Mastodon

Neiromet (Capsules) Instructions for Use

ATC Code

N06BX13 (Idebenone)

Active Substance

Idebenone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Nootropic agent with metabolic action. It enhances metabolic processes in the brain by activating the synthesis of glucose and ATP, improves blood supply and tissue oxygenation of the brain, 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; Tmax is 4 hours. It penetrates the blood-brain barrier in significant amounts and is distributed in brain tissues.

It does not accumulate. It is 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 disorders, decreased intellectual productivity and general activity, emotional lability; asthenic and astheno-depressive syndrome, moderately severe depressive syndrome; dizziness, tinnitus.

ICD codes

ICD-10 code Indication
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F31 Bipolar affective disorder
F32 Depressive episode
F33 Recurrent depressive disorder
F41.2 Mixed anxiety and depressive disorder
F48.0 Neurasthenia
H93.1 Tinnitus (subjective)
I67.2 Cerebral atherosclerosis
I69 Sequelae of cerebrovascular diseases
R42 Dizziness and giddiness
T90 Sequelae of injuries of head
ICD-11 code Indication
6A60.Z Bipolar type I disorder, unspecified
6A61.Z Bipolar type II disorder, unspecified
6A6Z Bipolar or similar disorder, unspecified
6A70.Z Single episode depressive disorder, unspecified
6A71.Z Recurrent depressive disorder, unspecified
6A73 Mixed depressive and anxiety disorder
6A8Z Affective disorders, unspecified
6C9Z Disruptive behavior or dissocial disorders, unspecified
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
8B25.Z Sequelae of cerebrovascular disease, unspecified
BD55 Asymptomatic stenosis of intracranial or extracranial artery
MB48.Z Dizziness and giddiness, unspecified
MC41 Tinnitus
NA0Z Head injury, unspecified

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 the capsules orally with water.

Administer the drug after meals to improve tolerability.

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

Do not exceed the maximum daily dose of 90 mg.

Take the last dose of the day before 5 p.m. to prevent potential sleep disturbances.

The standard course of treatment is 1.5 to 2 months.

If clinically indicated, repeat the course; a maximum of two to three treatment courses per year are permitted.

Adhere strictly to the prescribed dosage and duration of therapy.

Do not adjust the regimen without consulting your physician.

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

Influence on the ability to drive vehicles and mechanisms

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

Medical Disclaimer

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

Marketing Authorization Holder

Veropharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Neiromet Capsules 30 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Idebenone 30 mg

10 pcs. – blister packs (1) – cardboard packs.

Marketing Authorization Holder

Veropharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Neiromet Capsules 45 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Idebenone 45 mg

10 pcs. – blister packs (1) – cardboard packs.

TABLE OF CONTENTS