Instructions for use of Maxibren tablets 250mg 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 main action is antihypoxic and antiamnestic effect. 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.
MAXIBREN® 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. No cumulation was observed with repeated administration.
Indication
Asthenic and anxiety-neurotic conditions: restlessness, fear, anxiety.
Insomnia, nighttime restlessness in the elderly.
For the prevention of stressful conditions before surgeries or painful diagnostic tests.
Meniere's disease, dizziness associated with dysfunction of the vestibular analyzer of various origins.
For the 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
MAXIBREN® can be combined with other psychotropic drugs, reducing the doses of phenibut and concomitantly used drugs.
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 pathology 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 medicinal product contains lactose, therefore patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Use during pregnancy or breastfeeding
The use of the drug MAXIBREN® 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
MAXIBREN® should be taken orally before meals. Swallow the tablet whole with sufficient water. In order to reduce the irritating effect of phenibut on the gastrointestinal tract (see 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.
The course of treatment is 2–6 weeks.
Meniere's disease and dizziness associated with vestibular dysfunction of various origins. In case of vestibular dysfunction of infectious origin and Meniere's disease during the exacerbation period, MAXIBREN® is prescribed at 750 mg (3 tablets) 3 times a day for 5-7 days, after the severity of vestibular disorders decreases - at 250-500 mg (1-2 tablets) 3 times a day for 5-7 days, and then at 250 mg 1 time a day for 5 days. In case of a relatively mild course of the disease, MAXIBREN® is used at 250 mg (1 tablet) 2 times a day for 5-7 days, and then at 250 mg 1 time a day for 7-10 days.
To eliminate dizziness in vestibular dysfunction of vascular and traumatic genesis, MAXIBREN® is prescribed at a dose of 250 mg 3 times a day for 12 days.
To prevent motion sickness, take the drug at a dose of 250–500 mg once, one hour before the expected onset of motion sickness or when the first symptoms of motion sickness appear.
To relieve alcohol withdrawal syndrome, MAXIBREN® should be 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 should be prescribed to this group of patients.
Patients with renal insufficiency
There are no data on the adverse effects of the drug MAXIBREN® on patients with impaired renal function when using therapeutic doses.
No development of drug dependence or withdrawal syndrome was observed during the use of this medicinal product.
Scientific publications report isolated cases of tolerance to phenibut.
Children.
The medicine can be used in children aged 8 years and over.
Overdose
There are no data on overdose. MAXIBREN® 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, MAXIBREN® 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 estimated 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 if the instructions for medical use of the drug are not followed).
If during treatment you experience side effects not listed in this manual, or if any of these side effects are particularly severe, you should consult a doctor immediately.
Reporting adverse reactions after registration of a medicinal product is of great importance. 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 a 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, Buchansky district, Vyshneve, Kyivska st., 6.
