Atss-long pills effervescent 600mg, 20pcs

Composition

1 effervescent tablet contains:

Active ingredient:

acetylcysteine 600 mg

excipients:

citric acid anhydrous – of 625.00 mg;

sodium bicarbonate – of 327.00 mg;

sodium carbonate – of 104.00 mg;

mannitol – 72,80 mg;

lactose – 70,00 mg;

ascorbic acid – 75,00 mg;

sodium cyclamate – 30.75 per mg;

sodium saccharin dihydrate – 5.00 mg;

sodium citrate dihydrate – 0.45 mg;

flavoring Black Berry “In” – 40,00 mg.

Effervescent tablets 600 mgpervicepackage of 6,10 or 20 effervescent tablets in a polypropylene tube. Secondary packagingon 1 tube in a cardboard box together with the instructions for use.

Pharmacological action

Pharmacodynamics

Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge by directly affecting the rheological properties of sputum. The effect is due to the ability to break disulfide bonds of mucopolysaccharide chains and cause depolymerization of sputum mucoproteins, which leads to a decrease in sputum viscosity. 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 body’s antioxidant system and chemical detoxification.

The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effect 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.

PHARMACOKINETICS

Absorption is high. They are 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 “first pass” effect through the liver).

The time to reach the maximum concentration in blood plasma is 1-3 hours. Binding to plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).

The half-life (T 1/2) is about 1 hour, impaired liver function leads to an extension of T 1/2 to 8 hours. It penetrates the placental barrier. There are no data on the ability of acetylcysteine to cross the blood-brain barrier and be excreted in breast milk.

Indications

Respiratory diseases accompanied by the formation of viscous sputum that is difficult to separate:  * acute and chronic bronchitis, obstructive bronchitis; * tracheitis, laryngotracheitis; * pneumonia; * lung abscess; • bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis; * cystic fibrosis; Acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Contraindications

* hypersensitivity to acetylcysteine or other components of the drug; * acute peptic ulcer of the stomach and duodenum; * hemoptysis, pulmonary hemorrhage; * pregnancy; * lactation period; • children under 14 years of age (for this dosage form) • * lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution – a history of stomach and duodenal ulcer, bronchial asthma, obstructive bronchitis, liver and/or kidney failure, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, pruritus), esophageal varicose veins, adrenal diseases, arterial hypertension.

Side effects

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥ 1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), and very rare (

Allergic reactionsincastly: pruritus, 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 occasionally: shortness of breath, bronchospasm (mainly in patients with hyperreactivity of the bronchi in bronchial asthma).

From the side of the sensory organs often: tinnitus. From the gastrointestinal tract often: stomatitis, abdominal pain, nausea, vomiting, diarrhea, dyspepsia. Other very rare: headache, fever, isolated reports of bleeding due to hypersensitivity reactions, decreased platelet aggregation.

Interaction

With the simultaneous use of acetylcysteine and antitussive agents, sputum stagnation may occur due to the suppression of the cough reflex.

When used concomitantly with oral antibiotics (penicillins, tetracyclines, cephalosporins, etc. ), they may interact with the thiol group of acetylcysteine, which may lead to a decrease in their antibacterial activity.

Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours (except for cefixime and loracarbef).

Concomitant use with vasodilators and nitroglycerin may lead to increased vasodilator activity.

How to take, course of use and dosage

Inside, after eating. 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. Additional fluid intake increases the mucolytic effect of the drug.

For short-term colds, the duration of admission 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: :

Mucolytic therapy: Adults and children over 14 years of age: 1 effervescent tablet 1 time a day (600 mg).

Overdose

Symptoms: if an overdose is taken incorrectly or intentionally, it may cause diarrhea, vomiting, stomach pain, heartburn, and nausea.

Treatment: symptomatic.

Special

instructions FOR PATIENTS WITH DIABETES

1 effervescent tablet corresponds to 0.001 XE.

SPECIAL INSTRUCTIONS

When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, and easily oxidizing substances. Severe allergic reactions, such as Stevens-Johnson syndrome and Lyell’s syndrome, have been reported very rarely with acetylcysteine. If you experience changes in the skin and mucous membranes, you should immediately consult a doctor, stop taking the drug.

In patients with asthma and obstructive bronchitis, acetylcysteine should be administered with caution under systemic monitoring of bronchial patency. Do not take the drug immediately before bedtime (it is recommended to take the drug before 18.00).

EFFECT ON THE ABILITY TO DRIVE VEHICLES, MECHANISMS

There are no data on the negative effect of the drug ACC® Long in the recommended doses on the ability to drive vehicles and mechanisms.

Product form

round flat-cylindrical tablets of white color, with a chamfer and a risk on one side, with the smell of blackberries.

There may be a faint sulfur smell. Reconstituted solution: a colorless transparent solution with a blackberry smell, possibly a faint sulfur smell.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Acetylcysteine

Dosage form

soluble tablets

Description

Children over 14 years old, For adults

Indications

Pneumonia, Bronchitis, Cough, Sinusitis, Sinusitis, Otitis Media, Chronic Obstructive pulmonary Disease, Tracheitis