Afludol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

ATC Code

J05AX13 (Umifenovir)

Active Substance

Umifenovir (Rec.INN WHO registered)

Dosage Forms

	Afludol®	Film-coated tablets, 50 mg: 10, 12, 20, 24, 30, 36, 40 or 48 pcs.
		Film-coated tablets, 100 mg: 10, 12, 20, 24, 30, 36, 40 or 48 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is from white to white with a greenish-yellowish or brownish tint; surface roughness of the tablets is allowed.

Excipients: lactose monohydrate, povidone K-25, crospovidone, colloidal silicon dioxide (aerosil), magnesium stearate.

Shell composition Opadry II white (OY-L-28900) [lactose monohydrate, hypromellose, titanium dioxide, macrogol/PEG].

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
12 pcs. – contour cell packaging (1) – cardboard packs.
12 pcs. – contour cell packaging (2) – cardboard packs.
12 pcs. – contour cell packaging (3) – cardboard packs.
12 pcs. – contour cell packaging (4) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is from white to white with a greenish-yellowish or brownish tint; surface roughness of the tablets is allowed.

Excipients: lactose monohydrate, povidone K-25, crospovidone, colloidal silicon dioxide (aerosil), magnesium stearate.

Shell composition Opadry II white (OY-L-28900) [lactose monohydrate, hypromellose, titanium dioxide, macrogol/PEG].

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
12 pcs. – contour cell packaging (1) – cardboard packs.
12 pcs. – contour cell packaging (2) – cardboard packs.
12 pcs. – contour cell packaging (3) – cardboard packs.
12 pcs. – contour cell packaging (4) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; other antiviral agents

Pharmacological Action

Antiviral agent. Specifically suppresses influenza A and B viruses, coronavirus associated with severe acute respiratory syndrome. By the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the viral lipid envelope and cell membranes.

It has a moderate immunomodulatory effect. It has interferon-inducing activity, stimulates humoral and cellular immune responses, the phagocytic function of macrophages, and increases the body’s resistance to viral infections. Reduces the frequency of complications associated with viral infection, as well as exacerbations of chronic bacterial diseases.

Therapeutic efficacy in viral infections is manifested in a reduction in the severity of general intoxication and clinical phenomena, a reduction in the duration of the disease, and a decrease in the risk of complications.

It belongs to low-toxicity compounds (LD₅₀ >4 g/kg). It does not have any negative effects on the human body when taken orally in recommended doses.

Pharmacokinetics

Rapidly absorbed and distributed to organs and tissues. C_max in blood plasma when taken at a dose of 50 mg is reached after 1.2 hours, at a dose of 100 mg – after 1.5 hours.

Metabolized in the liver. T_1/2 is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%). 90% of the administered dose is excreted within the first 24 hours.

Indications

Prevention and treatment in adults and children: influenza A and B, acute respiratory viral infections, severe acute respiratory syndrome (including those complicated by bronchitis, pneumonia); secondary immunodeficiency states; complex therapy of chronic bronchitis, pneumonia and recurrent herpetic infection.

Prevention of postoperative infectious complications and normalization of immune status.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years of age.

ICD codes

Dosage Regimen

Take orally before a meal.

For treatment of influenza and other acute respiratory viral infections in adults and children over 12 years, administer a single dose of 200 mg four times daily for 5 days.

For children aged 6 to 12 years, administer a single dose of 100 mg four times daily for 5 days.

For children aged 3 to 6 years, administer a single dose of 50 mg four times daily for 5 days.

For post-exposure prophylaxis after contact with a sick person, administer the age-specific single dose once daily for 10-14 days.

For seasonal prophylaxis during an epidemic, administer the age-specific single dose twice weekly for 3 weeks.

For complex therapy of chronic bronchitis, pneumonia, or herpetic infection, use the treatment dosage for 5-7 days, then reduce to a single dose twice weekly for 4 weeks.

For prevention of postoperative complications, administer 200 mg two days before surgery, then on the day of surgery and for two days after.

For treatment of acute intestinal rotavirus infections in children over 3 years, use the standard 5-day treatment regimen appropriate for the child’s age.

Adhere strictly to the prescribed duration of therapy; do not exceed the recommended course.

Adverse Reactions

Rarely allergic reactions.

Contraindications

Children under 3 years of age; hypersensitivity to umifenovir.

Special Precautions

It does not exhibit central neurotropic activity and can be used in medical practice for preventive purposes in practically healthy individuals of various professions, including those requiring increased attention and coordination of movements (vehicle drivers, operators, etc.).

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.