Celestab^® (Capsules) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

ATC Code

N06BX13 (Idebenone)

Active Substance

Idebenone (Rec.INN registered by WHO)

Dosage Form

Celestab®

Capsules 45 mg: 10, 15, 20, 30, 40, 45, 60, 90, 120, or 180 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size №1, with a yellow body and cap; the capsule contents are a mixture of powder and granules from yellow to yellow-orange in color.

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, crospovidone, povidone K30, magnesium stearate.

Composition of the capsule body and cap: titanium dioxide, quinoline yellow dye, sunset yellow FCF dye, gelatin.

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

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A nootropic agent with 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 tissue, 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.

Antiasthenic, psychostimulant, and antidepressant effects are evident from the first days of administration; the nootropic effect manifests 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 impairments, decreased intellectual productivity and general activity, emotional lability; asthenic and astheno-depressive syndrome, moderately expressed depressive syndrome; dizziness, tinnitus.

ICD codes

Dosage Regimen

Take Celestab^®orally with a full glass of water.

Administer the capsules after meals to minimize potential gastrointestinal discomfort.

The standard adult dosage is 30 mg two to three times daily (one 45 mg capsule provides a 30 mg dose of Idebenone).

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

The typical treatment course is 1.5 to 2 months.

If clinically required, repeat treatment with two to three courses per year, as determined by a physician.

Do not exceed the prescribed dosage or duration of treatment.

Swallow the capsule whole; do not chew or crush.

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 machinery

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