FLUIMUCIL MUCOL SCIR600MG/15ML

FLUIMUCIL MUCOLITICAL

active ingredients

FLUIMUCIL MUCOLITICAL 600 mg effervescent tablets Each tablet contains: Active ingredient: N-acetylcysteine 600 mg. Excipients with known effects: aspartame, glucose, sodium. FLUIMUCIL MUCOLITICAL 600 mg granulated oral solution Each bag contains: Active ingredient: N-acetylcysteine 600 mg. Excipients with known effects: aspartame, glucose, lactose, sorbitol. FLUIMUCIL MUCOLITICAL 600 mg/15 ml syrup 15 ml of syrup contain: Active ingredient: N-acetylcysteine 600 mg. Excipients with known effects: glycol propylene, para-hydroxybenzoate methyl, para-hydroxybenzoate propylene, sodium, sorbitol. FLUIMUCIL MUCOLITICAL 200 mg, effervescent tablets One tablet contains: Active ingredient: N-acetylcysteine 200 mg. Excipients with known effects: sodium, aspartame. FLUIMUCIL MUCOLITICAL 200 mg, orosoluble tablets: One tablet contains: Active ingredient: N-acetylcysteine 200 mg. Excipients with known effet: sorbitol, sodium, aspartame. FLUIMUCIL MUCOLITICAL 200 mg, oral granulate A bag contains: Active ingredient: N-acetylcysteine 200 mg. Excipients with known effects: sucrose, glucose, yellow sunset (E110), lactose. FLUIMUCIL MUCOLITICAL 200 mg, granulated orally without sugar A bag contains: Active ingredient: N-acetylcysteine 200 mg. Excipients with known effects: sorbitol, aspartame. FLUIMUCIL MUCOLITICAL 100 mg, granulated orally A bag contains: Active ingredient: N-acetylcysteine 100 mg. Excipients with known effects: sucrose, yellow sunset (E110).FLUIMUCIL MUCOLITICAL 100 mg, granulated for oral solution without sugar A bag contains: Active ingredient: N-acetylcysteine 100 mg. Excipients with known effects: sorbitol, aspartame. FLUIMUCIL MUCOLITICAL 100 mg/5 ml, syrup A 150 ml bottle contains: Active ingredient: N-acetylcysteine 3,000 g (corresponding to 100 mg/5 ml syrup). Excipients with known effects: ethanol, methyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium. A 200 ml bottle contains: Active ingredient: N-acetylcysteine 4,000 g (corresponding to 100 mg/5 ml syrup). Excipients with known effects: ethanol, methyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium. For the full list of excipients, see paragraph 6.1.

Excellent

FLUIMUCIL MUCOLITICAL 600 mg granulated oral solution Aspartame, Orange Aroma (containing glucose and lactose), Sorbitol. FLUIMUCIL MUCOLITICAL 600 mg effervescent tablets Citric acid anidro, Aroma lemon (containing glucose), Aspartame, Sodium bicarbonate. FLUIMUCIL MUCOLITIC 600 mg/15 ml bottle syrup 200 mlParahydroxybenzoate, Propile paraidroxybenzoato, Sodium edetato, Carmellosa, Saccarina sodica, Aroma granatina (containing propylene glycol), Aroma fragola (containing propylene glycol), Sorbitol, Sodium hydroxide, Purified water. FLUIMUCIL MUCOLITICAL 200 mg orosoluble tablets Citric acid anidro, sorbitol, mannitol, polyethyleneglycol 6000, povidone, sodium bicarbonate, lemon aroma, mandarin aroma, aspartame, magnesium stearate, microcrystalline cellulose. FLUIMUCIL MUCOLITICAL 200 mg granulated for oral solution without sugar Sorbitol, aspartame, orange aroma. FLUIMUCIL MUCOLITICAL 200 mg granulated oral solutionOrange juice granular; Orange aroma (containing glucose and lactose); saccharin; yellow sunset (E 110); Sucrose. FLUIMUCIL MUCOLITICAL 200 mg effervescent tablets Citric acid anidro, sodium bicarbonate, lemon aroma, aspartame. FLUIMUCIL MUCOLITICAL 100 mg granulated oral solutionOrange juice granular; Orange aroma; Saccarina; And 110; Sucrose. FLUIMUCIL MUCOLITICAL 100 mg granulated per oral solution without sugar Sorbitol; Aspartame; Orange aroma. FLUIMUCIL MUCOLITIC 100 mg/5 ml bottle syrup 150 ml Parahydroxybenzoate, benzoate sodium, sodium edetato, sodium carbossimetilcellulose, raspberry aroma (containing propylene glycol and ethanol), sodium saccarinated, sodium hydroxide, purified water. FLUIMUCIL MUCOLITIC 100 mg/5 ml bottle syrup 200 ml Parahydroxybenzoate, benzoate sodium, sodium edetato, sodium carbossimetilcellulose, sodium cyclamate, sucralose, raspberry aroma (containing propylene glycol and ethanol), sodium saccarinated, sodium hydroxide, purified water.

Therapeutic indications

Treatment of respiratory diseases characterized by dense and viscous hypersecretion.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Children under 2 years of age. Pregnancy and breastfeeding (see paragraph 4.6).

Population

Adults: 1 bag of Fluimucil Mucolitico 200 mg granulate per oral solution (with or without sugar) or 2 bags of Fluimucil mucolitico 100 mg (with or without sugar) 2-3 times a day. Fluimucil Mucolitico 200 mg, orosoluble tablets and effervescent tablets: 1 tablet 2-3 times a day. Fluimucil Mucolitico 100 mg/5 ml, syrup: 10 ml 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 granulate per solution: a 15 ml scoop or an effervescent tablet or a sachet (preferably in the evening). Any adjustments to the dosage may concern the frequency of administrations or fractionation of the dose but must be included within the maximum daily dosage of 600 mg. Children over 2 years: Fluimucil Mucolitico 100 mg granulated per oral solution (with or without sugar): 1 bag of 2 to 4 times a day, according to age. Fluimucil Mucolitico 100 mg/5 ml, syrup: 1⁄2 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 Granulated oral solution: dissolve the contents of a sachet in a glass containing a little water mixing with a teaspoon. This makes it a pleasant solution that can be drunk directly from the glass or, in the case of small children, be given to teaspoons or in the bottle. The solution should be taken as soon as possible. Orosoluble tablets: maintain the tablet in the oral cavity until completely dissolved. Syrup: shake before use. Once opened, the syrup has a validity of 15 days. Effervescent tablets: dissolve a tablet in a glass containing a little water mixing with a teaspoon. To facilitate the exit of the tablet it is recommended to tear opening of the blister, using the side notches as indicated in the figure.

Conservation

Envelopes of 100 and 200 granulate per oral solution, 600 mg granulate per oral solution, 200 mg granulate per oral solution without sugar and 200 mg orosoluble tablets: Store at a temperature not exceeding 30°C.

Warnings

Patients with bronchial asthma must be strictly controlled during therapy, if bronchospasm occurs treatment with N-acetylcysteine must be immediately suspended and appropriate treatment must be initiated. 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). It requires special attention to the use of the medicine in patients suffering from peptic ulcer or with history of peptic ulcer, especially in the case of contemporary intake of other drugs with a well-known gastrolesive effect. Any presence of a sulphurous smell does not indicate alteration of the preparation but is proper to the active ingredient contained in it. The administration of N-acetylcysteine, especially at the beginning of the treatment, can fluidize bronchial secretions and increase the volume at the same time. If the patient is unable to cope effectively, in order to avoid secret retention, it is necessary to resort to postural drainage and bronchopiration. N-acetylcysteine can affect the metabolism of histamine. Therefore it should be used caution when administering Fluimucil Mucolitico in patients with histamine intolerance, as symptoms of hypersensitivity may occur. Important information about some excipients Benzoate Sodium 100 mg/5 ml syrup (150 ml and 200 ml) contains 15 mg benzoate sodium for the dose of 10 ml and 7.5 mg for the dose of 5 ml.Parahydroxybenzos Syrups contain parahydroxybenzoates that can cause delayed allergic reactions. Sorbitol Orosoluble tablets, 600 mg/15 ml syrup, 600 mg oral solution granulate and sugar-free oral solution granulate (100 mg and 200 mg) contain sorbitol. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given these medicines. Aspartame The orosoluble tablets, effervescent tablets, granulated oral solution from 600 mg and granulated oral solution without sugar from 100 and 200 mg contain aspartame, a source of phenylalanin that can be harmful in patients suffering from phenylchetonuria. Glucose 600 mg effervescent tablets, 600 mg oral solution granulate and 200 mg oral solution granulate contain glucose, patients suffering from rare glucose-galactose mal absorption problems should not take this medicine. Yellow sunset (E110) The granulate for oral solution of 100 mg and 200 mg contains yellow sunset (E110) which can cause allergic reactions. Sucrose Oral solution granulate 100 and 200 mg contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or isomaltase sucrasis failure, should not take this medicine. Sodium The orosoluble tablets contain 26.9 mg of sodium per tablet equivalent to 1.3% of the maximum daily intake recommended by the WHO that corresponds to 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 maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The syrup of 100 mg/5 ml (150 ml) contains 36.7 mg sodium per dose of 10 ml, equivalent to 1,83% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The syrup of 100 mg/5 ml (150 ml) contains 18.4 mg sodium per dose of 5 ml, equivalent to 0.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The syrup of 100 mg/5 ml (200 ml) contains 38.2 mg sodium per dose of 10 ml, equivalent to 1.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The syrup of 100 mg/5 ml (200 ml) contains 19,1 mg sodium for the dose of 5 ml, equivalent to 0.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The 600 mg/15 ml syrup contains 98.31 mg sodium for the 15 ml dose equivalent to 4.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. Lactose 600 mg oral solution granulate and 200 mg oral solution granulate contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. Propilene glycol The 100 mg/5 ml syrup (150 ml and 200 ml) contains 23.4 mg of glycol propylene for the dose of 10 ml and 11.7 mg for the dose of 5 ml. The 600 mg/15 ml syrup contains 168 mg of glycol propylene per dose (15 ml) equivalent to 11.2 mg/ml. Ethanol 100 mg/5 ml syrup (150 ml and 200 ml) contains 3.85 mg of alcohol (ethanol) in every 100 ml. The dose of this medicine is less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

Drug-farm interaction. Antitussive drugs and mucolitic agents, such as N-acetylcysteine should not be taken at the same time since the reduction of cough reflex could lead to an accumulation of bronchial secretions. Active carbon can reduce the effect of N-acetylcysteine. It is recommended not to mix other drugs to the solution of Fluimucil Mucolitico. The information available on antibiotic-N-acetylcysteine interaction refers to in vitro tests, in which the two substances have been mixed, which have evidenced a decreased activity of the antibiotic. However, for precautionary purposes, it is recommended to take oral antibiotics at least two hours from administration of N-acetylcysteine, excluding loracarbef. It has been shown that the simultaneous intake of nitroglycerin and N-acetylcystein causes significant hypotension and causes dilation of temporal artery with possible headache occurrence. If the simultaneous administration of nitroglycerin and N- acetylcysteine is necessary, it is necessary to monitor patients for the appearance of hypotension that can also be severe and alert them about the possible occurrence of cephalea. Pediatric population Interaction studies were carried out only in adults. Drug-test laboratory interactions N-acetylcysteine can cause interference with the colorimetric dosing method for the determination of salicylates. N-acetylcysteine can interfere with the test for the determination of ketones in the urine.

Effects

Summary of security profile The most frequently adverse events associated with oral administration of N-acetylcysteine are gastrointestinal. Less often hypersensitivity reactions include anaphylactic shock, anaphylactic/anaphylactic reactions, bronchospasm, angioedema, rash and itching. Tabled list of adverse reactions The following table shows the adverse reactions listed according to the classification and frequency system: very common (≥ 1/10), common (≥ 1/100 a Organ-systematic classification Adverse reactions Not common (≥1/1,000; Rare (≥1/10.000; Very rare ( Not known Immune system disorders Hypersensitivity   Anaphylactic shock, anaphylactic/ anaphylactic reaction   Diseases of the nervous system Cefa       Ear and labyrinth pathologies Tinnitus       Heart disease Tachycardia       Vascular diseases     Hemorrhage   Respiratory, chest and mediastinic pathologies   Broncospasmo, dispnea   Bronchial obstruction Gastrointestinal disorders Vomito, diarrhea, stomatitis, abdominal pain, nausea Dispepsia     Pathologies of skin and subcutaneous tissue Hives, rash, angioedema, itching       Systemic pathologies and conditions for administration Pyresia     Face Edema Diagnostic examinations Reduced blood pressure       Description of some adverse reactions In rare cases, the appearance of severe skin reactions occurred in time connection with N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell syndrome. Although in most cases at least one other suspect drug was identified more likely to be involved in the genesis of these mucocutaneous syndromes, in case of mucocutaneous alterations, it is appropriate to contact your physician and taking N- acetilcisteine should be immediately interrupted. Some studies have confirmed a reduction in platelet aggregation during N-acetylcysteine. The clinical significance of such evidence has not yet been defined. 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

No overdose cases were found regarding oral administration of N-acetylcysteine. Healthy volunteers, who for three months have taken a daily dose of N-acetylcysteine of 11,6 g, have not manifested serious adverse reactions. The doses up to 500 mg NAC/kg body weight, administered by mouth, were tolerated without any symptoms of intoxication. Synonyms Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. Treatment There are no specific antidotic treatments; overdose therapy is based on symptomatic treatment.

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

Source: Farmadati