Mucolik

INSTRUCTIONS for medical use of the medicinal product MUCOLIK (MUCOLIK)

Composition:

Active substance: carbocisteine;

5 ml of syrup contains 100 mg of carbocisteine;

Excipients: methyl p-hydroxybenzoate (E 218), sucrose, glycerol, sodium hydroxide, flavor "Banana" (contains propylene glycol), colorant Yellow FCF (E 110), purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear orange-colored liquid with banana flavor.

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 cleaving disulfide bridges of glycoproteins, it causes liquefaction of excessively viscous bronchial secretions, thereby facilitating expectoration.

The mucoregulatory effect of carbocysteine is associated with activation of sialyltransferase—the enzyme of goblet cells in the bronchial mucosa. Carbocysteine normalizes the quantitative ratio of acidic and neutral sialomucins in bronchial secretion, restoring its 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, 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 intensive metabolism in the gastrointestinal tract and first-pass liver effect). Carbocysteine and its metabolites are primarily excreted in urine. The elimination half-life is approximately 2 hours.

Clinical characteristics.

Indications.

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

Contraindications.

• Hypersensitivity to any component of the drug (particularly to methylparahydroxybenzoate or other parahydroxybenzoate salts).
• Peptic ulcer of the stomach or duodenum during the acute phase.
• First trimester of pregnancy due to insufficient data regarding teratogenic and embryotoxic effects.
• Children under 2 years of age.

Interaction with other medicinal products and other forms of interaction.

During treatment with Mucolic, cough suppressants and agents that inhibit bronchial secretion should not be used. Enhances the effectiveness of glucocorticoid (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-suppressing agents and/or substances that reduce secretion (such as atropine-like drugs).

The use of mucolytic agents may lead to impaired bronchial patency in children under 2 years of age 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 reassessed if there is no therapeutic effect or if symptoms worsen.

If productive cough with purulent sputum, high fever, or chronic bronchial or lung disease is present, the clinical situation should be re-evaluated.

The preparation contains sucrose and therefore is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency. Consult your doctor before taking this medicinal product if necessary.

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. May be harmful to teeth.

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

This medicinal product contains sodium: 5 mL of syrup contains 0.57 mmol (or 13 mg) of sodium. Caution is advised when administering to patients on a sodium-restricted diet.

The medicinal product contains methyl parahydroxybenzoate and the dye sunset yellow FCF (E 110), which may cause delayed allergic reactions.

Use during pregnancy or breastfeeding

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

During pregnancy (II and III trimesters) and breastfeeding, the preparation should be used only after careful assessment of the benefit-risk ratio for mother and fetus (infant), as determined by the physician. There are no data on the excretion of carbocisteine in breast milk.

Ability to influence reaction rate when driving or operating machinery

Does not affect.

Dosage and Administration

For oral use.

Mukolik is recommended for the treatment of children under 15 years of age. For accurate dosing, a measuring spoon with graduations is provided.

1 measuring spoon filled to the 5 ml mark contains 100 mg of carbocysteine.

Children aged 2 to 5 years.

200 mg (10 ml) of carbocysteine per day in 2 divided doses, i.e. 1 measuring spoon filled to the 5 ml mark, twice daily.

Children aged 5 to 15 years.

300 mg (15 ml) of carbocysteine per day in 3 divided doses, i.e. 1 measuring spoon filled to the 5 ml mark, three times daily.

The maximum single dose for children is 100 mg (5 ml) of carbocysteine.

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

Children.

The drug is intended for children aged 2 years and older.

Treatment of children should be carried out under medical supervision.

Overdose.

Symptoms: abdominal pain, nausea, diarrhea.

Treatment: symptomatic therapy.

Side effects.

Risk of impaired bronchial patency in children under 2 years of age (see sections "Contraindications" and "Special instructions").

Gastrointestinal disturbances may occur (stomach pain, nausea, vomiting, diarrhea), bronchorrhea (increased bronchial secretion). In such cases, dose reduction is recommended.

Allergic skin reactions such as urticaria, angioneurotic edema, pruritus, erythematous skin rashes (possibly delayed in time) are possible. Particular attention in patients with asthma is required due to the risk of bronchospasm (contraction of bronchial wall muscles leading to reduced airflow). In such cases, treatment must be discontinued.

Headache, muscle pain, dizziness, urinary incontinence, palpitations, and dyspnea may occur.

Particular attention in patients with thyroid dysfunction is required due to the risk of developing hypothyroidism.

Several cases of fixed drug eruptions have been reported. There have also been reports of isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

125 ml of 2% syrup in a bottle. One bottle and a measuring spoon are placed in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

JSC "Tekhnolohiya".

Manufacturer's address and location of business activity.

8 Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.