Fluimucil mucolytic 200 mg granules for oral solution 30 sachets orange flavour

Product Description

Zambon

Treatment of Respiratory Conditions; 30 Sachets

Composition

FLUIMUCIL MUCOLYTIC 200 mg, orodispersible tablets: One tablet contains: Active ingredient N-acetylcysteine ​​200 mg Excipients: sorbitol, sodium, aspartame FLUIMUCIL MUCOLYTIC 200 mg, granules for oral solution One sachet contains: Active ingredient N-acetylcysteine ​​200 mg Excipients: sucrose FLUIMUCIL MUCOLYTIC 200 mg, granules for oral solution without sugar One sachet contains: Active ingredient N-acetylcysteine ​​200 mg Excipients: sorbitol, aspartame FLUIMUCIL MUCOLYTIC 100 mg, granules for oral solution One sachet contains: Active ingredient N-acetylcysteine ​​100 mg Excipients: sucrose FLUIMUCIL MUCOLYTIC 100 mg, granules for oral solution without sugar One sachet contains: Active ingredient N-acetylcysteine ​​100 mg Excipients: sorbitol, aspartame FLUIMUCIL MUCOLYTIC 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) One 200 ml bottle contains: Active ingredient N-acetylcysteine ​​4,000 g (corresponding to 100 mg/5 ml of syrup) Excipients: methyl parahydroxybenzoate, sodium For the full list of excipients, see section 6.1.

Excipients

FLUIMUCIL MUCOLYTIC 200 mg including orosoluble 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 flavouring; Saccharin; E 110; Sucrose FLUIMUCIL MUCOLYTIC 100 mg granules for oral solution Orange juice granules; Orange flavouring; Saccharin; E 110; Sucrose. FLUIMUCIL MUCOLYTIC 100 mg granules for oral solution without sugar Sorbitol; Aspartame; Orange flavouring. FLUIMUCIL MUCOLYTIC 100 mg/5 ml syrup 150 ml bottle Methyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, raspberry flavouring, 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 flavoring, sodium saccharinate, sodium hydroxide, purified water.

Therapeutic indications

Treatment of respiratory conditions characterized by dense and viscous hypersecretion.

Contraindications

Hypersensitivity to the active substance or to any of the excipients and to 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 breastfeeding (see section 4.6).

Dosage

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: 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. 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), equivalent to 100 mg of N-acetylcysteine, 2 to 4 times a day, depending on age. The duration of therapy is 5 to 10 days in acute forms; in chronic forms, it should be continued, at the doctor's discretion, for periods of several months. Directions for use: Granules for oral solution: dissolve the contents of one sachet in a glass containing a little water, stirring as needed with a teaspoon. This produces a palatable 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 consumed as soon as it is ready. Orodispersible tablets: keep the tablet in the oral cavity until completely dissolved. Syrup: shake before use. Once opened, the syrup has a shelf life of 15 days.

Warnings and precautions

Patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment must be discontinued immediately. Mucolytics can 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 should therefore not be used in children under 2 years of age (see section 4.3). Particular caution is required when using the medicine in patients with peptic ulcers or a history of peptic ulcers, especially if other drugs known to cause gastro-intestinal damage are taken concomitantly. In the case of diabetics or those following low-calorie diets, it should be noted that the preparation in sachets contains sugar. In these cases, it is possible to use the sugar-free sachets. The possible presence of a sulphurous odor does not indicate an alteration of the preparation but is characteristic of the active ingredient it contains. The administration of N-acetylcysteine, especially at the beginning of treatment, can thin bronchial secretions and simultaneously 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 excipients: The syrup contains parahydroxybenzoates, which can cause delayed allergic reactions and, more rarely, immediate reactions with bronchospasm and urticaria. The orodispersible tablets and the sugar-free granules for oral solution contain sorbitol, therefore patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may have a laxative effect and its caloric value is 2.6 kcal/g. The sugar-free orodispersible tablets and granules for oral solution contain a source of phenylalanine, which may be harmful to patients with phenylketonuria. The 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 contain 2.2 g of sucrose per sachet, while the 100 mg granules for oral solution contain 4.3 g of sucrose per sachet, therefore, it should be taken into consideration by patients with diabetes mellitus. The tablets and syrup contain 26.9 and 16.6 mg of sodium per dose, respectively, which should be taken into account in patients with reduced kidney function or on a low-sodium diet.

Interactions

Drug-drug interaction Drug-drug interaction studies have been conducted only in adult patients. Antitussive drugs and N-acetylcysteine ​​should not be taken simultaneously, 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 recommended not to mix other drugs with the Fluimucil Mucolitico solution. The available information regarding the antibiotic-N-acetylcysteine ​​interaction refers to in vitro tests, in which the two substances were mixed, which showed a reduced activity of the antibiotic. However, as a precaution, it is recommended to take oral antibiotics at least two hours after administration of N-acetylcysteine. Concomitant administration of nitroglycerin and N-acetylcysteine ​​has been shown to cause significant hypotension and temporal artery dilation, with possible 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. Drug-laboratory test interactions N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. N-acetylcysteine ​​may cause interfere with the urine ketone test.

Side effects

The following table shows the frequency of adverse reactions that have occurred after taking oral N-acetylcysteine:

In very rare cases, the appearance of serious skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, has occurred in temporal connection with the intake of N-acetylcysteine. Although in most cases at least one other suspect drug has been identified as more likely to be 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 during the intake of N-acetylcysteine. The clinical significance of this evidence has not yet been defined.

Pregnancy and breastfeeding

Even though teratological studies conducted with Fluimucil Mucolitico on animals have not highlighted any teratogenic effect, as with other drugs, its administration during pregnancy and breastfeeding should be carried out only in case of real need under the direct supervision of a doctor.