Barboval (Drops) Instructions for Use

Marketing Authorization Holder

Farmak, JSC (Ukraine)

ATC Code

N05CB02 (Barbiturates in combination with other drugs)

Dosage Form

Barboval

Oral drops: 25, 30, or 50 ml dropper bottle.

Dosage Form, Packaging, and Composition

25 ml – dark glass dropper bottle (1) – cardboard packs.
30 ml – dark glass dropper bottle (1) – cardboard packs.
50 ml – dark glass dropper bottle (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Reflex-acting coronary dilator

Pharmacological Action

A combined drug that exerts coronary dilating, sedative, hypotensive, and antispasmodic action, and slows gastric and intestinal peristalsis.

Indications

• Neuroses (irritability, insomnia); hysteria.
• Angina pectoris; mild arterial hypertension; tachycardia (not associated with heart failure).
• Intestinal colic; flatulence.

ICD codes

Dosage Regimen

Administer orally with a small amount of water or sublingually on a piece of sugar.

For adults, use 10-15 drops per dose. For severe conditions, a single dose may be increased to 20-25 drops.

Take the drops 2-3 times per day. Adjust the frequency based on the severity of symptoms and individual patient response.

Limit the total duration of treatment to 10-15 days. Do not exceed this course without consulting a physician.

For sublingual administration, place the prescribed number of drops directly under the tongue or on a sugar cube and allow to dissolve completely.

Use the dropper provided with the bottle to ensure accurate dosing. Hold the dropper vertically for correct measurement.

Avoid operating vehicles or machinery after taking the drug due to potential drowsiness and dizziness.

Discontinue use and seek medical advice if symptoms persist or if adverse reactions occur.

Adverse Reactions

Monitor for drowsiness and dizziness.

Discontinue use immediately upon the appearance of any allergic reactions.

Drug Interactions

Exercise caution with concomitant use of other central nervous system depressants, including alcohol, as effects may be potentiated.

Be aware that phenobarbital is a known enzyme inducer and may accelerate the metabolism of other concurrently administered drugs, potentially reducing their therapeutic efficacy.

Contraindications

• Hypersensitivity to phenobarbital, menthol, bromisoval, or any other component of the combination.
• Severe hepatic or renal impairment.
• Porphyria.
• Severe respiratory insufficiency or conditions with depressed respiration.
• Myasthenia gravis.
• History of drug or alcohol dependence.

Overdose

Recognize symptoms of overdose, which include severe central nervous system depression, coma, hypotension, shallow breathing, and cardiac and respiratory failure.

Seek immediate medical attention. Treatment is supportive and may include gastric lavage, maintenance of vital functions, and monitoring of cardiovascular and respiratory status.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

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

Over-the-Counter

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.