Bronchitussen^® Vramed (Syrup) Instructions for Use

Marketing Authorization Holder

Unipharm, AD (Bulgaria)

Manufactured By

Unipharm, AD (Bulgaria)

Quality Control Release

SOFARMA, AO (Bulgaria)

ATC Code

R05DB20 (Other antitussive drugs in combination)

Active Substances

Ephedrine (BAN)

Glaucine (BP)

Dosage Form

Bronchitussen® Vramed

Syrup 5 mg+4 mg/5 g: 125 g bottle with a measuring spoon or cup

Dosage Form, Packaging, and Composition

Syrup is a viscous liquid from transparent to slightly opalescent, from light yellow to yellow-green or light brown in color, with a specific smell of basil oil.

Excipients: basil oil – 0.005 g, citric acid anhydride – 0.005 g, sucrose – 1.75 g, methylparahydroxybenzoate – 0.006 g, propylparahydroxybenzoate – 0.001 g, polysorbate 80 – 0.05 g, ethanol 96% (1.7% vol.) – 0.06 g, purified water – up to 5 g.

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

Clinical-Pharmacological Group

A drug with antitussive and bronchodilator action

Pharmacotherapeutic Group

Combined antitussive agent (centrally acting antitussive agent + sympathomimetic agent)

Pharmacological Action

A drug with antitussive and bronchodilator action.

Glaucine is a centrally acting antitussive agent that suppresses the cough center but does not have a depressant effect on the respiratory center.

Ephedrine is a sympathomimetic agent that has a bronchodilator effect and reduces swelling of the upper respiratory tract mucosa.

Basil essential oil has a mild sedative and antiseptic effect and suppresses the cough reflex.

Indications

Respiratory diseases in adults and children over 3 years of age

• Acute and chronic tracheobronchitis and bronchitis;
• Bronchial asthma;
• Whooping cough.

ICD codes

Dosage Regimen

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

For adults, take one tablespoon (15 ml) three to four times daily.

For children over 3 years and up to 10 years, take one teaspoon (5 ml) three times daily.

For children over 10 years, take two teaspoons (10 ml) three times daily.

Maintain intervals of approximately 4-6 hours between doses.

Do not exceed the recommended daily frequency or the stated single dose for the respective age group.

The maximum daily dose for adults is four tablespoons (60 ml).

The maximum daily dose for children over 10 years is six teaspoons (30 ml).

The maximum daily dose for children aged 3 to 10 years is three teaspoons (15 ml).

The duration of treatment is determined by the physician based on clinical response.

This medication is contraindicated for children under 3 years of age.

Adverse Reactions

The drug increases heart rate and blood pressure, inhibits intestinal peristalsis, dilates pupils, stimulates the central nervous system (mental and motor restlessness), and reduces appetite.

Drowsiness is possible in children.

Contraindications

• Hypersensitivity to the components of the drug;
• Angina pectoris;
• Atherosclerosis;
• Heart failure;
• Arterial hypertension;
• Arrhythmias;
• Glaucoma;
• Diabetes mellitus;
• Thyrotoxicosis;
• Prostate adenoma;
• Insomnia;
• Pregnancy;
• Lactation period.

Use in Pregnancy and Lactation

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

Pediatric Use

For children over 3 years and up to 10 years – 1 teaspoon 3 times/day; for children over 10 years – 2 teaspoons 3 times/day.

Overdose

Overdose may cause nausea, vomiting, central nervous system excitation, insomnia, and loss of appetite.

Treatment: gastric lavage, followed by symptomatic therapy.

Drug Interactions

Combined treatment

• With insulin and oral hypoglycemic agents may reduce the effect of antidiabetic drugs;
• With guanethidine (an antihypertensive agent) increases the risk of cardiac arrhythmias;
• With MAO inhibitors, antidepressants – arrhythmia, headache, hypertensive crisis, acute cerebrovascular accident are possible.

Storage Conditions

In places protected from light and out of reach of children, at a temperature of 15-30°C (59-86°F).

Shelf Life

The shelf life is 4 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

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.