Noobut® ic 100

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOOBUT® IC 100

Composition:

Active substance: phenibut;

1 sachet contains phenibut 100 mg;

Excipients: mannite (E 421), potassium acesulfame, isomalt (E 953), natural orange flavor.

Pharmaceutical form. Oral powder for solution.

Main physicochemical properties: white or almost white powder, in which yellow specks may be present.

Pharmacotherapeutic group.

Psychostimulants, agents 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 phenylethylamine. Its predominant effects are anti-hypoxic and anti-amnesic. Noobut® IC 100 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 100. It has been established that phenibut improves brain bioenergetics by enhancing the energy potential of neurons through improved mitochondrial function.

The medicinal product Noobut® IC 100 also possesses tranquilizing properties: it eliminates 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® IC 100 significantly reduces manifestations of asthenia and vasovegetative symptoms, including headache and the sensation of heaviness in the head. In patients with asthenia and emotionally labile individuals, administration of phenibut improves well-being from the first days of therapy without causing excitation.

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 can be detected in urine after 3 hours, while the concentration of phenibut in brain tissues does not decrease— it remains detectable in the brain for up to 6 hours. The next day, phenibut can only be detected in urine; it is found in urine up to 2 days after administration, but 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 instability, memory impairment, decreased concentration), restlessness, fear, anxiety, obsessive neurosis.

Stuttering, enuresis, tics.

Ménière’s disease in children, vertigo associated with vestibular apparatus dysfunction, prevention of motion sickness.

Prevention of stress states prior to surgeries or painful diagnostic procedures.

Contraindications.

Hypersensitivity to any component of the drug.

Acute renal failure.

Interaction with other medicinal products and other forms of interaction.

Noobut® IC 100 may be used with other medicinal products, including psychotropic agents – tranquilizers and neuroleptics (effects mutually enhanced). Noobut® IC 100 potentiates and prolongs the action of sedatives, narcotics, neuroleptics, and antiparkinsonian drugs.

Special precautions for use

When prescribing the medicinal product Noobut® IC 100 to children with gastrointestinal tract disorders, caution is required due to the irritant effect of phenibut. Such children should be prescribed lower doses of the medicinal product or advised to take it after meals.

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

One sachet of the medicinal product contains 1.5 g of isomalt (E 953). If intolerance to certain sugars has been diagnosed, consult a physician before taking Noobut® IC 100.

Use during pregnancy or breastfeeding

The use of this medicinal product during pregnancy or breastfeeding is not recommended, as there is insufficient data on the use of phenibut during these periods.

Effect on ability to drive or operate machinery

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

Method of Administration and Dosage.

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

Children aged 3–4 years: 100 mg (1 sachet) twice daily;
5–6 years: 100 mg (1 sachet) three times daily;
7–10 years: 200 mg (2 sachets) twice daily;
11–14 years: 200 mg (2 sachets) three times daily.

Maximum single doses for children: under 6 years – 100 mg; aged 7–10 years – 200 mg; aged 11–14 years – 300 mg.

For prevention of motion sickness, take a single dose of Noobut® IC 100 1 hour before travel by sea, land, or air.

Noobut® IC 100 can be combined with other psychotropic agents, which enhances its effectiveness (see section "Interaction with Other Medicinal Products and Other Forms of Interaction"). In such cases, the dosage of Noobut® IC 100 and of other concurrently administered medicinal products may be reduced.

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

Children.

Experience with use of the medicinal product in children under 3 years of age has not been studied.

Overdose.

Noobut® IC 100 is a low-toxicity medicinal product. It may become hepatotoxic only at daily doses of 7–14 g when used long-term. These doses significantly exceed the recommended average therapeutic doses according to the child's age. Eosinophilia and fatty liver degeneration were observed only when the maximum dose of the medicinal product was administered. 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 are required.

Adverse reactions.

Central nervous system: drowsiness (at the beginning of treatment), headache and dizziness (when doses above 2000 mg daily are used; reducing the dose decreases the intensity of this adverse effect).

Psychiatric disorders: 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: nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

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

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

If any undesirable 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.

Powder 2.5 g in sachets; 10 sachets in a pack.

Prescription status. Prescription only.

Manufacturer.

Limited liability company "INTERKHIM".

Manufacturer's address and site of business activity.

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