Noofen - instructions for use, dose, side effects, contraindications

active substance - aminophenylbutyric acid hydrochloride 250.0 mg; Excipients - lactose monohydrate 180.0 mg, potato starch 67.5 mg, calcium stearate 2.5 mg.

Capsule composition N 0 white: titanium dioxide E 171 2%, gelatin up to 100%.

Description:

hard gelatin capsules No. 0 in white, containing powder from white to white with a slightly creamy shade of color.

Pharmacotherapeutic group:nootropic remedy

ATX: & nbsp

N.06.B Psychostimulants and nootropic drugs

Pharmacodynamics:

The active substance of Noophen® aminophenylbutyric acid hydrochloride is a derivative of y-aminobutyric acid and phenylethylamine.Possesses tranquilizing properties, stimulates memory and learning ability, increases physical ability to work, eliminates psychoemotional tension, anxiety, fear and improves sleep. Does not affect cholino- and adrenergic receptors. The drug lengthens 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 disturbance, irritability, emotional lability, improves mental performance, improves well-being, increases interest and initiative, motivation for active activity without sedation or stimulation.

Unlike tranquilizers under the influence of Noofen®, psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions) are improved. No formation of addiction and dependence on the drug, withdrawal syndrome was noted.

Pharmacokinetics:

After ingestion, the drug is well absorbed and penetrates into all tissues of the body. About 0.1% of y-amino-β-phenylbutyric acid hydrochloride permeates the brain tissue from the accepted dose of the drug; in patients at young and old age, it is possible to increase penetration through the blood-brain barrier.After 3 hours of y-amino-β-phenylbutyric acid, the 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 6 hours. 80 - 95 of the drug is metabolized in the liver to pharmacologically inactive metabolites. 5% of the drug is excreted from the body by the kidneys unchanged. The next day after taking y-amino-β-phenylbutyric acid, the hydrochloride can be detected only in the urine; it is detected in the urine after 2 days after administration, but the detectable amount is 5% of the administered dose. The greatest binding of y-amino-β-phenylbutyric acid hydrochloride occurs in the liver (80 ^%), it is not specific. With repeated use of the drug does not accumulate in the body.

Indications:

- asthenic and anxiety-neurotic states;

- stuttering, tics and enuresis in children;

- insomnia and nightly anxiety in the elderly;

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

- prevention of motion sickness with kinetosis;

- as part of complex therapy for alcohol withdrawal syndrome for the relief of psychopathological and somatovegetativedisorders.

Contraindications:

Hypersensitivity to the active substance of the drug or excipients of the drug. Acute kidney failure. Pregnancy, lactation. Children up to 8 years of age (for this dosage form).

The preparation contains lactose. Do not use in patients with a rare congenital intolerance to galactose, a deficiency of lactase, or glucose-galactose malabsorption.

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

Pregnancy and lactation:

Use during pregnancy and during lactation is not recommended, as there is not enough clinical observation.

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

Dosing and Administration:

Inside after eating, squeezed with water. Capsule can not be chewed.

Asthenic and anxious - neurotic states:

Adults: 250-500 mg 3 times a day. Higher single doses: for adults - 750 mg, for patients over 60 years - 500 mg.If necessary, the daily dose is increased to 2.5 g (2500 mg). The course of treatment is 4-6 weeks.

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

Insomnia and night alarm the elderly: 250-500 mg 3 times a day.

To eliminate dizziness in the dysfunction of the vestibular analyzer of infectious genesis (otogenous labyrinthite) and Meniere's disease:

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 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.

To eliminate dizziness in dysfunctions of the vestibular analyzer of vascular and traumatic origin prescribe 250 mg 3 times a day for 12 days.

For prevention of motion sickness with kinetosis: 250-500 mg once for one hour before the proposed journey or when the first symptoms of motion sickness appear. The anti-soothing action of Noophen® is enhanced by increasing the dose of the drug.At the onset of severe manifestations of seasickness ("indomitable" vomiting and others), taking the drug orally is ineffective, even at a dose of 750-1000 mg.

As part of complex therapy for alcohol withdrawal syndrome for the treatment of psychopathological and somatovegetative disorders: in the first days of treatment: appoint 250-500 mg three times a day and 750 mg at night with a gradual decrease in the daily dose to normal for adults.

Never take a double dose to replace a missed dose.

Patients with renal and / or liver failure with prolonged use should monitor the performance of kidney and / or liver.

If liver function is impaired, high doses of the drug may cause hepatotoxicity. Patients are assigned less effective doses.

Side effects:

Noophen®, like other medicines, can cause side effects, which are not apparent in all patients. Noophen® is usually 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%), * - not known (can not be determined from available data).

Disturbances from the nervous system *: drowsiness and increased symptoms (at the beginning of treatment), dizziness, headache;

Disturbances from the gastrointestinal tract *: 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*; with prolonged use of high doses - hepatotoxicity.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Noofen® is low-toxic. Data on cases of overdose have not been reported.

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

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

Interaction:

In order to mutually potentiate, Noophen® can be combined with other psychotropic medications, reducing the dose of Noophen® and the combined medicines.

Extends and intensifies the effect of hypnotic, neuroleptic and antiparkinsonian drugs.

Special instructions:

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

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring both increased concentration and speed of psychomotor reactions, since the Some patients may experience disorders of the central nervous system, such as drowsiness and dizziness.

Form release / dosage:

Capsules of 250 mg.

Packaging:

10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil.

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

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001983

Date of registration:25.01.2013

The owner of the registration certificate:Olainfarm, AOOlainfarm, AO Latvia

Manufacturer: & nbsp

OLAINFARM, AS Latvia

Representation: & nbspOLAINFARM JSC OLAINFARM JSC Latvia

Information update date: & nbsp25.01.2013

Illustrated instructions

Instructions

Noofen® (Noophen®)