Fluimucil Mucolytic Expectorant Syrup 600 Mg-15 Ml

Fluimucil Mucolitico 600 mg/15 ml is an ideal syrup for treating respiratory conditions characterised by dense and viscous hypersecretion .

Fluimucil Mucolytic Syrup is an over-the-counter mucolytic expectorant drug based on N-acetylcysteine. This active ingredient helps dissolve phlegm and eliminate mucus present in the respiratory tract , improving breathing. The syrup can be used in case of a productive cough or in case of an increase in the production of thick and viscous mucus .

ACTIVE INGREDIENTS

Active ingredients contained in Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - What is the active ingredient of Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml?

Fluimucil Mucolitico 600 mg effervescent tablets, each tablet contains, active ingredient: N-acetylcysteine ​​600 mg. Excipients with known effects: aspartame, glucose, sodium. Fluimucil Mucolitico 600 mg granules for oral solution, each sachet contains, active ingredient: N-acetylcysteine ​​600 mg. Excipients with known effects: aspartame, sorbitol. Fluimucil Mucolitico 600 mg/15 ml syrup 15 ml of syrup contains, active ingredient: N-acetylcysteine ​​600 mg Excipients with known effects: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, sorbitol. Fluimucil Mucolitico 200 mg, effervescent tablets, one tablet contains, active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sodium, aspartame. Fluimucil Mucolitico 200 mg, orodispersible tablets, one tablet contains, active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sorbitol, sodium, aspartame. Fluimucil Mucolitico 200 mg, granules for oral solution, one sachet contains, active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sucrose, glucose, sunset yellow (E110), lactose. Fluimucil Mucolitico 200 mg, granules for oral solution without sugar, one sachet contains, active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sorbitol, aspartame. Fluimucil Mucolitico 100 mg, granules for oral solution, one sachet contains, active ingredient: N-acetylcysteine ​​100 mg. Excipients with known effects: sucrose, sunset yellow (E110). Fluimucil Mucolitico 100 mg, sugar-free granules for oral solution, one sachet contains, active ingredient: N-acetylcysteine ​​100 mg. Excipients with known effects: sorbitol, aspartame. Fluimucil Mucolitico 100 mg/5 ml syrup, one 150 ml bottle contains, active ingredient: 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. One 200 ml bottle contains, active ingredient: N-acetylcysteine ​​4,000 g (corresponding to 100 mg/5 ml of syrup). Excipients with known effect: ethanol, methyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium. For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - What does Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml contain?

Fluimucil Mucolitico 600 mg granules for oral solution: aspartame, orange flavouring, sorbitol. Fluimucil Mucolitico 600 mg effervescent tablets: anhydrous citric acid, lemon flavouring (containing glucose), aspartame, sodium bicarbonate. Fluimucil Mucolitico 600 mg/15 ml syrup 200 ml bottle: methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, carmellose, sodium saccharin, grenadine flavouring (containing propylene glycol), strawberry flavouring (containing propylene glycol), sorbitol, sodium hydroxide, purified water. Fluimucil Mucolitico 200 mg orodispersible tablets: anhydrous citric acid, sorbitol, mannitol, polyethylene glycol 6000, povidone, sodium bicarbonate, lemon flavouring, mandarin flavouring, aspartame, magnesium stearate, microcrystalline cellulose. Fluimucil Mucolitico 200 mg granules for oral solution without sugar: sorbitol, aspartame, orange flavouring. Fluimucil Mucolitico 200 mg granules for oral solution: orange juice granules; orange flavouring (containing glucose and lactose); saccharin; sunset yellow (E 110); sucrose. Fluimucil Mucolitico 200 mg effervescent tablets: anhydrous citric acid, sodium bicarbonate, lemon flavouring, aspartame. Fluimucil Mucolitico 100 mg granules for oral solution: orange juice granules; orange flavouring; saccharin; E 110; sucrose. Fluimucil Mucolitico 100 mg sugar-free granules for oral solution: sorbitol; aspartame; orange flavour. Fluimucil Mucolitico 100 mg/5 ml syrup 150 ml bottle: methyl parahydroxybenzoate, sodium benzoate, disodium edetate, sodium carboxymethylcellulose, raspberry flavour (containing propylene glycol and ethanol), sodium saccharin, sodium hydroxide, purified water. Fluimucil Mucolitico 100 mg/5 ml syrup 200 ml bottle: methyl parahydroxybenzoate, sodium benzoate, disodium edetate, sodium carboxymethylcellulose, sodium cyclamate, sucralose, raspberry flavour (containing propylene glycol and ethanol), sodium saccharin, sodium hydroxide, purified water.

DIRECTIONS

Therapeutic indications Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - Why is Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml used? What is it used for?

Treatment of respiratory conditions characterized by thick and viscous hypersecretion.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - When should Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml not be used?

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

DOSAGE

Quantity and method of taking Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - How do you take Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml?

Adults: 1 sachet of Fluimucil Mucolitico 200 mg granules for oral solution (with or without sugar) or 2 sachets of Fluimucil Mucolitico 100 mg (with or without sugar) 2-3 times a day. Fluimucil Mucolitico 200 mg, orodispersible tablets and effervescent tablets: 1 tablet 2-3 times a day. Fluimucil Mucolitico 100 mg/5 ml, syrup: 10 ml of syrup (1 measuring spoon), equivalent 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 solution: one 15 ml measuring spoon or one effervescent tablet or one 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 within the maximum daily dosage of 600 mg. Children over 2 years of age: Fluimucil Mucolitico 100 mg granules for oral solution (with or without sugar): 1 sachet 2 to 4 times a day, depending on age. Fluimucil Mucolitico 100 mg/5 ml, syrup: 1/2 measuring spoon 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, stirring 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 by teaspoon or in a bottle. The solution should be taken as soon as it is ready. Orodispersible tablets: keep the tablet in the oral cavity until it has completely dissolved. Syrup: shake before use. 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, it is recommended to tear open the blister, using the side notches as indicated.

CONSERVATION

Storage Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - How is Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml stored?

Sachets of 100 and 200 granules for oral solution, 600 mg granules for oral solution, 200 mg sugar-free granules for oral solution and 200 mg orodispersible tablets: store at a temperature not exceeding 30 degrees C.

WARNINGS

Warnings Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - About Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml it is important to know that:

Patients with bronchial asthma must be closely monitored during therapy. If bronchospasm occurs, treatment with N-acetylcysteine ​​must be immediately suspended and appropriate treatment must be started. Mucolytics may induce bronchial obstruction in children under 2 years of age. In fact, the ability to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways. They must therefore not be used in children under 2 years of age (see section 4.3). Particular attention is required when using the medicinal product in patients with peptic ulcer or a history of peptic ulcer, especially in the case of concomitant intake of other drugs with a known gastro-lesive effect. The possible presence of a sulphurous odour 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 treatment, may fluidify 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 ​​may influence histamine metabolism. Therefore, caution should be exercised when administering Fluimucil Mucolitico to patients with histamine intolerance, as hypersensitivity symptoms may occur. Important information on some of the 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. Parahydroxybenzoates: the syrups contain parahydroxybenzoates which may cause delayed-type allergic reactions. Sorbitol: The orodispersible tablets, the 600 mg/15 ml syrup, the 600 mg granules for oral solution and the sugar-free granules for oral solution (100 mg and 200 mg) contain sorbitol. The sorbitol content in oral medicinal products may alter the bioavailability of other concomitantly administered oral medicinal products. Patients with hereditary fructose intolerance should not be given these medicines. Aspartame: The orodispersible tablets, the effervescent tablets, the 600 mg granules for oral solution and the sugar-free granules for oral solution 100 and 200 mg contain aspartame, a source of phenylalanine which may be harmful to patients with phenylketonuria. Glucose: The 600 mg effervescent tablets and the 200 mg granules for oral solution contain glucose, patients with rare problems of glucose-galactose malabsorption should not take this medicine. Sunset yellow (E110): The 100 mg and 200 mg granules for oral solution contain sunset yellow (E110) which may cause allergic reactions. Sucrose: 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. Sodium: The orodispersible 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 syrup (150 ml) 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 syrup (150 ml) 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 syrup (200 ml) contains 38.2 mg sodium per 10 ml dose, equivalent to 1.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The 100 mg/5 ml syrup (200 ml) contains 19.1 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 600 mg/15 ml syrup contains 98.31 mg sodium per 15 ml dose, equivalent to 4.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Lactose: The 200 mg granules for oral solution contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Propylene glycol: The 100 mg/5 ml syrup (150 ml and 200 ml) contains 23.4 mg propylene glycol per 10 ml dose and 11.7 mg per 5 ml dose. The 600 mg/15 ml syrup contains 168 mg propylene glycol per dose (15 ml) equivalent to 11.2 mg/ml. Ethanol: The 100 mg/5 ml syrup (150 ml and 200 ml) contains 3.85 mg alcohol (ethanol) in each 100 ml. The amount of this medicine in one dose 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.

INTERACTIONS

Interactions Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml - Which medicines or foods can modify the effect of Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml?'

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 N-acetylcysteine. It is advisable not to mix other drugs with the Fluimucil Mucolitico 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 oral antibiotics 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 determines dilation of the temporal artery with possible onset of headache. If concomitant administration of nitroglycerin and N-acetylcysteine ​​is necessary, patients should be monitored for hypotension, which may be severe, and alerted to the possible onset of headache. Paediatric population: interaction studies have been performed only in adults. Drug-laboratory test interactions: N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. N-acetylcysteine ​​may interfere with the test for the determination of ketones in urine.

SIDE EFFECTS

Like all medicines, Fluimucil Mucolitico Sciroppo Espettorante 600 Mg-15 Ml can cause side effects - What are the side effects of Fluimucil Mucolitico Sciroppo Espettorante 600 Mg-15 Ml?

Summary of safety profile: The most frequently reported adverse events associated with oral administration of N-acetylcysteine ​​are gastrointestinal in nature. Less frequently, hypersensitivity reactions have been reported, including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash and pruritus. List of adverse reactions: The following adverse reactions are listed below by classification and frequency: very common (>= 1/10), common (>= 1/100 to < 1/10), uncommon (>= 1/1,000 to < 1/100), rare (>= 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Immune system disorders. Uncommon (>=1/1,000; <1/100): hypersensitivity; very rare (<1/10,000): anaphylactic shock, anaphylactic/anaphylactoid reaction. Nervous system disorders. Uncommon (>=1/1,000; <1/100): headache. Ear and labyrinth disorders. Uncommon (>=1/1,000; <1/100): tinnitus. Cardiac disorders. Uncommon (>=1/1,000; <1/100): tachycardia. Vascular disorders. Very rare (<1/10,000): haemorrhage. Respiratory, thoracic and mediastinal disorders. Rare (>=1/10,000; <1/1,000): bronchospasm, dyspnoea; not known: bronchial obstruction. Gastrointestinal disorders. Uncommon: (>=1/1,000; <1/100): vomiting, diarrhoea, stomatitis, abdominal pain, nausea; rare (>=1/10,000; <1/1,000): dyspepsia. Skin and subcutaneous tissue disorders. Uncommon (>=1/1,000; <1/100): urticaria, rash, angioedema, pruritus. General disorders and administration site conditions. Uncommon (>=1/1,000; <1/100): pyrexia; not known: facial oedema. Diagnostic tests. Uncommon (>=1/1,000; <1/100): decreased blood pressure. Description of some adverse reactions: in 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's syndrome. Although in most cases at least one other suspect drug has been identified that is more likely to be involved in the genesis of the above-mentioned 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 during the intake of N-acetylcysteine. The clinical significance of these findings has not yet been defined. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation 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.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Fluimucil Mucolitico Expectorant Syrup 600 Mg-15 Ml

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