Novobenone (Capsules) Instructions for Use

Marketing Authorization Holder

Time Pharm, LLC (Russia)

Manufactured By

Pharmproekt, JSC (Russia)

ATC Code

N06BX13 (Idebenone)

Active Substance

Idebenone (Rec.INN registered by WHO)

Dosage Form

Novobenone

Capsules 30 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules No. 1, yellow, gelatin, hard, opaque; the capsule contents are granules containing pellets and a powder of yellow or yellow-orange color with inclusions ranging from light yellow to orange, white inclusions are allowed.

Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, povidone K17, magnesium stearate.

Capsule shell components: gelatin, titanium dioxide [E171], quinoline yellow dye [E104], sunset yellow FCF dye [E110].

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic drugs; other psychostimulants and nootropic drugs

Pharmacological Action

Nootropic agent, has a metabolic effect. It enhances metabolic processes in the brain by activating the synthesis of glucose and ATP, improves blood supply and oxygenation of brain tissues, promotes the elimination of lactates; increases the intensity and speed of neurophysiological reactions of brain structures.

By slowing down lipid peroxidation, it protects neuronal and mitochondrial membranes from damage.

From the first days of administration, an antiasthenic, psychostimulant, and antidepressant effect is manifested; the nootropic effect appears after 3-4 weeks of administration.

Pharmacokinetics

Absorption is rapid and high; T_max is 4 hours. Penetrates the blood-brain barrier in significant amounts and is distributed in brain tissues. Does not accumulate. Excreted by the kidneys.

Indications

Psycho-organic syndrome against the background of cerebrovascular disorders and age-related involutional changes of the brain; cerebroasthenic disorders of vascular, traumatic, psychogenic (neurasthenia) etiology: memory and/or attention impairments, decreased intellectual productivity and general activity, emotional lability; asthenic and astheno-depressive syndrome, moderately severe depressive syndrome; dizziness, tinnitus.

ICD codes

Dosage Regimen

Take orally. The standard adult dosage is 30 mg taken two to three times daily.

Administer each dose after meals to improve gastrointestinal tolerance.

Take the last daily dose before 5 p.m. to minimize the risk of sleep onset disturbances.

The standard course of treatment is 1.5 to 2 months.

If clinically required, repeat courses may be conducted. The recommended frequency is two to three courses per year.

Do not exceed the prescribed dosage or duration of treatment.

Adverse Reactions

From the central nervous system: sleep onset disturbance, mental agitation, headache.

Other: dyspepsia, allergic reactions.

Contraindications

Chronic renal failure, hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Special Precautions

Effect on the ability to drive vehicles and operate machinery

Do not take while working for vehicle drivers and patients whose profession requires high concentration and speed of psychomotor reactions.

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

Rx Only

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.