Noobut ic 500

INSTRUCTIONS for medical use of the medicinal product NOOBUT® IC 500

Composition:

Active substance: phenibut;

1 sachet contains phenibut 500 mg;

Excipients: mannite (E 421), potassium acesulfame, natural orange flavor.

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: white or almost white powder, with possible yellow specks.

Pharmacotherapeutic group.

Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents. Phenibut.

ATC code N06B X22.

Pharmacological Properties

Pharmacodynamics

Phenibut is a derivative of γ-aminobutyric acid and phenethylamine. Its primary effects are anti-hypoxic and anti-amnestic. Noobut® IC 500 improves memory and attention, enhances learning processes, and increases physical and mental performance. Psychological parameters (speed and accuracy of sensorimotor reactions) improve under the influence of Noobut® IC 500. It has been established that phenibut improves brain bioenergetics by enhancing mitochondrial function, thereby increasing the energy potential of neurons.

Noobut® IC 500 also possesses tranquilizing properties: it reduces psychoemotional tension, anxiety, fear, emotional lability, and irritability, while improving sleep. Phenibut binds exclusively to GABAB receptors in the brain, producing a moderate calming effect without causing undesirable sedative effects such as drowsiness, dizziness, or reduced attention and performance. The drug prolongs the latent period and reduces the duration and intensity of nystagmus, exerting an antiepileptic effect. It does not affect cholinergic or adrenergic receptors.

Noobut® IC 500 significantly reduces manifestations of asthenia and vasovegetative symptoms, including headache and a sensation of heaviness in the head. In patients with asthenia and emotionally labile individuals, phenibut improves well-being from the first days of therapy without causing excitation.

In patients with psychogenic erectile dysfunction, phenibut exerts tranquilizing, anti-asthenic, and psychoenergizing effects, thereby activating central pro-erectile mechanisms.

Pharmacokinetics

Phenibut is rapidly absorbed after oral administration and penetrates into all tissues of the body, completely crossing the blood-brain barrier. Distribution in the liver and kidneys is close to uniform, while in the brain and blood it is lower than uniform. A significant amount of administered phenibut is detectable in urine within 3 hours; meanwhile, phenibut concentration in brain tissue does not decrease and remains detectable in the brain for up to 6 hours. The next day, phenibut can only be detected in urine; it remains detectable in urine for up to 2 days after administration, although the amount detected constitutes only 5% of the administered dose. The highest binding of phenibut occurs in the liver (80%), and this binding is non-specific. No accumulation is observed upon repeated administration.

Clinical characteristics.

Indications.

Asthenic and anxiety-neurotic states (emotional lability, impaired memory, reduced attention span), restlessness, fear, anxiety, psychopathy, obsessive neurosis.

In elderly patients – insomnia, nocturnal restlessness.

Prophylaxis of stress conditions prior to surgery or painful diagnostic procedures.

Meniere’s disease, dizziness associated with vestibular dysfunction of various etiologies, prevention of motion sickness.

As an adjunctive agent (for suppression of psychopathological and somatovegetative disturbances) during treatment of alcohol withdrawal syndrome.

Treatment of erectile dysfunction of psychogenic and mixed origin in men, as monotherapy as well as part of combined therapy.

Contraindications.

Hypersensitivity to any component of the drug.

Acute renal failure.

Interaction with other medicinal products and other forms of interactions.

Noobut® IC 500 may be used concomitantly with other medicinal products, including psychotropic agents – tranquilizers and neuroleptics (mutual enhancement of effects). Noobut® IC 500 potentiates and prolongs the effects of sedatives, narcotics, neuroleptics, and antiparkinsonian drugs.

Special precautions for use.

Patients with gastrointestinal disorders should use caution when taking the medicinal product Noobut® IC 500 due to the irritant effect of phenibut. Such patients should use lower doses of the medicinal product or take it after meals.

During prolonged use, blood cell counts and liver function test parameters should be monitored.

Use during pregnancy or breastfeeding.

The use of this medicinal product is not recommended during pregnancy or breastfeeding due to insufficient data on phenibut use during these periods.

Ability to influence reaction speed when driving or operating machinery.

Patients who experience drowsiness, dizziness, or other central nervous system disturbances during treatment should refrain from driving or operating machinery.

Method of administration and dosage.

Dissolve the contents of the sachet in half a glass of boiled water and take orally. The treatment course lasts 2–6 weeks.

The medicinal product should be administered at a dose of 500 mg 1–3 times daily. To reduce the irritating effect of phenibut on the gastrointestinal tract (see section "Special precautions"), the medicinal product may be taken after meals.

Noobut® IC 500 can be combined with other psychotropic agents, which enhances its efficacy (see section "Interaction with other medicinal products and other types of interactions"). In such cases, the dosage of Noobut® IC 500 and of other concomitantly administered medicinal products may be reduced.

For the treatment of vertigo due to vestibular analyzer dysfunction of infectious origin (otogenic labyrinthitis) and Ménière's disease: administer the medicinal product during exacerbation at a dose of 500 mg four times daily for 5–7 days; as vestibular disturbances subside – 500 mg 2–3 times daily for 5–7 days, followed by 500 mg once daily for 5 days. In cases of relatively mild disease, administer the medicinal product at a dose of 500 mg once daily for 5–7 days, then 100 mg 2–3 times daily for 7–10 days. To achieve the recommended dosage, use the medicinal product Noobut® IC 100.

For the treatment of vertigo due to vestibular analyzer dysfunction of vascular and traumatic origin: administer the medicinal product at a dose of 500 mg 1–2 times daily for 12 days.

For prevention of motion sickness: administer the medicinal product as a single dose of 500 mg one hour before the expected onset of motion sickness or upon the appearance of the first symptoms.

The effect of the medicinal product Noobut® IC 500 increases with increasing dosage. In the presence of pronounced symptoms (vomiting, nausea), administration of the medicinal product is poorly effective even at a dose of 1000 mg.

For the treatment of alcohol withdrawal syndrome: during the first days of therapy, administer the medicinal product at a dose of 500 mg 2–3 times during the day and 500 mg at night, gradually reducing the daily dose to the usual adult dose.

For the treatment of erectile dysfunction of psychogenic and mixed origin in men: administer the medicinal product at a dose of 500 mg once daily. The treatment course is 21–28 days.

If one or several doses have been missed, continue the treatment course according to the previously prescribed dosage regimen.

Children.

The medicinal product in this dosage form is not intended for use in children.

Overdose.

Noobut® IC 500 is a low-toxicity medicinal product. It may become hepatotoxic only when administered at daily doses of 7–14 g over a prolonged period. These doses significantly exceed the recommended therapeutic doses (therapeutic dose is 500–2000 mg). Only when the maximum dose was administered were eosinophilia and fatty liver degeneration observed. When lower doses were used, such changes were not noted.

Symptoms: drowsiness, nausea, vomiting, possible development of arterial hypotension, acute renal failure.

Treatment: gastric lavage; symptomatic therapy. In case of complications (arterial hypotension, renal failure), supportive and symptomatic measures should be implemented.

Adverse Reactions.

Central nervous system: drowsiness (at the beginning of treatment), headache and dizziness (when doses exceeding 2000 mg per day are used; the intensity of this adverse effect decreases with dose reduction).

Psychiatric disorders: emotional lability, sleep disturbances (these adverse reactions may occur in children if the medicinal product is used without following the instructions for medical use).

Gastrointestinal system: nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

Hepatobiliary system: hepatotoxicity (with prolonged use of high doses).

Immune system: allergic reactions, including rash, itching, urticaria, skin redness.

If any adverse reactions occur, consult a physician.

Shelf life: 3 years.

Storage conditions:

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging:

2.5 g powder in sachets; 10 sachets per pack.

Prescription status: Prescription only.

Manufacturer:

Limited liability company "INTERKHIM".

Manufacturer's address and place of business:

40-A, 21st km, Starokyivska Road, Odesa, Ukraine, 65025.