Orvitol^® NP (Capsules) Instructions for Use

Marketing Authorization Holder

Natur Produkt Europe, B.V. (Netherlands)

Manufactured By

Herkel B.V. (Netherlands)

Quality Control Release

NATUR PRODUKT EUROPE, B.V. (Netherlands)

ATC Code

J05AX (Other antiviral drugs)

Active Substance

Umifenovir (Rec.INN WHO registered)

Dosage Forms

	Orvitol® NP	Capsules 50 mg: 10, 20, 30 or 40 pcs.
		Capsules 100 mg: 10, 20, 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Capsules colorless transparent size No. 3. The capsule contents are a white powder with a shade ranging from creamy to grayish-beige.

Excipients: calcium hydrogen phosphate dihydrate 9.275 mg, magnesium stearate 1.3 mg, microcrystalline cellulose 56.625 g, colloidal silicon dioxide 1.05 mg.

10 pcs. – PVC/Aluminum blisters (1) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (2) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (3) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (4) – cardboard packs.

Capsules colorless transparent size No. 1. The capsule contents are a white powder with a shade ranging from creamy to grayish-beige.

Excipients: calcium hydrogen phosphate dihydrate 18.445 mg, magnesium stearate 2.615 mg, microcrystalline cellulose 113.245 g, colloidal silicon dioxide 2.095 mg.

10 pcs. – PVC/Aluminum blisters (1) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (2) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (3) – cardboard packs.
10 pcs. – PVC/Aluminum blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Antiviral agent

Pharmacological Action

Antiviral agent, has immunomodulatory and anti-influenza action, specifically suppresses influenza A and B viruses, severe acute respiratory syndrome (SARS).

The antiviral action is due to the suppression of the fusion of the virus lipid envelope with cell membranes upon virus contact with the cell.

Has interferon-inducing properties, stimulates humoral and cellular immune responses, the phagocytic function of macrophages, increases the body’s resistance to viral infections.

Therapeutic efficacy, due to the suppression of influenza and ARVI viruses, is manifested in a reduction in the severity of intoxication and catarrhal phenomena, the duration of fever, and the overall duration of the disease.

Prevents the development of post-influenza complications, reduces the frequency of exacerbations of chronic bacterial diseases.

Pharmacokinetics

Absorption is rapid. Rapidly distributed to organs and tissues. T_max when taken at a dose of 50 mg is 1.2 h, 100 mg is 1.5 h. Metabolized in the liver. T_1/2 is 17-21 h. About 40% is excreted unchanged, mainly through the intestine (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, ARVI (including those complicated by bronchitis, pneumonia); secondary immunodeficiency states, severe acute respiratory syndrome (SARS);
• Complex therapy of chronic bronchitis, pneumonia, and recurrent herpetic infection;
• Prevention of postoperative infectious complications and normalization of immune status in adults;
• As part of complex therapy for acute intestinal infections of rotavirus etiology in children over 3 years (50 mg) and children over 6 years (100 mg).

ICD codes

Dosage Regimen

Orally, before meals.

For non-specific prophylaxis

• in case of direct contact with patients with influenza and other ARVIchildren from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg once a day for 10-14 days;
• during the epidemic of influenza and other ARVI, to prevent exacerbations of chronic bronchitis, recurrence of herpetic infectionchildren from 3 to 6 years – 50 mg, from 6 to 12 years -100 mg, over 12 years and adults – 200 mg twice a week for 3 weeks.

For treatment

• influenza, other ARVI without complicationschildren from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days;
• influenza, other ARVI with the development of complications (bronchitis, pneumonia, etc.)children from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 3 times a day for 5 days, then a single dose once a week for 3-4 weeks.

In complex therapy of chronic bronchitis, herpetic infectionchildren from 3 to 6 years – 50 mg, from 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 3 times a day for 5 days, then a single dose twice a week for 3-4 weeks.

Prevention of postoperative complicationsadults – 200 mg 2 days before surgery, then 200 mg on the 2nd and 5th day after surgery.

As part of complex therapy for acute intestinal infections of rotavirus etiologychildren over 12 years and adults are prescribed 200 mg 4 times a day (every 6 h) for 5 days, aged from 6 to 12 years – 100 mg 4 times a day (every 6 h) for 5 days, aged from 3 to 6 years – 50 mg 4 times a day (every 6 h) for 5 days.

Adverse Reactions

Rarely allergic reactions.

Contraindications

• Children’s age (under 3 years);
• Pregnancy and lactation period;
• Hypersensitivity.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 3 years.

Special Precautions

Does not exhibit central neurotropic activity, taking the drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

No negative effects were noted when prescribed with other medicinal products.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children!

Shelf Life

Shelf life – 3 years.

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.