Coldact^® Broncho (Syrup) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Manufactured By

Shreya Life Sciences, Pvt.Ltd. (India)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Dosage Form

Coldact® Broncho

Syrup: bottle 100 ml with a measuring spoon

Dosage Form, Packaging, and Composition

Syrup in the form of a thick solution from light orange to orange in color, with a characteristic odor.

Excipients: sucrose – 4000 mg, methylparahydroxybenzoate – 18 mg, propylparahydroxybenzoate – 2 mg, disodium edetate – 2 mg, sorbitol 70% solution – 1000 mg, glycerol (glycerin) – 500 mg, menthol – 1 mg, citric acid monohydrate – 2 mg, sodium citrate – 5 mg, melon flavor (H 32734) – 0.03 ml, sunset yellow FCF dye (E110) – 0.66 mg, purified water – q.s. to 10 ml.

100 ml – dark glass bottles (1) complete with a measuring spoon – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Coldact^® Broncho syrup is a combined drug, the Guaifenesin and ambroxol included in its composition reduce the viscosity of bronchial secretion 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.

Indications

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

ICD codes

Dosage Regimen

Shake the bottle thoroughly before each use.

Use the provided measuring spoon for accurate dosing; do not use household teaspoons.

For adults and children over 12 years: administer 20 ml (4 teaspoons) orally, three times daily.

For children 6 to 12 years: administer 10 ml (2 teaspoons) orally, two to three times daily.

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

Do not exceed the recommended daily dosage or frequency of administration.

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

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

Contraindicated in children under 6 years of age.

Adverse Reactions

Possible: increased blood pressure, tachycardia, headache, drowsiness, dizziness, dryness of mucous membranes, loss of appetite, difficulty urinating, allergic reactions (rash, itching, angioedema), nausea, vomiting, constipation, diarrhea, pain in the epigastric region, increased excitability, sleep onset disturbance, mydriasis, accommodation paralysis, increased intraocular pressure.

In children, excitation, anxiety and irritability may occur.

In elderly patients, confusion or irritability is also possible.

Contraindications

• Hypersensitivity to any component of the drug;
• Concomitant use of other drugs containing substances that are part of Coldact^® Broncho;
• Concomitant use of tricyclic antidepressants, MAO inhibitors, beta-blockers;
• Convulsions of any etiology;
• Severe atherosclerosis of the coronary arteries;
• Arterial hypertension;
• Diabetes mellitus;
• Thyrotoxicosis;
• Pheochromocytoma;
• Closed-angle glaucoma;
• Peptic ulcer of the stomach and duodenum;
• Prostate adenoma;
• Glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy;
• Lactation period;
• Children’s age (under 6 years).

With caution — renal and/or hepatic insufficiency.

Use in Pregnancy and Lactation

Contraindicated during pregnancy. Breastfeeding should be discontinued during treatment.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Recommended dose for children 6-12 years

10 ml (2 teaspoons) 2-3 times a day.

The drug intake should be evenly distributed throughout the day.

Contraindicated in children under 6 years.

Geriatric Use

In elderly patients, confusion or irritability is possible.

Special Precautions

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

Urine may turn pink.

Overdose

Symptoms: increased severity of side effects.

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

Drug Interactions

The drug enhances the effect of sedatives, ethanol.

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

When used with glucocorticosteroids (prednisolone, dexamethasone, triamcinolone) the risk of developing glaucoma increases.
Chlorphenamine when used simultaneously with MAO inhibitors (nialamide), furazolidone can lead to hypertensive crisis, excitation, hyperpyrexia.

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

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

Storage Conditions

Store at a temperature not exceeding 25°C (77°F), do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the date indicated on the packaging.

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.