Bisolvon Linctus Strawberry Syrup 4mg/5ml Children's Fatty Cough 200ml

NAME
BISOLVON LINCTUS 4 MG / 5 ML STRAWBERRY FLAVOR SYRUP

PHARMACOTHERAPEUTIC CATEGORY
Mucolytic.

ACTIVE PRINCIPLES
Bromhexine hydrochloride.

EXCIPIENTS
Benzoic acid, liquid maltitol, sucralose, strawberry flavor, cherry flavor, hydroxyethylcellulose, purified water.

INDICATIONS
Treatment of secretion disorders in acute and chronic respiratory diseases.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; contraindicated in children younger 'less 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 the doctor; contraindicated during lactation.

DOSAGE
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 patients with diabetes 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 ml equal to 2 mg of bromhexine hydrochloride and 5 ml equal to 4 mg of bromhexine hydrochloride) .

STORAGE
This medicine does not require any special storage conditions.

WARNINGS
Treatment with the medicine leads to 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 blisters 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 the underlying disease or by 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. 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 younger 'less 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 than 2 years. The medicine contains liquid maltitol. This medicine can 'have a mild laxative effect.

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

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). The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

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 the drug during pregnancy. It is not known whether bromhexine and its metabolites pass into human milk. Available pharmacodynamic and toxicology data on 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.