Kascebene (Capsules) Instructions for Use

Marketing Authorization Holder

Alkaloid AD Skopje (Republic of North Macedonia)

ATC Code

R05CB03 (Carbocisteine)

Active Substance

Carbocisteine (Rec.INN registered by WHO)

Dosage Form

Kascebene

Capsules 375 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, with a dark yellow body and cap; the capsule contents are a white or almost white powder.

Excipients: corn starch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, mannitol, colloidal silicon dioxide.

Composition of the hard gelatin capsule titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), gelatin.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Mucolytic drug

Pharmacotherapeutic Group

Drugs used for cough and colds; expectorants, excluding combinations with antitussives; mucolytic agents

Pharmacological Action

Mucolytic agent. The action is due to the activation of sialyl transferase, an enzyme of the goblet cells of the bronchial mucosa.

It normalizes the quantitative ratio of acidic and neutral sialomucins in the bronchial secretion. It reduces the viscosity of bronchial secretions and discharge from the paranasal sinuses, facilitates the discharge of sputum and mucus, and reduces cough.

It promotes the regeneration of the mucous membrane, normalizes its structure, and activates the activity of the ciliated epithelium. It restores the secretion of immunoglobulin IgA (specific protection) and the number of sulfhydryl groups of mucus components (nonspecific protection), and improves mucociliary clearance.

Pharmacokinetics

After oral administration, Carbocisteine is rapidly absorbed. Bioavailability is low (less than 10% of the administered dose).

C_max in blood serum and in the respiratory tract mucosa is reached 2-3 hours after administration and is maintained in the mucosa for 8 hours. It is metabolized in the liver.

It is excreted mainly by the kidneys, partially unchanged (30-60%), partially as metabolites. T_1/2 is about 2 hours.

Indications

Acute and chronic bronchopulmonary diseases and diseases of the ENT organs, accompanied by the formation of viscous, difficult-to-discharge sputum (tracheitis, bronchitis, tracheobronchitis, bronchial asthma, bronchiectasis) and mucus (inflammatory diseases of the middle ear, nose and its paranasal sinuses – rhinitis, otitis media, sinusitis); preparation of the patient for bronchoscopy or bronchography.

ICD codes

Dosage Regimen

Administer orally. Swallow the capsules whole with a sufficient amount of water.

For adults, the standard dosage is two capsules (750 mg) taken three times daily. This constitutes a total daily dose of 2.25 g.

After achieving the desired clinical effect, reduce the maintenance dose to one capsule (375 mg) taken three or four times daily. This constitutes a total daily dose of 1.5 g.

For pediatric patients, use only age-appropriate dosage forms. This specific 375 mg capsule formulation is not intended for young children.

The duration of treatment should not exceed 8 days without consulting a physician for re-evaluation.

Exercise caution in elderly patients and those with a history of gastrointestinal ulcer disease.

Discontinue use immediately and consult a physician if signs of gastrointestinal bleeding occur.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, epigastric pain, gastrointestinal bleeding.

From the immune system: allergic skin rash and anaphylactic reactions, including urticaria, angioedema, itching, exanthema, fixed drug eruption.

From the skin and subcutaneous tissues bullous dermatitis, Stevens-Johnson syndrome.

General reactions dizziness, weakness, malaise.

Contraindications

Hypersensitivity to carbocisteine; peptic ulcer of the stomach and duodenum in the acute stage; chronic glomerulonephritis (in the acute phase); cystitis; pregnancy; childhood – depending on the dosage form.

With caution history of peptic ulcer of the stomach and duodenum; breastfeeding period; elderly patients; simultaneous use of drugs that increase the risk of gastrointestinal bleeding.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Use in Renal Impairment

Contraindicated in chronic glomerulonephritis in the acute phase.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the carbocisteine drug leaflets regarding contraindications for the use of specific carbocisteine dosage forms in children of different ages.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Caution should be exercised when using carbocisteine in elderly patients, with a history of peptic ulcer of the stomach and duodenum, and with simultaneous use of drugs that increase the risk of gastrointestinal bleeding. If gastrointestinal bleeding develops, carbocisteine should be discontinued.

Effect on ability to drive vehicles and machinery

During treatment with carbocisteine, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities due to the possibility of dizziness and weakness.

Drug Interactions

Carbocisteine enhances the effectiveness of therapy with corticosteroids and antibacterial drugs in the treatment of infectious and inflammatory diseases of the upper and lower respiratory tract.

Carbocisteine potentiates the bronchodilator effect of theophylline.

The effect of carbocisteine is weakened by antitussives and m-anticholinergic agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.