KOFIMUCIL MUCOL * 30BUST 200MG
Therapeutic indications
Treatment of respiratory diseases characterized by thick and viscous hypersecretion.
Dosage and method of use
Adults: 1 sachet of KOFIMUCIL MUCOLITICO 200 mg granules for oral solution 2–3 times a day The duration of therapy is from 5 to 10 days in acute and chronic forms will be continued, in the opinion of the doctor, for periods of a few months. The use of the product is reserved for adults. How to use Dissolve the contents of a sachet in a glass containing a little water, stirring as needed with a teaspoon. The solution should be taken as soon as it is ready.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Generally contraindicated in pregnancy and lactation (see section 4.6). Children under the age of 12.
Side effects
The following are the undesirable effects (and their frequency) that occurred after taking oral N-acetylcysteine, organized according to the MedDRA system organ class.
Classification organ-systemic |
Adverse reactions |
Uncommon (≥1 / 1,000; |
Rare (≥1 / 10,000; |
Very rare ( |
Not known |
Disorders of the immune system |
Hypersensitivity |
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Anaphylactic shock, anaphylactic / anaphylactoid reaction |
|
Nervous system disorders |
Headache |
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Ear and labyrinth disorders |
Tinnitus |
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Cardiac pathologies |
Tachycardia |
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Vascular pathologies |
|
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Hemorrhage |
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Respiratory, thoracic and mediastinal disorders |
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Bronchospasm, dyspnoea |
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Bronchial obstruction |
Gastrointestinal disorders |
Vomiting, diarrhea, stomatitis, abdominal pain, nausea |
Dyspepsia |
|
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Skin and subcutaneous tissue disorders |
Urticaria, rash, angioedema, pruritus |
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General disorders and administration site conditions |
Pyrexia |
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Edema of the face |
Diagnostic tests |
Reduced blood pressure |
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In very rare cases, severe skin reactions have 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 more likely involved in the genesis of the aforementioned mucocutaneous syndromes has been identified, in case of mucocutaneous alterations it is advisable to discontinue the intake of N-acetylcysteine. Some studies have confirmed a reduction in platelet aggregation when taking N-Acetylcysteine. The clinical significance of these findings has not yet been defined.
Special warnings
Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. Administer the medicine with particular care to patients with peptic ulcer or with a history of peptic ulcer, especially in the case of concomitant use of other drugs with a known gastric-damaging effect. The administration of acetylcysteine, especially at the beginning of the treatment, by thinning the bronchial secretions, can increase the volume at the same time. If the patient is unable to expectorate effectively, postural drainage and bronchoaspiration should be used to avoid secretion retention. The possible presence of a sulphurous odor does not indicate alteration of the preparation but is typical of the active ingredient contained therein. Important information about some of the ingredients The medicine contains sucrose (each dose of KOFIMUCIL MUCOLITICO provides 2.24 g of sucrose): therefore, this medicine should be taken with caution in subjects suffering from rare problems of hereditary fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase insufficiency. Furthermore, this sugar intake must be considered for administration in diabetic subjects or those who follow low-calorie diets.
Pregnancy and breastfeeding
The administration of acetylcysteine during pregnancy and during the lactation period, should be carried out only in case of real need under the direct supervision of the doctor.
Expiration and retention
Store in the original package to protect the medicine from moisture.
Interactions with other drugs
Drug-drug interactionDrug-drug interaction studies have only been conducted in adult patients. Antitussive drugs and 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 carbon can reduce the effect of acetylcysteine. It is recommended not to mix other drugs with the KOFIMUCIL 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 recommended to take antibiotics by mouth at least two hours after the administration of N-acetylcysteine. It has been shown that the simultaneous intake of nitroglycerin and N-acetylcysteine causes significant hypotension and causes dilation of the temporal artery with possible onset of headache. If the simultaneous administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for the onset of hypotension, which can also be severe, and warned about the possible onset of headache.Drug-laboratory test interactionsN – Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. N-Acetylcysteine can interfere with the test for the determination of ketones in urine.
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.SymptomsOverdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.TreatmentThere are no specific antidotic treatments; overdose therapy is based on symptomatic treatment.
Active principles
One sachet contains: Active ingredient Acetylcysteine 200 mg.Excipients: sucrose 2.24 g. For the complete list of excipients see par. 6.1.
Excipients
Granular orange juice; orange flavor; saccharin; sunset yellow (and 110); sucrose.