FLUIMUCIL MUCOL * OS 10BUST600MG
Treatment of respiratory diseases characterized by thick and viscous hypersecretion.
Dosage and method of use
Adults: 1 sachet of Fluimucil Mucolytic 200 mg granules for oral solution (with or without sugar) or 2 sachets of Fluimucil Mucolytic 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 scoop), equal to 200 mg of N-acetylcysteine, 2-3 times a day. Fluimucil Mucolitico 600 mg / 15 ml syrup, Fluimucil Mucolitico 600 mg effervescent tablets and Fluimucil Mucolitico 600 mg granules for sugar-free solution: a 15 ml measuring spoon or an effervescent tablet or a sachet (preferably in the evening). Any dose adjustments may relate to the frequency of administration or dose splitting but must still be within the maximum daily dose of 600 mg.Children over 2 years of age: Fluimucil Mucolytic 100 mg granules for oral solution (with or without sugar): 1 sachet 2 to 4 times a day, according to age. Fluimucil Mucolytic 100 mg / 5 ml, syrup: ½ measuring spoon of syrup (5 ml), equal to 100 mg of N-acetylcysteine, 2 to 4 times a day according to age. The duration of therapy is from 5 to 10 days.Method of administration Granules for oral solution: dissolve the contents of one sachet in a glass containing a little water, stirring as needed with a teaspoon. In this way, a pleasant solution is obtained which can be drunk directly from the glass or, in the case of small children, be given in teaspoons or in a bottle. The solution should be taken as soon as it is ready.Buccal tablets: keep the tablet in the oral cavity until it is 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, stirring as needed with a teaspoon. To facilitate the release of the tablet, we recommend the tear-off opening of the blister, using the side notches as shown in the figure.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under the age of 2. Pregnancy and breast-feeding (see section 4.6).
Summary of the safety profileThe adverse events most frequently associated with oral administration of N-acetylcysteine are gastrointestinal in nature. Hypersensitivity reactions including anaphylactic shock, anaphylactic / anaphylactoid reactions, bronchospasm, angioedema, rash and pruritus have been reported less frequently.Tabular list of adverse reactionsAdverse reactions listed by classification system and frequency are presented in the following table: very common (≥ 1/10), common (≥ 1/100 to
Description of some adverse reactions
| Organ-systemic classification || Adverse reactions |
| Uncommon (≥1 / 1,000; || Rare (≥1 / 10,000; || Very rare ( || Not known |
|Disorders of the immune system ||Hypersensitivity || ||Anaphylactic shock, anaphylactic / anaphylactoid reaction || |
|Nervous system disorders ||Headache || || || |
|Ear and labyrinth disorders ||Tinnitus || || || |
|Cardiac pathologies ||Tachycardia || || || |
|Vascular pathologies || || ||Hemorrhage || |
|Respiratory, thoracic and mediastinal disorders || ||Bronchospasm, dyspnoea || ||Bronchial obstruction |
|Gastrointestinal disorders ||Vomiting, diarrhea, stomatitis, abdominal pain, nausea ||Dyspepsia || || |
|Skin and subcutaneous tissue disorders ||Urticaria, rash, angioedema, pruritus || || || |
|General disorders and administration site conditions ||Pyrexia || || ||Face edema |
|Diagnostic tests ||Reduced blood pressure || || || |
In very rare cases, severe skin reactions have 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 more likely involved in the genesis of the aforementioned mucocutaneous syndromes has been identified, in case of mucocutaneous alterations it is advisable to consult 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 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Patients with bronchial asthma should be closely monitored during therapy, if bronchospasm occurs, treatment with N-acetylcysteine should be discontinued immediately and appropriate treatment initiated. Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the 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 less than 2 years of age (see section 4.3). The use of the medicinal product in patients with peptic ulcer or with a history of peptic ulcer requires particular attention, especially in the case of concomitant use of other drugs with a known gastric-damaging effect. The possible presence of a sulphurous odor does not indicate alteration of the preparation but is typical of the active ingredient contained therein. The administration of N-acetylcysteine, especially at the beginning of the treatment, can thin the bronchial secretions and at the same time increase their volume. If the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid secretion retention. N-acetylcysteine can affect histamine metabolism. Therefore caution should be used when administering Mucolytic Fluimucil to patients with histamine intolerance, as hypersensitivity symptoms may occur. Important information about some of the ingredients The syrup contains parahydroxybenzoates which can cause delayed-type allergic reactions. The buccal tablets, 600 mg / 15 ml syrup and granules for oral solution without sugar contain sorbitol. Patients with hereditary fructose intolerance should not be given this medicine. The buccal tablets, effervescent tablets and granules for oral solution without sugar contain aspartame, a source of phenylalanine which may be harmful in patients with phenylketonuria. The 100 mg and 200 mg granules for oral solution contain sunset yellow (E110) which can cause allergic reactions. The 100 and 200 mg granules for oral solution contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. The 200 mg granules for oral solution contains 2.2 g of sucrose per sachet while the 100 mg granules for oral solution contains 4.3 g of sucrose per sachet so it should be taken into consideration in patients with diabetes mellitus. The buccal tablets contain 26.9 mg of sodium per dose, equivalent to 1.3% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. The effervescent tablets contain 156.9 mg of sodium per dose, equivalent to 7.8% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. The 100mg / 5ml (150ml) syrup contains 37.5mg sodium per 10ml serving, equivalent to 1.8% of the WHO recommended maximum daily intake of 2g sodium for an adult . The 100mg / 5ml (150ml) syrup contains 18.8mg sodium per 5ml serving, equivalent to 0.9% of the WHO recommended maximum daily intake of 2g sodium for an adult . The 100mg / 5ml (200ml) syrup contains 38.2mg sodium per 10ml serving, equivalent to 1.9% of the WHO recommended maximum daily intake of 2g sodium for an adult. The 100 mg / 5 ml (200 ml) syrup contains 19.1 mg of sodium for the 5 ml dose, equivalent to 0.9% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for one adult. The 600mg / 15ml syrup contains 96.6mg sodium per 15ml serving, equivalent to 4.8% of the WHO recommended maximum daily intake of 2g sodium for an adult.
Pregnancy and breastfeeding
Even if the teratological studies conducted with Fluimucil Mucolytic on animals have not shown any teratogenic effect, however, as for other drugs, its administration during pregnancy and during the period of breastfeeding with mother's milk, should be carried out only in case of real need. .
Expiration and retention
Sachets of 100 and 200 granules for oral solution, 600 mg granules for oral solution without sugar, 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 reduced cough reflex could lead to an accumulation of bronchial secretions. Activated carbon can reduce the effect of N-acetylcysteine. It is advisable not to mix other drugs with Fluimucil Mucolytic solution. The information available on 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 advisable to take antibiotics by mouth at least two hours after the administration of N-acetylcysteine with the exception of 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 possible onset of headache. If the simultaneous administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for the onset of hypotension, which can also be severe, and warned about the possible onset of headache.Pediatric populationInteraction studies have only been performed in adults.Drug-laboratory test interactionsN-acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. N-acetylcysteine can interfere with the test for the determination of ketones in urine.
No cases of overdose have been reported with respect to oral administration of N-acetylcysteine. Healthy volunteers, who for three months took a daily dose of N-acetylcysteine equal to 11.6 g, did not show any 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 antidotic treatments; overdose therapy is based on symptomatic treatment.
FLUIMUCIL MUCOLITICO 600 mg effervescent tabletsEach tablet contains:Active principleN-acetylcysteine 600 mg Excipients with known effects: sodium, aspartameFLUIMUCIL MUCOLITICO 600 mg granules for oral solution without sugarEach sachet contains:Active principleN-acetylcysteine: 600 mg Excipients with known effects: aspartame, sorbitolFLUIMUCIL MUCOLITICO 600 mg / 15 ml syrup15 ml of syrup contain:Active principleN-acetylcysteine: 600 mg Excipients with known effects: methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, sodium, sorbitolFLUIMUCIL MUCOLITICO 200 mg, effervescent tablets:One tablet contains:Active principleN-acetylcysteine: 200 mg Excipients with known effects: sodium, aspartameFLUIMUCIL MUCOLITICO 200 mg, buccal tablets: One tablet contains: Active principleN-acetylcysteine: 200 mg Excipients with known effects: sorbitol, sodium, aspartameFLUIMUCIL MUCOLITICO 200 mg, granules for oral solutionOne sachet contains:Active principleN-acetylcysteine: 200 mg Excipients with known effects: sucrose, sunset yellow (E110)FLUIMUCIL MUCOLITICO 200 mg, granules for oral solution without sugarOne sachet contains:Active principleN-acetylcysteine: 200 mg Excipients with known effects: sorbitol, aspartameFLUIMUCIL MUCOLITICO 100 mg, granules for oral solutionOne sachet contains:Active principleN-acetylcysteine: 100 mg Excipients with known effects: sucrose, sunset yellow (E110)FLUIMUCIL MUCOLITICO 100 mg, granules for oral solution without sugarOne sachet contains:Active principleN-acetylcysteine: 100 mg Excipients with known effects: sorbitol, aspartameFLUIMUCIL MUCOLITICO 100 mg / 5 ml, syrupA 150ml bottle contains:Active principleN-acetylcysteine: 3,000 g (corresponding to 100 mg / 5 ml of syrup) Excipients with known effects: methyl parahydroxybenzoate, sodium One bottle of 200 ml contains:Active principleN-acetylcysteine: 4,000 g (corresponding to 100 mg / 5 ml syrup) Excipients with known effect: methyl parahydroxybenzoate, sodium For a full list of excipients, see section 6.1
FLUIMUCIL MUCOLITICO 600 mg granules for oral solution without sugarAspartame, Orange flavor, Sorbitol.FLUIMUCIL MUCOLITICO 600 mg effervescent tabletsAnhydrous citric acid, Lemon flavor, Aspartame, Sodium bicarbonate.FLUIMUCIL MUCOLITICO 600 mg / 15 ml syrup 200 ml bottleMethyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium edetate, Carmellose, Saccharin sodium, Grenadine flavor, Strawberry flavor, Sorbitol, Sodium hydroxide, Purified water.FLUIMUCIL MUCOLITICO 200 mg including orosolubleAnhydrous citric acid, sorbitol, mannitol, polyethylene glycol 6000, povidone, sodium bicarbonate, lemon flavor, mandarin flavor, aspartame, magnesium stearate, microcrystalline cellulose.FLUIMUCIL MUCOLITICO 200 mg granules for oral solution without sugarSorbitol, aspartame, orange flavor.FLUIMUCIL MUCOLITICO 200 mg granules for oral solutionOrange juice granules; Orange flavor; Saccharin; E 110; Sucrose.FLUIMUCIL MUCOLITICO 200 mg including effervescentAnhydrous citric acid, sodium bicarbonate, lemon flavor, aspartame.FLUIMUCIL MUCOLITICO 100 mg granules for oral solutionOrange juice granules; Orange flavor; Saccharin; E 110; Sucrose.FLUIMUCIL MUCOLITICO 100 mg granules for oral solution without sugarSorbitol; Aspartame; Orange flavor.FLUIMUCIL MUCOLITICO 100 mg / 5 ml syrup 150 ml bottleMethyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, raspberry flavor, sodium saccharinate, sodium hydroxide, purified water.FLUIMUCIL MUCOLITICO 100 mg / 5 ml syrup 200 ml bottleMethyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, sodium cyclamate, sucralose, raspberry flavor, sodium saccharinate, sodium hydroxide, purified water.