Noofen capsules 250mg, No. 20

• asthenic and anxious-neurotic states;

• stuttering, tics and enuresis in children;

• insomnia and nocturnal anxiety in the elderly;

• Meniere's disease, dizziness associated with dysfunction of the vestibular analyzer of various origins;

• prevention of motion sickness in kinetosis;

• as part of complex therapy for alcohol withdrawal syndrome for the relief of psychopathological and somatovegetative disorders.

Inside after meals with water. The capsule must not be chewed.

Asthenic and anxiety-neurotic states: adults - 250-500 mg 3 times / day. The maximum single dose for adults is 750 mg, for patients over 60 years of age - 500 mg. If necessary, the daily dose is increased to 2.5 g. The course of treatment is 4-6 weeks.

Stuttering, tics and enuresis in children aged 8 to 14 years - 250 mg 2-3 times / day; in children over 14 years of age - doses for adults.

Insomnia and night anxiety in elderly patients - 250-500 mg 3 times / day.

To eliminate dizziness with dysfunction of the vestibular analyzer of infectious origin (otogenic labyrinthitis) and Meniere's disease: during an exacerbation, 750 mg is prescribed 3 times / day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg 3 times / day within 5-7 days, then - 250 mg 1 time / day for 5 days. With a relatively mild course of the disease - 250 mg 2 times / day for 5-7 days, then 250 mg 1 time / day for 7-10 days.

To eliminate dizziness with dysfunctions of the vestibular analyzer of vascular and traumatic genesis , 250 mg is prescribed 3 times / day for 12 days.

For the prevention of motion sickness in kinetosis: 250-500 mg once, 1 hour before the intended travel or when the first symptoms of motion sickness appear. The anti-pumping effect of Noofen increases with an increase in the dose of the drug. With the onset of severe manifestations of seasickness (including indomitable vomiting), oral administration of the drug is ineffective even at a dose of 750-1000 mg.

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

Do not take a double dose to replace a missed dose.

In patients with renal and / or hepatic insufficiency with prolonged use, it is necessary to monitor the indicators of renal and / or liver function.

In case of impaired liver function, high doses of the drug can cause hepatotoxicity. For such patients, the drug is prescribed in smaller doses.

Active ingredient: aminophenylbutyric acid hydrochloride - 250 mg

Excipients: lactose monohydrate - 180 mg, potato starch - 67.5 mg, calcium stearate - 2.5 mg.

The composition of capsules No. 0 is white: titanium dioxide (E171) - 2%, gelatin - up to 100%.

• acute renal failure;

• pregnancy;

• lactation period;

• children under 8 years of age (for this dosage form);

• rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption (since the drug contains lactose);

• hypersensitivity to the components of the drug.

The drug should be prescribed with caution to patients with erosive and ulcerative diseases of the gastrointestinal tract (due to the irritating effect of the drug, it is recommended to prescribe the drug in smaller doses).

Description:

Hard gelatin capsules, size No. 0, white; the contents of the capsules are white to white powder with a slightly creamy shade.

Composition:

Active ingredient: aminophenylbutyric acid hydrochloride - 250 mg

Excipients: lactose monohydrate - 180 mg, potato starch - 67.5 mg, calcium stearate - 2.5 mg.

The composition of capsules No. 0 is white: titanium dioxide (E171) - 2%, gelatin - up to 100%.

Clinical and pharmacological group: Nootropic drug with anxiolytic activity

Pharmaco-therapeutic group: Psychostimulants and nootropics

pharmachologic effect

Nootropic drug derived from gamma-aminobutyric acid and phenylethylamine. It has tranquilizing properties, stimulates memory and learning, increases physical performance, eliminates psycho-emotional tension, anxiety, fear and improves sleep. Does not affect choline and adrenergic receptors.

The drug lengthens the latency period and shortens the duration and severity of nystagmus. Significantly reduces the manifestations of asthenia and vaso-vegetative symptoms, incl. headache, a feeling of heaviness in the head, sleep disturbance, irritability, emotional lability, increases mental performance, improves well-being, increases interest and initiative, motivation for vigorous activity without sedation or excitement.

Unlike tranquilizers, under the influence of NoofenЃ, psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions) are improved. The formation of addiction and dependence to the drug, withdrawal syndrome was not noted.

Pharmacokinetics

Absorption and distribution

After oral administration, the drug is well absorbed and penetrates into all tissues of the body. About 0.1% of ?-amino - ? - phenylbutyric acid hydrochloride of the taken dose of the drug penetrates into the brain tissue; in patients at a young and old age, an increase in penetration through the BBB is possible. After 3 hours, ?-amino - ? - phenylbutyric acid hydrochloride is found in the urine, at the same time the concentration in the brain tissues does not decrease, it is found in the brain after another 6 hours.

With repeated use, the drug does not accumulate in the body.

The greatest binding of ?-amino - ?-phenylbutyric acid hydrochloride occurs in the liver (80%), it is not specific.

Metabolism and excretion

80-95% of the drug is metabolized in the liver to pharmacologically inactive metabolites. 5% is excreted from the body by the kidneys unchanged. The next day after taking the drug? -Amino -? - phenylbutyric acid hydrochloride can be detected only in urine; it is determined in urine 2 days after administration, however, the detectable amount is 5% of the administered dose.

Indications

• asthenic and anxious-neurotic states;

• stuttering, tics and enuresis in children;

• insomnia and nocturnal anxiety in the elderly;

• Meniere's disease, dizziness associated with dysfunction of the vestibular analyzer of various origins;

• prevention of motion sickness in kinetosis;

• as part of complex therapy for alcohol withdrawal syndrome for the relief of psychopathological and somatovegetative disorders.

Dosage regimen

Inside after meals with water. The capsule must not be chewed.

Asthenic and anxiety-neurotic states: adults - 250-500 mg 3 times / day. The maximum single dose for adults is 750 mg, for patients over 60 years of age - 500 mg. If necessary, the daily dose is increased to 2.5 g. The course of treatment is 4-6 weeks.

Stuttering, tics and enuresis in children aged 8 to 14 years - 250 mg 2-3 times / day; in children over 14 years of age - doses for adults.

Insomnia and night anxiety in elderly patients - 250-500 mg 3 times / day.

To eliminate dizziness with dysfunction of the vestibular analyzer of infectious origin (otogenic labyrinthitis) and Meniere's disease: during an exacerbation, 750 mg is prescribed 3 times / day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg 3 times / day within 5-7 days, then - 250 mg 1 time / day for 5 days. With a relatively mild course of the disease - 250 mg 2 times / day for 5-7 days, then 250 mg 1 time / day for 7-10 days.

To eliminate dizziness with dysfunctions of the vestibular analyzer of vascular and traumatic genesis , 250 mg is prescribed 3 times / day for 12 days.

For the prevention of motion sickness in kinetosis: 250-500 mg once, 1 hour before the intended travel or when the first symptoms of motion sickness appear. The anti-pumping effect of Noofen increases with an increase in the dose of the drug. With the onset of severe manifestations of seasickness (including indomitable vomiting), oral administration of the drug is ineffective even at a dose of 750-1000 mg.

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

Do not take a double dose to replace a missed dose.

In patients with renal and / or hepatic insufficiency with prolonged use, it is necessary to monitor the indicators of renal and / or liver function.

In case of impaired liver function, high doses of the drug can cause hepatotoxicity. For such patients, the drug is prescribed in smaller doses.

Side effect

NoofenЃ, like other medicines, can cause side effects, although not every patient gets them. NoofenЃ is generally well tolerated.

Classification of adverse reactions by frequency of development: very often (? 10%); often (? 1%, but <10%); infrequently (? 0.1%, but <1%); rarely (? 0.01%, but <0.1%); very rare (<0.01%); * - unknown (cannot be determined from the available data).

From the nervous system *: drowsiness and increased symptoms (at the beginning of treatment), dizziness, headache.

From the digestive system *: nausea (at the beginning of treatment).

Skin and subcutaneous tissue disorders: rarely - allergic reactions (skin rash, itching).

From the liver and biliary tract *: with prolonged use in high doses - hepatotoxicity.

Contraindications for use

• acute renal failure;

• pregnancy;

• lactation period;

• children under 8 years of age (for this dosage form);

• rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption (since the drug contains lactose);

• hypersensitivity to the components of the drug.

The drug should be prescribed with caution to patients with erosive and ulcerative diseases of the gastrointestinal tract (due to the irritating effect of the drug, it is recommended to prescribe the drug in smaller doses).

Application during pregnancy and lactation

Application during pregnancy and during breastfeeding is not recommended, because there are not enough clinical observations.

In experimental studies on animals, mutagenic, teratogenic and embryotoxic effects of the drug have not been established.

Application for impaired renal function

Contraindicated in acute renal failure.

Application in children

Contraindicated in children under 8 years of age.

special instructions

With prolonged use, it is necessary to control the cellular composition of the blood, indicators of liver function.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, patients need to be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, since some patients may experience central nervous system disorders, such as drowsiness and dizziness.

Overdose

NoofenЃ is low-toxic. Overdose cases have not been reported.

Symptoms: drowsiness, nausea, vomiting, dizziness. With prolonged use in high doses, eosinophilia, arterial hypotension, renal impairment, fatty degeneration of the liver (intake of more than 7 g) can develop.

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

Drug interactions

For the purpose of mutual potentiation, NoofenЃ can be combined with other nootropic drugs, reducing the dose of Noofen and combined drugs.

It lengthens and enhances the effect of hypnotics, antipsychotics and antiparkinsonian drugs.

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years.

Terms of sale

The drug is available with a prescription.