Active substanceIdebenonIdebenon
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  • Dosage form: & nbspCapsules
    Composition:
    1 capsule contains:
    active substance: idebenone 45 mg;
    Excipients: lactose monohydrate 132.0 mg, microcrystalline cellulose 60.0 mg, corn starch 30.0 mg, crospovidone 24.0 mg, povidone 6.0 mg, magnesium stearate 3.0 mg; capsules of hard gelatinous [titanium dioxide - 1.333%, dye quinoline yellow - 0.9197%, dye sunset yellow - 0.0044%, gelatin - up to 100%].

    Description:Capsules number 1 with a body and a lid of yellow color. The contents of the capsules are powder from yellow to yellow-orange color.
    Pharmacotherapeutic group:Nootropic remedy
    ATX: & nbsp

    N.06.B.X.13   Idebenon

    Pharmacodynamics:Nootropic agent, which has a metabolic and trophic effect. It has membrane-stabilizing properties, slows down lipid peroxidation, protects membranes of neurons and mitochondria from damages. It is an antioxidant. In the experiment, it has been established that the inhibition of apoptosis occurs under the influence of idebenone. This effect is based on both the antioxidant properties of the drug and its ability to stimulate the production of neurotrophic factors.Under the experimental conditions in the culture of nerve tissue idebenon prevented the formation of free radicals, while the concentration of oxidative damage products of proteins decreased. Idebenon activates the formation of ATP, as well as the utilization of glucose in the nervous tissue, and the likelihood of lactate-acidosis is reduced in parallel. In addition to the acetylcholinergic system, it acts on the serotonergic system. From the first days of admission shows anti-asthenic, psychostimulating and antidepressant effect, nootropic effect is realized a little later, after 3-4 weeks of admission.
    Pharmacokinetics:Absorption is fast and high. The time to reach the maximum concentration of idebenone in the blood plasma (TCmax) -4 hours. When ingested after a meal, the bioavailability of idebenone increases. It penetrates the blood-brain barrier in significant quantities and is distributed in the brain tissues. Do not cumulate. The half-life is about 18 hours. It is metabolized in the liver, excreted by the kidneys.
    Indications:
    In the treatment of cognitive and behavioral disorders, as a result of brain pathology of vascular and degenerative origin.
    In the treatment of cognitive and behavioral disorders against cerebrovascular insufficiency and age-related involuntary changes in the brain.

    Contraindications:Hypersensitivity to idebenon or other components of the drug, chronic renal failure, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, age to 18 years.
    Pregnancy and lactation:
    The safety of the drug in pregnant women is not established. The use of the drug during pregnancy is possible if the expected benefit for the mother exceeds the possible risk to the fetus.
    The use of the drug in the period of breastfeeding is contraindicated. In preclinical studies it was shown that idebenon penetrates into breast milk. If you need to use the drug during breastfeeding, breastfeeding should be discontinued.

    Dosing and Administration:
    Inside, after meals (last reception no later than 17 hours).
    For 45 mg (1 capsule) 2 times a day. The course of treatment is determined by the doctor.

    Side effects:
    From the immune system: skin rash, itching.
    From the nervous system and psyche: convulsions, delirium, hallucinations, agitation, hyperkinesis, dromomania, vertigo, headache, restlessness, dizziness, insomnia, drowsiness, stupor.
    From the gastrointestinal tract: nausea, vomiting, anorexia, abdominal pain, diarrhea.
    From the side of the blood: agranulocytosis, anemia, leukopenia, thrombocytopenia. From the liver and bile ducts: increased activity of aspartate aminotransferase, hyperbilirubinemia, increased activity of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and g-glutamyl transferase in the blood.
    From the side of the kidneys and urinary tract: increased plasma urea concentration.
    From the side of metabolism: increased plasma concentrations of total cholesterol and triglycerides.
    General disorders: malaise.
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:There is no information about overdose. Treatment is symptomatic.
    Interaction:Interaction with other drugs has not been established.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, patients need to give up employment in potentially hazardous activities that require increased attention and speed of psychomotor reactions, such as vehicle management, moving vehicle maintenance or the use of complex equipment.
    Form release / dosage:
    Capsules 45 mg.
    Packaging:
    For 10, 15, 30 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    1, 2, 3, 4, 6 contour mesh packages together with the instruction for use are placed in a pack of cardboard.
    Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years.
    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002535
    Date of registration:16.07.2014
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp16.07.2014
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