Idebenon (Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

N06BX13 (Idebenone)

Active Substance

Idebenone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A nootropic agent with a metabolic action. It enhances metabolic processes in the brain by activating the synthesis of glucose and ATP, improves blood supply and oxygenation of brain tissues, and promotes the elimination of lactates; it 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 action is manifested; the nootropic effect appears after 3-4 weeks of use.

Pharmacokinetics

Absorption is rapid and high; T_max 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; cerebrasthenic 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

Open the list of 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.

Administer orally as capsules.

Take 30 mg two to three times daily.

Always take doses after meals to improve tolerability.

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

The standard course of treatment is 1.5 to 2 months.

If clinically required, repeat the treatment course two to three times per year.

Do not exceed the prescribed daily dosage.

For long-term therapy, adhere to the prescribed intervals between treatment courses.

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 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

Idebenon [Canonpharma Production, CJS (Russia)]
Capsules 30 mg: 10, 15, 20, 30, 60 or 120 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Idebenone

Capsules 30 mg: 10, 15, 20, 30, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules	1 caps.
Idebenone	30 mg

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (20) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
15 pcs. – blister packs (1) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (8) – cardboard packs.

Idebenon [Canonpharma Production, CJS (Russia)]
Capsules 45 mg: 10, 15, 20, 30, 60 or 120 pcs.