Fluimucil mucolytic 10 effervescent tablets

FLUIMUCIL MUCOL*10CPR EFF600MG

Therapeutic indications

Treatment of respiratory diseases characterized by dense and viscous hypersecretion.

Dosage and method of use

Adults: 1 sachet of Mucolytic Fluimucil 200 mg granules for oral solution (with or without sugar) or 2 sachets of Mucolytic Fluimucil 100 mg (with or without sugar) 2-3 times a day. Fluimucil Mucolytic 200 mg, buccal tablets and effervescent tablets: 1 tablet 2-3 times a day. Fluimucil Mucolytic 100 mg/5 ml, syrup: 10 ml of syrup (1 measuring spoon), equal to 200 mg of N-acetylcysteine, 2-3 times a day. Fluimucil Mucolytic 600 mg/15 ml syrup, Fluimucil Mucolytic 600 mg effervescent tablets and Fluimucil Mucolytic 600 mg granules for solution: a 15 ml measuring spoon or an effervescent tablet or a sachet (preferably in the evening). Any dosage adjustments may concern the frequency of administration or the fractionation of the dose but must in any case be included within the maximum daily dosage of 600 mg.Children over 2 years old: Fluimucil Mucolytic 100 mg granules for oral solution (with or without sugar): 1 sachet 2 to 4 times a day, depending on age. Fluimucil Mucolytic 100 mg/5 ml, syrup: ½ scoop of syrup (5 ml), equal to 100 mg of N-acetylcysteine, 2 to 4 times a day depending on age. The duration of therapy is 5 to 10 days.Method of administration Granules for oral solution: dissolve the contents of a sachet in a glass containing a little water, mixing as needed with a teaspoon. This results in a pleasant solution that can be drunk directly from the glass or, in the case of small children, given in teaspoons or in a bottle. The solution should be taken as soon as it is ready.Oral soluble tablets: keep the tablet in the oral cavity until it has completely dissolved.Syrup: shake before using. Once opened, the syrup is valid for 15 days. Effervescent tablets: dissolve one tablet in a glass containing a little water, mixing as needed with a teaspoon. To facilitate the release of the tablet, we recommend tearing open the blister, using the side notches as indicated in the figure.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Children under 2 years of age. Pregnancy and breast-feeding (see section 4.6).

Side effects

Safety profile summaryThe adverse events most frequently associated with the oral administration of N-acetylcysteine are gastrointestinal in nature. Less frequently, hypersensitivity reactions including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash and pruritus have been reported.Tabular list of adverse reactionsThe following table shows the adverse reactions listed according to the classification and frequency system: very common (≥ 1/10), common (≥ 1/100 to

Description of some adverse reactionsIn very rare cases, the appearance of serious skin reactions has occurred in temporal connection with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell syndrome. Although in most cases at least one other suspected drug has been identified which is more likely involved in the genesis of the aforementioned mucocutaneous syndromes, in case of mucocutaneous alterations it is advisable to contact your doctor and the intake of N-acetylcysteine must be stopped immediately. Some studies have confirmed a reduction in platelet aggregation when taking N-acetylcysteine. The clinical significance of these findings has not yet been defined.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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

Patients suffering from bronchial asthma must be closely monitored during therapy; if bronchospasm appears, treatment with N-acetylcysteine must be immediately suspended and appropriate treatment must be started. Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of 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 under 2 years of age (see section 4.3). The use of the medicine in patients suffering from peptic ulcer or with a history of peptic ulcer requires particular attention, especially in case of simultaneous intake of other drugs with a known gastro-injurious effect. The possible presence of a sulphurous odor does not indicate alteration of the preparation but is specific to the active ingredient contained in it. The administration of N-acetylcysteine, especially at the beginning of treatment, can fluidize bronchial secretions and increase their volume at the same time. If the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid retention of secretions. N-acetylcysteine can affect histamine metabolism. Therefore, caution should be used when administering Fluimucil Mucolytic to patients with histamine intolerance, as hypersensitivity symptoms may occur. Important information about some excipients Sodium benzoate The 100 mg/5 ml syrup (150 ml and 200 ml) contains 15 mg of sodium benzoate for the 10 ml dose and 7.5 mg for the 5 ml dose.ParahydroxybenzoatesSyrups contain parahydroxybenzoates which can cause delayed allergic reactions.SorbitolThe buccal tablets, 600 mg/15 ml syrup, 600 mg granules for oral solution and 100 mg and 200 mg sugar-free granules for oral solution contain sorbitol. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given these medicines.AspartameThe buccal tablets, effervescent tablets, granules for oral solution 600 mg and granules for sugar-free oral solution 100 and 200 mg contain aspartame, a source of phenylalanine which may be harmful in patients with phenylketonuria.GlucoseThe 600 mg effervescent tablets, the 600 mg granules for oral solution and the 200 mg granules for oral solution contain glucose, patients suffering from rare problems of glucose-galactose malabsorption should not take this medicine.Sunset Yellow (E110)The granules for oral solution 100 mg and 200 mg contain sunset yellow (E110) which may cause allergic reactions.SucroseThe granules for oral solution 100 and 200 mg contain sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.SodiumThe buccal tablets contain 26.9 mg sodium per tablet equivalent to 1.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The 200 mg and 600 mg effervescent tablets contain 156.9 mg sodium per dose, equivalent to 7.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The 100 mg/5 ml (150 ml) syrup contains 36.7 mg sodium per 10 ml dose, equivalent to 1.83% of the WHO recommended maximum daily intake of 2 g sodium for an adult . The 100 mg/5 ml (150 ml) syrup contains 18.4 mg sodium per 5 ml dose, equivalent to 0.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult . The 100 mg/5 ml (200 ml) syrup contains 38.2 mg of sodium per 10 ml dose, equivalent to 1.9% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. The 100 mg/5 ml (200 ml) syrup contains 19.1 mg sodium per 5 ml dose, equivalent to 0.9% of the WHO recommended maximum daily intake which corresponds to 2 g sodium per adult. The 600 mg/15 ml syrup contains 98.31 mg of sodium per 15 ml dose equivalent to 4.9% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult.LactoseThe 600 mg granules for oral solution and the 200 mg granules for oral solution contain lactose. Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.Propylene glycolThe 100 mg/5 ml syrup (150 ml and 200 ml) contains 23.4 mg of propylene glycol for the 10 ml dose and 11.7 mg for the 5 ml dose. The 600 mg/15 ml syrup contains 168 mg of propylene glycol per dose (15 ml) equivalent to 11.2 mg/ml.EthanolThe 100 mg/5 ml syrup (150 ml and 200 ml) contains 3.85 mg of alcohol (ethanol) in every 100 ml. The dose quantity of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce any noticeable effects.

Pregnancy and breastfeeding

Although the teratological studies conducted with Fluimucil Mucolytic on animals have not shown any teratogenic effect, however, as with other drugs, its administration during pregnancy and during the period of breastfeeding with breast milk should be carried out only in case of actual need. .

Expiration and conservation

Sachets of 100 and 200 granules for oral solution, 600 mg granules for oral solution, 200 mg granules for oral solution without sugar and 200 mg buccal tablets: store at a temperature not exceeding 30°C.

Interactions with other drugs

Drug-drug interaction. Antitussive drugs and mucolytic agents, such as N-acetylcysteine, should not be taken at the same time as the reduction of the cough reflex could lead to an accumulation of bronchial secretions. Activated charcoal can reduce the effect of N-acetylcysteine. It is advisable not to mix other drugs with the Fluimucil Mucolytic solution. The information available regarding the antibiotic-N-acetylcysteine interaction refers to in vitro tests, in which the two substances were mixed, which showed a decreased activity of the antibiotic. However, as a precaution, it is recommended to take oral antibiotics at least two hours after the administration of N-acetylcysteine, excluding loracarbef. It has been shown that the simultaneous intake of nitroglycerin and N-acetylcysteine causes significant hypotension and causes dilation of the temporal artery with the possible onset of headache. If the simultaneous administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for the appearance of hypotension which can even be severe and alerted to the possible onset of headache.Pediatric populationInteraction studies have only been carried out in adults.Drug-laboratory test interactionsN-acetylcysteine may cause interference with the colorimetric assay method for determining salicylates. N-acetylcysteine may interfere with urine ketone testing.

Overdose

No cases of overdose have been found with oral administration of N-acetylcysteine. Healthy volunteers, who took a daily dose of 11.6 g of N-acetylcysteine for three months, did not experience serious adverse reactions. Doses up to 500 mg NAC/kg body weight, administered orally, were tolerated without any symptoms of intoxication.SymptomsOverdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.TreatmentThere are no specific antidotal treatments; Overdose therapy is based on symptomatic treatment.

Active principles

FLUIMUCIL MUCOLITIC 600 mg effervescent tabletsEach tablet contains:Active principle: N-acetylcysteine 600 mg. Excipients with known effects: aspartame, glucose, sodium.FLUIMUCIL MUCOLITIC 600 mg granules for oral solutionEach sachet contains:Active principle: N-acetylcysteine 600 mg. Excipients with known effects: aspartame, glucose, lactose, sorbitol.FLUIMUCIL MUCOLITIC 600 mg/15 ml syrup15 ml of syrup contains:Active principle: N-acetylcysteine 600 mg. Excipients with known effects: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, sorbitol.FLUIMUCIL MUCOLITIC 200 mg, effervescent tabletsOne tablet contains:Active principle: N-acetylcysteine 200 mg. Excipients with known effects: sodium, aspartame.FLUIMUCIL MUCOLITIC 200 mg, buccal tablets:One tablet contains:Active principle: N-acetylcysteine 200 mg. Excipients with known effects: sorbitol, sodium, aspartame.FLUIMUCIL MUCOLITIC 200 mg, granules for oral solutionOne sachet contains:Active principle: N-acetylcysteine 200 mg. Excipients with known effects: sucrose, glucose, sunset yellow (E110), lactose.FLUIMUCIL MUCOLITIC 200 mg, granules for oral solution without sugarOne sachet contains:Active principle: N-acetylcysteine 200 mg. Excipients with known effects: sorbitol, aspartame.FLUIMUCIL MUCOLITIC 100 mg, granules for oral solutionOne sachet contains:Active principle: N-acetylcysteine 100 mg. Excipients with known effects: sucrose, sunset yellow (E110).FLUIMUCIL MUCOLITIC 100 mg, granules for oral solution without sugarOne sachet contains:Active principle: N-acetylcysteine 100 mg. Excipients with known effects: sorbitol, aspartame.FLUIMUCIL MUCOLITIC 100 mg/5 ml, syrupA 150 ml bottle contains:Active principle: N-acetylcysteine 3,000 g (corresponding to 100 mg/5 ml of syrup). Excipients with known effects: ethanol, methyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium. A 200 ml bottle contains:Active principle: N-acetylcysteine 4,000 g (corresponding to 100 mg/5 ml of syrup). Excipients with known effects: ethanol, methyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium. For the full list of excipients, see section 6.1.

Excipients

FLUIMUCIL MUCOLITIC 600 mg granules for oral solutionAspartame, Orange flavor (containing glucose and lactose), Sorbitol.FLUIMUCIL MUCOLITIC 600 mg effervescent tabletsAnhydrous citric acid, Lemon flavor (containing glucose), Aspartame, Sodium bicarbonate.FLUIMUCIL MUCOLITIC 600 mg/15 ml syrup 200 ml bottleMethyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium edetate, Carmellose, Sodium saccharin, Grenadine flavoring (containing propylene glycol), Strawberry flavoring (containing propylene glycol), Sorbitol, Sodium hydroxide, Purified water.FLUIMUCIL MUCOLITIC 200 mg buccal tabletsAnhydrous citric acid, sorbitol, mannitol, polyethylene glycol 6000, povidone, sodium bicarbonate, lemon flavoring, mandarin flavoring, aspartame, magnesium stearate, microcrystalline cellulose.FLUIMUCIL MUCOLITIC 200 mg granules for oral solution without sugarSorbitol, aspartame, orange flavouring.FLUIMUCIL MUCOLITIC 200 mg granules for oral solutionOrange juice granules; Orange flavor (containing glucose and lactose); saccharin; sunset yellow (E 110); Sucrose.FLUIMUCIL MUCOLITIC 200 mg effervescent tablets Anhydrous citric acid, sodium bicarbonate, lemon flavouring, aspartame. FLUIMUCIL MUCOLITIC 100 mg granules for oral solutionOrange juice granules; Orange flavour; Saccharin; E 110; Sucrose.FLUIMUCIL MUCOLITIC 100 mg granules for oral solution without sugarSorbitol; Aspartame; Orange flavour.FLUIMUCIL MUCOLITIC 100 mg/5 ml syrup 150 ml bottleMethyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethyl cellulose, raspberry flavor (containing propylene glycol and ethanol), sodium saccharinate, sodium hydroxide, purified water.FLUIMUCIL MUCOLITIC 100 mg/5 ml syrup 200 ml bottleMethyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethyl cellulose, sodium cyclamate, sucralose, raspberry flavor (containing propylene glycol and ethanol), sodium saccharinate, sodium hydroxide, purified water.