Amkesol® uno

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

Composition:

Active substance: carbocisteine;

1 ml of syrup contains 20 mg of carbocisteine;

Excipients: glycerol, methylparahydroxybenzoate (E 218), sucrose, caramel flavour, sodium hydroxide, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: slightly yellowish transparent liquid with a caramel odour.

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 in goblet cells of the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretions, restoring their viscosity and elasticity. It activates ciliated 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 (non-specific protection). It exerts anti-inflammatory effects due to kinin-inhibiting activity of sialomucins, leading to reduced edema and bronchoconstriction.

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 primarily excreted in urine. Elimination half-life is approximately 2 hours.

Clinical characteristics.

Indications.

Treatment of symptoms related to bronchial secretion disorders and impaired sputum expectoration, particularly in acute bronchopulmonary diseases such as acute bronchitis; during exacerbations of chronic respiratory diseases.

Contraindications.

• Children under two years of age;
• Hypersensitivity to the active substance or to any of the excipients of the medicinal product;
• Peptic ulcer of the stomach and duodenum in the period of exacerbation;
• First trimester of pregnancy — due to insufficient data regarding teratogenic and embryotoxic effects.

Interaction with other medicinal products and other forms of interaction.

During treatment with Amkesol® Uno, antitussive agents and agents that suppress bronchial secretion should not be used. This medicinal product enhances the effectiveness of glucocorticoid therapy (mutually) and antibacterial therapy.

Special precautions for use

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 cough-suppressant agents and/or substances that reduce secretion (atropine-like group).

The use of mucolytic agents may lead to impaired bronchial patency in children aged 2 years and older due to limited ability to clear bronchial secretions, related to age-specific anatomical and physiological characteristics. Mucolytic agents should not be used in children under 2 years of age (see sections "Contraindications" and "Special precautions for use").

Treatment should be re-evaluated if there is no therapeutic effect or if symptoms worsen.

In cases of productive cough with purulent sputum, high fever, or chronic bronchial or pulmonary disease, the clinical situation should be reassessed.

The medicinal product should be used with caution in patients with a history of peptic ulcer disease of the stomach or duodenum.

The medicinal product contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

This medicinal product contains 3.5 g of sucrose in 5 ml of syrup, which should be taken into account for patients on a low-carbohydrate diet or those with diabetes mellitus.

This medicinal product contains sodium, specifically: 5 ml of syrup contains 0.57 mmol (or 13 mg) of sodium. This should be considered for patients on a sodium-controlled diet.

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

Use during pregnancy or breastfeeding

In animal studies, no teratogenic effects were observed. The absence of teratogenic effects in animals indicates that congenital malformations are not expected in humans. To date, there have been no reports of teratogenic effects during the post-marketing period. There are no data on the passage of carbocisteine into breast milk.

During pregnancy (II and III trimesters) and breastfeeding, the medicinal product should be used only after careful evaluation by a physician of the benefit-risk ratio for the mother and fetus (child).

Ability to influence reaction rate when driving or operating machinery

Does not affect.

Dosage and Administration.

Take orally.

Amkesol® Uno 2%, syrup, is recommended for the treatment of children under 15 years of age. For accurate dosing, a measuring spoon with graduations is provided. 1 ml of syrup contains 20 mg of carbocisteine.

The maximum single dose of the syrup for children is 100 mg of carbocisteine.

The duration of carbocisteine treatment in children should be as short as possible, not exceeding 5 days.

Children.

The medicinal product should be administered to children aged 2 years and older.

Treatment of children should be carried out under medical supervision.

Overdose.

Symptoms: stomach pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Adverse Reactions

• There is a risk of developing impaired bronchial patency in children under 2 years of age (see sections "Contraindications" and "Special Warnings and Precautions for Use").
• Allergic skin reactions such as itching, erythematous skin rashes, urticaria, and angioneurotic edema may occur.
• Several cases of fixed drug eruption have been reported.
• Gastrointestinal disturbances (stomach pain, nausea, vomiting, diarrhea) are possible (see section "Special Warnings and Precautions for Use").
• Gastrointestinal bleeding (see section "Special Warnings and Precautions for Use").
• Isolated cases of bullous dermatitis, such as Stevens–Johnson syndrome and erythema multiforme, have been reported.

Reporting of Adverse Reactions

Reporting suspected adverse reactions after registration of the medicinal product is of great importance. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should 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 the reach and sight of children.

Packaging. 100 ml in glass or polymer bottles.

One glass bottle together with a measuring spoon in a cardboard box.

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

Category of Supply. Over-the-counter (without prescription).

Manufacturer. JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's Address and Place of Business.

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