Broncholytin^® (Syrup) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

R05DB20 (Other antitussive drugs in combination)

Active Substances

Ephedrine (BAN)

Glaucine (BP)

Dosage Form

Broncholytin®

Syrup 5.75 mg+4.6 mg/5 ml: 125 g bottle with a measuring spoon or cup

Dosage Form, Packaging, and Composition

Syrup as a thick liquid from transparent to slightly opalescent, from light yellow to yellow-green or light brown in color, with a specific odor.

Excipients: basil oil – 5.75 mg, citric acid monohydrate – 2.99 mg, sucrose – 2012 mg, methylparaben – 6.9 mg, propylparaben – 1.15 mg, polysorbate 80 – 57.5 mg, ethanol 96% (1.7% v/v) – 69 mg, purified water – up to 5 ml.

125 g – dark glass bottles (1) with a measuring spoon or cup – cardboard packs.
125 g – dark polyethylene terephthalate bottles (1) with a measuring spoon or cup – cardboard packs.

Clinical-Pharmacological Group

A drug with antitussive and bronchodilator action

Pharmacotherapeutic Group

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

Pharmacological Action

A combined medicinal product with antitussive and bronchodilatory action.

Glaucine hydrobromide suppresses the cough center without causing respiratory depression, constipation, or drug dependence.

Ephedrine dilates the bronchi, stimulates respiration, and, due to its vasoconstrictive action, eliminates edema of the bronchial mucosa.

Basil oil has a mild sedative, antimicrobial, and antispasmodic effect.

Pharmacokinetics

Absorption

After oral administration, Glaucine hydrobromide and Ephedrine hydrochloride are rapidly and well absorbed from the gastrointestinal tract. The C_max of glaucine is reached after 1.5 hours.

Metabolism and Excretion

Glaucine hydrobromide is metabolized in the liver and excreted mainly in the urine.

Ephedrine hydrochloride is excreted in the urine unchanged. The T_1/2 is 3-6 hours.

Indications

As part of the complex therapy of various diseases of the respiratory tract accompanied by a dry cough, including:

• Acute inflammatory diseases of the upper respiratory tract;
• Acute and chronic bronchitis;
• Tracheobronchitis;
• COPD;
• Bronchial asthma;
• Pneumonia;
• Bronchiectasis;
• Whooping cough.

ICD codes

Dosage Regimen

Administer the syrup orally using the provided measuring spoon or cup.

For adults, the standard dose is 10 ml three to four times daily.

For children aged 3 to 10 years, administer 5 ml three times daily.

For children over 10 years of age, administer 10 ml three times daily.

Maintain a minimum interval of 4-6 hours between individual doses.

Do not exceed the maximum daily dose for any patient group.

Adjust the dosing frequency based on the severity of cough symptoms and clinical response.

For adult dosing, the maximum of four times daily is reserved for more severe cases.

Continue treatment for the duration prescribed by the physician.

Discontinue use and consult a physician if cough persists beyond one week or is accompanied by fever, rash, or persistent headache.

Shake the bottle well before each use.

Note that the formulation contains ethanol and sucrose; consider this in patients with relevant contraindications.

Adverse Reactions

From the cardiovascular system tachycardia, extrasystole, increased blood pressure.

From the central nervous system tremor, agitation, insomnia, dizziness, in children – drowsiness.

From the sensory organs visual impairment.

From the digestive system nausea, vomiting, anorexia, constipation.

From the endocrine system increased libido, dysmenorrhea.

From the urinary system difficulty urinating, urinary retention in patients with prostatic hyperplasia.

Dermatological reactions rash, increased sweating.

Other tachyphylaxis.

Contraindications

• Arterial hypertension;
• Ischemic heart disease;
• Severe organic heart diseases;
• Heart failure;
• Pheochromocytoma;
• Thyrotoxicosis;
• Insomnia;
• Closed-angle glaucoma;
• Prostatic hyperplasia with clinical manifestations;
• First trimester of pregnancy;
• Lactation period (breastfeeding);
• Children under 3 years of age;
• Hypersensitivity to the components of the drug used.

With caution

Patients with a tendency to develop drug dependence. The dosage form contains ethanol, so caution should be exercised when prescribing the drug to children, patients with liver diseases, chronic alcoholism, epilepsy, brain diseases, and in the second and third trimesters of pregnancy.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy and during breastfeeding.

During other periods of pregnancy, this agent should be used with caution.

Use in Hepatic Impairment

Broncholytin^® should be prescribed with caution to patients with liver diseases.

Pediatric Use

Contraindication: children under 3 years of age.

Special Precautions

It should be taken into account that the dosage form contains ethanol.

Effect on the ability to drive vehicles and machinery

Due to the possible occurrence of dizziness and visual disturbances, caution should be exercised when performing work requiring increased attention and speed of psychomotor reactions, including when driving vehicles and operating machinery.

Drug Interactions

This agent can be used simultaneously with antibiotics, antipyretics, and vitamins.

Ephedrine weakens the effect of opioid analgesics and hypnotics.

When ephedrine is used simultaneously with cardiac glycosides, quinidine, tricyclic antidepressants, the risk of arrhythmias increases.

With the simultaneous use of ephedrine with reserpine and MAO inhibitors, a sharp increase in blood pressure is possible.

With the simultaneous use of ephedrine with non-selective beta-blockers, a decrease in the bronchodilatory effect is possible.

There are no data on the drug interaction of glaucine with other medicinal products.

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.