Instructions for Bibright tablets 250 mg blister No. 20
Composition
active ingredient: phenibut;
1 tablet contains phenibut 250 mg;
Excipients: lactose monohydrate; potato starch; calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets from white to white with a yellowish tint, oval in shape with a biconvex surface.
Pharmacotherapeutic group
Other psychostimulants and nootropics.
ATX code N06B X22
Pharmacological properties
Pharmacodynamics.
Phenibut is a derivative of γ-aminobutyric acid and phenylethylamine.
Its dominant action is antihypoxic and antiamnestic. Phenibut improves memory and attention, promoting learning processes, increases physical and mental performance. Psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions) under the influence of phenibut improve. It has been established that phenibut increases the energy potential of the neuron by improving the functions of mitochondria.
Phenibut also has tranquilizer properties: it eliminates psychoemotional tension, anxiety, fear, emotional lability, irritability, improves sleep, prolongs and enhances the effect of hypnotics, narcotics, neuroleptics and anticonvulsants. Phenibut binds in the brain exclusively to GABA-β receptors, therefore it exhibits 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.
BiBright 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, the use of phenibut improves well-being without excitement.
Pharmacokinetics.
Absorption and distribution
Phenibut is well absorbed after oral administration and penetrates well into all tissues of the body, passes well through the blood-brain barrier (about 0.1% of the administered dose of the drug penetrates into the brain tissue, and in young and elderly people it is much higher). The greatest binding of phenibut occurs in the liver (80%), it is non-specific.
Biotransformation and excretion
80–95% of phenibut is metabolized in the liver, the metabolites are pharmacologically inactive.
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 the drug in the brain tissue does not decrease - it is detected in the brain for 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. Cumulation is not observed with repeated administration.
Indication
Asthenic and anxiety-neurotic states: restlessness, fear, anxiety.
Insomnia, nighttime restlessness in the elderly.
Prevention of stressful conditions before surgeries or painful diagnostic tests.
Meniere's disease, dizziness associated with dysfunction of the vestibular analyzer of various origins.
Prevention of motion sickness (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, tics in children aged 8 to 14 years.
As an adjunct in the treatment of alcohol withdrawal syndrome.
Contraindication
Hypersensitivity to the components of the drug.
Acute renal failure.
Pregnancy and breastfeeding.
Interaction with other medicinal products and other types of interactions
Phenibut can be combined with other psychotropic drugs, reducing the doses of BiBrite and concomitant medications.
Phenibut enhances and prolongs the effects of hypnotics, narcotics, neuroleptics, and anti-Parkinsonian drugs.
Application features
The drug should be used with caution in patients with gastrointestinal disorders due to the irritating effect of phenibut. To protect the mucous membrane from the irritating effect of phenibut, these patients should be prescribed lower doses and the drug should be used after meals.
In case of long-term treatment, blood cell counts and liver function tests should be monitored.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this medicine.
Use during pregnancy or breastfeeding
The use of BiBright during pregnancy or breastfeeding is contraindicated, as there is insufficient data on the use of the drug during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients who experience drowsiness, dizziness, or other central nervous system reactions during treatment with the drug should refrain from driving or operating other mechanisms.
Method of administration and doses
BiBright is taken orally before meals. The tablet is swallowed whole with a sufficient amount of water. 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.
For asthenic and anxiety-neurotic conditions, adults are prescribed 250–500 mg (1–2 tablets) 3 times a day. The highest single doses: for adults – 750 mg, for elderly patients – 500 mg.
The course of treatment is 2–3 weeks. If necessary, the course of treatment can be extended to 4–6 weeks.
Children aged 8 to 14 years - 250 mg (1 tablet) 3 times a day.
BiBright 250 mg tablets can be used as an alternative dosage form.
The course of treatment is 2-6 weeks.
Meniere's disease and dizziness associated with vestibular dysfunction of various origins.
In case of dysfunction of the vestibular apparatus of infectious origin and Meniere's disease during the period of exacerbation, BiBright is prescribed at 750 mg (3 tablets) 3 times a day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg (1-2 tablets) 3 times a day for 5-7 days, and then 250 mg 1 time a day for 5 days. In case of a relatively mild course of the disease, BiBright is used at 250 mg (1 tablet) 2 times a day for 5-7 days, and then 250 mg 1 time a day for 7-10 days.
To eliminate dizziness in vestibular dysfunction of vascular and traumatic origin, BiBright is prescribed at 250 mg 3 times a day for 12 days.
To prevent motion sickness, the drug is taken at a dose of 250–500 mg once, one hour before the expected onset of motion sickness or at the first symptoms of motion sickness.
To relieve alcohol withdrawal syndrome, BiBright is prescribed in the first days of treatment at 250–500 mg 3 times a day and 750 mg at night, with a gradual decrease in the daily dose to the usual adult dose.
Patients with hepatic insufficiency
In patients with hepatic insufficiency, high doses of the drug may cause hepatotoxicity. Lower doses are prescribed to this group of patients.
Patients with renal insufficiency
There are no data on the adverse effects of BiBrite on patients with renal impairment when used at therapeutic doses.
No development of drug dependence or withdrawal syndrome was observed during the use of this medicinal product.
Isolated cases of tolerance to phenibut can be found in literary sources.
Children.
The drug can be used in children aged 8 years and over.
Overdose
There are no data on overdose. BiBright is a low-toxic drug, only in a daily dose of 7–14 g in case of prolonged use it can be hepatotoxic. These doses significantly exceed the recommended average therapeutic doses, according to the patient's age (the average therapeutic dose is 500–2000 mg).
Symptoms: drowsiness, nausea, vomiting, dizziness.
With prolonged use of high doses of phenibut, the development of arterial hypotension, acute renal failure, eosinophilia and fatty liver disease is possible.
Treatment: gastric lavage. Symptomatic therapy.
There is no specific antidote.
Adverse reactions
Like all medicines, BiBrite can cause side effects, although not everybody gets them.
Classification of adverse reactions by frequency of development: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be determined from the available data).
Nervous system: frequency unknown - drowsiness (at the beginning of treatment), headache and dizziness (in the case of doses above 2000 mg per day, the severity of the side effect decreases with decreasing the dose).
On the part of the digestive tract: frequency unknown - nausea (at the beginning of treatment), vomiting, diarrhea, pain in the epigastric region.
On the part of the hepatobiliary system: frequency unknown - hepatotoxicity (with prolonged use of high doses).
Immune system disorders: frequency unknown - hypersensitivity reactions, including urticaria, erythema, rash, angioedema, facial edema, tongue edema.
Skin and subcutaneous tissue disorders: rarely - allergic reactions (rash, itching).
On the part of the psyche: frequency unknown - emotional lability, sleep disorders (these adverse reactions may be observed in children when using the drug without following the recommendations of the instructions for medical use of the drug).
If during treatment you experience side effects not listed in this manual, or if any of these side effects are particularly severe, you should immediately consult a doctor.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
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
10 tablets in a blister. 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
"ASTRAPHARM" LLC.
Location of the manufacturer and address of its place of business.
Ukraine, 08132, Kyiv region, Kyiv-Svyatoshynskyi district, Vyshneve, Kyivska st., 6.
