Noophen, capsules 250mg, 20pcs

Composition

Active ingredient:

aminophenylbutyric acid hydrochloride 250 mg

Auxiliary substances:

lactose monohydrate-180 mg,

potato starch-67.5 mg,

calcium stearate-2.5 mg.

Composition of capsules No. 0 white color:

titanium dioxide (E 171) – 2%, gelatin – up to 100%.

Pharmacological action

Noophen is a nootropic drug, a derivative of gamma-aminobutyric acid and phenylethylamine. It has tranquilizing properties, stimulates memory and learning ability, increases physical ability to work, eliminates psychoemotional tension, anxiety, fear, and improves sleep. It does not affect the choline and adrenergic receptors.

The drug prolongs the latent period and shortens the duration and severity of nystagmus. Significantly reduces the manifestations of asthenia and vasovegetative symptoms, including headache, a feeling of heaviness in the head, sleep disorders, irritability, emotional lability, increases mental performance, improves well-being, increases interest and initiative, motivation to active activities without sedation or excitement.

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

Pharmacokinetics

Suction and distribution

After oral use, the drug is well absorbed and penetrates into all body tissues. About 0.1% of gamma-amino-beta-phenylbutyric acid hydrochloride from the taken dose of the drug penetrates into the brain tissue; in young and elderly patients, it is possible to increase penetration through the BBB. After 3 hours, γ-amino-β-phenylbutyric acid hydrochloride is detected in the urine, at the same time, the concentration in brain tissues does not decrease, it is detected in the brain after another 6 hours.

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

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

Metabolism and elimination

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

Indications

• asthenic and anxiety-neurotic states;
• stuttering, tics and enuresis in children;
• insomnia and nighttime anxiety in the elderly;
• Meniere’s disease, dizziness associated with vestibular analyzer dysfunction of various origins;
• prevention of motion sickness in kinetoses;
• as part of complex therapy for alcohol withdrawal syndrome to stop psychopathological and somatovegetative disorders.

Use during pregnancy and lactation

Use during pregnancy and lactation is not recommended, because there are not enough clinical observations.

No mutagenic, teratogenic, or embryotoxic effects of the drug have been established in experimental animal studies.

Contraindications

• 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 (because the drug contains lactose);
• hypersensitivity to the components of the drug.

With caution, the drug should be prescribed 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).

Side effects

Nervous system disorders:  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).

Liver and biliary tract disorders:  with prolonged use in high doses – hepatotoxicity.

If any of these side effects get worse, or if the patient has noticed any other side effects, you should inform your doctor.

Interaction

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

Prolongs and enhances the effect of sleeping pills, antipsychotic and antiparkinsonian drugs.

How to take, course of use and dosage

Inside after a meal, washed down with water. The capsule should not be chewed.

Asthenic and anxiety-neurotic states:  adults – 250-500 mg 3 times a 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 a day; in children over 14 years-adult doses.

Insomnia and nighttime anxiety in elderly patients-250-500 mg 3 times a day.

To eliminate dizziness in patients with dysfunction of the vestibular analyzer of infectious origin (otogenic labyrinthitis) and Meniere’s disease:  in the period of exacerbation,750 mg is prescribed 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 1 time a day for 5 days. With a relatively mild course of diseases – 250 mg 2 times a day for 5-7 days, then 250 mg 1 time a 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 a day for 12 days.

For the prevention of motion sickness in kinetosis: 250-500 mg once 1 hour before the intended trip or when the first symptoms of motion sickness appear. The anti-motion sickness effect of Noophen is enhanced by increasing the dose of the drug. With the onset of severe manifestations of seasickness (including “indomitable” vomiting), taking the drug orally is ineffective even at a dose of 750-1000 mg.

As part of complex therapy for alcohol withdrawal syndrome to stop psychopathological and somatovegetative disorders in the first days of treatment,250-500 mg is 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.

If liver function is impaired, high doses of the drug can cause hepatotoxicity. Such patients are prescribed the drug in smaller doses.

Overdose

Noophen® is low-toxic. No overdose cases were reported.

Symptoms:  drowsiness, nausea, vomiting, dizziness. With prolonged use of high doses, eosinophilia, arterial hypotension, impaired renal activity, and fatty liver dystrophy may develop (taking more than 7 g).

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

Special instructions

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

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment, patients should be careful when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions, since some patients may experience CNS disorders, such as drowsiness and dizziness.

Form of production

Capsules

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Aminophenylbutyric acid

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 8 years of age

Indications

Meniere’s Disease, Enuresis, Insomnia, Asthenia, Seasickness, Neurosis