Noben^® (Capsules) Instructions for Use

Marketing Authorization Holder

Abbott Laboratories, LLC (Russia)

Manufactured By

Aliym, JSC (Russia)

Contact Information

ABBOTT LABORATORIES LLC (Russia)

ATC Code

N06BX13 (Idebenone)

Active Substance

Idebenone (Rec.INN registered by WHO)

Dosage Form

Noben®

Capsules 30 mg: 10, 20, 30, 60, 90 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No.1, yellow; capsule contents – powder with granules or powder of yellow or yellow-orange color with inclusions ranging from light yellow to orange, white inclusions are allowed.

Excipients :

Capsule contents lactose monohydrate – 102 mg, microcrystalline cellulose (type 101), potato starch, povidone (low molecular weight medical polyvinylpyrrolidone or plasdone) (K17), magnesium stearate.

Capsule shell composition titanium dioxide (E171), quinoline yellow dye (E104), sunset yellow FCF dye (E110), 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 (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
10 pcs. – blister packs (12) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

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

Pharmacological Action

A nootropic agent with metabolic and trophic action. It has membrane-stabilizing properties, slows down lipid peroxidation, and protects neuronal and mitochondrial membranes from damage. It is an antioxidant.

Experimental studies have established that under the influence of idebenone, inhibition of apoptosis processes occurs. This effect is based both on the antioxidant properties of the drug and its ability to stimulate the production of neurotrophic factors. In experimental conditions in nerve tissue culture, Idebenone prevented the formation of free radicals, while reducing the concentration of products of oxidative protein damage.

Idebenone activates ATP formation and glucose utilization in nerve tissue, while simultaneously reducing the likelihood of lactate acidosis. In addition to the cholinergic system, it acts on the serotonergic system. From the first days of administration, it exhibits anti-asthenic, psychostimulant, and antidepressant effects; the nootropic effect is realized somewhat later, after 3-4 weeks of administration.

Pharmacokinetics

Absorption

Absorption is rapid and complete. C_max in blood plasma is reached after 4 hours. When taken orally after meals, the bioavailability of idebenone increases.

Distribution

Non-clinical data show that Idebenone easily penetrates all tissues, with relatively high concentrations in the intestine, liver, and kidneys. On average, 96% of idebenone is bound to plasma proteins. It penetrates the blood-brain barrier and is localized in significant amounts in mitochondria. Does not accumulate.

Metabolism

Metabolized by the liver. Biotransformation occurs through oxidative shortening of the side chain and reduction of the quinone ring followed by conjugation with glucuronides and sulfates. The main metabolites in plasma (up to 99%) are idebenone conjugates. The main metabolizing enzyme of idebenone has not been identified. Inhibitors and inducers of CYP2C19, CYP1A2, and CYP3A4 may affect the metabolism of idebenone. Their clinical significance is unknown.

Elimination

T_1/2 is about 18 hours, excreted in urine (about 60-80%) and feces.

Indications

• Treatment of cognitive and behavioral disorders resulting from vascular and degenerative brain pathology;
• Treatment of cognitive and behavioral disorders against the background of cerebrovascular insufficiency and age-related involutional changes in the brain.

ICD codes

Dosage Regimen

Take the capsules orally, after meals to increase bioavailability.

Administer the last daily dose no later than 5 PM to prevent potential sleep disturbances.

The standard adult dosage is 30 mg (one capsule) taken two to three times daily.

The total daily dose should not exceed 90 mg (three capsules).

Swallow the capsules whole with a sufficient amount of water; do not chew or crush.

The duration of the treatment course is determined individually by the physician based on the underlying condition and therapeutic response.

Clinical improvement, particularly the nootropic effect, may become apparent after three to four weeks of continuous administration.

Do not adjust the dosage or frequency of administration without medical supervision.

For patients with specific conditions, the prescribing physician may initiate therapy with a lower frequency.

Adverse Reactions

The most frequent adverse reactions (≥10%) during idebenone administration, manifested in various clinical studies, were nausea, dyspepsia, diarrhea (mild to moderate, usually not requiring treatment discontinuation), nasopharyngitis, cough, back pain.

Most clinical studies were conducted in rather specific conditions, and higher dosages of idebenone were used. On this basis, the frequency of adverse reactions in clinical studies may not reflect their frequency in clinical practice. Information on adverse reactions in clinical studies should be considered for the purpose of identifying drug-dependent reactions and their approximate frequency.

WHO classification of adverse reaction frequency: very common (≥1/10), common (≥1/100 but < 1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10,000), frequency not known (cannot be estimated from available data).

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk ratio of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to idebenone or to any of the excipients included in the drug;
• Chronic renal failure;
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Age under 18 years.

With caution

Since Idebenone is capable of inhibiting platelet aggregation in vitro, it is considered that the drug should be used with caution in patients with a history of hemorrhagic stroke or in patients receiving anticoagulants.

Use in Pregnancy and Lactation

Pregnancy

The safety of the drug use in pregnant women has not been established. Use of the drug during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

The use of the drug during breastfeeding is contraindicated. Preclinical studies have shown that Idebenone passes into breast milk. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years.

Special Precautions

Idebenone metabolites may cause chromaturia (change in urine color to reddish-brown), which does not require dose adjustment or treatment discontinuation. However, to rule out masking diseases in case of chromaturia, a urinalysis is necessary.

Excipients

The drug Noben^® contains lactose. Patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug.

Effect on ability to drive vehicles and operate machinery

During treatment, patients should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, such as driving vehicles, operating moving machinery, or using complex equipment.

Overdose

Symptoms increased severity of dose-dependent adverse reactions.

Treatment if necessary, activated charcoal is prescribed and symptomatic therapy is carried out.

Drug Interactions

Interaction with other medicinal products has not been established.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.