Fluimucil Mucolytic 600 mg/15 ml Expectorant Syrup 200 ml

Therapeutic indications

Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Dosage

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 oral solution without sugar: a 15 ml measuring spoon or an effervescent tablet or a sachet (preferably in the evening). Possible dose adjustments may relate to the frequency of administration or dose splitting but must still be 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 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 in the acute forms and in the chronic forms it will be continued, in the opinion of the doctor, for periods of a few months. Method of administration Granules for oral solution : dissolve the contents of one sachet in a glass containing a little water, mixing 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, 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 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, we recommend the tear-off opening of the blister, using the side notches.

Overdose

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. Symptoms 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.

Contraindications

Hypersensitivity to the active substance or to any of the excipients and other closely related substances from a chemical point of view. The drug is contraindicated in children under 2 years of age. Generally contraindicated in pregnancy and lactation (see section 4.6).

Side effects

Below is a table relating to the frequency of adverse reactions that occurred after taking N-acetylcysteine by mouth:

Organ-systemic classification	Adverse reactions
	Uncommon (≥1 / 1,000; <1/100)	Rare (≥1 / 10,000; <1 / 1,000)	Very rare (<1 / 10,000)	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, there has been the appearance of severe skin reactions 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 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 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 ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Even if the teratological studies conducted with Fluimucil Mucolytic on animals did not show any teratogenic effect, however, as for other drugs, its administration during pregnancy and during the lactation period, should be carried out only in case of actual need under the direct doctor's check.

Special warnings

Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. 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. Important information about some of the ingredients The syrup contains parahydroxybenzoates which may cause delayed allergic reactions and, more rarely, immediate reactions with bronchospasm and urticaria. The buccal tablets, 600 mg / 15 ml syrup and granules for oral solution without sugar contain sorbitol therefore patients with rare hereditary problems of fructose intolerance should not take this medicine. The buccal tablets, effervescent tablets and granules for oral solution without sugar contain 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 therefore 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 and effervescent tablets contain respectively 26.9 and 156.9 mg of sodium per tablet. The syrup of 100 mg / 5 ml (150 ml) and the syrup of 100 mg / 5 ml (200 ml) contain respectively 37.59 and 38.21 mg of sodium per 10 ml dose, while for the 5 ml dose contain 18.8 and 19.11 mg. Finally, the 600mg / 15ml syrup contains 96.6mg sodium per 15ml serving. The quantities of sodium must be taken into account in the case of patients with reduced kidney function or who follow a low sodium diet.

Expiry and Retention

Sachets of 100 and 200 mg 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.

Active principles

FLUIMUCIL MUCOLITICO 600 mg effervescent tablets Each tablet contains: Active ingredient N-acetylcysteine 600 mg Excipients with known effects: sodium, aspartame FLUIMUCIL MUCOLITICO 600 mg granules for oral solution without sugar Each sachet contains: Active ingredient N-acetylcysteine 600 mg Excipients with known effects : aspartame, sorbitol FLUIMUCIL MUCOLITICO 600 mg / 15 ml syrup 15 ml syrup contain: Active ingredient N-acetylcysteine mg 600 Excipients with known effects: methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, sodium, sorbitol FLUIMUCIL MUCOLITICO 200 mg, effervescent tablets : One tablet contains: Active ingredient N-acetylcysteine mg 200 Excipients with known effects: sodium, aspartame FLUIMUCIL MUCOLITICO 200 mg, buccal tablets: One tablet contains: Active ingredient N-acetylcysteine mg 200 Excipients with known effects: sorbitol, sodium, aspartame FLUIMUCIL MUCOLITICO 200 mg, granules for oral solution One sachet contains: Principle at tivo N-acetylcysteine mg 200 Excipients with known effects: sucrose, sunset yellow (E110) FLUIMUCIL MUCOLITICO 200 mg, granules for oral solution without sugar One sachet contains: Active ingredient N-acetylcysteine mg 200 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, granules for oral solution without sugar One sachet contains: Active ingredient N-acetylcysteine 100 mg Excipients with known effects: sorbitol, aspartame FLUIMUCIL MUCOLITICO 100 mg / 5 ml, syrup One bottle of 150 ml contains: Active ingredient N-acetylcysteine g 3,000 (corresponding to 100 mg / 5 ml of syrup) Excipients with known effects: methyl parahydroxybenzoate, sodium One bottle of 200 ml contains: Active ingredient N-acetylcysteine g 4,000 (corresponding to 100 mg / 5 ml of syrup) Eccipient i with known effects: methyl parahydroxybenzoate, sodium For a full list of excipients, see section 6.1

Excipients

FLUIMUCIL MUCOLITICO 600 mg granules for oral solution without sugar Aspartame, Orange flavor, Sorbitol. FLUIMUCIL MUCOLITICO 600 mg effervescent tablets Anhydrous citric acid, Lemon flavor, Aspartame, Sodium bicarbonate. FLUIMUCIL MUCOLITICO 600 mg / 15 ml syrup bottle 200 ml Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Sodium edetate, Carmellose, Saccharin sodium, Grenadine flavor, Strawberry flavor, Sorbitol, Sodium hydroxide, Purified water. FLUIMUCIL MUCOLITICO 200 mg including orosoluble Citric acid anhydrous, 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 sugar Sorbitol, aspartame, orange flavor. FLUIMUCIL MUCOLITICO 200 mg granules for oral solution Granular orange juice; Orange flavor; Saccharin; E 110; Sucrose FLUIMUCIL MUCOLITICO 200 mg including effervescent Anhydrous citric acid, sodium bicarbonate, lemon flavor, aspartame. FLUIMUCIL MUCOLITICO 100 mg granules for oral solution Granular orange juice; Orange flavor; Saccharin; E 110; Sucrose. FLUIMUCIL MUCOLITICO 100 mg granules for oral solution without sugar Sorbitol; Aspartame; Orange flavor. MUCOLITICO FLUIMUCIL 100 mg / 5 ml syrup 150 ml bottle Methyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, raspberry flavor, sodium saccharinate, sodium hydroxide, purified water. FLUIMUCIL MUCOLITICO 100 mg / 5 ml syrup bottle 200 ml Methyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, sodium cyclamate, sucralose, raspberry flavor, sodium saccharinate, sodium hydroxide, purified water.