Noobut ic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOOBUT® IS

Composition:

Active substance: phenibut;

1 tablet contains 100 mg (0.1 g) or 250 mg (0.25 g) of phenibut;

Excipients: lactose monohydrate, potato starch, povidone, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are white or white with a yellowish tint, flat cylindrical in shape, with a bevel; on one surface of the tablet the company's trademark is imprinted, on the other surface – a line.

Pharmacotherapeutic group.

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

ATC code N06B X22.

Pharmacological Properties

Pharmacodynamics

Phenibut is a derivative of γ-aminobutyric acid (GABA) and phenylethylamine. Its predominant effects are anti-hypoxic and anti-amnestic. The medicinal product Noobut® IS improves memory and attention, facilitates learning processes, and enhances both physical and mental performance. Psychological parameters (speed and accuracy of sensorimotor reactions) improve under the influence of the drug.

It has been established that phenibut improves brain bioenergetics by increasing the energy potential of neurons through enhanced mitochondrial function.

The medicinal product Noobut® IS also possesses tranquilizing properties: it reduces psychoemotional tension, anxiety, fear, emotional lability, irritability, and improves sleep. Phenibut binds exclusively to GABAB receptors in the brain, thus exerting 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® IS 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.

Pharmacokinetics

Phenibut is well absorbed after oral administration and readily penetrates all tissues of the body, crossing the blood-brain barrier effectively (approximately 0.1% of the administered dose reaches brain tissue, with significantly higher penetration observed in both young and elderly individuals). The highest binding of phenibut occurs in the liver (80%), and this binding is nonspecific. Distribution in the liver and kidneys is close to uniform, whereas in the brain and blood it is lower than uniform.

80−95% of phenibut is metabolized in the liver; the metabolites are pharmacologically inactive.

A significant amount of administered phenibut can be detected in urine within 3 hours. At the same time, phenibut concentration in brain tissue does not decrease—phenibut remains detectable in brain tissue for up to 6 hours. By the next day, phenibut is detectable only in urine; it can still be detected in urine up to 2 days after administration, though the amount detected constitutes only 5% of the administered dose. No accumulation is observed with repeated administration.

Clinical characteristics.

Indications.

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

Insomnia, nocturnal restlessness in elderly patients.

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

Meniere's disease, dizziness associated with vestibular analyzer dysfunction of various origins.

Prevention of kinetosis (a specific condition characterized by nausea, vomiting, prostration, and vestibular dysfunction caused by being in a moving object such as a ship or airplane).

Stuttering, enuresis, tics in children aged 3 to 14 years.

As an adjunctive agent in the treatment of alcohol withdrawal syndrome.

Contraindications.

Hypersensitivity to any component of the medicinal product. Acute renal failure. Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interactions.

The medicinal product Noobut® IS can be combined with other psychotropic medicinal products, reducing the doses of Noobut® IS and concomitantly administered medicinal products.

The medicinal product Noobut® IS potentiates and prolongs the effects of hypnotics, narcotics, neuroleptics, and anti-parkinsonian drugs.

Special precautions for use.

Patients with gastrointestinal disorders should use Noobut® IS with caution due to the irritant effect of phenibut. Such patients should use lower doses of the medicinal product or take the drug after meals.

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

The medicinal product contains lactose and therefore should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Animal studies have not revealed mutagenic, teratogenic, or embryotoxic effects of phenibut. Adequate and well-controlled studies on the safety of phenibut use in pregnant or breastfeeding women have not been conducted. Therefore, the use of Noobut® IS during pregnancy or breastfeeding is contraindicated.

Ability to affect reaction speed when driving or operating machinery.

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

Method of Administration and Dosage

The medicinal product should be taken orally. The tablet should be swallowed whole with sufficient amount of water. To reduce the irritating effect of phenibut on the gastrointestinal tract (see section "Special Warnings and Precautions for Use"), the medicinal product may be taken after food.

Adults

Asthenic and anxiety-neurotic states

Administer 250–500 mg three times daily.

Maximum single dose: for adults – 750 mg, for elderly patients – 500 mg.

The treatment course lasts 2–3 weeks. If necessary, the treatment course may be extended to 4–6 weeks.

Meniere’s disease and vertigo associated with vestibular dysfunction of various origins

For treatment of vertigo associated with infectious-origin vestibular dysfunction and during exacerbation of Meniere’s disease, administer 750 mg three times daily for 5–7 days; after reduction in severity of vestibular disturbances – 250–500 mg three times daily for 5–7 days, followed by 250 mg once daily for 5 days. In cases of relatively mild disease course, administer 250 mg twice daily for 5–7 days, followed by 250 mg once daily for 7–10 days.

For treatment of vertigo due to vascular or traumatic vestibular dysfunction, administer 250 mg three times daily for 12 days.

Prophylaxis of kinetosis

Administer 250–500 mg as a single dose 1 hour before anticipated onset of motion sickness or upon appearance of first symptoms of motion discomfort.

As part of complex therapy in alcohol withdrawal syndrome

During the first days of therapy, administer 250–500 mg three times during the day and 750 mg at night, with gradual reduction of the daily dose to the usual adult dose.

Patients with hepatic impairment

High doses of the medicinal product may be hepatotoxic in patients with hepatic impairment. Lower doses should be used in this patient group.

Patients with renal impairment

There are no data regarding adverse effects of the medicinal product in patients with renal impairment when therapeutic doses are used.

Children

The treatment course is 2–6 weeks.

For prevention of motion sickness, take a single dose of the medicinal product Noobut® IC one hour before traveling by sea, land, or air.

The medicinal product Noobut® IC can be combined with psychotropic agents, which increases its effectiveness (see section "Interaction with other medicinal products and other types of interactions").

Drug dependence and withdrawal syndrome have not been observed with the use of phenibut.

Literature reports isolated cases of tolerance to phenibut.

If one or several doses have been missed, continue taking the medicinal product at previously prescribed doses. In case of worsening of general condition, consult a physician.

Children.

The medicinal product can be used in children aged 3 to 14 years.

Overdose.

Data on overdose are lacking. Noobut® IC is a low-toxicity medicinal product; hepatotoxicity may occur only at daily doses of 7–14 g with prolonged use. These doses significantly exceed the recommended average therapeutic doses according to patient age.

Symptoms: drowsiness, nausea, vomiting, dizziness.

With prolonged use of high doses of phenibut, arterial hypotension, acute renal failure, eosinophilia, and fatty liver dystrophy may develop.

Treatment: gastric lavage. Symptomatic therapy.

There is no specific antidote.

Side effects.

Noobut® IS, like other medicinal products, may cause adverse reactions, although they do not occur in all patients.

Adverse reactions associated with the use of the medicinal product are classified by organ systems and frequency. Frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

Nervous system disorders: frequency not known – drowsiness (at the beginning of treatment), headache, dizziness (when doses above 2000 mg per day are used; reducing the dose decreases the intensity of this adverse effect).

Psychiatric disorders: frequency not known – emotional lability, sleep disturbances (these adverse reactions may occur in children if the medicinal product is used without following the recommendations of the instructions for medical use).

Gastrointestinal disorders: frequency not known – nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

Hepatobiliary disorders: frequency not known – hepatotoxicity (with long-term use of high doses).

Immune system disorders: frequency not known – hypersensitivity reactions, including urticaria, erythema, angioneurotic edema, facial swelling, tongue swelling.

Skin and subcutaneous tissue disorders: rare – allergic reactions (rash, itching).

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.

10 tablets in a blister; 2 blisters per carton.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "INTERSIM".

Manufacturer's address and place of business.

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