Bibright

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BiBright

Composition:

Active ingredient: phenibut;

1 tablet contains phenibut 250 mg;

Excipients: lactose monohydrate; potato starch; calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets from white to white with a yellowish tint, oval-shaped, with a biconvex surface.

Pharmacotherapeutic group.

Other psychostimulants and nootropic agents.

ATC code N06B X22

Pharmacological Properties

Pharmacodynamics

Phenibut is a derivative of γ-aminobutyric acid and phenylethylamine.

Its primary effects are anti-hypoxic and anti-amnestic. Phenibut improves memory and attention, facilitates learning processes, and enhances both physical and mental performance. Psychological parameters (attention, memory, speed and accuracy of sensorimotor reactions) improve under the influence of phenibut. It has been established that phenibut increases the energy potential of neurons by improving mitochondrial function.

Phenibut also possesses anxiolytic properties: it reduces psychoemotional tension, anxiety, fear, emotional lability, irritability, improves sleep, and prolongs and enhances the effects of hypnotics, narcotic agents, neuroleptics, and anticonvulsants. Phenibut binds exclusively to GABA-β receptors in the brain, thus exerting a moderate calming effect without causing undesirable sedative effects such as drowsiness, dizziness, reduced attention, or impaired performance. The drug prolongs the latent period and reduces the duration and intensity of nystagmus, and has antiepileptic activity. It does not affect cholinergic or adrenergic receptors.

BiBright significantly reduces symptoms 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 general well-being without causing excitation.

Pharmacokinetics

Absorption and Distribution

Phenibut is well absorbed after oral administration and readily penetrates all body tissues. It crosses the blood-brain barrier effectively (approximately 0.1% of the administered dose reaches brain tissue, with significantly greater penetration observed in both young and elderly individuals). The highest binding of phenibut occurs in the liver (80%), and this binding 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, while in the brain and blood it is lower than uniform. A significant amount of administered phenibut can be detected in urine within 3 hours; meanwhile, the concentration of the drug in brain tissue does not decrease—phenibut remains detectable in the brain for up to 6 hours. The following day, phenibut is detectable only in urine; it can still be found in urine up to 2 days after administration, although the amount detected constitutes only 5% of the administered dose. No accumulation is observed with repeated administration.

Clinical characteristics.

Indications.

Asthenic and anxious-neurotic conditions: restlessness, fear, anxiety.

Insomnia, nocturnal restlessness in elderly people.

Prevention of stress conditions prior to surgeries 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, tics in children aged 8 to 14 years.

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

Contraindications.

Hypersensitivity to the components of the drug.

Acute renal failure.

Pregnancy and lactation period.

Interaction with other medicinal products and other forms of interaction.

Phenibut can be combined with other psychotropic medicinal products, allowing for reduction of Bibrain's dosage and doses of concomitantly administered drugs.

Phenibut enhances and prolongs the effects of hypnotics, narcotics, neuroleptics, and anti-parkinsonian medicinal products.

Special precautions for use.

The medicinal product should be used with caution in patients with gastrointestinal disorders due to the irritant effect of phenibut. To protect the mucosa from the irritating action of phenibut, lower doses should be prescribed to these patients, and the medicinal product should be administered after meals.

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

The product contains lactose; therefore, it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The use of BiBright during pregnancy or breastfeeding is contraindicated due to insufficient data on the use of the drug during these periods.

Ability to affect reaction speed when driving or operating machinery.

Patients who experience drowsiness, dizziness, or other central nervous system reactions while taking the drug should refrain from driving or operating machinery.

Method of Administration and Dosage

Bibright is taken orally before meals. The tablet should be swallowed whole with sufficient amount of water. To reduce the irritant effect of phenibut on the gastrointestinal tract (see section "Special Precautions"), the medication may be taken after meals.

For asthenic and anxiety-neurotic conditions in adults: 250–500 mg (1–2 tablets) three times daily. Maximum single doses: for adults – 750 mg; for elderly patients – 500 mg.

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

Children aged 8 to 14 years: 250 mg (1 tablet) three times daily.

Bibright 250 mg tablets may be used as an alternative dosage form.

The treatment course lasts 2–6 weeks.

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

In vestibular dysfunction of infectious origin and during exacerbation of Meniere’s disease, Bibright is prescribed at 750 mg (3 tablets) three times daily for 5–7 days; when vestibular disturbances subside – 250–500 mg (1–2 tablets) three times daily for 5–7 days, followed by 250 mg once daily for 5 days. In cases of relatively mild disease, Bibright is administered at 250 mg (1 tablet) twice daily for 5–7 days, followed by 250 mg once daily for 7–10 days.

For relief of dizziness in vascular and traumatic vestibular dysfunction: Bibright is prescribed at 250 mg three times daily for 12 days.

For prevention of kinetosis: the medication should be taken as a single dose of 250–500 mg one hour before the expected onset of motion sickness or at the appearance of first symptoms of motion discomfort.

For management of alcohol withdrawal syndrome: during the first days of treatment, Bibright is prescribed at 250–500 mg three times daily and 750 mg at night, with gradual reduction of the daily dose to the standard adult dose.

Patients with hepatic impairment

High doses of the drug may cause hepatotoxicity in patients with hepatic impairment. Lower doses should be prescribed for this patient group.

Patients with renal impairment

There are no data indicating adverse effects of Bibright on patients with impaired kidney function when therapeutic doses are used.

No drug dependence or withdrawal syndrome has been observed during use of this medication.

Isolated cases of tolerance to phenibut have been reported in the literature.

Children

The drug may be used in children aged 8 years and older.

Overdose

Data regarding overdose are limited. Bibright is a low-toxicity medication; however, at daily doses of 7–14 g during prolonged use, it may become hepatotoxic. These doses significantly exceed the recommended average therapeutic doses according to patient age (average therapeutic dose is 500–2000 mg).

Symptoms: drowsiness, nausea, vomiting, dizziness.

Prolonged use of high doses of phenibut may lead to arterial hypotension, acute renal failure, eosinophilia, and fatty liver degeneration.

Treatment: gastric lavage. Symptomatic therapy.

There is no specific antidote.

Side effects

Like all medicinal products, BIBRIGHT may cause side effects, although not everyone experiences them.

Classification of adverse reactions by frequency of occurrence: 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).

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

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

Hepatobiliary system: frequency not known – hepatotoxicity (with prolonged use of high doses).

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

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

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

If any adverse reactions not listed in this instruction occur during treatment, or if any of the listed adverse reactions are severe, consult a physician immediately.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 tablets in a blister. 2 blisters per cardboard box.

Prescription status.

Prescription only.

Marketing Authorization Holder: LLC "BAUM PHARM GmbH REPRESENTATION".

Address of Marketing Authorization Holder: 66 Shyrokа Street, Lviv, 79052, Ukraine.

Manufacturer:

LLC "ASTRAFARM", Ukraine.

Manufacturer's address and site of manufacturing activity:

6 Kyivska Street, Vyshneve, Bucha district, Kyiv region, 08132, Ukraine.