SOLMUCOL MUCOLITICAL 30CPR600MG

SOLMUCOL MUCOLITICAL 600 MG COMPRESSE ANDFFERENCES

active ingredients

Each 600 mg tablet contains: Active ingredient: acetylcysteine 600 mg. Excipient with known effectSodium. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Treatment of respiratory diseases characterized by dense and viscous hypersecretion.

Contraindications

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

Population

Population. . Adults : 200 mg, 2-3 times a day, or 600 mg 1 time a day (preferably in the evening). The duration of therapy is from 5 to 10 days in acute forms. In chronic forms it will be continued, according to the doctor, for periods of a few months. Method of administration : Oral use. Melt a tablet in half a glass of water mixing to the need with a teaspoon.

Conservation

No special temperature condition for storage. Keep the pipe closed, to keep the medicine safe from moisture.

Warnings

It requires special attention to the use of the medicine in patients suffering from peptic ulcer or with history of peptic ulcer, especially in the case of contemporary intake of other drugs with a well-known gastrolesive effect. In case of generalized rash or other allergic symptoms during oral therapy with acetylcysteine, the administration of the drug must be suspended. In particular, patients with bronchial asthma must be strictly controlled during therapy; if bronchospasm appears the treatment must be immediately suspended. The administration of acetylcysteine, especially at the beginning of the treatment, can smooth the bronchial secretions and increase the volume at the same time. If the patient is unable to cope effectively, in order to avoid secret retention, it is necessary to resort to postural drainage or, possibly, to bronchopiration. The eventual presence of a sulphurous smell does not indicate alteration of the preparation but is proper to the active ingredient contained in it. Pediatric population: Keep the medicine out of reach and view of children. Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. Mucolitics should therefore not be used in children under 2 years of age (see paragraph 4.3). Information on certain excipients with known effects. . SOLMUCOL MUCOLITICAL 600 mg effervescent tablets contains: Approximately 194 mg of sodium (main component of the kitchen 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 in mind this information in the case of patients with reduced kidney function or following a low sodium diet.

Interactions

Drug-farm interaction: It is to avoid the contemporary administration of a bronchial mucolitic and a substance that inhibits secretions (e.g. an anticolinergic). Antitussive and acetylcysteine drugs should not be taken at the same time since the reduction of cough reflex could lead to an accumulation of bronchial secretions. Active carbon can reduce the effect of acetylcysteine. It is recommended not to mix other drugs to the solution of SOLMUCOL MUCOLITICAL. Because of its radical -SH, acetylcysteine can interfere chemically with different penicillins, tetracyclines, cephalosporins, aminoglycosides, macrolides and amphotericin B, if these substances are mixed in the same solution. The information available on antibiotic-acetylcysteine interaction refers to in vitro tests, in which the two substances have been mixed, which have evidenced a decreased activity of the antibiotic. In the case of contemporary use of SOLMUCOL MUCOLITICO with the oral forms of antibiotics mentioned above, it is recommended to take separately the two medicines with at least two hours of interval between one and the other. It has been shown that the simultaneous intake of nitroglycerin and acetylcystein causes significant hypotension and causes dilation of temporal artery with possible headache occurrence. If the simultaneous administration of nitroglycerin and acetylcysteine is necessary, it is necessary to monitor patients for the appearance of hypotension that can also be severe and alert them about the possible occurrence of cephalea. Drug-test laboratory interactions: Acetylcysteine can cause interference with the colorimetric dosing method for the determination of salicylates. Acetylcysteine can interfere with the test for the determination of ketones in the urine. Pediatric population: Interaction studies were carried out only on adult patients.

Effects

Below are the side effects identified during the post-marketing experience; the frequency of adverse reactions presented in the table is defined by the following convention: - very common (≥ 1/10); - common (≥ 1/100, - not common (≥ 1/1000, - rare (≥ 1/10000, - very rare ( - not known (frequency cannot be defined on the basis of available data).

Immune system disorders	Not common	Hypersensitivity
	Very rare	Anaphylactic shock, anaphylactic/anaphylactic reaction.
Diseases of the nervous system	Not common	Cephalea.
Ear and labyrinth pathologies	Not common	Tinnitus.
Heart disease	Not common	Tachycardia.
Vascular system pathologies	Very rare	Hemorrhage.
Respiratory, chest and mediastinic pathologies	Rare	Broncospasmo, dispnea.
	Notable	Bronchial obstruction.
Gastrointestinal diseases	Not common	Vomito, diarrhea, stomatitis, abdominal pain, nausea.
	Rare	Despair.
Pathologies of skin and subcutaneous tissue	Not common	Hives, rash, angioedema, itching.
Systemic pathologies and conditions for administration	Not common	Pyrexia.
	Notable	Edema of the face.
Diagnostic examinations	Not common	Reduced blood pressure.

In rare cases, the appearance of severe skin reactions in temporal connection with the intake of acetylcysteine, such as Stevens-Johnson syndrome and Lyell syndrome occurred. Although in most cases at least another suspect drug has been identified most likely involved in the genesis of these mucocutaneous syndromes, in case of mucocutaneous alterations, it is appropriate to contact your doctor and the intake of acetylcysteine should be immediately interrupted. Some studies have confirmed a reduction in platelet aggregation during acetylcysteine intake. The clinical significance of such evidence has not yet been defined. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In subjects treated with high doses of acetylcysteine by mouth, no particular signs and symptoms have emerged. Healthy volunteers, who for three months have taken a daily dose of acetylcysteine of 11,6 g, have not manifested serious adverse reactions. The doses of up to 500 mg NAC/kg body weight, administered by mouth, were tolerated without any symptoms of intoxication. Synonyms Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. Treatment There are no specific antidotic treatments; overdose therapy is based on symptomatic treatment.

Theological studies conducted with acetylcysteine on animals have not shown any teratogenic effect; however, there are no man-controlled studies. Therefore, its administration during pregnancy and during the nursing period may be carried out only in case of actual need and under the direct control of the doctor.

Source: Farmadati