Instruction for use: Anvifen

Dosage form: capsules

Active substance: Aminophenylbutyric acid

ATX

N05BX Other anxiolytics

Pharmacological groups:

Nootropic remedy [Nootropics]

Nootropic means [Anxiolytics]

The nosological classification (ICD-10)

F06.6 Organic emotionally labile [asthenic] disorder: Somatogenic depression; Somatogenic psychosis

F10.3 Abstinence: Alcohol withdrawal syndrome; Abstinence syndrome; Abstinence syndrome with alcoholism; Abstinence; Alcohol abstinence; Alcohol withdrawal status; Alcohol withdrawal syndrome; Postabstinctive disorder; Post-abstinence condition; Hangover syndrome; Abstinence syndrome; Alcohol abstinence syndrome; Alcohol withdrawal syndrome; Abstinence condition

F41.9 Anxiety disorder, unspecified: Neurotic disorders with anxiety syndrome; Severe anxiety; Neuro-like symptomatology; Neuro-like disorders; Neuro-like conditions; Neuroses with anxiety symptoms; Neuroses with a sense of anxiety; Acute situational and stress anxiety; Acute attack of anxiety; Severe Anxiety; Situational Anxiety Disorder; State of anxiety; Anxious and delusional component; Alarming state; Anxiety; Anxiety Disorders; Anxiety syndrome; Sense of anxiety; Alarm conditions; Chronic neurotic anxiety; Susto; Psychopathy with a predominance of anxiety and anxiety; Anxiety disorders in neurotic and neurosis-like states; Anxious neuroses; Anxious and delusional state; Acute situational stress alarm; Depressed mood with elements of anxiety

F48.9 Neurotic disorder, unspecified: Neurosis; Secondary neurotic symptom; Other neurotic conditions; Neurosis with increased irritability; Neuroses; Neuroses of all kinds; Neuroses with retardation; Neuroses of the heart; Neurotic disorders in alcoholism; Neurotic disorders with retardation; Neurotic disorders with anxiety syndrome; Neurotic reactions; Neurotic symptoms with alcoholism; Neurotic states; Neurotic syndrome; Neurotic disorder; Attack of neurological dysfunction; School neurosis; Emotional Stress

F95.9 Unspecified tics: Generalized tics; Coprolalia

F98.0 Enuresis of inorganic nature: Urinary incontinence; Incontinence of non-hormonal etiology; Incontinence of inorganic etiology; Functional enuresis in children; Children's enuresis

F98.5 Stammering [Stammering]: Stammering and other speech defects in children; Logoneurosis; The clonic form of stuttering; Stuttering

G47 Sleep disorders

H81.0 Meniere's disease: Meniere's syndrome/ disease; Meniere's disease; Meniere's syndrome; Labyrinth dropsy; endolymphatic hydrops

H81.4 Vertigo of central origin: Vertigo labyrinthine origin; vestibular vertigo; Vertigo of vascular origin

H81.9 Unspecified Violation of vestibular function: Labyrinth, vestibular disorders; Labyrinth disorders; vestibular nystagmus; kohleovestibulyarny disorder; Kohleovestibulyarny syndrome vascular origin; Violation of the microcirculation in the maze; Ischemic disorders of hearing and balance

T75.3 Motion Slewing: Movement Disease; Disease of the air; Disease of the sea; Kinetosis; Airsickness; Seasickness; Swaying; Symptoms of motion sickness; Kinetosis; The motion sickness syndrome

Composition

Capsules - 1 caps.

active substance: Aminophenylbutyric acid hydrochloride 25 mg; 50 mg; 125 mg; 250 mg

Auxiliary substances: giprolose - 1,3 / 1,3 / 1,7 / 2 mg; Silicon dioxide colloid - 3,2 / 3,2 / 4/8 mg; Lactose - 109.1 / 84.1 / 42.5 / 86.5 mg; Magnesium stearate 1.4 / 1.4 / 1.8 / 3.5 mg

Hard gelatin capsule: for dosage of 25 mg - water, gelatin, titanium dioxide (E171); For dosage of 50 mg - water, gelatin, dye azorubin (E122), dye diamond blue (E133), dye quinoline yellow (E104), titanium dioxide (E171); For the dosage of 125 mg - water, gelatin, dye azorubin (E122), dye diamond blue (E133), titanium dioxide (E171); For dosage of 250 mg - water, gelatin, dye azorubin (E122), dye diamond blue (E133), titanium dioxide (E171)

Description of dosage form

Capsules, 25 mg: hard gelatin, size 3, white.

Capsules, 50 mg: hard gelatin, size 3, body white, lid blue.

Capsules, 125 mg: hard gelatin, size 2, body white, lid blue.

Capsules, 250 mg: hard gelatinous, size No. 0, body white, cover dark blue.

Contents of capsules: a mixture of powder and / or granules of white or white with a yellowish hue.

Pharmachologic effect

Mode of action - antioxidant, anticonvulsant, nootropic, tranquilizing, antiaggregant.

Pharmacodynamics

Nootropic agent, facilitates GABA-mediated transmission of nerve impulses to the central nervous system (direct effect on GABAergic receptors). The tranquilizing effect is combined with the activating effect. It also has antiplatelet, antioxidant and some anticonvulsant action.

Improves the functional state of the brain due to the normalization of its metabolism and influence on the cerebral blood flow (increases volumetric and linear speed, reduces vascular resistance, improves microcirculation, has antiaggregant effect). It prolongs the latent period and shortens the duration and severity of nystagmus.

Does not affect cholino- and adrenergic receptors. Reduces vasovegetative symptoms (including headache, sensation of heaviness in the head, sleep disturbance, irritability, emotional lability). At the course reception increases physical and mental efficiency (attention, memory, speed and accuracy of sensory-motor reactions).

Reduces the manifestations of asthenia (improves well-being, increases interest and initiative - motivation of activity) without sedation or arousal.

Helps reduce feelings of anxiety, tension and anxiety, normalizes sleep.

People of advanced age do not cause CNS depression, muscular-relaxing aftereffect is most often absent.

Pharmacokinetics

Absorption is high, it penetrates well into all tissues of the body and through the BBB (about 0.1% of the administered dose of the drug 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 pharmacologically inactive. Does not cumulate. After 3 hours begins to be excreted by the kidneys, while the concentration in the brain tissue does not decrease and is detected for another 6 hours. About 5% is excreted by the kidneys unchanged, in part - with bile.

Indications for the drug Anvifen

Asthenic and anxiety-neurotic states;

Stuttering, tics and enuresis in children;

Insomnia and nightly anxiety in the elderly;

Meniere's disease, dizziness associated with dysfunctions of the vestibular analyzer of various genesis;

Prevention of motion sickness with kinetosis;

In the complex therapy of alcohol withdrawal syndrome for the relief of psychopathological and somatovegetative disorders.

Contraindications

Hypersensitivity;

pregnancy;

The period of breastfeeding;

Age up to 3 years.

With caution: erosive and ulcerative lesions of the gastrointestinal tract; liver failure.

Side effects

Drowsiness, nausea. Enhancement of irritability, agitation, anxiety, dizziness, headache (at the first receptions), allergic reactions.

Interaction

Extends and enhances the effect of hypnotics, narcotic analgesics, neuroleptics, antiparkinsonian and antiepileptic drugs.

Dosing and Administration

Inside, after eating, 2-3-week courses.

Adults and children from 14 years - 250-500 mg 3 times a day (maximum daily dose - 2500 mg). Children 3-8 years - 50-100 mg 3 times a day; 8 - 14 years - 250 mg 3 times a day.

A single maximum dose in adults and children from the age of 14 is 750 mg, in people over 60 years - 500 mg, for children under 8 years - 150 mg, from 8 to 14 years - 250 mg.

Alcohol withdrawal: 250-500 mg 3 times a day and 750 mg at night, with a gradual decrease in the daily dose to normal for adults.

Treatment of dizziness with dysfunction of the vestibular apparatus and Meniere's disease: 250 mg 3 times a day for 14 days.

Prevention of motion sickness: 250-500 mg once, 1 hour before the expected start of the pitching or when the first symptoms of seasickness appear.

Anti-sweating action of the drug Anvifen® is enhanced by increasing the dose of the drug. At the onset of severe manifestations of seasickness (vomiting, etc.), the administration of the drug Anvifen® is ineffective even in doses of 750-1000 mg.

Overdose

Symptoms: severe drowsiness, nausea, vomiting, fatty degeneration of the liver (taking more than 7 g), eosinophilia, lowering blood pressure, impaired renal function.

Treatment: gastric lavage, the appointment of activated charcoal and symptomatic therapy.

Special instructions

With prolonged use, it is necessary to periodically monitor the performance of the liver and peripheral blood.

Influence on the ability to drive vehicles and work with machinery. It is necessary to refrain from potentially dangerous activities that require increased concentration.

Release form

Capsules, 25 mg, 50 mg, 125 mg, 250 mg. In the contour blister packing 10 pcs. 1, 2, 3 or 5 contour mesh packages in a pack of cardboard.

Manufacturer

ZAO Pharmproject. 

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Anvifen

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

The shelf life of the drug Anvifen

3 years.

Do not use beyond the expiration date printed on the package.