Bellataminal^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

Contact Information

Pharmtsentr Vilar JSC (Russia)

ATC Code

N05CB02 (Barbiturates in combination with other drugs)

Dosage Form

Bellataminal®

Film-coated tablets 100 mcg+300 mcg+20 mg: 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light yellow in color, biconvex in shape.

Excipients: refined sugar, potato starch, povidone (polyvinylpyrrolidone), calcium stearate.

Shell composition: refined sugar, colloidal silicon dioxide (Aerosil A-380), magnesium hydroxycarbonate (basic magnesium carbonate), titanium dioxide, gelatin, beeswax, tropaeolin O.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Sedative

Pharmacological Action

Combined drug. It has alpha-adrenergic blocking, m-cholinolytic, and sedative effects.

Indications

• Increased irritability;
• Insomnia;
• Neurogenic menstrual cycle disorders;
• Neurodermatitis (to relieve itching);
• Vegetative-vascular dystonia (as part of complex therapy).

ICD codes

Dosage Regimen

Take the drug orally, after meals.

For adults, the standard dose is 1 tablet taken 2-3 times per day.

The maximum daily dose is 3 tablets.

The typical treatment duration is from 2 to 4 weeks.

Do not exceed the prescribed dosage or duration of treatment.

Adjust the frequency of administration based on individual tolerance and therapeutic response.

Take the last dose of the day in the evening to manage insomnia and increased irritability.

For neurogenic menstrual cycle disorders, initiate treatment several days before the expected onset of symptoms.

In cases of neurodermatitis, use the drug to relieve itching as part of a comprehensive treatment plan.

For vegetative-vascular dystonia, use only as a component of complex therapy.

Do not use in children and adolescents under 18 years of age.

Conduct repeated courses of treatment only after consultation with a doctor.

Discontinue use and seek medical advice if severe adverse reactions occur.

Adverse Reactions

Possible allergic reactions, dry mouth, drowsiness, accommodation paresis.

Contraindications

• Angina pectoris and other severe manifestations of atherosclerosis;
• Spasm of peripheral arteries;
• Closed-angle glaucoma;
• Pregnancy;
• Breastfeeding;
• Childbirth;
• Age under 18 years;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor reactions, and good vision.

Overdose

Symptoms: dizziness, lethargy, drowsiness, tachycardia, dilated pupils, impaired accommodation, difficulty urinating, intestinal atony, convulsions; in severe cases – stupor, coma.

Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.

Drug Interactions

The effect of the drug is enhanced by alpha- and beta-adrenergic agonists, nicotine.

Storage Conditions

List B. The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is 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.