Amkesol® uno

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMKESOL® UNO (AMKESOL UNO)

Composition:

Active ingredient: carbocisteine;

1 ml of syrup contains carbocisteine 50 mg;

Excipients: glycerol, methylparahydroxybenzoate (E 218), sucrose, yellow FCF (E 110), caramel flavor, sodium hydroxide, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear liquid, yellow to orange in color, with a caramel odor; a brownish tint may be present.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Mucolytic agents. Carbocisteine. ATC code R05CB03.

Pharmacological properties.

Pharmacodynamics.

Carbocysteine affects the gel phase of respiratory tract mucus: by breaking disulfide bridges of glycoproteins, it causes liquefaction of excessively viscous bronchial secretions, thus facilitating expectoration.

The mucoregulatory effect of carbocysteine is associated with activation of sialyltransferase – an enzyme of goblet cells in the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretion, restores its viscosity and elasticity. It activates ciliary epithelium function and improves mucociliary clearance. It promotes regeneration of the respiratory tract mucosa, normalizes its structure, reduces hyperplasia of goblet cells, and consequently decreases mucus production. It restores secretion of immunologically active IgA (specific protection) and increases the number of sulfhydryl groups in mucus components (nonspecific protection). It exhibits anti-inflammatory effect due to kinin-inhibiting activity of sialomucins, resulting in reduced edema and bronchoobstruction.

Pharmacokinetics.

After oral administration, carbocysteine is rapidly absorbed. Peak plasma concentration of the active substance is reached within 2 hours. Bioavailability is low – less than 10% of the administered dose – due to extensive metabolism in the gastrointestinal tract and first-pass liver effect. Carbocysteine and its metabolites are mainly excreted by the kidneys. The elimination half-life is approximately 2 hours.

Clinical characteristics.

Indications.

Treatment of symptoms related to bronchial secretion disorders and impaired sputum clearance, particularly in acute bronchopulmonary diseases such as acute bronchitis, and during exacerbations of chronic respiratory diseases in adults and children aged 15 years and older.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients (see section "Special precautions").
• Peptic ulcer of the stomach and duodenum in the acute phase.

Interaction with other medicinal products and other forms of interaction.

During treatment with Amkesol® Uno, antitussive agents and drugs that suppress bronchial secretion should not be used. This medicinal product enhances the efficacy of glucocorticoid therapy (mutually) and antibacterial therapy. Use with caution in patients taking medications that may cause gastrointestinal bleeding.

Special precautions for use

Special warnings

Productive cough is a fundamental protective mechanism of the bronchopulmonary system and therefore should not be suppressed. It is irrational to combine medicinal products that modify bronchial secretion with agents that suppress cough and/or substances that reduce secretion (such as atropine-like drugs).

Precautions for use

In case of gastrointestinal disorders (stomach pain, nausea, vomiting, diarrhea), the dose should be reduced.

The medicinal product should be used with caution in elderly patients, in patients with a history of peptic ulcer of the stomach or duodenum, and in patients who are concurrently taking medicinal products that may cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, treatment should be discontinued.

The medicinal product contains sucrose. Its use is not recommended in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. This medicinal product contains 5.25 g of sugar in 15 ml of 5% syrup. This should be taken into account for patients with diabetes mellitus.

This medicinal product contains sodium, which should be taken into account for patients on a sodium-controlled diet.

This medicinal product contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

This medicinal product contains the colorant sunset yellow FCF (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding

Teratogenic effects were not observed in animal studies. The absence of teratogenic effects in animals indicates that developmental abnormalities are not expected in humans.

There are insufficient data on the clinical use of carbocisteine in pregnant women.

Therefore, carbocisteine is not recommended during pregnancy.

There are no data on the passage of carbocisteine into breast milk. Thus, breastfeeding during carbocisteine treatment is not recommended.

Ability to influence reaction rate when driving or operating machinery

Does not affect.

Method of Administration and Dosage.

FOR ADULTS AND CHILDREN AGED 15 YEARS AND OLDER.

Dosage

The dosing cup filled to the 15 ml mark contains 750 mg of carbocysteine.

Take 1 dose (15 ml) three times daily, preferably between meals.

The duration of treatment should be short and must not exceed 5 days.

Method of Administration

For oral use.

Children.

The medication may be administered to children aged 15 years and older.

Treatment of children should be conducted under medical supervision.

Overdose.

Symptoms: stomach pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Side effects.

• Allergic skin reactions such as itching, erythematous rash, urticaria, and angioedema are possible.
• Several cases of fixed drug eruption have been reported.
• Gastrointestinal disturbances (epigastric pain, nausea, vomiting, diarrhea) may occur (see section "Dosage and Administration").
• Gastrointestinal bleeding (see section "Dosage and Administration").
• Isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme, have been reported.

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

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

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 100 ml in glass bottles or polymer bottles.

One glass bottle together with a dosing cup in a cardboard box.

One polymer bottle together with a measuring cup in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

PJSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business activity.

1, Gordiyenkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.