Fluimucil mucolytic 200 mg - no-sugar granules for oral solution 30 sachets orange flavour

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.

Warnings

Patients suffering from bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment must be stopped immediately.

Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the capacity 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.

Particular caution is required when using the medicine in patients with peptic ulcers or a history of peptic ulcers, especially if they are taking other drugs known to cause gastro-intestinal damage at the same time. 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 sachet package. 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 retention of secretions.

Interactions

• Drug-drug interactions:Drug-drug interaction studies have been conducted only on adult patients. Antitussive drugs and N-acetylcysteine ​​should not be taken simultaneously since 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 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 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.
• Drug-laboratory test interactions: N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. interfere with the test for determining ketones in urine.

Pregnancy and breastfeeding

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 real need under the direct supervision of a doctor.

Format

30 orange-flavored sachets, sugar-free.