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Nobazit® (Tablets, Capsules) Instructions for Use

ATC Code

J05AX17 (Enisamium iodide)

Active Substance

Enisamium iodide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug. Interferon synthesis inducer

Pharmacotherapeutic Group

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

Pharmacological Action

Antiviral agent, a derivative of isonicotinic acid. It effectively suppresses the action of influenza viruses and other pathogens of acute respiratory viral infections (ARVI) due to a direct (inhibitory) effect on the process of virus penetration through the cell membrane.

It has interferonogenic properties, promotes an increase in the concentration of endogenous interferon (interferon alpha and interferon gamma) in blood plasma by 3-4 times.

It increases the body’s resistance to viral infections.

It reduces the acute clinical manifestations of viral intoxication and helps to shorten the duration of the disease.

Pharmacokinetics

Absorption

After oral administration, it quickly enters the blood; Cmax in the blood is observed 2-2.5 hours after administration.

Metabolism and Excretion

Enisamium iodide and its metabolites circulate in the bloodstream for a long time (T1/2 is 13.5-14 hours), are metabolized in the liver and are rapidly eliminated from tissues (T1/2 is 2-3 hours). It is excreted 90-95% in the urine as metabolites.

Indications

Treatment of influenza and other acute respiratory viral infections (ARVI), including as part of complex therapy.

ICD codes

ICD-10 code Indication
J06.9 Acute upper respiratory infection, unspecified
J10 Influenza due to identified seasonal influenza virus
ICD-11 code Indication
1E30 Influenza due to identified seasonal influenza virus
CA07.0 Acute upper respiratory tract infection of unspecified site

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take orally with a sufficient amount of water.

Initiate treatment at the first signs of influenza or other acute respiratory viral infection (ARVI).

For adults and adolescents aged 18 years and older, the standard dosage is one 125 mg tablet or capsule four times daily.

Maintain a regular dosing schedule, approximately every 6 hours.

The standard course of treatment is 5 days.

Continue the full course even if symptoms improve earlier to ensure complete viral suppression.

Do not exceed the recommended daily dose of 500 mg (four tablets/capsules).

If a dose is missed, take it as soon as remembered; if it is almost time for the next dose, skip the missed dose and resume the regular schedule.

Do not double the dose to compensate for a missed one.

The duration of therapy can be adjusted by a physician based on the clinical response and severity of the infection.

Use only in patients for whom the product is indicated and who have no contraindications.

Adverse Reactions

Allergic reactions hypersensitivity reactions, including skin rash, urticaria, angioedema, itching.

From the digestive system dry mouth and bitter taste, swelling of the oral mucosa, hypersalivation, yellow staining of the tongue, nausea, vomiting, heartburn, abdominal pain, heaviness in the right hypochondrium, diarrhea, flatulence.

From the respiratory system shortness of breath, throat irritation.

In the post-registration period the following adverse reactions were reported in isolated cases: headache, dizziness, weakness, blood pressure fluctuations.

Contraindications

History of allergic reactions regardless of the nature of the allergen; severe organic lesions of the liver and kidneys; pregnancy; lactation (breastfeeding) period; age under 18 years; hypersensitivity to enisamium iodide.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Not recommended for use in severe liver dysfunction.

Use in Renal Impairment

Not recommended for use in severe renal dysfunction.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

There are no specific restrictions for use.

Special Precautions

Should be used with caution in patients with thyroid diseases, especially with hyperthyroidism.

Drug Interactions

Enhances the effect of antibacterial and immunomodulatory agents.

Combination with ascorbic acid and other vitamins is advisable.

Can be prescribed simultaneously with recombinant interferon.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Or

Avexima Siberia LLC (Russia)

Dosage Form

Bottle OTC Icon Nobazit® Film-coated tablets, 500 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, oblong, biconvex, with a score on one side; on the cross-section: from light yellow to yellow or yellow with a greenish tint.

1 tab.
Enisamium iodide (methylbenzylcarbamidopyridinium iodide) 500 mg

Excipients: lactose monohydrate – 133.6 mg, microcrystalline cellulose 101 – 40 mg, sucrose – 36 mg, povidone K17 – 14.4 mg, copovidone – 5.6 mg, crospovidone – 15.2 mg, talc – 7.6 mg, calcium stearate – 7.6 mg.

Shell composition Aquarius Prime BAN314047 Yellow – 24 mg (hypromellose – 15.84 mg, titanium dioxide – 5.3748 mg, caprylic/capric triglyceride – 2.16 mg, yellow iron oxide dye – 0.168 mg, red iron oxide dye – 0.0012 mg, quinoline yellow dye – 0.456 mg).

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Nobazit® Capsules 500 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 00, opaque, white body, red cap; capsule contents – powder yellow or yellow with a greenish tint; white inclusions are allowed.

1 caps.
Enisamium iodide 500 mg

Excipients: lactose monohydrate – 144 mg, talc – 6.6 mg, colloidal silicon dioxide – 3.4 mg, calcium stearate – 6 mg.

Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Cap composition titanium dioxide – 2.5%, crimson dye (Ponceau 4R) – 1.36%, red iron oxide dye – 0.85%, gelatin – up to 100%.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Or

Avexima Siberia LLC (Russia)

Dosage Forms

Bottle OTC Icon Nobazit® Capsules 125 mg: 10, 20, 30, 40, 50 or 60 pcs.
Capsules 250 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 3, opaque, body and cap orange; capsule contents – powder yellow or yellow with a greenish tint; white inclusions are allowed.

1 caps.
Enisamium iodide 125 mg

Excipients: lactose monohydrate – 36 mg, talc – 1.65 mg, colloidal silicon dioxide – 0.85 mg, calcium stearate – 1.5 mg.

Capsule shell composition (body and cap) titanium dioxide (E171) – 1.3333%, sunset yellow dye (E122) – 0.4418%, gelatin – up to 100%.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

Capsules hard gelatin, size 1, opaque, body and cap orange; capsule contents – powder yellow or yellow with a greenish tint; white inclusions are allowed.

1 caps.
Enisamium iodide 250 mg

Excipients: lactose monohydrate – 72 mg, talc – 3.3 mg, colloidal silicon dioxide – 1.7 mg, calcium stearate – 3 mg.

Capsule shell composition (body and cap) titanium dioxide (E171) – 1.3333%, sunset yellow dye (E122) – 0.4418%, gelatin – up to 100%.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Or

Avexima Siberia LLC (Russia)

Dosage Forms

Bottle Rx Icon Nobazit® Film-coated tablets, 125 mg: 10 or 20 pcs.
Film-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; on the cross-section, the core is from light yellow to yellow or yellow with a greenish tint.

1 tab.
Enisamium iodide (calculated as 100% anhydrous substance) 125 mg

Excipients: lactose monohydrate – 33.4 mg, microcrystalline cellulose 101 – 10 mg, sucrose (sugar) – 9 mg, povidone K-17 (plasdone K-17) – 3.6 mg, copovidone (plasdone S-630) – 1.4 mg, crospovidone (polyplasdone XL-10) – 3.8 mg, talc – 1.9 mg, calcium stearate – 1.9 mg.

Film coating composition Aquarius Prime BAN314047 Yellow – 6 mg (hypromellose – 3.96 mg, titanium dioxide – 1.3437 mg, caprylic/capric triglyceride – 0.54 mg, yellow iron oxide dye – 0.042 mg, red iron oxide dye – 0.0003 mg, quinoline yellow dye – 0.114 mg).

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.

Film-coated tablets yellow, round, biconvex; on the cross-section, the core is from light yellow to yellow or yellow with a greenish tint.

1 tab.
Enisamium iodide (calculated as 100% anhydrous substance) 250 mg

Excipients: lactose monohydrate – 66.8 mg, microcrystalline cellulose 101 – 20 mg, sucrose (sugar) – 18 mg, povidone K-17 (plasdone K-17) – 7.2 mg, copovidone (plasdone S-630) – 2.8 mg, crospovidone (polyplasdone XL-10) – 7.6 mg, talc – 3.8 mg, calcium stearate – 3.8 mg.

Film coating composition Aquarius Prime BAN314047 Yellow – 12 mg (hypromellose – 7.92 mg, titanium dioxide – 2.6874 mg, caprylic/capric triglyceride – 1.08 mg, yellow iron oxide dye – 0.084 mg, red iron oxide dye – 0.0006 mg, quinoline yellow dye – 0.228 mg).

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Nobazit® Forte Capsules 500 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 00, opaque, white body, red cap; capsule contents – powder yellow or yellow with a greenish tint; white inclusions are allowed.

1 caps.
Enisamium iodide 500 mg

Excipients: lactose monohydrate, talc, colloidal silicon dioxide, calcium stearate.

Capsule body composition: titanium dioxide, gelatin.
Capsule cap composition titanium dioxide, crimson dye (Ponceau 4R), red iron oxide dye, gelatin.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Or

Avexima Siberia LLC (Russia)

Dosage Forms

Bottle Rx Icon Nobazit® Pro Film-coated tablets, 125 mg: 10 or 20 pcs.
Film-coated tablets, 250 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; on the cross-section, the core is from light yellow to yellow or yellow with a greenish tint.

1 tab.
Enisamium iodide (calculated as 100% anhydrous substance) 125 mg

Excipients: lactose monohydrate – 33.4 mg, microcrystalline cellulose 101 – 10 mg, sucrose (sugar) – 9 mg, povidone K-17 (plasdone K-17) – 3.6 mg, copovidone (plasdone S-630) – 1.4 mg, crospovidone (polyplasdone XL-10) – 3.8 mg, talc – 1.9 mg, calcium stearate – 1.9 mg.

Film coating composition Aquarius Prime BAN314047 Yellow – 6 mg (hypromellose – 3.96 mg, titanium dioxide – 1.3437 mg, caprylic/capric triglyceride – 0.54 mg, yellow iron oxide dye – 0.042 mg, red iron oxide dye – 0.0003 mg, quinoline yellow dye – 0.114 mg).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Film-coated tablets yellow in color, round, biconvex; on the cross-section, the core is from light yellow to yellow or yellow with a greenish tint.

1 tab.
Enisamium iodide (calculated as 100% anhydrous substance) 250 mg

Excipients: lactose monohydrate – 66.8 mg, microcrystalline cellulose 101 – 20 mg, sucrose (sugar) – 18 mg, povidone K-17 (plasdone K-17) – 7.2 mg, copovidone (plasdone S-630) – 2.8 mg, crospovidone (polyplasdone XL-10) – 7.6 mg, talc – 3.8 mg, calcium stearate – 3.8 mg.

Film coating composition Aquarius Prime BAN314047 Yellow – 12 mg (hypromellose – 7.92 mg, titanium dioxide – 2.6874 mg, caprylic/capric triglyceride – 1.08 mg, yellow iron oxide dye – 0.084 mg, red iron oxide dye – 0.0006 mg, quinoline yellow dye – 0.228 mg).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

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