Fluimucil mucolytic 600mg 10 sachets granules for oral solution

Mucolytic Fluimucil 600mg 30 granulated sachets for oral solution is an effective treatment for respiratory diseases characterized by thick and viscous hypersecretion. Each sachet contains N-acetylcysteine 200 mg, an active ingredient known for its mucolytic properties, which helps to thin mucus, facilitating its expectoration. This product is particularly suitable for those suffering from respiratory conditions that require a decongestant and mucolytic action. The granules are designed to be dissolved in water, offering a practical and easy-to-take oral solution. With 30 sachets per pack, Fluimucil mucolytic 600mg guarantees continuous treatment, ideal for managing respiratory symptoms effectively. N-acetylcysteine It is a widely used mucolytic agent recognized for its ability to improve breathing and reduce mucus viscosity.

INDICATIONS

Why is Fluimucil mucolytic 600mg 10 sachets granules for oral solution used? What is it for?

Treatment of respiratory diseases characterized by dense and viscous hypersecretion.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Fluimucil mucolytic 600mg 10 sachets granules for oral solution?

Composition

Fluimucil Mucolytic 600 mg effervescent tablets Each tablet contains: Active ingredient: N-acetylcysteine 600 mg. Excipients with known effects: aspartame, glucose, sodium. Fluimucil Mucolytic 600 mg granules for oral solution Each sachet contains: Active ingredient: N-acetylcysteine ​​600 mg. Excipients with known effects: aspartame, glucose, lactose, sorbitol. Fluimucil Mucolytic 600 mg/15 ml syrup 15 ml of syrup contain: Active ingredient: N-acetylcysteine ​​600 mg. Excipients with known effects: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, sorbitol. Fluimucil Mucolytic 200 mg, effervescent tablets One tablet contains: Active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sodium, aspartame. Fluimucil Mucolytic 200 mg, buccal tablets: One tablet contains: Active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sorbitol, sodium, aspartame. Fluimucil Mucolytic 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 Mucolytic 200 mg, granules for oral solution without sugar. One sachet contains: Active ingredient: N-acetylcysteine ​​200 mg. Excipients with known effects: sorbitol, aspartame. Fluimucil Mucolytic 100 mg, granules for oral solution One sachet contains: Active ingredient: N-acetylcysteine ​​100 mg. Excipients with known effects: sucrose, sunset yellow (E110). Fluimucil Mucolytic 100 mg, granules for oral solution without sugar. One sachet contains: Active ingredient: N-acetylcysteine ​​100 mg. Excipients with known effects: sorbitol, aspartame. Fluimucil Mucolytic 100 mg/5 ml, syrup A 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. A 200 ml bottle contains: Active ingredient: 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.

Excipients

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

DOSAGE

How is Fluimucil mucolytic 600mg 10 sachets granules for oral solution taken?

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 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 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 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 use. 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 AND SIDE EFFECTS

When should Fluimucil mucolytic 600mg 10 sachets granules for oral solution not be used and what side effects can it cause?

Contraindications

Hypersensitivity to the active ingredient or to any of the excipients (see the section "What is the composition of Fluimucil mucolytic 600mg 10 sachets, granules for oral solution?"). Children under 2 years of age. Pregnancy and breastfeeding with breast milk ((see the section "Can Fluimucil mucolytic 600mg 10 sachets granules for oral solution be used during pregnancy and breastfeeding?")).

Side effects

Summary of the safety profile The 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 reactions The following table shows the adverse reactions listed according to classification and frequency system: very common (≥ 1/10), common (≥ 1/100 to less than 1/10), uncommon (≥ 1/1,000 to less than 1/100), rare (≥ 1/10,000 to less than 1/1,000), very rare (less than to 1/10,000) and not known (the frequency cannot be established from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Organ-systemic classification Adverse reactions Uncommon (≥1/1,000; less than 1/100) Rare (≥1/10,000; less than 1/1,000) Very rare (less than 1/10,000) Not known Immune system disorders Hypersensitivity Anaphylactic shock, anaphylactic/anaphylactoid reaction Nervous system disorders Headache Ear and labyrinth disorders Tinnitus Cardiac disorders Tachycardia Vascular disorders Haemorrhage Respiratory, thoracic and mediastinal disorders Bronchospasm, dyspnoea Bronchial obstruction Gastrointestinal disorders Vomiting, diarrhoea, stomatitis, abdominal pain, nausea Dyspepsia Skin and subcutaneous tissue disorders Urticaria, rash, angioedema, pruritus Systemic disorders and conditions relating to the administration site Pyrexia Edema of the face Diagnostic tests Reduced 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 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 reactions Reporting 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

INTERACTIONS

Which medicines or foods can modify the effect of Fluimucil mucolytic 600mg 10 sachets, granules for oral solution?

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 population Interaction studies have only been performed 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 urine ketone testing.

PREGNANCY AND BREASTFEEDING

Can Fluimucil mucolytic 600mg 10 sachets granules for oral solution be used during 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 only be carried out in case of actual need.

WARNINGS

What are the warnings of Fluimucil mucolytic 600mg 10 sachets granules for oral solution?

Warnings and precautions

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 must therefore not be used in children under 2 years of age ((see the section "When should Fluimucil mucolytic 600mg 10 sachets granules for oral solution not be used and what side effects can it cause?")). The use of the medicine in patients suffering from peptic ulcers or with a history of peptic ulcers 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. Parahydroxybenzoates Syrups contain parahydroxybenzoates which may cause delayed allergic reactions. Sorbitol The buccal tablets, the 600 mg/15 ml syrup, the 600 mg granules for oral solution and the granules for sugar-free oral solution (100 mg and 200 mg) 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. Aspartame The 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 to patients with phenylketonuria. Glucose The 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. Sucrose The 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. Sodium The 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 of sodium per 10 ml dose, equivalent to 1.83% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for a 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 of 2 g sodium for an adult. The 600 mg/15 ml syrup contains 98.31 mg of sodium per 15 ml dose equivalent to 4.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. Lactose The 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 glycol The 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. Ethanol 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.

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. Symptoms Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. Treatment There are no specific antidotal treatments; Overdose therapy is based on symptomatic treatment.

Driving vehicles and using machinery

N-acetylcysteine does not influence the ability to drive and use machines.

CONSERVATION

How is Fluimucil mucolytic 600mg 10 sachets granules for oral solution stored?

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.

FORMAT

What is the format of Fluimucil mucolytic 600mg 10 sachets granules for oral solution?

10 sachets

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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