ACETYLCYSTEINE ANG * 30BUST
Treatment of respiratory diseases characterized by thick and viscous hypersecretion: acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, mucoviscidosis and bronchiectasis. Antidotic treatment Accidental or voluntary intoxication with paracetamol. Uropathy due to iso– and cyclophosphamide.
Dosage and method of use
Treatment of respiratory affections ADULTS • 1 sachet of ANGENERIC ACETYLCYSTINE 200 mg powder for oral solution or 2 sachets of ANGENERIC ACETYLCYSTIN 100 mg powder for oral solution, 2-3 times a day. • 1 effervescent tablet of ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets per day (preferably in the evening). Possible dose adjustments may relate to the frequency of administration or dose splitting but must still be within the maximum daily dose of 600 mg. For the prevention of exacerbations, the use of ACETYLCYSTEINE ANGENERICO 200 mg powder for oral solution sachets is recommended. CHILDREN over 2 years of age • 1 sachet of ANGENERIC ACETYLCYSTEINE 100 mg powder for oral solution, 2-4 times a day, according to age. The duration of the therapy is 5-10 days in the acute and chronic forms, it will be continued, in the opinion of the Doctor, for periods of a few months. Accidental or deliberate intoxication with paracetamol Orally, initial dose of 140 mg / kg body weight to be administered as soon as possible, within 10 hours of taking the toxic agent, followed every 4 hours and for 1–3 days by doses single of 70 mg / kg of weight. Uropathy due to iso– and cyclophosphamide In a typical course of iso– and cyclophosphamide chemotherapy of 1,200 mg / m² body surface area per day for 5 days every 28 days, acetylcysteine can be administered orally at a dose of 4 g / day on the days of chemotherapy treatment, distributed in 4 doses of 1 g. How to use ANGENERIC ACETYLCYSTEINE 100 mg and 200 mg powder for oral solution Dissolve the contents of the sachet in a glass containing a little water, stirring as needed with a teaspoon. The powder can also be dissolved in fruit juice or iced tea. ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets Dissolve one tablet in half a glass of water, stirring as needed with a teaspoon. In this way a pleasant solution is obtained which can be drunk directly from the glass or, in the case of small children, be given in teaspoons or with a bottle. The solution should be swallowed immediately after its preparation. Take the solution preferably after meals. The mucolytic effect of acetylcysteine is favored by the intake of liquids.
Hypersensitivity to product components and other closely related substances from a chemical point of view. Generally contraindicated in pregnancy and lactation (see section 4.6 "Pregnancy and lactation"). The drug is contraindicated in children under 2 years of age, with the exception of antidotic treatment.
Below is a table relating to the frequency of adverse reactions following the oral intake of N-acetylcysteine:
| Classification organ-systemic || Adverse reactions |
| Uncommon (≥1 / 1,000; || Rare (≥1 / 10,000; || Very rare ( || Not known |
|Disorders of the immune system ||Hypersensitivity || ||Anaphylactic shock, anaphylactic / anaphylactoid reaction || |
|Nervous system disorders ||Headache || || || |
|Ear and labyrinth disorders ||Tinnitus || || || |
|Cardiac pathologies ||Tachycardia || || || |
|Diseases of the vascular system || || ||Hemorrhage || |
|Respiratory, thoracic and mediastinal disorders || ||Bronchospasm, dyspnoea || ||Bronchial obstruction |
|Gastrointestinal disorders ||Vomiting, diarrhea, stomatitis, abdominal pain, nausea ||Dyspepsia || || |
|Skin and subcutaneous tissue disorders ||Urticaria, rash, angioedema, itching || || || |
|General disorders and administration site conditions ||Pyrexia || || ||Edema of the face |
|Diagnostic tests ||Reduced blood pressure || || || |
In very rare cases, there has been the appearance of severe skin reactions in temporal connection with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell's syndrome: 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 when taking N-acetylcysteine. The clinical significance of these findings has not yet been defined.
Patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment should be stopped immediately. 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 gastro-damaging effect. 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 and bronchoaspiration should be used to avoid secretion retention. Mucolytics can induce bronchial obstruction in children less than 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. They should therefore not be used in children less than 2 years of age (see section 4.3). The possible presence of a sulphurous odor does not indicate alteration of the preparation, but is typical of the active ingredient contained therein. Important information about some of the excipients In the case of diabetic subjects or those who follow low-calorie diets, it should be borne in mind that the preparation in sachets contains sugar in an amount corresponding to about ½ coffee spoon for each sachet. ANGENERIC ACETYLCYSTEINE powder for oral solution, contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets contains anhydrous lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Pregnancy and breastfeeding
Even if the teratological studies conducted with acetylcysteine on animals have not shown any teratogenic effect, however, as for other drugs, its administration during pregnancy and during the lactation period, should be carried out only in case of real need under the direct control of the Doctor.
Expiration and retention
ANGENERIC ACETYLCYSTEINE 100 mg powder for oral solution Store in the original carton and outer carton ANGENERIC ACETYLCYSTEINE 200 mg powder for oral solution Store in the original carton and outer carton ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets This medicine does not require any special storage conditions
Interactions with other drugs
Drug-drug interaction Drug-drug interaction studies have only been conducted in adult patients. Antitussive drugs and N-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 N-acetylcysteine. It is recommended not to mix other drugs with the ANGENERIC ACETYLCYSTEINE 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 the simultaneous administration of nitroglycerin and N-acetylcysteine is necessary, patients should be monitored for the onset of hypotension, which can also be severe, and informed about 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.
No cases of overdose have been reported with respect to oral administration of N-acetylcysteine. Healthy volunteers, who for three months took a daily dose of N-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. Symptoms 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.
ANGENERIC ACETYLCYSTEINE 100 mg powder for oral solution Each sachet contains: Active principle: acetylcysteine 100 mg. Excipients sucrose For the full list of excipients, see section 6.1. ANGENERIC ACETYLCYSTEINE 200 mg powder for oral solution Each sachet contains: Active principle: acetylcysteine 200 mg. Excipients sucrose For the full list of excipients, see section 6.1. ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets Each effervescent tablet contains: Active principle: acetylcysteine 600 mg Excipients anhydrous lactose For a full list of excipients, see section 6.1.
ANGENERIC ACETYLCYSTEINE 100 mg powder for oral solution Each sachet contains: sucrose - ascorbic acid - saccharin - orange flavor. ANGENERIC ACETYLCYSTEINE 200 mg powder for oral solution Each sachet contains: sucrose - ascorbic acid - saccharin - orange flavor. ANGENERIC ACETYLCYSTEINE 600 mg effervescent tablets Each tablet contains: anhydrous citric acid - sodium bicarbonate - anhydrous sodium carbonate - mannitol - anhydrous lactose - ascorbic acid - sodium cyclamate - sodium saccharin dihydrate - sodium citrate - blackberry flavor.