Jocet^® (Syrup) Instructions for Use

Marketing Authorization Holder

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.) (India)

ATC Code

R05CB10 (Mucolytic drugs in combination)

Dosage Form

Jocet®

Syrup: bottle 100 ml or 200 ml 1 pc. with measuring cup included

Dosage Form, Packaging, and Composition

Syrup of orange color.

Excipients : sodium methylparaben, sodium propylparaben, sucrose, propylene glycol, sodium saccharin, sorbic acid, glycerol, citric acid monohydrate, sorbitol (non-crystallizing) liquid, sunset yellow dye, purified water.

100 ml – dark glass bottles (1) with a measuring cup included – cardboard packs.
100 ml – dark polyethylene terephthalate bottles (1) with a measuring cup included – cardboard packs.

Clinical-Pharmacological Group

Drug with mucolytic, expectorant and bronchodilatory action

Pharmacotherapeutic Group

Expectorant

Pharmacological Action

A combined drug that has bronchodilatory, expectorant, and mucolytic action.

Salbutamol is a bronchodilator agent that stimulates β₂-adrenergic receptors of the bronchi, preventing or relieving bronchospasm.

Bromhexine is a mucolytic agent that has expectorant and weak antitussive action. It reduces sputum viscosity by depolymerizing acidic mucopolysaccharides and stimulating secretory cells of the bronchial mucosa. It activates the cilia of the ciliated epithelium, improving sputum discharge.

Guaifenesin reduces the surface tension and adhesive properties of sputum, increases the serous component of bronchial secretion, reduces sputum viscosity, activates the ciliary apparatus of the bronchi, facilitates sputum removal, and promotes the transition of non-productive cough to productive.

Menthol has an antispasmodic action, mildly stimulates the secretion of bronchial glands, has antiseptic properties, and has a soothing effect and reduces irritation of the respiratory tract mucosa.

Pharmacokinetics

Information on the pharmacokinetics of the drug is not provided.

Indications

Acute and chronic bronchopulmonary diseases accompanied by difficult sputum discharge

• Bronchial asthma;
• Chronic bronchitis;
• Pulmonary emphysema;
• COPD;
• Tracheobronchitis;
• Pneumonia;
• Pneumoconiosis;
• Pulmonary tuberculosis.

ICD codes

Dosage Regimen

Administer the drug orally. Use the provided measuring cup for accurate dosing.

For children under 6 years of age, administer 1 teaspoon (5 ml) three times daily.

For children aged 6 to 12 years, administer 1 to 2 teaspoons (5-10 ml) three times daily.

For adults and children over 12 years of age, administer 2 teaspoons (10 ml) three times daily.

Maintain a dosing interval of approximately 6 to 8 hours. Do not exceed the recommended daily dosage.

Shake the bottle well before each use. Measure doses precisely using the supplied cup.

Consult a physician if symptoms persist or worsen after several days of therapy. Adjust dosage only under medical supervision.

Adverse Reactions

From the central nervous system headache, dizziness, increased nervous excitability, sleep disturbance, drowsiness, tremor, convulsions.

From the digestive system nausea, vomiting, diarrhea, exacerbation of gastric and duodenal ulcers; very rarely – increased activity of liver transaminases.

From the cardiovascular system tachycardia, decreased blood pressure, collapse.

From the urinary system pink coloration of urine.

Allergic reactions skin rash, urticaria, paradoxical bronchospasm.

Contraindications

• Tachyarrhythmia;
• Myocarditis;
• Aortic stenosis;
• Decompensated diabetes mellitus;
• Thyrotoxicosis;
• Glaucoma;
• Hepatic and/or renal failure;
• Gastric and duodenal ulcer in the acute phase;
• Gastric bleeding;
• Pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to the components of the drug.

With caution the drug should be used in diabetes mellitus, arterial hypertension, history of gastric and duodenal ulcer; simultaneously with antitussive agents, non-selective beta-adrenergic receptor blockers, MAO inhibitors.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

The use of the drug is contraindicated in hepatic failure.

Use in Renal Impairment

The use of the drug is contraindicated in renal failure.

Pediatric Use

Children under 6 years of age – 1 tsp. (5 ml) 3 times/day; from 6 to 12 years – 1-2 tsp. (5-10 ml) 3 times/day.

Special Precautions

Guaifenesin colors the urine pink.

It is not recommended to take the drug with alkaline drinks.

Overdose

Symptoms increased manifestations of side effects.

Treatment symptomatic therapy.

Drug Interactions

Beta₂-adrenomimetic agents, theophylline and other xanthines, when used simultaneously with the drug, increase the likelihood of tachyarrhythmias.

MAO inhibitors and tricyclic antidepressants enhance the effect of salbutamol and may lead to a sharp decrease in blood pressure.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Simultaneous use with drugs containing codeine and other antitussive agents impedes the discharge of liquefied sputum.

Bromhexine, which is part of the drug, promotes the penetration of antibiotics into the lung tissue.

It is not recommended to use simultaneously with non-selective beta-adrenergic receptor blockers.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.