Instructions Noobut IC 500 powder for oral solution 500 mg/dose sachet 2.5 g No. 10
Composition
active ingredient: phenibut;
1 sachet contains phenibut 500 mg;
excipients: mannitol (E 421), acesulfame potassium, natural orange flavoring.
Dosage form
Powder for oral solution.
Main physicochemical properties: white or almost white powder, in which yellow inclusions are allowed.
Pharmacotherapeutic group
Psychostimulants, drugs used for attention deficit hyperactivity disorder (ADHD), nootropics. Other psychostimulants and nootropics. Phenibut.
ATX code N06B X22.
Pharmacological properties
Pharmacodynamics.
Phenibut is a derivative of γ-aminobutyric acid and phenylethylamine. Its dominant action is antihypoxic and antiamnestic. Noobut® IC 500 improves memory and attention, improving learning processes, increases physical and mental performance. Psychological indicators (speed and accuracy of sensory-motor reactions) under the influence of the drug Noobut® IC 500 improve. It has been established that phenibut improves brain bioenergetics, increasing the energy potential of neurons by improving mitochondrial functions.
Also, the drug Noobut® IC 500 has the properties of a tranquilizer: it eliminates psycho-emotional tension, anxiety, fear, emotional lability, irritability, improves sleep. Phenibut binds in the brain exclusively to GABA receptors, therefore it has a moderate sedative effect, but does not cause undesirable sedative effects: drowsiness, dizziness, decreased attention and performance. The drug prolongs the latent period and reduces the duration and severity of nystagmus, has an antiepileptic effect. It does not affect cholinergic and adrenoreceptors.
Noobut® IC 500 significantly reduces the manifestations of asthenia and vasovegetative symptoms, including headache, feeling of heaviness in the head. In patients with asthenia and in emotionally labile individuals, when using phenibut, the well-being improves without excitement from the first days of therapy.
In patients with psychogenic erectile dysfunction, phenibut, exhibiting a tranquilizing, anti-asthenic, and psycho-energetic effect, activates central pro-erectile mechanisms.
Pharmacokinetics.
Phenibut is rapidly absorbed after oral administration and penetrates into all tissues of the body, completely passing through the blood-brain barrier. Distribution in the liver and kidneys is close to uniform, and in the brain and blood - less uniform. After 3 hours, a noticeable amount of the administered phenibut is detected in the urine, while the concentration of phenibut in the brain tissues does not decrease, it is detected in the brain after another 6 hours. The next day, phenibut can only be detected in the urine; it is found in the urine for another 2 days after administration, but the detected amount is only 5% of the administered dose. The greatest binding of phenibut occurs in the liver (80%), it is non-specific. Cumulation is not observed with repeated administration.
Indication
Asthenic and anxiety-neurotic conditions (emotional lability, memory impairment, decreased concentration), restlessness, fear, anxiety, psychopathy, obsessive-compulsive neurosis.
Elderly patients have insomnia and nighttime restlessness.
Prevention of stressful conditions before surgeries or painful diagnostic examinations.
Meniere's disease, dizziness associated with dysfunction of the vestibular analyzer of various etiologies, prevention of dizziness.
As an adjunct (for the relief of psychopathological and somatovegetative disorders) during the treatment of alcohol withdrawal syndrome.
Treatment of men with erectile dysfunction of psychogenic and mixed genesis as monotherapy, as well as as part of complex therapy.
Contraindication
Increased individual sensitivity to any components of the drug.
Acute renal failure.
Interaction with other medicinal products and other types of interactions
Noobut® IC 500 can be used with other medications, including psychotropic drugs – tranquilizers and neuroleptics (the effects are mutually enhanced). Noobut® IC 500 enhances and prolongs the effect of hypnotics, narcotics, neuroleptics and anti-Parkinsonian drugs.
Application features
Patients with gastrointestinal disorders should be cautious when using Noobut® IC 500 due to the irritating effect of phenibut. Such patients should use lower doses of the drug or take the drug after meals.
In case of prolonged use, it is necessary to monitor the cellular composition of the blood and liver function tests.
Use during pregnancy or breastfeeding
It is not recommended to use the drug during pregnancy or breastfeeding, as there is insufficient data on the use of phenibut during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience drowsiness, dizziness, or other central nervous system disorders during treatment with the drug should refrain from driving or operating other mechanisms.
Method of administration and doses
Dissolve the contents of the sachet in 0.5 cups of boiled water and take orally. The course of treatment is 2-6 weeks.
The drug should be used at a dose of 500 mg 1-3 times a day. In order to reduce the irritating effect of phenibut on the gastrointestinal tract (see the section "Special instructions"), the drug can be taken after meals.
Noobut® IC 500 can be combined with other psychotropic drugs, which increases its effectiveness (see the section "Interaction with other drugs and other types of interactions"), while the dose of Noobut® IC 500 and other drugs used with it can be reduced.
For the treatment of dizziness in case of dysfunction of the vestibular analyzer of infectious genesis (otogenic labyrinthitis) and Meniere's disease, the drug is used during the period of exacerbation at 500 mg 4 times a day for 5-7 days, with a decrease in the severity of vestibular disorders - 500 mg 2-3 times a day for 5-7 days, and then - 500 mg 1 time a day for 5 days. With a relatively mild course of the disease, the drug is used at 500 mg 1 time a day for 5-7 days, and then - 100 mg 2-3 times a day for 7-10 days. To achieve the recommended dose, use the drug Noobut® IC 100.
For the treatment of dizziness in case of dysfunction of the vestibular analyzer of vascular and traumatic origin, the drug should be used at a dose of 500 mg 1-2 times a day for 12 days.
To prevent swaying, the drug should be administered once at a dose of 500 mg 1 hour before the expected onset of swaying or at the first symptoms of swaying.
The effect of the drug Noobut® IC 500 increases with increasing dose. In the presence of pronounced manifestations (vomiting, nausea), the use of the drug is ineffective even at a dose of 1000 mg.
For the treatment of alcohol withdrawal syndrome, in the first days of therapy, the drug should be used at a dose of 500 mg 2-3 times during the day and 500 mg at night with a gradual decrease in the daily dose to the usual adult dose.
For the treatment of men with erectile dysfunction of psychogenic and mixed genesis, the drug is administered at a dose of 500 mg once a day. The course of treatment is 21–28 days.
If one or more times the next dose has not been taken in advance, the course of treatment should be continued according to the previously prescribed doses.
Children.
The medicine in this dosage is not used in children.
Overdose
Noobut® IC 500 is a low-toxic drug, only in a daily dose of 7-14 g in case of prolonged use it can be hepatotoxic. The indicated doses significantly exceed the recommended therapeutic doses (therapeutic dose is 500-2000 mg). Only in the case of using the maximum dose of the drug were eosinophilia and fatty liver observed. If the drug was used in lower doses, 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 taken.
Side effects
From the nervous system: drowsiness (at the beginning of treatment), headache and dizziness (when using doses above 2000 mg per day, the severity of the side effect decreases with decreasing dose).
Mental disorders: emotional lability, sleep disorders (these adverse reactions may be observed in children if the drug is used without following the instructions for medical use).
Gastrointestinal: nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.
On the part of the hepatobiliary system: hepatotoxicity (with prolonged use of high doses).
On the part of the immune system: allergic reactions, including rash, itching, urticaria, redness of the skin.
If any adverse reactions occur, you should seek medical advice.
Expiration date
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 per sachet; 10 sachets per pack.
Vacation category
According to the recipe.
Producer
Additional Liability Company "INTERCHEM".
Location of the manufacturer and address of its place of business.
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
