Fenibut-LekT - instructions for use, dose, side effects, contraindications

Nootropic agent facilitates gamma-aminobutyric acid (GABA) mediated transmission of nerve impulses in the central nervous system (CNS) (direct effect on GABA receptors), also has a tranquilizing and psychostimulating effect. Improves the functional state of the brain due to the normalization of tissue metabolism and effects on cerebral circulation (increases the volume and linear speed of cerebral blood flow, reduces the tone of the vessels of the brain, improves microcirculation). Helps reduce or disappear feelings of anxiety, tension, anxiety and fear, normalizes sleep. Does not affect cholino- and adrenergic receptors. Extends the latent period and shortens the duration and severity of nystagmus. Reduces manifestations of asthenia and vaso-vegetative symptoms (in t.ch. headache, a feeling of heaviness in the head, sleep disorders, irritability, emotional lability). It improves psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions). With the course of admission increases physical and mental performance, improves the condition of patients with motor and speech disorders.In patients with asthenia, the state of health improves from the first days of therapy; increases interest and initiative (motivation of activity) without sedation or arousal.

People of advanced age do not cause central nervous system depression, muscle-relaxing aftereffect is most often absent. Reduces the inhibitory effect of ethanol on the central nervous system (CNS). Malotoxic.

Pharmacokinetics:

Absorption is high, it penetrates well into all tissues of the body and across the blood-brain barrier (BBB) (about 0.1% of the injected dose penetrates the brain tissue, and to a much greater extent in young and elderly people). Evenly distributed in the liver and kidneys. Metabolized in the liver - 80-95%, metabolites are not pharmacologically active. Do not cumulate. After 3 hours begins to be excreted by the kidneys, while the concentration in the brain tissue does not decrease, and it is found in the brain for another 6 hours. About 5% is excreted by the kidneys unchanged, in part - with bile.

Indications:

- Asthenic and anxiety-neurotic states, anxiety, fear, obsessive-compulsive disorder, psychopathy;

- stuttering and tics in children, enuresis;

- Insomnia and nightmares in the elderly;

- Meniere's disease, dizziness associated with dysfunctions of the vestibular analyzer of various genesis (including with otogenous labyrinthitis, vascular and traumatic disorders); prevention of motion sickness with kinetosis;

- as part of complex therapy in the treatment of alcohol withdrawal syndrome.

Contraindications:

Hypersensitivity to the active substance and excipients of the drug, acute renal failure, pregnancy, breastfeeding, children under 3 years.

Patients with rare hereditary diseases, such as intolerance lactose or glucose-galactose malabsorption should not take the drug (in the presence of lactose in the composition).

Carefully:Patients with erosive and ulcerative diseases of the gastrointestinal tract, because of the irritant effect of the drug, it is recommended to prescribe it in smaller doses.

Pregnancy and lactation:It is not recommended to use during pregnancy, during lactation.

Dosing and Administration:

Take inside after eating, squeezed with water.

Tablets can be divided into two parts. Dosage of half a tablet is 125 mg. Asthenic and anxiety-neurotic states:

Adults: 250-500 mg 3 times a day.The maximum single dose is 750 mg, for patients older than 60 years, 500 mg. The course of treatment is 2-3 weeks. If necessary, the course of treatment can be extended to 4-6 weeks. Children: from 3 to 8 years - 125 mg to 3 times a day; from 8 to 14 years - 250 mg 3 times a day; children over 14 years of age - doses for adults.

Stammering, tics and enuresis in children: from 3 to 8 years - 125 mg to 3 times a day; from 8 to 14 years - 250 mg 3 times a day; children over 14 years of age - doses for adults.

Insomnia and nightly anxiety in the elderly: 250-500 mg 3 times a day.

Ménière's disease, dizziness associated with dysfunction of the vestibular analyzer of various genesis: during an exacerbation appoint 750 mg 3 times a day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg 3 times a day for 5-7 days, then 250 mg once a day for for 5 days. With a relatively easy course of the disease - 250 mg 2 times a day for 5-7 days, then 250 mg once a day for 7-10 days.

For treatment of dizziness with dysfunctions of the vestibular analyzer of vascular and traumatic genesis: prescribe 250 mg 3 times a day for 12 days.

Prevention of motion sickness with kinetosis: 250-500 mg once for 1 hour before the proposed journey or when the first symptoms of motion sickness appear.The anti-sweating action is enhanced by increasing the dose of the drug. The drug is ineffective in the manifestations of motion sickness ("indomitable" vomiting and others).

As part of complex therapy for alcohol withdrawal syndrome for the relief of psychopathological and somatovegetative disorders: at the beginning of treatment in the afternoon for 250-500 mg 3 times a day and at night 750 mg, with a gradual decrease in the daily dose to the usual for adults.

Side effects:

Aminophenylbutyric acid hydrochloride (phenybut), like other medicinal drugs, can cause side effects, which are not apparent in all patients. Usually aminophenylbutyric acid hydrochloride (phenybut) is well tolerated.

Classification of adverse reactions according to the frequency of development: very frequent (≥ 10%); frequent ≥ 1 but <10%); infrequent (≥ 0.1 but <1%); rare (≥ 0.01 but 0.1%); very rare (<0.01%), the frequency is unknown (can not be determined from available data).

Violations from the nervous system: frequency unknown - drowsiness and increased symptoms (at the beginning of treatment), dizziness, headache;

Disturbances from the gastrointestinal tract: frequency unknown - nausea (at the beginning of treatment);

Disturbances from the skin and subcutaneous tissues; rarely - allergic reactions (skin rash, itching);

Disturbances from the liver and bile ducts: the frequency is unknown - hepatotoxicity (with prolonged use of high doses).

If any of the undesirable reactions indicated in the instructions for use are aggravated, or if you notice other undesirable reactions not listed in the instructions, inform your doctor.

Overdose:

Symptoms: drowsiness, nausea, vomiting, lower blood pressure, impaired renal function.

With prolonged use, it is possible to develop a hepatotoxic effect, including the development of fatty liver dystrophy (taking more than 7 g), eosinophilia.

Treatment: gastric lavage, symptomatic therapy, maintenance of vital functions. There is no specific antidote.

In case of overdose, seek medical help immediately.

Interaction:

For the purposes of mutual potentiation, aminophenylbutyric acid hydrochloride (phenybut) can be combined with other psychotropic drugs, reducing the dose of aminophenylbutyric acid hydrochloride (phenibut) and the combined drugs.

Extends and enhances the effect of sleeping pills, narcotic analgesics, anticonvulsant, neuroleptic and antiparkinsonian drugs.

Special instructions:

With prolonged use (more than 2-3 weeks), it is necessary to monitor the liver function and the blood picture. It is not effective at the expressed phenomena of motion sickness (including indomitable vomiting, dizziness).

Effect on the ability to drive transp. cf. and fur:

During the treatment period it is necessary to refrain from potentially dangerous activities requiring increased attention and high speed of psychomotor reactions.

Form release / dosage:Tablets 250 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3, 5 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004511

Date of registration:27.10.2017

Expiration Date:27.10.2022

The owner of the registration certificate:PATENT-FARM, CJSC PATENT-FARM, CJSC Russia

Manufacturer: & nbsp

Tyumen Chemical - Pharmaceutical Plant, OJSC Russia

Information update date: & nbsp04.12.2017

Illustrated instructions

Instructions

Fenibut-LekT (Phenybut-LekT)