MUCOLITHIC SOLMUCOL * 30CPR600MG

MUCOLITHIC SOLMUCOL * 30CPR600MG

Therapeutic indications

Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Dosage and method of use

Dosage.Adults: 200 mg, 2-3 times a day, or 600 mg once a day (preferably in the evening). The duration of therapy is from 5 to 10 days in acute forms. In the chronic forms it will be continued, in the opinion of the doctor, for periods of a few months. Method of administration : Oral use. Dissolve one tablet in half a glass of water, stirring as needed with a teaspoon.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Generally contraindicated during pregnancy and lactation (see section 4.6). The drug is contraindicated in children under 2 years of age.

Side effects

The undesirable effects identified during the post-marketing experience are listed below; The frequency of adverse reactions presented in the table is defined using the following convention: -very common (≥ 1/10);-common (≥ 1/100, -uncommon (≥ 1/1000, -rare (≥ 1/10000, -very rare (-not known (frequency cannot be estimated from the available data).

In very rare cases, severe skin reactions have occurred in temporal connection with the intake of 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 consult your doctor and the intake of acetylcysteine should be stopped immediately. Some studies have confirmed a reduction in platelet aggregation when taking acetylcysteine. The clinical significance of these findings has not yet been defined.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

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 gastrically damaging effect. In case of generalized rash or other allergic symptoms during oral therapy with acetylcysteine, the administration of the drug should be suspended. In particular, patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment must be stopped immediately. The administration of 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 or, possibly, 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.Pediatric population: Keep this medicine out of the reach and sight of children. Mucolytics can induce bronchial obstruction in children under 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. Mucolytics should therefore not be used in children less than 2 years of age (see section 4.3).Information on some excipients with known effects.SOLMUCOL MUCOLITICO 600 mg effervescent tabletsContains: About 194 mg of sodium (main component of table salt) per tablet. This is equivalent to 9.7% of the maximum daily intake recommended by the WHO which corresponds to 2 g of Sodium for an adult; keep this information in mind in the case of patients with reduced kidney function or who follow a low sodium diet.

Pregnancy and breastfeeding

Teratological studies conducted with acetylcysteine on animals did not show any teratogenic effect; however, no controlled studies in humans are available. Therefore, its administration during pregnancy and during the lactation period can be carried out only in case of real need and under the direct supervision of the doctor.

Expiration and retention

No particular temperature conditions for storage. Keep the tube tightly closed to keep the medicine away from moisture.

Interactions with other drugs

Drug-drug interaction: Simultaneous administration of a bronchial mucolytic and a substance that inhibits secretions (for example an anticholinergic) should be avoided. 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 SOLMUCOL MUCOLITICO solution. Due to its -SH radical, acetylcysteine can chemically interfere with various penicillins, tetracyclines, cephalosporins, aminoglycosides, macrolides and amphotericin B, if these substances are mixed in the same solution. The information available on the antibiotic-acetylcysteine interaction refers to in vitro tests, in which the two substances were mixed, which showed a decreased activity of the antibiotic. In the case of simultaneous use of SOLMUCOL MUCOLITICO with the oral forms of the aforementioned antibiotics, it is advisable to take the two drugs separately with at least two hours of interval between one and the other. It has been shown that the simultaneous intake of nitroglycerin and acetylcysteine causes significant hypotension and causes dilation of the temporal artery with possible onset of headache. If the simultaneous administration of nitroglycerin and 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 interactions: Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. Acetylcysteine can interfere with the test for the determination of ketones in urine.Pediatric population: Interaction studies have only been performed in adult patients.

Overdose

In subjects treated with high doses of oral acetylcysteine, there were no particular signs and symptoms. Healthy volunteers, who for three months took a daily dose of 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

Each 600 mg tablet contains:Active principle: acetylcysteine 600 mg.Excipient with known effect: sodium. For the full list of excipients, see section 6.1.

Excipients

Citric acid, maltodextrin, sodium bicarbonate, orange flavor, leucine and sodium saccharin.