Mucocil Solution dispersible tablets 600mg, No. 10

• Mucolytic agent for the treatment of acute and chronic respiratory diseases associated with excessive secretion of bronchial secretions: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, atelectasis of the mucous membrane stopper).

• Catarrhal and purulent otitis media, sinusitis, sinusitis (relief of secretion discharge).

• Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

Dispersible tablets can be taken in different ways: the tablet can be swallowed whole with water or dissolved in water before taking. The tablets should be dissolved in at least 50 ml of water. Stir the resulting suspension thoroughly before use.

Mucolytic therapy

Adults: 600 mg (in terms of the required number of dispersible tablets) 1 time per day or 300 mg (in terms of the required number of dispersible tablets) 2 times a day or 200 mg (in terms of the required number of dispersible tablets) 3 times a day.

The maximum daily dose of apetylcysteine ??is 600 mg / day.

Children:

- children from 2 to 6 years old: 100 mg (in terms of the required number of dispersible tablets) 2-3 times a day (corresponds to 200-300 mg of apetylcysteine ??per day).

- children from 6 to 14 years old: 100 mg (in terms of the required number of dispersible tablets) 3-4 times a day or 200 mg (in terms of the required number of dispersible tablets) 2 times a day (corresponds to 300-400 mg of acetylcysteine ??per day ).

- children over 14 years old: 300 mg (in terms of the required number of dispersible tablets) 2 times a day or 200 mg (in terms of the required number of dispersible tablets) 2-3 times a day (corresponds to 400-600 mg of acetylcysteine ??per day).

Cystic fibrosis

- children from 2 to 6 years old: 100 mg (in terms of the required number of dispersible tablets) 3-4 times a day (corresponds to 300-400 mg of acetylcysteine ??per day);

- children from 6 to 14 years old: 100 mg (in terms of the required number of dispersible tablets) 4 times a day or 200 mg (in terms of the required number of dispersible tablets) 2-3 times a day (corresponds to 400-600 mg of acetylcysteine ??per day );

- children over 14 years old and adults: 200 mg (in terms of the required number of dispersible tablets) 3 times a day or 300 mg (in terms of the required number of dispersible tablets) 2 times a day (corresponds to 600 mg of acetylcysteine ??per day).

The duration of the course of treatment should be assessed individually. In acute diseases, the duration of the course of treatment is from 5 to 10 days; in the treatment of chronic diseases - up to several months (on the recommendation of a doctor).

If after treatment there is no improvement or symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions.

Dispersible tablets, white or white with a beige shade, with slight marbling and surface roughness, oval, biconvex, with a scribble, with a characteristic odor.

1 tab. acetylcysteine ??600 mg

Excipients: microcrystalline cellulose - 409.2 mg, lactose monohydrate (milk sugar) - 60 mg, crospovidone - 60 mg, povidone K25 - 24 mg, lemon flavoring - 12 mg, sodium saccharinate - 9.9 mg, aspartame - 8.1 mg, citric acid monohydrate - 3.9 mg, colloidal silicon dioxide - 9 mg, magnesium stearate - 3.9 mg.

• Hypersensitivity to acetylcysteine ??and other components of the drug;

• peptic ulcer of the stomach and duodenum in the acute stage,

• hemoptysis

• pulmonary bleeding

• hereditary lactose intolerance,

• lactase deficiency

• glucose-galactose malabsorption,

• phenylketonuria,

• children under 2 years of age (for dispersible tablets 100 mg, 200 mg),

• children under 14 years of age (for dispersible tablets 600 mg),

• pregnancy and breastfeeding period.

  Carefully:

• Bronchial asthma, hepatic and / or renal failure, adrenal diseases, esophageal varicose veins, arterial hypertension, a tendency to pulmonary hemorrhage, hemoptysis, a history of gastric ulcer and duodenal ulcer, histamine intolerance (avoid long-term use of the drug, because acetylcysteine ??affects the metabolism of histamine and can lead to signs of intolerance such as headache, vasomotor rhinitis, itching).

Pharmokinetics

Absorption

Acetylcysteine ??is well absorbed when taken orally. It is immediately deacetylated to cysteine ??in the liver. A mobile equilibrium of free and plasma protein-bound acetylcysteine ??and its metabolites (cysteine, cystine, diacetylcysteine) is observed in the blood. Due to the high 'first pass' effect through the liver, the bioavailability of acetylcysteine ??is about 10%.

Distribution

Acetylcysteine ??is distributed both unchanged (20%) and in the form of active metabolites (80%), penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. The volume of distribution of acetylcysteine ??varies from 0.33 to 0.47 l / kg, the maximum plasma concentration is reached within 1-3 hours after oral administration and is 15 mmol / l, the connection with plasma proteins is 50% after 4 hours after administration and decreases up to 20% after 12 hours. Penetrates the placental barrier.

Metabolism

After oral administration, acetylcysteine ??is rapidly and extensively metabolized in the intestinal walls with the formation of a pharmacologically active metabolite - cysteine, as well as cystine, diacetylcysteine.

Withdrawal

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines. The half-life is about 1 hour; in case of impaired liver function, it increases to 8 hours.

Overdose

Acetylcysteine, when taken at a dose of 500 mg / kg / day, does not cause signs and symptoms of overdose.

Symptoms

Symptoms include nausea, vomiting, and diarrhea.

Treatment

There is no specific antidote, and treatment is symptomatic.

Side effects

For each frequency group, adverse events are presented in order of decreasing severity.

From the immune system: infrequently - hypersensitivity; very rarely - anaphylactic shock, anaphylactic / anaphylactoid reaction.

From the nervous system: infrequently - headache.

On the part of the hearing organs and inner ear: infrequently - tinnitus.

From the side of the heart: infrequently - tachycardia.

From the vascular system: very rarely - bleeding.

On the part of the respiratory organs of the nursing aunt and mediastinum: rarely - bronchospasm, dyspnea.

Gastrointestinal disorders: infrequently - vomiting, diarrhea, stomatitis, abdominal pain, nausea; rarely - dyspepsia.

Skin and subcutaneous tissue disorders: infrequently - urticaria, rash, angioedema, itching.

General disorders and conditions at the sites of application: infrequently - pyrexia; frequency unknown - facial edema.

Analyzes and studies: infrequently - low blood pressure.

In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported, chronologically dependent on the use of acetylcysteine. In most cases, at least one concurrent drug could be involved in triggering the aforementioned mucocutaneous syndromes. For this reason, you should immediately consult a doctor if any new changes in the skin or mucous membranes occur, and immediately stop taking acetylcysteine.

A decrease in platelet aggregation in the presence of acetylcysteine ??has been confirmed by various studies. The clinical significance has not yet been established.

If you have any side effects indicated in the instructions, or they are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Special conditions

The drug contains aspartame, its use in patients with phenylketonuria is contraindicated.

When dissolving acetylcysteine, it is necessary to use glassware, avoid contact with metal, rubber surfaces, oxygen and easily oxidizing substances.

With the use of acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) have been reported very rarely. If changes occur in the skin and mucous membranes, you should immediately consult a doctor, and stop taking the drug.

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ??with caution under systematic monitoring of bronchial patency.

You should not take the drug just before bedtime (it is recommended to take the drug before 18:00).

Acetylcysteine ??can insignificantly affect histamine metabolism, therefore, care must be taken when using the drug for long-term treatment of patients suffering from histamine intolerance, with symptoms of intolerance (headache, vasomotor rhinitis, itching).

Influence on the ability to drive vehicles and mechanisms:

In therapeutic doses, acetylcysteine ??does not affect the ability to drive vehicles and mechanisms.

Drug interactions

The combined use of acetylcysteine ??with antitussives can increase sputum congestion due to suppression of the cough reflex.

With simultaneous use with antibiotics such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, their interaction with the thiol group of acetylcysteine ??is possible, which leads to a decrease in the activity of both drugs. Therefore, the interval between taking these drugs should be at least 2 hours.

The simultaneous intake of acetylcysteine ??and nitroglycerin can cause a marked decrease in blood pressure and headache.

The simultaneous use of acetylcysteine ??and carbamazepine can be expressed in subtherapeutic levels of carbamazepine.

Activated carbon can reduce the effects of acetylcysteine.

Acetylcysteine ??eliminates the toxic effects of paracetamol.

Acetylcysteine ??can interfere with the colorimetric determination of salicylates. Acetylcysteine ??may interfere with urine ketone analysis.