Descrizione Clinica
LISOMUCIL 100 MG/5 ML OF SYRUP
active ingredients
1 ml syrup contains: Active ingredient: carbocysteine 20 mg. Excipients with known effects: Syrup with sugar: sucrose, methyl parahydroxybenzoate (E218), and red cochineal A (E124) Syrup without sugar: liquid maltitol, methyl parahydroxybenzoate (E218), sodium and red cochineal A (E124). For the full list of excipients, see paragraph 6.1.Excellent
LISOMUCIL TOSSE MUCOLITICS syrup with sugar Saccarosio, methyl parahydroxybenzoate, vanillin, red cochineal A (E124), raspberry aroma, cherry aroma, sodium hydroxide, purified water. LISOMUCIL TOSSE MUCOLITICS syrup without sugar Hydroxyetylcellulose, sodium saccharin, liquid maltitol, sodium parahydroxybenzoate methyl, cochineal red A (E124), cherry-lampone aroma, sodium hydroxide, purified water.Therapeutic indications
LISOMUCIL TOSSE MUCOLITICS syrup with sugar Mucolitic and fluidizing in the acute and chronic affections of the respiratory system. LISOMUCIL TOSSE MUCOLITICS syrup without sugar Mucolitic and fluidizing in the acute and chronic affections of the respiratory system, in particular in case of low-fat diets of glucids, normocaloric or hypocaloric.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Gastroduodenal active ulcer. Children under 2 years of age.Population
Unless otherwise prescribed, the following posological scheme may be adopted: - over 5 years: 1 teaspoon dispenser, 2 - 3 times a day. - between 2 and 5 years: 1⁄2 - 1 teaspoon dispenser, 2 times a day. These doses can be increased according to prescription. The recommended maximum duration of treatment is 5 days. Treatment for longer periods may be carried out, according to the doctor's judgment.Conservation
Store at a temperature below 25°C.Warnings
Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Gastrointestinal bleeding Cases of gastrointestinal bleeding have been reported with the use of carbocysteine It is recommended caution in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant drugs known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, the patient must stop treatment with carboxysteine. Asthmatic and debilitated patients It is recommended to take specific precautions in patients with severe respiratory failure, in patients with asthma and with a history of bronchospasm, as well as in debilitated patients. The use of carboxysteine causes a decrease in the viscosity of the mucus and an increase in the removal of the mucus, both through the epithelial activity, and through the reflex of the cough. Therefore, there is an increase in cough and inspectorate. The use of antitussive medicines inhibits cough reflex and increases the risk of airway obstruction, due to an increase in mucus accumulation in respiratory tract. Concurrent use of this medicine with sedative medications of cough and/or medicines that inhibit bronchial secretion (e.g. anti-muscarinic medicines) is not recommended. LISOMUCIL TOSSE MUCOLITIC syrup with sugar contains 3.5 g sucrose for 5 ml syrup (1 teaspoon). Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. The daily posology of 3 teaspoons per day (equal to 15 ml syrup) provides 10,5 g sucrose, while the posology of 2 teaspoons per day (equal to 10 ml syrup) provides 7 g sucrose. To consider in people with diabetes mellitus. LISOMUCIL TOSSE MUCOLITIC syrup without sugar contains liquid maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The liquid maltitol contained in the syrup does not favor the occurrence of caries. LISOMUCIL TOSSE MUCOLITICS syrup without sugar and LISOMUCIL TOSSE MUCOLITIC syrup with sugar contains red cochineal A (E 124) which can cause allergic reactions. LISOMUCIL TOSSE MUCOLITICS syrup without sugar and LISOMUCIL TOSSE MUCOLITIC syrup with sugar contains methyl parahydroxybenzoate (E218) which can cause allergic reactions (also delayed). LISOMUCIL TOSSE MUCOLITIC syrup without sugar contains 13,4 mg sodium per dose of 5 ml (1 teaspoon). The daily dosage of 3 teaspoons per day (equal to 15 ml of syrup) provides 40 mg of sodium, while the posology of 2 teaspoons (equal to 10 ml of syrup) provides 26.8 mg of sodium equivalent respectively to 2% and 1.34% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult.LISOMUCIL TOSSE MUCOLITIC syrup with sugar contains less than 1 mmol (23 mg) of sodium for 5 ml syrup (1 teaspoon), i.e. essentially ‘without sodium’.Interactions
They are not known, at the present state of knowledge, incompatibility neither between the administration of carbocysteine and the most common drugs of use in the treatment of the diseases of the upper and lower airways, nor with foods or laboratory tests.Effects
The side effects are listed according to the following frequency classification: Very common (≥ 1/10); common (≥ 1/100, immune system disorders. Frequency not known: anaphylactic reaction, allergic skin rashes, fixed eruption from drugs. Gastrointestinal diseases. Very common: diarrhea, nausea and upper frequency abdominal pain; do not note: epigastric discomfort, vomiting and gastrointestinal bleeding (in this case interrupt treatment and consult your doctor to establish suitable therapy) Pathologies of skin and subcutaneous tissue frequency not known: bollous dermatitis, Steven-Johnson syndrome, multiform erythema, toxic rash skin rash. In such cases stop treatment and consult your doctor to establish suitable therapy. Respiratory, thoracic and mediastinic pathologies. Frequency not known: bronchial obstruction. In such cases stop treatment and consult your doctor to establish suitable therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
Symptoms due to overdose include: headaches, nausea, diarrhea, gastralgia. Provoking vomiting and possibly practicing gastric lavender.LISOMUCIL MUCOLITIC TOSSE is contraindicated in pregnancy and during breast milk lactation (see paragraph 4.3). Clinical data are not available.
Source: Farmadati
