1 effervescent tablet contains:
active substance :
acetylcysteine 600 mg
anhydrous citric acid - 625.00 mg;
sodium bicarbonate - 327.00 mg;
sodium carbonate - 104.00 mg;
mannitol - 72.80 mg;
lactose - 70.00 mg;
ascorbic acid - 75.00 mg;
sodium cyclamate - 30.75 mg;
sodium saccharinate dihydrate - 5.00 mg;
sodium citrate dihydrate - 0.45 mg;
blackberry flavor “B” - 40.00 mg.
Effervescent tablets 600 mg
For 6, 10 or 20 effervescent tablets in a tube of polypropylene.
1 tube in a cardboard bundle along with instructions for use.
Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The action is due to the ability to break the disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins of sputum, which leads to a decrease in the viscosity of sputum. The drug remains active in the presence of purulent sputum.
It has an antioxidant effect, based on the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidative radicals and, thus, neutralize them. In addition, acetylcysteine promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body. The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effects of free radical oxidation, which is characteristic of an intense inflammatory reaction. With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.
Absorption is high. It is rapidly metabolized in the liver with the formation of a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Oral bioavailability is 10% (due to the presence of a pronounced effect of "first passage" through the liver).
The time to reach maximum plasma concentration is 1-3 hours. Communication with plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). The half-life (T1 / 2) is about 1 hour, impaired liver function leads to an extension of T1 / 2 to 8 hours. It penetrates the placental barrier. Data on the ability of acetylcysteine to cross the blood-brain barrier and excreted in breast milk are not available.
Diseases of the respiratory system, accompanied by the formation of viscous difficult to separate sputum:
• acute and chronic bronchitis, obstructive bronchitis;
• tracheitis, laryngotracheitis;
• lung abscess;
• bronchiectatic disease, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis;
• cystic fibrosis;
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).
• hypersensitivity to acetylcysteine or other components of the drug;
• peptic ulcer of the stomach and duodenum in the acute stage;
• hemoptysis, pulmonary hemorrhage;
• lactation period;
• children's age up to 14 years (for this dosage form);
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution - a history of gastric and duodenal ulcer, asthma, obstructive bronchitis, liver and / or renal failure, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine affects the histamine metabolism and may lead to signs of intolerance such as headache, vasomotor rhinitis, pruritus), varicose veins of the esophagus, adrenal disease, arterial hypertension.
According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); the frequency is unknown (the frequency of occurrence of phenomena cannot be determined based on available data).
infrequently: skin itch, rash, exanthema, urticaria; angioedema, decreased blood pressure, tachycardia;
very rarely: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
From the respiratory system
rarely: dyspnea, bronchospasm (mainly in patients with bronchial hyperreactivity in asthma).
From the sensory organs
infrequently: tinnitus. From the gastrointestinal tract
infrequently: stomatitis, pain in the abdomen, nausea, vomiting, diarrhea, dyspepsia.
very rare: headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, a decrease in platelet aggregation.
With the simultaneous use of acetylcysteine and antitussive agents due to suppression of the cough reflex, sputum congestion may occur.
With simultaneous use with oral antibiotics (penicillins, tetracyclines, cephalosporins, etc.), they may interact with the thiol group of acetylcysteine, which can lead to a decrease in their antibacterial activity.
Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours (except cefixime and loracarbef).
Simultaneous use with vasodilating agents and nitroglycerin can lead to increased vasodilating action.
How to take, course of administration and dosage
Inside, after a meal. Effervescent tablets should be dissolved in one glass of water.
Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. An additional intake of liquid enhances the mucolytic effect of the drug.
With short-term colds, the duration of administration is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect.
In the absence of other prescriptions, it is recommended to adhere to the following dosages:
Adults and children over 14 years of age: 1 effervescent tablet 1 time per day (600 mg).
Symptoms: in case of an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are observed.
PUNISHMENT FOR PATIENTS WITH SUGAR DIABETES
1 effervescent tablet corresponds to 0.001 XE.
When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances. With the use of acetylcysteine, cases of the development of severe allergic reactions, such as Stevens-Johnson syndrome and Lyell syndrome, have been very rarely reported. If changes in the skin and mucous membranes occur, you should immediately consult a doctor, you must stop taking the drug.
In patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systemic control of bronchial obstruction.
You should not take the drug immediately before bedtime (it is recommended to take the drug before 18.00).
INFLUENCE ON ABILITY TO DRIVE VEHICLES, MECHANISMS
There is no evidence of the negative effect of ACC® Long in recommended doses on the ability to drive vehicles or mechanisms.
round flat-cylindrical tablets of white color, with a facet and a risk on one side, with a smell of a blackberry.
May have a slight sulfuric odor.
Reconstituted solution: a colorless, clear solution with a blackberry smell; a faint sulfuric odor may be present.