Lisomucil Mucolytic Cough 100 mg/5 ml Syrup for Children 200 ml
Respiratory system, mucolytics.
ACTIVE INGREDIENTS. 1 ml syrup contains: active ingredient: carbocysteine 20 mg. Excipients with known effects: syrup with sugar: sucrose, methyl parahydroxybenzoate, and cochineal red A (E124); syrup without sugar: liquid maltitol, methyl parahydroxybenzoate, and cochineal red A (E124). For the full list of excipients, see section 6.1. EXCIPIENTS LISOMUCIL TOXSE MUCOLITIC Syrup with sugar: sucrose, methyl p arahydroxybenzoate, vanillin, cochineal red A (E124), lampo ne flavor, cherry flavor, sodium hydroxide, purified water.
LISOMUCIL TOXSE MUCOLITICS sugar-free syrup: hydroxyethyl cellulose, saccharin sod ica, maltitol liquid, methyl parahydroxybenzoate sodium, cocci niglia red A (E124), cherry-lampone flavor, sodium hydroxide, purified water.
INDICATIONS LISOMUCIL COUGH MUCOLITIC SYRUP with sugar: mucolytic and thinning agent in acute and chronic respiratory disorders.
LISOMUCIL TOSSE MUCOLITIC SYRUP without sugar: mucolytic and fluidifying in acute and chronic affections of the respiratory system, especially in case of low-carbohydrate, normocalor ic or hypocaloric diets.
CONTRAINDICATIONS/SECONDARY EFFECTS Hypersensitivity to the active ingredient or any of the excipien ts listed in section 6.1. Gastroduodenal ulcer.
LISOMUCIL COUGH MUCOLITIC SYRUP is contraindicated in children under 2 years of age.
POSOLOGY Unless otherwise prescribed, the following dosage sc heme may be adopted: over 5 years of age: 1 measuring spoon, 2 to 3 times daily; between 2 and 5 years of age: 1/2 to 1 measuring spoon, 2 times daily. These doses may be increased according to medic a prescription.
STORAGE Store at a temperature below 25 degrees C.
WARNINGS Mucolytics may induce bronchial obstruction in children younger than 2 years of age. In fact, the ability to drain bronc hial mucus is limited in this age group because of the physiologic characteristics of the airways. They should therefore not be used in children younger than 2 years of age (see section 4.3). Caution is recommended in elderly patients, those with a history of gastroduodenal ulcers, or those who are taking medications known to cause gastrointestinal bleeding. Patients should interr ompose treatment with carbocysteine if gastr ointestinal bleeding occurs.
LISOMUCIL TOXSE MUCOLITIC Syrup with sugar contien e sucrose in the amount of 140 g per 200 ml bottle; this should be kept in mind in case of diabetes or hypocaloric diet. The daily posol ogy of 3 teaspoons per day (equal to 15 ml syrup) provides 10.5 g sucrose, while the posol ogy of 2 teaspoons per day (equal to 10 ml syrup) provides 7 g sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrose-isomerase enzyme deficiency should not take this medication.
LISOMUCIL TOSSE MUCOLITIC SYRUP or sugar-free contains polyols (liquid maltitol): patients with rare hereditary problems of fructose intolerance should not take this medicine. The liquid maltitol contained in LISOMUCIL TOXSE MUCOLITICS sugar-free syrup does not promote the occurrence of caries.
LISOMUCIL TOXSE MUCOLITIC SYRUP contains cocci nile red A (E 124), which can cause allergic reactions.
LISOMUCIL TOXSE MUCOLITIC SYRUP contains methyl parahydroxybenzoate which may cause allergic reactions (even delayed). In case of low-sodium diet, be aware that the recommended dose of 5 ml of syrup contains about 13 mg of sodium.
INTERACTIONS There are no known, to the present state of knowledge, incompatibilities n e 'between the administration of carbocysteine and the most common drugs of use in the therapy of upper and lower airway disorders, nor with food or laboratory tests.
UNDESIRABLE EFFECTS. Undesirable effects are listed according to the following frequency classification: very common (>= 1/10); common (>= 1/100, < 1/ 10); uncommon (>= 1/1000, < 1/100); rare (>= 1/10,000, < 1/1000); molto rare (< 1/10,000), not known (frequency cannot be defined based on available data). Immune system disorders. F requency not known: anaphylactic reaction. Gastrointestinal disorders. Very common: diarrhea, nausea, and upper abdominal pain; frequency not known: vomiting and gastrointestinal bleeding (If this occurs, inte rrupt treatment and consult physician to institute appropriate therapy). Skin and subcutaneous tissue disorders. Frequency not known: Steven-Johnson syndrome, erythema multiforme, to ssic rash, drug eruption, rash. Bronchial obstruction may also be ve rificated (frequency not known). In such cases, inte rrupt treatment and consult your physician to institute appropriate therapy. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after the drug is authorized is important, as it allows for continuous monitoring of the benefit/risk ratio of the drug. Health care professionals are asked to report any suspected adverse reactions through the national reporting system at www.agenz iafarmaco.gov.it/en/responders. PREGNANCY AND LACTATION Not applicable: the product is indicated for pediatric use only.