In what water to dilute ACC 200 powder. ACC powder: instructions for use

The composition of the medicine ACC 200 includes the active ingredient acetylcysteine (200 mg), as well as additional components: sodium bicarbonate, citric anhydride, ascorbic acid, mannitol, sodium citrate, saccharin, lactose anhydride, flavor.

Release form

ACC 200 is produced in effervescent tablets, white color, round flat shape, on the one hand - risk. They have a blackberry aroma. Contained in packs of 4, 20, 25 pcs.

pharmachologic effect

The drug has a mucolytic effect. Due to the fact that the structure of the molecule contains acetylcysteine ​​of sulfhydryl groups, the disulfide bonds of sputum acid mucopolysaccharides break. As a result of this process, the viscosity of the mucus decreases. ACC 200 also shows activity in patients with purulent sputum.

If acetylcysteine ​​is used prophylactically, in patients with cystic fibrosis and chronic , the severity and frequency of exacerbations decreases.

Pharmacokinetics and pharmacodynamics

After internal administration, the drug is rapidly absorbed. Metabolism, in which the metabolite is formed - and other metabolites, passes in the human liver.

Bioavailability with internal administration is 10%, the connection with plasma proteins is 50%. The highest concentration is observed after 1-3 hours. It is excreted in the urine, the half-life is 1 hour.

Indications for use

The use of ACC 200 is indicated in such cases:

• in diseases of the respiratory system, if the formation of viscous sputum occurs, which is difficult to separate (acute / chronic / obstructive bronchitis, bronchiectasis, cystic fibrosis, pneumonia, , );

Contraindications

It is contraindicated to take pills in the following cases:

• high sensitivity to acetylcysteine ​​or other ingredients of drugs;
• period of exacerbation ;
• pulmonary bleeding;
• hemoptysis;
• lactose intolerance, lack of lactase;
• glucose-galactose malabsorption;
• child under 2 years of age.

Use this medicine with caution in ulcers. duodenum and a history of histamine intolerance. Also, the medicine is carefully prescribed to people with varicose veins of the esophagus, obstructive bronchitis, diseases of the adrenal glands, liver failure and, arterial hypertension .

Side effects

There may be such side effects in the process of taking the drug:

• nervous system: noise in ears, ;
• the cardiovascular system: lowering , ;
• digestion: , nausea, vomiting, ;
• allergic reactions: single manifestations - bronchospasm , skin rash;
• other reactions: single manifestations - bleeding.

Effervescent tablets ACC 200, instructions for use (Method and dosage)

Instructions for use ACC 200 provides that the drug, like the powder, is prescribed to patients after 14 years of age, 200 mg two to three times a day.

Patients from 6 to 14 years old use 1 tablet twice a day.

Children aged 2 to 5 years should take half an ACC 200 tablet two to three times a day.

Patients with cystic fibrosis after 6 years are shown taking 1 table. 3 times a day, children under 6 years of age are prescribed a remedy at the rate of 400 mg of acetylcysteine ​​per day. If the patient's weight exceeds 30 kg, the dose, if necessary, is increased to 800 mg per day.

If colds are being treated, the course of admission lasts 5-7 days.

Before taking the medicine, and after that, you need to drink plenty of fluids to enhance the mucolytic effect of the drug. You need to drink the drug after a meal.

The method of diluting the tablets is the same as the method of using the powder. They need to be dissolved in half a glass of water, drink the solution immediately.

Overdose

If an overdose of the drug occurs, nausea, stomach pain, , . Dangerous and severe manifestations have not yet been noted.

Interaction

It should be borne in mind that while taking ACC 200 and other cough suppressants, dangerous mucus stagnation may develop due to the fact that the cough reflex is suppressed. Therefore, such drugs must be combined carefully.

Acetylcysteine ​​may enhance vasodilatory effects if these drugs are taken at the same time.

Synergism of acetylcysteine ​​with bronchodilators is observed.

Acetylcysteine ​​is not pharmaceutically compatible with (penicillins, cephalosporins, , ) and proteolytic .

When taken simultaneously, acetylcysteine ​​reduces the absorption of tetracycline, cephalosporins, penicillins. Therefore, you need to take such drugs with an interval of at least two hours.

If acetylcysteine ​​is in contact with rubber, metals, the formation of sulfides occurs, which have a characteristic odor.

Terms of sale

ACC 200 can be bought without a prescription.

Storage conditions

Keep away from children, away from moisture and light, store at a temperature not exceeding 30 degrees. Close the tube tightly after removing the tablet.

Best before date

Keep 3 years.

special instructions

If ACC 200 is prescribed to patients with bronchial asthma and obstructive bronchitis, it is necessary to do this carefully and constantly monitor bronchial patency.

In case of development of any side effects you need to stop treatment and consult a doctor.

If necessary, dissolve the drug should use glassware.

Patients with should take into account that ACC 200 contains sucrose.

The tool does not affect the ability to concentrate, drive vehicles.

Analogues

Means that are analogues of ACC 200 are drugs ACC Long , , , N-acetylcysteine , Mukomist , Acestine , Mukonex etc. Which of these means is the most optimal, the doctor determines on an individual basis.

children

Not intended for children under two years of age.

During pregnancy and lactation

Since there are no clear data on the effect of the drug during pregnancy, it is not prescribed during pregnancy, as well as during breastfeeding.

Instructions for medical use

medicinal product

ACC ® 200

Tradename

International non-proprietary name

Acetylcysteine

Dosage form

Powder for solution for oral administration 200 mg

Compound

1 sachet contains 3 g of powder

active substance: acetylcysteine ​​200 mg

Excipients: sucrose, ascorbic acid, saccharin, dry orange flavor 1:1000 Sotteri 289**

(**- Orange flavor essence 11.1%, dextrose anhydride 82.7%, lactose 6.2%)

Description

Homogeneous powder of white color, not containing particle agglomerates, with an orange smell.

The reconstituted solution is colorless, clear or slightly opalescent.

Pharmacotherapeutic group

Medicines to relieve the symptoms of colds and coughs.

Expectorants. Mucolytics. Acetylcysteine

ATX code R05 CB01

Pharmacological properties

Pharmacokinetics

Following oral administration, acetylcysteine ​​is rapidly absorbed from the gastrointestinal tract (GIT) and metabolized in the liver to cysteine, the pharmacologically active metabolite, as well as to diacetylcysteine, cystine, and various mixed disulfides.

Due to the high first pass effect through the liver, the bioavailability of acetylcysteine ​​is very low (approximately 10%).

In humans, maximum plasma concentrations are reached after 1-3 hours. The maximum plasma concentration of the cysteine ​​metabolite is about 2 µmol/l. The binding of acetylcysteine ​​to plasma protein is approximately 50%.

Acetylcysteine ​​is excreted through the kidneys almost exclusively in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).

The plasma half-life is approximately 1 hour and is mainly determined by hepatic biotransformation. Therefore, impaired liver function leads to a prolongation of the plasma elimination half-life up to 8 hours.

Pharmacodynamics

Acetylcysteine ​​is a derivative of the amino acid cysteine. Acetylcysteine ​​has secretolytic and secretomotor action in respiratory tract. It breaks disulfide bonds between mucopolysaccharide chains and has a depolymerizing effect on DNA chains (with purulent sputum). Due to these mechanisms, the viscosity of sputum decreases.

An alternative mechanism of acetylcysteine ​​is based on the ability of its reactive sulfhydryl group to bind chemical radicals and thereby render them harmless.

Acetylcysteine ​​increases the synthesis of glutathione, which is important for the detoxification of toxic substances. This explains its antidote effect in paracetamol poisoning.

When used prophylactically, it has a protective effect on the frequency and severity of exacerbations of bacterial infections, which has been found in patients with chronic bronchitis and cystic fibrosis.

Indications for use

Secretolytic therapy for acute and chronic diseases bronchi and lungs, accompanied by a violation of the formation and excretion of sputum.

Method of application and dosage

ACC ® 200 is taken only as a prepared solution, after meals.

Adults and teenagers aged 14 and over

1 sachet of powder 2-3 times a day (corresponding to 400-600 mg of acetylcysteine ​​per day).

Children and teenagers from 6 to 14 years old

1 sachet of powder 2 times a day (corresponds to 400 mg of acetylcysteine ​​per day).

The duration of treatment depends on the type and severity of the disease and should be determined by the attending physician.

Solution preparation:

The powder dissolves in a glass of boiled water and is taken after meals.

Side effects

Infrequently(≥1/1000, <1/100)

- allergic reactions (itching, urticaria, skin rash, bronchospasm, angioedema)

Tachycardia

Arterial hypotension

Headache

Fever

Stomatitis, abdominal pain, diarrhea, vomiting, heartburn, nausea

Noise in ears

Rarely (≥1/10000, <1/1000)

Shortness of breath, bronchospasm mainly in patients with increased reactivity of the bronchial system associated with bronchial asthma

Dyspepsia

Very rarely (< 1/10 000)

Bleeding and hemorrhage associated in part with hypersensitivity reactions

Anaphylactic reactions, up to anaphylactic shock

Stevens-Johnson syndrome, Lyell's syndrome

unknown

swelling of the face

Contraindications

Hypersensitivity to any component of the drug

Peptic ulcer of the stomach and duodenum in the acute stage

Hemoptysis, pulmonary hemorrhage

Bronchial asthma in the acute stage

Phenylketonuria

Children's age up to 6 years

Fructose intolerance, glucose-galactose or sucrose-isomaltose malabsorption syndrome

Carefully: esophageal varicose veins, bronchial asthma, adrenal diseases, liver and / or kidney failure, arterial hypertension.

Drug Interactions

The simultaneous use of acetylcysteine ​​and antitussives can cause dangerous secretory stasis due to a decrease in the cough reflex. For this reason, this combination therapy option should be based on a particularly accurate diagnosis.

To achieve the best therapeutic effect, oral antibiotics (penicillins, tetracyclines and aminoglycosides) should be administered separately, with a two-hour time interval. This does not apply to cefixime and loracarbef.

The use of activated charcoal in large doses can weaken the effect of acetylcysteine.

The simultaneous use of nitroglycerin and acetylcysteine ​​should be carried out under the supervision of a physician, since it is possible to increase the vasodilating effect and the inhibitory effect on platelet aggregation.

Acetylcysteine ​​may interfere with the colorimetric quantitation of salicylates.

Acetylcysteine ​​may interfere with urinalysis for ketone bodies.

special instructions

In the event of changes in the skin and mucous membranes, the patient should immediately stop taking acetylcysteine ​​and consult a doctor.

Patients with bronchial asthma and obstructive bronchitis ACC ® 200 should be administered with caution under the systematic monitoring of bronchial conduction due to the risk of bronchospasm.

The use of the drug ACC ® 200 can lead to liquefaction of sputum in the bronchi and some increase in its volume. With insufficient cough reflex applied: postural drainage or aspiration.

Patients with histamine intolerance should take ACC 200 in short courses, due to the influence on the metabolism of histamine itself, the possible appearance of symptoms of intolerance (eg headache, runny nose, itching).

1 sachet contains 2.7 g of sucrose. This should be taken into account when prescribing ACC ® 200 to patients with diabetes mellitus.

Pregnancy and lactation

The use of the drug ACC ® 200 during pregnancy and lactation is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus and child, although animal studies have not revealed any direct or indirect toxicity affecting pregnancy, embryonic and / or postnatal development.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Does not affect.

Overdose

Symptoms: nausea, vomiting, diarrhea; in children there is a risk of hypersecretion.

Treatment: symptomatic.

Release form and packaging

3 g in sachets. 20 or 50 sachets, together with instructions for medical use in the state and Russian languages, are put into a pack of cardboard

Storage conditions

Store at a temperature not exceeding 30°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiry date stated on the package.

Terms of dispensing from pharmacies

Without recipe

Manufacturer/Packer

Lindopharm GmbH, Germany

Registration certificate holder

Geksal AG, Germany

Address of the organization accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Representative office of Sandoz Pharmaceuticals d.d. JSC in the Republic of Kazakhstan, Almaty, st. Luganskogo 96,

Phone number: +7 727 258 10 48, fax: +7 727 258 10 47

e-mail: [email protected]

8 800 080 0066 - free dial-up number within Kazakhstan

P N015473/01

Trade name of the drug:

ACC® 200

International non-proprietary name:

acetylcysteine (acetylcysteine)

Chemical name ACC® 200 :

N-acetyl L-cysteine

Dosage form ACC® 200:

effervescent tablets

Composition of ACC® 200

1 effervescent tablet contains:

active substance: acetylcysteine ​​- 200.0 mg;

Excipients: citric acid anhydride - 558.5 mg; sodium hydrogen carbonate - 300.0 mg; mannitol - 60.0 mg; ascorbic acid - 25.0 mg; lactose anhydride - 70.0 mg; sodium citrate - 0.5 mg; saccharin - 6.0 mg; blackberry flavor "B" - 20.0 mg.

ACC® 200 Description:

white, round, flat tablets with a blackberry odor.

Pharmacotherapeutic group:

mucolytic agent.

ATX code:

R05CB01

Pharmacological properties

Pharmacodynamics

The presence of sulfhydryl groups in the structure of acetylcysteine ​​contributes to the rupture of disulfide bonds of sputum acid mucopolysaccharides, which leads to a decrease in the viscosity of mucus. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The drug remains active in the presence of purulent sputum.

With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

ACC® 200 Indications for use:

Respiratory diseases accompanied by the formation of viscous sputum difficult to separate: acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis.

Acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Contraindications:

Hypersensitivity to acetylcysteine ​​or other components of the drug. Peptic ulcer of the stomach and duodenum in the acute stage, hemoptysis, pulmonary hemorrhage, pregnancy, breastfeeding.

Carefully

varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and / or kidney failure.

Acetylcysteine ​​should be used with caution in patients prone to pulmonary bleeding, hemoptysis.

Pregnancy and lactation period:

As a safety precaution, due to insufficient data, prescribing the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

ACC® 200 dosage:

Adults and adolescents over the age of 14:

2-3 times a day, 1 effervescent tablet (400-600 mg of acetylcysteine ​​per day).

Children aged 6 to 14:3 times a day for 1/2 effervescent tablet, or 2 times a day for 1 effervescent tablet (300 - 400 mg of acetylcysteine).

Children aged 2 to 5 years:2-3 times a day, 1/2 effervescent tablet (200-300 mg of acetylcysteine).

Cystic fibrosis:

For patients with cystic fibrosis and weighing more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine ​​per day.

Children aged 2 to 6 years - 1/2 effervescent tablet 4 times a day (400 mg of acetylcysteine ​​per day).

Effervescent tablets should be dissolved in half a glass of water and taken after meals. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.

Additional fluid intake enhances the mucolytic effect of the drug.

With 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 against infections.

Note for diabetic patients:

1 effervescent tablet corresponds to 0.006 bread. units

Side effects:

In rare cases, headaches, inflammation of the oral mucosa (stomatitis) and tinnitus are observed. Extremely rare - diarrhea, vomiting, heartburn and nausea, a drop in blood pressure,increased heart rate (tachycardia). In isolated cases, allergic reactions are observed, such as bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, itching and urticaria. In addition, there are isolated reports of the development of bleeding due to the presence of hypersensitivity reactions. With the development of side effects, you should stop taking the drug and consult a doctor. Overdose:

With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are observed. So far, no severe and life-threatening side effects have been observed.

Interaction with other means:

With the simultaneous use of acetylcysteine ​​​​andantitussivesdue to the suppression of the cough reflex, mucus stagnation may occur. Therefore, such combinations should be chosen with caution.

Concomitant use of acetylcysteine ​​andnitroglycerinmay lead to an increase in the vasodilating effect of the latter.

Pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.

Upon contact with metals, rubber, sulfides are formed with a characteristic odor.

Reduces the absorption of penicillins, cephalosporins, tetracyclines (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

Special instructions:

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ​​with caution under the systematic control of bronchial patency.

When treating patients with diabetes, it must be taken into account that the tablets contain sucrose: 1 effervescent tablet corresponds to 0.006 bread. units

When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

Influence on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions

There are no data on the negative effect of the drug ACC® 200 at recommended doses on the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.

АЦЦ® 200 release form:

20 or 25 tablets in an aluminum or plastic tube.

1 tube of 20 tablets or 2 or 4 tubes of 25 tablets with instructions for use in a cardboard box.

4 tablets in strips of 3-layer material: paper / polyethylene / aluminum.

15 strips with instructions for use in a cardboard box.

Storage conditions:

In a dry place, out of reach of children, at a temperature not exceeding 25 °C.

Close the tube tightly after taking the pill!

Shelf life of the medicinal product:

3 years.

Do not use after the stated expiration date.

Vacation from pharmacies:

Without recipe.

Manufacturer

Sandoz d.d., Verovshkova 57, 1000 Ljubljana, Slovenia.

Manufactured by Salutas Pharma GmbH, Germany.

Send consumer claims to ZAO Sandoz:

Description of the dosage form

Effervescent tablets, 100 mg: round flat-cylindrical white, with a smell of blackberry. There may be a slight sulfur odor. Reconstituted Solution: colorless transparent with blackberry smell. There may be a slight sulfur odor.

Granules for oral solution preparation (orange): homogeneous, white, without agglomerates, with an orange smell.

Syrup: clear, colorless, slightly viscous solution with a cherry smell.

pharmachologic effect

Pharmacodynamics

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 sputum mucoproteins, which leads to a decrease in its 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 oxidizing 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.

Pharmacokinetics

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. Bioavailability when taken orally is 10% (due to the presence of a pronounced effect of the first passage through the liver). Tmax in plasma 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). T 1 / 2 is about 1 hour, liver dysfunction leads to an extension of T 1 / 2 to 8 hours. Penetrates through the placental barrier. There are no data on the ability of acetylcysteine ​​to penetrate the BBB and be excreted in breast milk.

Indications for ACC ®

For all dosage forms

diseases of the respiratory system, accompanied by the formation of viscous sputum difficult to separate:

Acute and chronic bronchitis;

Obstructive bronchitis;

Tracheitis;

laryngotracheitis;

Pneumonia;

lung abscess;

bronchiectasis;

Bronchial asthma;

Chronic obstructive pulmonary disease;

bronchiolitis;

cystic fibrosis;

acute and chronic sinusitis;

inflammation of the middle ear (otitis media).

Contraindications

For all dosage forms

hypersensitivity to acetylcysteine ​​or other components of the drug;

peptic ulcer of the stomach and duodenum in the acute stage;

hemoptysis, pulmonary bleeding;

pregnancy;

breastfeeding period;

children's age up to 2 years.

For effervescent tablets, 100 mg, optional

lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully: peptic ulcer of the stomach and duodenum in history; bronchial asthma; obstructive bronchitis; hepatic and / or renal 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, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

For mortar pellets optional

sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency.

Carefully: peptic ulcer of the stomach and duodenum in history; arterial hypertension; varicose veins of the esophagus; bronchial asthma; obstructive bronchitis; diseases of the adrenal glands; hepatic and / or renal failure; histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine ​​affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching).

extra for syrup

Carefully: peptic ulcer of the stomach and duodenum in history; bronchial asthma; hepatic and / or renal 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, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

Use during pregnancy and lactation

Data on the use of acetylcysteine ​​during pregnancy and breastfeeding are limited. The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Side effects

According to WHO, adverse reactions are classified according to their frequency of development as follows: very often (≥1 / 10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000); частота неизвестна — по имеющимся данным установить частоту возникновения не представлялось возможным.

Allergic reactions: infrequently - pruritus, rash, exanthema, urticaria, angioedema, decreased blood pressure, tachycardia; very rarely - anaphylactic reactions up to shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the respiratory system: rarely - shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

From the gastrointestinal tract: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea; heartburn, dyspepsia (except syrup).

From the sense organs: infrequently - tinnitus.

Others: very rarely - headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, a decrease in platelet aggregation.

Interaction

For all dosage forms

With the simultaneous use of acetylcysteine ​​and antitussives, due to the suppression of the cough reflex, sputum stagnation may occur. Therefore, such combinations should be chosen with caution.

Simultaneous administration of acetylcysteine ​​with vasodilators and nitroglycerin may lead to increased vasodilating action.

With simultaneous use with antibiotics for oral administration (including penicillins, tetracyclines, cephalosporins), their interaction with the thiol group of acetylcysteine ​​is possible, 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 for cefixime and loracarbene).

In contact with metals, rubber, sulfides are formed with a characteristic odor.

Dosage and administration

inside, after meal.

Mucolytic therapy

Adults and children over 14 years of age: 2 tab. effervescent 100 mg 2-3 times a day or 2 packs. ACC ® granules for the preparation of a solution of 100 mg 2-3 times a day, or 10 ml of syrup 2-3 times a day (400-600 mg of acetylcysteine ​​per day).

Children from 6 to 14 years old: 1 tab. effervescent 100 mg 3 times a day or 2 tablets. effervescent 2 times a day, or 1 pack. ACC ® granules for solution 3 times a day or 2 packs. 2 times a day, or 5 ml of syrup 3-4 times a day or 10 ml of syrup 2 times a day (300-400 mg of acetylcysteine ​​per day).

Children from 2 to 6 years old: 1 tab. effervescent 100 mg or 1 pack. ACC ® granules for the preparation of a solution of 100 mg 2-3 times a day, or 5 ml of syrup 2-3 times a day (200-300 mg of acetylcysteine ​​per day).

cystic fibrosis

For patients with cystic fibrosis (a congenital metabolic disorder with frequent infections of the bronchial tract) and weighing more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine ​​per day.

Children over 6 years old: 2 tab. effervescent 100 mg or 2 pak. ACC ® granules 100 mg for solution 3 times a day, or 10 ml syrup 3 times a day (600 mg acetylcysteine ​​per day).

Children from 2 to 6 years old: 1 tab. effervescent 100 mg or 1 pack. ACC ® granules 100 mg for solution, or 5 ml syrup 4 times a day (400 mg acetylcysteine ​​per day).

Effervescent tablets should be dissolved in 1 glass of water and taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.

Granules for oral solution (orange) should be dissolved in water, juice or iced tea and taken after meals.

Additional fluid intake enhances the mucolytic effect of the drug. With 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 against infections.

ACC ® syrup is taken with a measuring syringe or a measuring cup, which is in the package. 10 ml of syrup corresponds to 1/2 measuring cup or 2 filled syringes.

Using a measuring syringe

1. Open the vial cap by pushing it in and turning it counterclockwise.

2. Remove the plug with a hole from the syringe, insert it into the neck of the vial and press it in until it stops. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial.

3. Insert the syringe firmly into the stopper. Carefully turn the bottle upside down, pull the syringe plunger down and draw up the required amount of syrup. If air bubbles are visible in the syrup, press the plunger all the way down, then refill the syringe. Return the vial to its original position and remove the syringe.

4. Syrup from the syringe should be poured onto a spoon or directly into the child's mouth (into the buccal area, slowly, so that the child can swallow the syrup properly), while taking the syrup, the child should be in an upright position.

5. After use, rinse the syringe with clean water.

Note for diabetic patients: 1 effervescent tablet corresponds to 0.006 XE; 1 pack ACC ® granules for the preparation of a solution of 100 mg corresponds to 0.24 XE; 10 ml (2 measuring spoons) of ready-to-use syrup contain 3.7 g of D-glucitol (sorbitol), which corresponds to 0.31 XE.

Overdose

Symptoms: acetylcysteine ​​at doses up to 500 mg/kg did not cause any symptoms of intoxication. With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea can be observed. Children may experience hypersecretion of sputum.

Treatment: symptomatic.

special instructions

When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

When using acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely. If there are changes in the skin and mucous membranes, you should immediately consult a doctor, the drug should be stopped.

In patients with bronchial asthma and obstructive bronchitis, acetylcysteine ​​should be administered with caution under the systemic control of bronchial patency.

Do not take the drug immediately before bedtime (it is recommended to take the drug before 18:00).

Influence on the ability to drive vehicles and work with mechanisms. There are no data on the negative effect of the drug in recommended doses on the ability to drive vehicles, mechanisms.

Special precautions for the disposal of unused medicinal product. There is no need for special precautions when destroying unused product.

extra for syrup

The use of the drug in patients with renal and / or hepatic insufficiency should be avoided in order to avoid additional formation of nitrogenous compounds.

1 ml of syrup contains 41.02 mg of sodium. This should be taken into account when using the drug in patients on a diet aimed at limiting sodium intake (with a reduced sodium / salt content).

Release form

Effervescent tablets, 100 mg.

When packing Hermes Pharma Ges.m.b.Kh., Austria: 20 tab. effervescent in a plastic or aluminum tube. 1 tube of 20 tab. effervescent in a cardboard box.

Granules for oral solution (orange), 100 mg. 3 g granules in bags of combined material (aluminum foil/paper/PE). 20 pack in a cardboard box.

Syrup, 20 mg/ml. In dark glass bottles, sealed with white caps with a sealing membrane, child-resistant, with a protective ring, 100 ml.

Dosing devices:

Transparent measuring cup (cap), graduated at 2.5; 5 and 10 ml;

Transparent dosing syringe, graduated at 2.5 and 5 ml, with white plunger and adapter ring for attaching to the vial.

1 vial together with dosing devices in a cardboard box.

Manufacturer

Effervescent tablets

1. Hermes Pharma Ges.m.b.H., Austria.

2. Hermes Artsnaimittel GmbH, Germany.

Granules for solution preparation

Marketing authorization holder: Sandoz d.d., Verovshkova 57, 1000 Ljubljana, Slovenia.

Produced by: Lindopharm GmbH, Neustraße 82, 40721 Hilden, Germany.

Syrup

Pharma Wernigerode GmbH, Germany.

Marketing authorization holder: Sandoz d.d. Verovshkova 57, Ljubljana, Slovenia.

Country of origin

Product group

Mucolytic drug

Release form

• Granules for the preparation of a solution for oral administration, 3 g - sachets - 20 pcs per pack. Effervescent tablets - 20 pcs per pack.

Description of the dosage form

• Granules for the preparation of oral solution (orange) white, homogeneous, without agglomerates, with the smell of orange. Granules for solution for oral administration are white, homogeneous, no larger than 1.5 mm, without agglomerates and mechanical impurities, with the smell of lemon and honey. Effervescent tablets, white, round, flat, notched, with a blackberry odor.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• Acetylcysteine ​​200 mg Excipients: ascorbic acid, citric acid anhydride, lactose anhydride, mannitol, sodium citrate, sodium bicarbonate, saccharin, blackberry flavor "B". Acetylcysteine ​​200 mg Excipients: ascorbic acid, saccharin, sucrose (sucrose), orange flavor. Acetylcysteine ​​200 mg Excipients: ascorbic acid, saccharin, sucrose (sucrose), lemon and honey flavors.

ACC 200 indications for use

• - diseases of the respiratory system, accompanied by increased formation of viscous mucus that is difficult to separate (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis, laryngitis); - acute and chronic sinusitis; - otitis media.

ACC 200 contraindications

• - peptic ulcer of the stomach and duodenum in the acute phase; - hemoptysis; - pulmonary bleeding; - pregnancy; - lactation period (breastfeeding); - children's age up to 6 years (preparation in the form of granules for the preparation of a solution for oral administration 200 mg); - children's age up to 14 years (dosage forms of the drug containing 600 mg of acetylcysteine); - hypersensitivity to acetylcysteine ​​and other components of the drug. With caution, the drug should be used in patients with esophageal varicose veins, with an increased risk of developing pulmonary hemorrhage and hemoptysis, with bronchial asthma, adrenal diseases, liver and / or kidney failure. ACC LONG should not be administered to children under 14 years of age. In this category of patients, it is recommended to use dosage forms of the drug for oral administration with a lower content of acetylcysteine.

ACC 200 dosage

• 200 mg

ACC 200 side effects

• From the side of the central nervous system: rarely - headache, tinnitus. From the digestive system: rarely - stomatitis; in some cases - diarrhea, vomiting, heartburn and nausea. From the side of the cardiovascular system: in some cases - a drop in blood pressure, tachycardia. On the part of the respiratory system: in isolated cases - the development of pulmonary bleeding as a manifestation of a hypersensitivity reaction. Allergic reactions: in isolated cases - bronchospasm (mainly in patients with a hyperreactive bronchial system in bronchial asthma), skin rash, itching and urticaria.

drug interaction

Storage conditions

• store in a dry place
• keep away from children

Synonyms

• Acetylcysteine, ACC 100, ACC-Long, Mukonex, Fluimucil, Exomuc 200, N-AC-Ratiopharm