Lisomucil mucolytic syrup without sugar 023185097

LISOMUCIL COUGH MUC * AD SCIR SZ

Therapeutic indications

Symptomatic therapy of respiratory diseases accompanied by cough and phlegm in adults.

Dosage and method of use

The recommended dosage is as follows: 1 measuring cup or 1 tablespoon (15 ml of product equal to 750 mg of carbocysteine) 3 times a day with an interval of 8 hours between one intake and another. The maximum recommended duration of treatment is 5 days. Treatment for longer periods can be carried out, according to the doctor's judgment.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Active gastroduodenal ulcer. Pregnancy and breastfeeding. Children and adolescents.

Side effects

Undesirable 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 rash, fixed drug eruption.Gastrointestinal disorders.Very common: diarrhea, nausea and upper abdominal pain Frequency not known: epigastric discomfort, vomiting and gastrointestinal bleeding (in this case, stop treatment and consult your doctor to institute appropriate therapy).Skin and subcutaneous tissue disorders.Frequency not known: bullous dermatitis, Steven-Johnson syndrome, erythema multiforme, toxic skin rash, rash. In such cases, stop the treatment and consult your doctor to establish a suitable therapy.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Gastrointestinal bleedingCases of gastrointestinal bleeding have been reported with the use of carbocysteine. Caution is advised in the elderly, in patients with a history of gastroduodenal ulcers or in patients taking concomitant medications known to increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding, patients should stop carbocysteine treatment.Asthmatic and debilitated patientsIt is recommended that specific precautions be taken in patients with severe respiratory insufficiency, in patients with asthma and a history of bronchospasm, as well as in debilitated patients. The use of carbocysteine causes a decrease in mucus viscosity and an increase in mucus removal, both through ciliary epithelial activity, and through the cough reflex. Therefore, an increase in cough and sputum is expected. The use of antitussive medicines inhibits the cough reflex and increases the risk of airway obstruction, due to increased mucus accumulation in the airways. The concomitant use of this medicinal product with cough suppressant medicinal products and / or medicinal products that inhibit bronchial secretion (e.g. anti-muscarinic medicinal products) is not recommended. LISOMUCIL MUCOLITICO COUGH syrup with sugar contains 6 g of sucrose per 15 ml of syrup (1 measuring spoon or 1 tablespoon). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. To be taken into consideration in people with diabetes mellitus. The excipient aromatic elixir of LISOMUCIL COUGH MUCOLITICO syrup with sugar contains 200 mg of ethyl alcohol (ethanol) per dose of 15 ml (one measuring cup or spoon) which is equivalent to 4 mg / kg per dose of 15 ml of syrup. The amount of ethyl alcohol in 15ml of this medicine is equivalent to less than 5ml of beer or 2ml of wine. The small amount of alcohol in this medicine will not produce relevant effects. For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations. LISOMUCIL MUCOLITICO syrup with sugar and LISOMUCIL MUCOLITICO syrup without sugar contain methyl para-hydroxybenzoate which can cause allergic reactions (even delayed). LISOMUCIL MUCOLYTIC COUGH syrup without sugar contains 90 mg of sodium per 15 ml (1 tablespoon) dose and 270 mg of sodium for 3 tablespoons per day equivalent to 4.5% and 13.5% of the maximum daily intake, respectively. recommended by the WHO which corresponds to 2 g of sodium for an adult. LISOMUCIL COUGH MUCOLYTIC syrup with sugar contains less than 1 mmol (23 mg) sodium per 15 ml serving, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

LISOMUCIL MUCOLYTIC COUGH is contraindicated in pregnancy and during breastfeeding (see section 4.3). No clinical data are available.

Expiration and retention

LISOMUCIL COUGH MUCOLITHIC syrup with sugar:store below 25 ° C.LISOMUCIL COUGH MUCOLITHIC syrup without sugar: This medicine does not require any storage conditions.

Interactions with other drugs

At the present state of knowledge, there is no known incompatibility between the administration of carbocysteine and the most common drugs used in the treatment of upper and lower respiratory tract diseases, nor with food or laboratory tests.

Overdose

Symptoms due to overdose include: headache, nausea, diarrhea, stomach pain. Induce vomiting and possibly perform gastric lavage.

Active principles

1 ml of syrup contains:Active principle: carbocysteine 50 mg. Excipients with known effects : Syrup with sugar: sucrose, methyl parahydroxybenzoate (E218), aromatic elixir (ethanol 82%). Sugar-free syrup: methyl parahydroxybenzoate, sodium. For the full list of excipients, see section 6.1.

Excipients

LISOMUCIL COUGH MUCOLITHIC syrup with sugar:sucrose, methyl parahydroxybenzoate, caramel powder, aromatic elixir (82% ethanol), cinnamon essence, sodium hydroxide, purified water.LISOMUCIL COUGH MUCOLITHIC syrup without sugar:glycerol, hydroxyethylcellulose, sodium saccharin, sodium methyl parahydroxybenzoate, caramel powder, flavoring, sodium hydroxide, purified water.