MUCOLITHIC SOLMUCOL * 24CPR 200

MUCOLITHIC SOLMUCOL * 24CPR 200

Therapeutic indications

Treatment of respiratory diseases characterized by thick and viscous hypersecretion.

Dosage and method of use

Dosage Adults Granules for oral solution, buccal tablets and effervescent tablets200 mg, 2-3 times a day, or 600 mg once a day (preferably in the evening).Syrup10 ml of syrup, equal to 200 mg of acetylcysteine, 2-3 times a day.Pediatric population Children over 2 years of age Granules for oral solution and buccal tablets100 mg 2 to 4 times a day, according to age.Syrup5 ml of syrup, equal to 100 mg of acetylcysteine, 2 to 4 times a day according to age. 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. Possible dose adjustments may relate to the frequency of administration or dose fractionation but must still be within the maximum daily dosage of 600 mg. Method of administration Oral use.Granules for oral solution: dissolve the contents of the sachet in half a glass of water and mix until completely dissolved.Buccal tablets: let the tablet dissolve slowly in the mouth without chewing it.Effervescent tablets: dissolve one tablet in half a glass of water, stirring as needed with a teaspoon.Syrup: tear off the guarantee seal and screw the cap clockwise until the powder falls into the bottle. Shake vigorously until completely dissolved; unscrew the cap and pour the recommended amount into the measuring cup, contained in the package together with the syrup. After each opening of the bottle, carefully screw the cap back on.

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 reactionsReporting 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:http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

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. If generalized rash or other allergic symptoms occur during oral acetylcysteine therapy, drug administration should be discontinued. 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 populationKeep 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 100 mg buccal tabletscontains: §sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.SOLMUCOL MUCOLITICO 200 mg buccal tabletscontains: §sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine; §aspartame: this medicine contains a source of phenylalanine. It can be harmful in case of patients with phenylketonuria.SOLMUCOL MUCOLITICO 600 mg effervescent tabletscontains: § about 194 mg ofsodiumper dose; keep this information in mind in the case of patients with reduced kidney function or who follow a low sodium diet.SOLMUCOL MUCOLITICO 100 mg / 5 ml syrupcontains: §maltitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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 only be carried out in case of real need and under the direct supervision of the doctor.

Expiration and retention

SOLMUCOL MUCOLITICO granules for oral solution, buccal tablets and syrup: store below 25 ° C. SOLMUCOL MUCOLITICO effervescent tablets: no particular temperature conditions for storage. Keep the tube tightly closed to keep it away from moisture.

Interactions with other drugs

Drug-drug interactionSimultaneous 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 interactionsAcetylcysteine 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 populationInteraction 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

Buccal tablets Each 100 mg tablet contains: § active principle : acetylcysteine 100 mg; § excipient with known effects : sorbitol. Each 200 mg tablet contains: § active principle : acetylcysteine 200 mg; § excipient with known effects : sorbitol, aspartame. Effervescent tablets Each 600 mg tablet contains: § active principle : acetylcysteine 600 mg; §excipient with known effect: sodium. Granules for oral solution Each sachet of 100 mg granules for oral solution contains: § active principle : acetylcysteine 100 mg. Each 200 mg sachet of granules for oral solution contains: § active principle : acetylcysteine 200 mg. Each 600 mg sachet of granules for oral solution contains: § active principle : acetylcysteine 600 mg. Syrup 5 ml of reconstituted syrup contains: § active principle : acetylcysteine 100 mg; § excipient with known effects : maltitol. For the full list of excipients, see section 6.1.

Excipients

SOLMUCOL MUCOLITICO 100 mg buccal tabletsSodium bicarbonate, potassium bicarbonate, sorbitol, xylitol, magnesium stearate, orange flavor *.SOLMUCOL MUCOLITICO 200 mg buccal tabletsSodium bicarbonate, potassium bicarbonate, sorbitol, xylitol, magnesium stearate, anhydrous colloidal silica, lemon flavored aspartame.SOLMUCOL MUCOLITICO 100 mg, 200 mg, 600 mg granules for oral solutionXylitol, sodium saccharin, anhydrous colloidal silica, orange flavor *SOLMUCOL MUCOLITICO 600 mg effervescent tabletsCitric acid, maltodextrin, sodium bicarbonate, orange flavor, leucine and sodium saccharinSOLMUCOL MUCOLITICO 100 mg / 5 ml tropical and apricot flavored syrupSodium citrate, sodium benzoate (E211), potassium sorbate (E202), sodium edetate, tropical flavor, apricot flavor, maltitol syrup, purified water.SOLMUCOL MUCOLITICO 100 mg / 5 ml strawberry and raspberry flavored syrupSodium citrate, sodium benzoate (E211), potassium sorbate (E202), sodium edetate, strawberry flavor, raspberry flavor, maltitol syrup, purified water.* The orange flavor is composed of orange essential oil without terpenes, gum arabic, maltodextrin.