Ascoril BS (Solution) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

ATC Code

R05C (Expectorants, excluding combinations with antitussives)

Active Substances

Bromhexine (Rec.INN registered by WHO)

Guaifenesin (Rec.INN registered by WHO)

Salbutamol (Rec.INN registered by WHO)

Dosage Form

Ascoril BS

Oral solution 2 mg+50 mg+1 mg/5 ml: 100 ml or 200 ml bottle with measuring cup

Dosage Form, Packaging, and Composition

Oral solution as a clear, colorless or yellowish liquid with a characteristic odor.

Excipients: sodium benzoate, sodium citrate, sodium chloride, sucralose, citric acid monohydrate, blackcurrant flavor* (flavor “Black Currant” ID 20158, Black Currant ID 20158), pineapple flavor** (flavor “Pineapple” Super PH, Pineapple Super PH Flavour), levomenthol, purified water.

* Blackcurrant flavor: propylene glycol 1520, water, nature-identical flavors, ethanol, flavor preparation, artificial flavoring substance, natural flavoring substance.
** Pineapple flavor: flavor preparation, nature-identical flavors, propylene glycol 1520, artificial flavoring substance.

100 ml – orange polyethylene terephthalate bottle with a white screw-on aluminum cap with first-opening control and a red “G” logo (1) with a measuring cup^× – cardboard carton.
200 ml – orange polyethylene terephthalate bottle with a white screw-on aluminum cap with first-opening control and a red “G” logo (1) with a measuring cup^× – cardboard carton.

^× The bottle is supplied with a 10 ml capacity HDPE measuring cup with a “G” logo.
1 bottle together with a measuring cup and instructions for use is placed in a cardboard carton.

Clinical-Pharmacological Group

Drug with mucolytic, expectorant and bronchodilatory action

Pharmacotherapeutic Group

Combined expectorant

Pharmacological Action

A combined drug with bronchodilatory, expectorant and mucolytic action.

Salbutamol is a bronchodilator that stimulates β₂-adrenergic receptors in the bronchi, blood vessels, and myometrium. It prevents or eliminates bronchospasm, reduces resistance in the airways, and increases vital lung capacity. It causes dilation of the coronary arteries and does not reduce blood pressure.

Bromhexine is a mucolytic agent with expectorant and antitussive action. It increases the serous component of bronchial secretion; activates the cilia of the ciliated epithelium, reduces sputum viscosity, increases its volume, and improves discharge.

Guaifenesin is a mucolytic agent that reduces the surface tension of the structures of the bronchopulmonary apparatus; stimulates secretory cells of the bronchial mucosa that produce neutral polysaccharides, depolymerizes acid mucopolysaccharides, reduces sputum viscosity, activates the bronchial ciliary apparatus, facilitates sputum removal and promotes the transition of non-productive cough to productive.

Indications

Acute bronchitis, including tracheobronchitis; acute bronchitis caused by respiratory viruses; chronic bronchitis not otherwise specified (NOS); COPD; asthmatic bronchitis; pneumonia.

ICD codes

Dosage Regimen

Administer orally three times daily.

Use the provided measuring cup for accurate dosing.

For adults and children over 12 years: take 10 ml per dose.

For children 6 to 12 years: take 5 ml per dose.

For children 2 to 5 years: take 2.5 ml per dose.

Contraindicated in children under 2 years of age.

Limit the treatment course to a maximum of 4-5 days.

Consult a physician if symptoms persist beyond this duration.

Do not exceed the recommended dose or frequency of administration.

Do not use with other cough suppressants.

Monitor for signs of hypersensitivity reactions.

Be aware that guaifenesin may cause pink discoloration of urine.

Patients with diabetes should monitor blood glucose levels.

Discontinue use and seek medical attention if bronchospasm occurs.

Adverse Reactions

Cardiovascular system: common – tachycardia; rare – arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole, peripheral vasodilation; frequency unknown – myocardial ischemia.

Nervous system: very common – tremor; common – headache; very rare – hyperactivity.

Digestive system: possible – exacerbation of gastric and duodenal ulcers, nausea, vomiting, diarrhea and pain in the upper abdomen.

Skin and subcutaneous tissues: severe skin adverse reactions are possible, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis.

Immune system: possible – angioedema, rash, urticaria, itching, hypersensitivity, anaphylactic reaction, anaphylactic shock.

Metabolism: rare – hypokalemia.

Musculoskeletal system: common – muscle cramps; very rare – sensation of muscle tension.

Respiratory system: possible – bronchospasm.

Kidneys and urinary system: possible – pink coloration of urine.

Contraindications

Hypersensitivity to bromhexine, guaifenesin, salbutamol; pregnancy, breastfeeding; tachyarrhythmia, myocarditis; heart defects (including aortic stenosis); decompensated diabetes mellitus; thyrotoxicosis; glaucoma; hepatic and/or renal failure; gastric and duodenal ulcer in the acute phase; gastric bleeding; children under 2 years of age.

With caution

Diabetes mellitus; arterial hypertension; gastric and duodenal ulcer in remission; hyperthyroidism; angina pectoris; severe cardiovascular diseases; in bronchial diseases accompanied by excessive accumulation of secretions.

Should not be used in combination with beta-blockers.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated for use in hepatic failure.

Use in Renal Impairment

Contraindicated for use in renal failure.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Special Precautions

Bromhexine

Patients should be warned about a possible increase in mucus secretion.

If lesions of the skin or mucous membranes occur, you should immediately seek medical help and, as a precaution, stop taking bromhexine hydrochloride.

Guaifenesin

Do not use simultaneously with cough suppressants or combined cold medicines.

Guaifenesin colors the urine pink.

Excessive use of Guaifenesin may cause kidney stone formation.

If urine is collected within 24 hours after taking guaifenesin, its metabolite may change the color of the urine, and 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA) may be determined in the laboratory.

Salbutamol

Bronchodilators should not be used as the sole or primary treatment for patients with severe or unstable asthma. In severe asthma, regular assessment of the condition is necessary, including determination of lung function, as patients are at risk of severe attacks and even death. If treatment becomes ineffective, patients should seek medical help.

The dose or frequency of use should be increased only on the recommendation of a doctor.

Salbutamol causes peripheral vasodilation, which may be accompanied by reflex tachycardia and increased cardiac output or thyrotoxicosis. It should be used with caution in patients suffering from angina pectoris, severe forms of tachycardia or thyrotoxicosis.

Like other beta-adrenergic receptor agonists, salbutamol can cause reversible metabolic changes, such as increased blood glucose concentration. Patients with diabetes may be unable to compensate for the increase in blood glucose concentration, and ketoacidosis has been reported in such patients.

Effect on the ability to drive vehicles and mechanisms

Given the profile of side effects (dizziness, drowsiness and others), it is recommended to refrain from driving vehicles and mechanisms, from engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions during treatment.

Drug Interactions

Theophylline and other xanthines, when used concomitantly, increase the likelihood of tachyarrhythmias.

The salbutamol included in the combination is not recommended for patients who are taking MAO inhibitors and/or tricyclic antidepressants.

Use with caution concomitantly with anesthetic agents, such as chloroform, cyclopropane, halothane and other halogen-containing drugs.

It is not recommended to use this combination simultaneously with non-selective beta-adrenergic receptor blockers, such as propranolol.

Diuretics and corticosteroids enhance the hypokalemic effect of salbutamol.

Concomitant administration with drugs containing codeine and other antitussives makes it difficult to discharge liquefied sputum.

The bromhexine contained in the drug promotes the penetration of antibiotics into the lung tissue.

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

Rx Only

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.