FROBEMUCIL 10CPR EFF 600MG

FROBEMUCIL 600 MG COMPRESENT EFFERENCES

active ingredients

Each effervescent tablet contains 600 mg of acetylcysteine. Excipients with known effects: lactose, sodium and sorbitol. For the full list of excipients, see paragraph 6.1.

Excellent

Citric acid anidro, ascorbic acid, sodium citrate dihydrate, sodium cyclamate, sodium saccharin, mannitol, sodium hydrogen carbonate, sodium carbonate anidro, lactose anidro, lemon aroma “AU” (code 132; containing sorbitol).

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. Pregnancy and breastfeeding (see paragraph 4.6). The drug is contraindicated in children under 2 years of age.

Population

Population: 1 tablet per day (preferably in the evening) or second prescription. The duration of therapy is from 5 to 10 days. Method of administration: Melt the tablet in a glass containing a little water, stirring in need with a teaspoon.

Conservation

Polypropylene pipe: do not store at temperature above 30°C.

Warnings

Patients with bronchial asthma must be strictly controlled during therapy. If bronchospasm occurs the treatment with N-acetylcysteine must be immediately suspended and appropriate treatment must be initiated. 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. The eventual presence of a sulphurous smell does not indicate alteration of the preparation but is precisely the active ingredient contained in it. The administration of N-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 and bronchopiration. N-acetylcysteine can affect the metabolism of histamine. Therefore, caution should be used when administering Frobemucil in patients with histamine intolerance as symptoms of hypersensitivity may occur. 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. They must not be used in children under 2 years of age (see paragraph 4.3). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. This medicine contains 138.85 mg of sodium per tablet equivalent to 6.9% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. This medicine contains 40 mg of sorbitol per tablet. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered.

Interactions

Drug-farm interaction: Antitussive drugs and mucolitic agents, such as N-acetylcysteine, 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 N-acetylcysteine. It is recommended not to mix other drugs in Frobemucil. The information available on antibiotic-N-acetylcysteine interaction refers to in vitro tests, in which the two substances have been mixed, which have evidenced a decreased activity of the antibiotic. However, for precautionary purposes, it is recommended to take oral antibiotics at least two hours from administration of N-acetylcysteine, excluding loracarbef. It has been shown that the simultaneous intake of nitroglycerin and N-acetylcystein causes significant hypotension and causes dilation of temporal artery with possible headache occurrence. If the simultaneous administration of nitroglycerin and N-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. Pediatric population: Interaction studies were carried out only in adults. Drug-test interaction of laboratory: N-acetylcysteine can cause interference with the colorimetric dosing method for the determination of salicylates. N-acetylcysteine can interfere with the test for the determination of ketones in the urine.

Effects

Security profile summary: The most frequently adverse events associated with oral administration of N-acetylcysteine are gastrointestinal. Less often hypersensitivity reactions include anaphylactic shock, anaphylactic/anaphylactic reactions, bronchospasm, angioedema, rash and itching. Tabled list of adverse reactions. The following table shows the adverse reactions listed according to the classification and frequency system: very common (≥ 1/10), common (≥ 1/100, ≥ 1/1.000, ≥ 1/10.000, Classification organo-system Adverse reactions/Frequency Common (≥>1/100; Not common (≥1/1,000; Rare (≥1/10.000; Very rare ( Notable Immune system disorders   Hypersensitivity   Anaphylactic shock, anaphylactic/ anaphylactic reaction   Diseases of the nervous system   Cefa       Ear and labyrinth pathologies   Tinnitus       Heart disease   Tachycardia       Vascular diseases       Hemorrhage   Respiratory, chest and mediastinic pathologies     Broncospasmo, dispnea   Bronchial obstruction Gastrointestinal diseases   Vomito, diarrhea, stomatitis, abdominal pain, nausea Dispepsia     Pathologies of skin and subcutaneous tissue Exantema Orticaria, rash, angioedema, itching       Systemic pathologies and conditions for administration   Pyrexia     Face Edema Diagnostic examinations   Reduced blood pressure       Description of some adverse reactions: In very rare cases, the appearance of serious skin reactions in temporal connection with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell syndrome, has occurred.Although in most cases at least one other suspect drug has been identified as more likely to be involved in the genesis of the above-mentioned mucocutaneous syndromes, in case of mucocutaneous alterations it is advisable to contact your doctor and the intake of N-acetylcysteine must be stopped immediately.Some studies have confirmed a reduction in platelet aggregation during the intake of N-acetylcysteine.The clinical significance of these findings has not yet been defined. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.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.

Overdosing

No overdose cases were found regarding oral administration of N-acetylcysteine. Healthy volunteers, who for three months have taken a daily dose of N-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. Symptoms Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea. Treatment There are no specific antidote treatments;overdose therapy is based on symptomatic treatment.

Although teratological studies conducted with acetylcysteine on animals have not highlighted any teratogenic effect, however, as with other drugs, its administration during pregnancy and during breastfeeding should be carried out only in case of real need.

Source: Farmadati