LISOMUCIL COUGH MUC TO SCIR 5%

LISOMUCIL TOSSE MUCOLITICAL 750 MG/15 ML SCIROPPOSE

active ingredients

1 ml syrup contains: Active ingredient: 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 paragraph 6.1.

Excellent

LISOMUCIL TOSSE MUCOLITICS syrup with sugar: sucrose, methyl parahydroxybenzoate, caramel powder, aromatic elixir (ethanol 82%), cinnamon essence, sodium hydroxide, purified water. LISOMUCIL TOSSE MUCOLITICS syrup without sugar: glycerol, hydroxyetylcellulose, sodium saccharin, sodium parahydroxybenzoate methyl, caramel powder, aromatizing, hydroxide sodium, purified water.

Therapeutic indications

Symptomatic therapy of respiratory diseases accompanied by cough and catarrh in adult.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. Gastroduodenal active ulcer. Pregnancy and nursing. Children and teenagers.

Population

The recommended dosage is as follows: 1 meter 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 the other. The recommended maximum duration of treatment is 5 days. Treatment for longer periods may be carried out, according to the doctor's judgment.

Conservation

LISOMUCIL TOSSE MUCOLITICS syrup with sugar: keep at a temperature below 25°C. LISOMUCIL TOSSE MUCOLITICS syrup without sugar: this medicine does not require any conservation conditions.

Warnings

Gastrointestinal bleeding Cases of gastrointestinal bleeding were 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, patients 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 6 g sucrose for 15 ml syrup (1 doser or 1 tablespoon). Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. To consider in people with diabetes mellitus. The excipient aromatic elixir of LISOMUCIL TOSSE MUCOLITIC syrup with sugar contains 200 mg of ethyl alcohol (ethanol) per dose of 15 ml (a doser or a spoon) which is equivalent to 4 mg/kg per dose of 15 ml syrup. The amount of ethyl alcohol in 15 ml of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects. For those who carry out sports activities, the use of drugs containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations. LISOMUCIL TOSSE MUCOLITICS syrup with sugar and LISOMUCIL TOSSE MUCOLITICS syrup without sugar contain methyl para-hydroxybenzoate which can cause allergic reactions (also delayed). LISOMUCIL TOSSE MUCOLITICS syrup without sugar contains 90 mg of sodium per dose of 15 ml (1 tablespoon) and 270 mg of sodium for the dose of 3 tablespoons per day equivalent respectively to 4.5% and 13.5% 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 15 ml of dose, 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 disease. Very common: diarrhea, nausea and upper abdominal pain Frequency does not notice: 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, skin toxic eruption, skin rash. 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