Acc® 100

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AСС® 100 (ACC® 100) AСС® 200 (ACC® 200)

Composition:

Active substance: acetylcysteine;

1 tablet contains acetylcysteine 100 mg or 200 mg;

Excipients: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, mannite (E 421), anhydrous lactose, ascorbic acid, sodium citrate, sodium saccharin, blackberry flavor "B" (contains sorbitol (E 420)).

Pharmaceutical form. Effervescent tablets.

Main physicochemical properties:

100 mg tablets: white, round, flat tablets with a blackberry odor;

200 mg tablets: white, round, flat tablets with a blackberry odor and a score line on one side.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Mucolytic agents.

ATC code R05C B01.

Pharmacological properties.

Pharmacodynamics. Acetylcysteine (ACC) is a mucolytic expectorant used to liquefy sputum in respiratory diseases associated with the production of thick mucus. Acetylcysteine is a derivative of the amino acid cysteine. The mucolytic effect of the drug is of chemical nature. Due to its free sulfhydryl group, acetylcysteine breaks the disulfide bonds of acidic mucopolysaccharides, leading to depolymerization of sputum mucoproteins, reduction of mucus viscosity, and facilitating expectoration and clearance of bronchial secretions. The drug retains activity in the presence of purulent sputum.

Acetylcysteine also possesses antioxidant and pneumoprotective properties, due to the binding of chemical radicals by its sulfhydryl groups, thereby neutralizing them. Furthermore, the drug promotes increased synthesis of glutathione – an important factor in intracellular protection not only against oxidative toxins of exogenous and endogenous origin but also against various cytotoxic substances. This characteristic of acetylcysteine allows its effective use in paracetamol overdose.

Pharmacokinetics.

After oral administration, acetylcysteine is rapidly and completely absorbed and undergoes hepatic metabolism, forming cysteine, a pharmacologically active metabolite, as well as diacetylcysteine, cystine, and subsequently mixed disulfides. Bioavailability is very low – approximately 10%. Maximum plasma concentration is reached within 1–3 hours after administration. Plasma protein binding is approximately 50%. Acetylcysteine is excreted by the kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine).

The elimination half-life is primarily determined by rapid biotransformation in the liver and is approximately 1 hour. In cases of impaired liver function, the elimination half-life is prolonged to 8 hours.

Clinical characteristics.

Indications.

Treatment of acute and chronic diseases of the bronchopulmonary system that require reduction of sputum viscosity, improvement of its expectoration and coughing up.

Contraindications.

Hypersensitivity to acetylcysteine or to other components of the drug. Active stage of gastric and duodenal peptic ulcer, hemoptysis, pulmonary hemorrhage, severe exacerbation of bronchial asthma.

Interaction with other medicinal products and other forms of interaction.

Interaction studies were conducted only in adults.

Concurrent use of antitussive agents with acetylcysteine may enhance sputum retention due to suppression of the cough reflex.

When used concomitantly with antibiotics such as tetracyclines (except doxycycline), ampicillin, amphotericin B, cephalosporins, and aminoglycosides, interaction with the thiol group of acetylcysteine may occur, leading to reduced activity of both agents. Therefore, the interval between administration of these drugs should be at least 2 hours. This does not apply to cefixime and loracarbef.

Activated charcoal reduces the efficacy of acetylcysteine.

It is not recommended to dissolve acetylcysteine together with other drugs in the same glass.

Significant hypotension and marked dilation of temporal arteries have been observed when nitroglycerin and acetylcysteine are administered simultaneously. When concomitant use of nitroglycerin and acetylcysteine is necessary, patients should be monitored for potentially severe hypotension, and they should be warned about the possibility of headache.

Acetylcysteine reduces the hepatotoxic effect of paracetamol.

Synergism between acetylcysteine and bronchodilators has been observed.

Acetylcysteine may act as a cysteine donor and increase glutathione levels, which promotes detoxification of oxygen free radicals and certain toxic substances in the body.

Upon contact with metals or rubber, sulfides with a characteristic odor are formed; therefore, glassware should be used for dissolving the drug.

Effect on laboratory tests.

Acetylcysteine may interfere with colorimetric assays for salicylates and with determination of ketone bodies in urine.

Special precautions for use

There have been isolated reports of severe skin reactions (Stevens-Johnson syndrome and Lyell's syndrome) associated with the use of acetylcysteine. Therefore, if any changes in the skin or mucous membranes occur, the drug should be discontinued immediately and a physician should be consulted regarding further treatment.

The drug should be administered with caution to patients with a history of gastric or duodenal ulcer, especially when other medications that irritate the gastric mucosa are taken concomitantly.

Acetylcysteine affects histamine metabolism; therefore, long-term therapy should not be prescribed to patients with histamine intolerance, as it may lead to symptoms of intolerance (headache, vasomotor rhinitis, pruritus).

Acetylcysteine should be prescribed with caution to patients with a history of bronchial asthma.

Patients with bronchial asthma must be under close medical supervision during treatment due to the risk of bronchospasm. If bronchospasm occurs, acetylcysteine therapy should be discontinued immediately.

Acetylcysteine should be administered with caution to patients with hepatic or renal impairment to avoid accumulation of nitrogen-containing substances in the body.

The use of acetylcysteine, particularly at the beginning of treatment, may cause liquefaction of bronchial secretions and increase their volume, especially in children under 2 years of age. If the patient is unable to effectively expectorate mucus, postural drainage and bronchoaspiration may be required.

Effervescent tablets contain sodium compounds. One 100 mg tablet contains 4.2 mmol (or 96 mg) of sodium; one 200 mg tablet contains 4.3 mmol (or 99 mg) of sodium. This should be taken into account by patients on a sodium-restricted diet, who should use the product with caution.

Since the medicinal product contains sorbitol (E 420), it should not be used by patients with rare hereditary fructose intolerance.

The product contains lactose; therefore, it should not be used by patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, acetylcysteine may be used only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence the speed of reactions while driving or operating machinery

Does not affect.

Dosage and Administration.

For adults and children aged 14 years and older: administer 400–600 mg of acetylcysteine per day, divided into 1–3 doses.

For children aged 6 to 14 years: administer 400–600 mg per day, divided into 2–3 doses.

For children aged 2 to 6 years: administer 200–400 mg per day, divided into 2 doses.

The medication should be taken after meals. The tablet should be dissolved in a glass of water and the solution consumed as quickly as possible. Additional fluid intake enhances the mucolytic effect of the drug.

The duration of treatment for chronic diseases is determined by the physician depending on the nature and course of the disease. For acute uncomplicated conditions, acetylcysteine should be used for 4–5 days.

Children.

The drug may be administered to children aged 2 years and older.

Overdose.

There are no reported cases of overdose with oral administration of acetylcysteine. Volunteers have taken 11.6 g of acetylcysteine per day for 3 months without any serious adverse effects. Oral doses up to 500 mg of acetylcysteine/kg body weight/day were tolerated without any symptoms of intoxication.

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

Treatment: symptomatic therapy.

Adverse Reactions

The following classification is used to describe the frequency of adverse effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000).

Cardiovascular system: uncommon – tachycardia, arterial hypotension.

Nervous system: uncommon – headache.

Skin: uncommon – allergic reactions (itching, urticaria, exanthema, eczema, rash, angioneurotic edema).

Auditory system: uncommon – tinnitus.

Respiratory system: rare – dyspnea, bronchospasm (mainly in patients with bronchial hyperreactivity associated with bronchial asthma), rhinorrhea.

Gastrointestinal tract: uncommon – heartburn, dyspepsia, stomatitis, abdominal pain, nausea, vomiting, diarrhea, unpleasant breath odor.

General disorders: uncommon – fever.

Severe skin reactions (Stevens-Johnson syndrome and Lyell's syndrome) have been reported. With the use of acetylcysteine, very rare cases of bleeding have been reported, mostly associated with the development of hypersensitivity reactions. Cases of decreased platelet aggregation have been observed, although there is no clinical confirmation. Very rare cases of Quincke's edema (angioedema), facial swelling, anemia, hemorrhage, anaphylactic reactions, or even anaphylactic shock have been reported.

Shelf life. 2 years – for the tube. 3 years – for the sachet.

Storage conditions.

Store at a temperature not exceeding 25 °C (for the tube). Keep the tube tightly closed.

Store at a temperature not exceeding 30 °C (for the sachet). Keep out of reach of children.

Packaging.

20 tablets in a tube; 1 tube in a cardboard box.

1 tablet in a sachet; 20 sachets in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

SALUTAS Pharma GmbH (batch release).

Hermes Pharma Ges.m.b.H. (bulk manufacturer, packaging).

Hermes Arzneimittel GmbH (alternative bulk manufacturer, packaging).

Manufacturer's address and location of business operations.

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

Schwimmschulweg 1a, 9400 Wolfsberg, Austria.

Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany.