Kofimucil Oral Mucolytic Soluz Grat 30 Bust 200mg

NAME
KOFIMUCIL MUCOLITICO 200 MG GRANULATE FOR ORAL SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.

ACTIVE PRINCIPLES
Acetylcysteine.

EXCIPIENTS
Granular orange juice; orange flavor; saccharin; sunset yellow (and 110); sucrose.

INDICATIONS
Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; generally contraindicated in pregnancy and lactation; children under the age of 12.

DOSAGE
Adults: 1 sachet of 200 mg granules for oral solution 2-3 times a day. 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 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, mixing as needed with a teaspoon. The solution should be taken as soon as it is ready.

STORAGE
Store in the original package to protect the medicine from humidity.

WARNINGS
Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. Administer the medicinal product 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. Administration of diacetylcysteine, especially at the beginning of treatment, by thinning bronchial secretions, can increase their 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 proper to the active ingredient contained therein. The medicinal product contains sucrose: therefore, this medicinal product 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 following low-calorie diets.

INTERACTIONS
Drug-drug interaction studies have only been conducted in adult patients. Antitussive drugs and acetylcysteine must 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 medicine 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 simultaneous administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for the onset of hypotension, which can also be severe, and alerted to the possible onset of headache. Drug-laboratory test interactions N-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.

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. Disorders of the immune system. Uncommon: hypersensitivity '; very rare: anaphylactic shock, anaphylactic / anaphylactoid reaction. Nervous system disorders. Uncommon: headache. Ear and labyrinth disorders. Uncommon: tinnitus. Cardiac pathologies. Uncommon: tachycardia. Vascular pathologies. Very rare: haemorrhage. Respiratory, thoracic and mediastinal disorders. Rare: bronchospasm, dyspnoea; not known: bronchial obstruction. Gastrointestinal disorders. Uncommon: vomiting, diarrhea, stomatitis, abdominal pain, nausea; rare: dyspepsia. Skin and subcutaneous tissue disorders. Uncommon: urticaria, rash, angioedema, pruritus. General disorders and administration site conditions. Uncommon: pyrexia; not known: edema of the face. Diagnostic tests. Uncommon: low blood pressure. 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.

PREGNANCY AND BREASTFEEDING
The administration of acetylcysteine during pregnancy and during the lactation period, should be carried out only in case of real need.