Acc® hot drink honey lemon

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AСС® HOT DRINK HONEY LEMON (ACC® ORAL HOT SOLUTION HONEY LEMON)

Composition:

Active substance: acetylcysteine;

One sachet contains acetylcysteine 200 mg or 600 mg;

Excipients: sucrose, ascorbic acid, sodium saccharin, lemon flavoring, honey flavoring.

Pharmaceutical form. Powder for oral solution.

Main physicochemical properties:

200 mg powder: white to yellowish powder, possible presence of agglomerates, with lemon/honey odor;

600 mg powder: white to yellowish powder, possible presence of agglomerates, with lemon/honey odor.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Mucolytic agents.

ATC code R05C B01.

Pharmacological properties.

Pharmacodynamics.

Acetylcysteine (ACC) is a mucolytic and expectorant agent used to liquefy sputum in respiratory tract diseases associated with the production of thick mucus. Acetylcysteine is a derivative of the amino acid cysteine. The mucolytic effect of the drug has a 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 its activity in the presence of purulent sputum.

Acetylcysteine also possesses antioxidant and pneumoprotective properties, which are due to the binding of reactive 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 unique property of acetylcysteine allows its effective use in paracetamol overdose.

Pharmacokinetics.

After oral administration, acetylcysteine is rapidly and completely absorbed and undergoes hepatic metabolism to form cysteine, a pharmacologically active metabolite, as well as dithioacetylcysteine, 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, dithioacetylcysteine).

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 up to 8 hours.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to acetylcysteine or to any other components of the medicinal product. Exacerbation stage of gastric or duodenal 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.

The use of antitussive agents concomitantly with acetylcysteine may promote sputum retention due to suppression of the cough reflex.

When administered simultaneously with antibiotics such as tetracyclines (except doxycycline), ampicillin, amphotericin B, cephalosporins, aminoglycosides, interaction with the thiol group of acetylcysteine may occur, leading to reduced activity of both agents. Therefore, the interval between administration of these agents 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 in the same glass with other medicinal products.

Significant arterial hypotension and marked dilation of the temporal artery have been observed when nitroglycerin and acetylcysteine are used concomitantly. When simultaneous administration of nitroglycerin and acetylcysteine is necessary, patients should be monitored for arterial hypotension, which may be severe; patients should also be warned about the possibility of headache.

Acetylcysteine reduces the hepatotoxic effect of paracetamol.

Synergism between acetylcysteine and bronchodilators has been reported.

Acetylcysteine may act as a cysteine donor and increase glutathione levels, promoting 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 the 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 the patient should consult a physician 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 used concomitantly.

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

Acetylcysteine should be prescribed with caution to patients with bronchial asthma due to the risk of bronchospasm. When pouring the contents of the sachet into a container during solution preparation, the powder may become airborne and irritate the nasal mucosa, potentially causing reflex bronchospasm. If bronchospasm occurs, acetylcysteine treatment should be discontinued immediately.

Acetylcysteine should be administered with caution in patients with hepatic or renal impairment to avoid accumulation of nitrogen-containing compounds 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 sputum, postural drainage and bronchoaspiration may be required.

The product contains sucrose and therefore should not be administered to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption syndrome.

Information for diabetic patients

One sachet of powder (200 mg acetylcysteine) contains 2.5 g of sucrose (0.21 bread units).

One sachet of powder (600 mg acetylcysteine) contains 2 g of sucrose (0.17 bread units).

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 affect reaction rate while driving or operating machinery

Does not affect.

Method of administration and dosage.

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 contents of the sachet should be dissolved by stirring in ½ glass of cold water, then add hot but not boiling water to make a full glass. Mix and drink the solution as soon as possible after cooling to a comfortable temperature. The sequence of dissolving the powder (cold water first, then hot water) must not be changed. 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.

Powder 200 mg: for use in children aged 2 years and older.

Powder 600 mg: for use in children aged 14 years and older.

Overdose.

There are no reports of overdose cases with oral administration of acetylcysteine.

Volunteers took 11.6 g of acetylcysteine per day for three months without experiencing any serious adverse effects. Oral doses up to 500 mg acetylcysteine/kg body weight/day were tolerated without any symptoms of intoxication.

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

Treatment: symptomatic treatment.

Side effects.

The following classification is used to describe the frequency of adverse effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000).

Cardiovascular system: uncommon – tachycardia, arterial hypotension.

Nervous system: uncommon – headache.

Skin: uncommon – allergic reactions (pruritus, 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; however, there is no clinical confirmation. Very rare cases of Quincke’s edema (angioedema), facial swelling, anemia, hemorrhages, anaphylactic reactions, or even anaphylactic shock have been reported.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

Powder 200 mg: 3 g of powder in a sachet. 20 sachets in a cardboard box.

Powder 600 mg: 3 g of powder in a sachet. 6 sachets in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

Salyutas Pharma GmbH (batch release).

Lindopharm GmbH (bulk manufacturer, testing, packaging).

Zambon Switzerland Ltd (bulk manufacturer, testing, packaging).

Manufacturer's address and location of business activity.

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

Neue Strasse 82, 40721 Hilden, Germany.

Via Industria 13, 6814 Cadempino, Switzerland.