 mg (equivalent to abromexina 3.65 mg).
021004041
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Bisolvon Linctus Mucolytic...

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