Rinicold Broncho (Syrup) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

ATC Code

R05CB10 (Mucolytic drugs in combination)

Dosage Form

Rinicold Broncho

Syrup: bottle 50, 60 or 100 ml

Dosage Form, Packaging, and Composition

Syrup thick, from light orange to orange in color, with a characteristic odor.

Excipients: sucrose, methylparaben, propylparaben, disodium edetate, sorbitol, glycerol, menthol, citric acid, sodium citrate, melon flavor, sunset yellow dye, purified water.

100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with mucolytic, expectorant, anti-allergic and vasoconstrictive action

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the "common cold"

Pharmacological Action

A combined drug used for colds. Guaifenesin and ambroxol reduce the viscosity of bronchial secretions and facilitate expectoration.

Chlorphenamine Maleate has an anti-allergic effect: it eliminates lacrimation, itching in the eyes and nose.

Phenylephrine hydrochloride has a vasoconstrictive effect, reduces swelling and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.

Pharmacokinetics

Pharmacokinetic data for Rinicold Broncho are not provided.

Indications

• Symptomatic treatment of colds, influenza, and acute respiratory viral infections (ARVI) accompanied by cough with difficult-to-expectorate viscous sputum.

ICD codes

Dosage Regimen

Administer the syrup orally. Shake the bottle thoroughly before each use.

For adults and children over 12 years, the dose is 20 ml (4 teaspoons) taken three times daily.

For children aged 6 to 12 years, the dose is 10 ml (2 teaspoons) taken two to three times daily.

Space doses evenly throughout the day to maintain consistent therapeutic levels.

Do not administer to children under 6 years of age; this age group is contraindicated.

Use a calibrated measuring spoon or cup for accurate dose measurement; do not use household spoons.

The maximum duration of self-treatment without medical supervision is 7 days.

Discontinue use and consult a physician if symptoms persist or worsen.

Be aware that phenylephrine may cause increases in blood pressure; monitor accordingly.

Chlorphenamine may cause drowsiness; exercise caution when operating machinery or driving.

Adverse Reactions

From the cardiovascular system: possible increase in blood pressure, tachycardia.

From the central nervous system: headache, drowsiness, dizziness, increased excitability, sleep onset disturbance. In children, agitation, anxiety, irritability may occur. In elderly patients, confusion and irritability may also occur.

From the digestive system: nausea, vomiting, constipation, diarrhea, pain in the epigastric region.

From the organ of vision: mydriasis, accommodation paralysis, increased intraocular pressure.

Allergic reactions: skin rash, itching, angioedema.

Other: dryness of mucous membranes, difficulty urinating.

Contraindications

• Convulsions of various etiologies;
• Severe atherosclerosis of the coronary arteries;
• Arterial hypertension;
• Diabetes mellitus;
• Thyrotoxicosis;
• Pheochromocytoma;
• Closed-angle glaucoma;
• Gastric and duodenal ulcer;
• Prostate adenoma;
• Glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy;
• Lactation period (breastfeeding);
• Childhood (under 6 years);
• Concomitant use of tricyclic antidepressants, MAO inhibitors, beta-blockers;
• Concomitant use of other drugs containing the active substances that are part of Rinicold Broncho;
• Hypersensitivity to the components of the drug.

With caution the drug should be prescribed for renal and/or hepatic insufficiency.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

With caution the drug should be prescribed for hepatic insufficiency.

Use in Renal Impairment

With caution the drug should be prescribed for renal insufficiency.

Pediatric Use

Contraindication: childhood (under 6 years).

Special Precautions

It is not recommended to take the drug for more than 7 days without a doctor’s prescription.

When using the drug, urine may turn pink.

Overdose

Symptoms: increased severity of adverse reactions.

Treatment: gastric lavage, intake of activated charcoal, laxatives (vaseline oil, saline laxatives); symptomatic therapy. In case of severe disorders, a doctor should be consulted.

Drug Interactions

The drug enhances the effect of sedatives, ethanol.

Concomitant use with antidepressants, phenothiazine derivatives (chlorpromazine, trifluoperazine, levomepromazine), antiparkinsonian and antipsychotic drugs increases the risk of urinary retention, dry mouth, constipation.

Concomitant use with glucocorticosteroids (prednisolone, dexamethasone, triamcinolone) increases the risk of glaucoma. Chlorphenamine, when used concomitantly with MAO inhibitors (nialamide), furazolidone, can lead to hypertensive crisis, agitation, hyperpyrexia.

Concomitant use with tricyclic antidepressants enhances the sympathomimetic effect, with halothane – increases the risk of ventricular arrhythmia, with guanethidine – reduces its hypotensive effect. Guanethidine, in turn, enhances the alpha-adrenostimulating activity of phenylephrine, which is part of the drug.

Concomitant use of ambroxol and guaifenesin with antitussives leads to difficulty in expectoration of sputum.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.