Noofrofen-farkos

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOOTROFEN-FARKOS (NOOTROFEN-FARKOS)

Composition:

Active substance: phenibut;

1 tablet contains 250 mg of phenibut;

Excipients: lactose monohydrate; potato starch; calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round, biconvex tablets, white to off-white in colour, with a score line on one side.

Pharmacotherapeutic group.

Other psychostimulants and nootropic agents. ATC code N06BX22.

Pharmacological properties.

Pharmacodynamics.

NOOTROPHEN-PHARCOS is a derivative of γ-aminobutyric acid (GABA) and phenylethylamine. Its predominant action is anti-hypoxic and anti-amnestic. NOOTROPHEN-PHARCOS improves memory and attention, facilitates learning processes, and increases physical and mental performance. Psychological parameters (attention, memory, speed and accuracy of sensorimotor reactions) improve under the influence of NOOTROPHEN-PHARCOS. It has been established that NOOTROPHEN-PHARCOS enhances the neuron's energy potential by improving mitochondrial function.

NOOTROPHEN-PHARCOS also possesses tranquilizing properties: it relieves psychoemotional tension, anxiety, fear, emotional lability, irritability, improves sleep, and prolongs and enhances the effects of hypnotics, narcotics, neuroleptics, and anticonvulsants. NOOTROPHEN-PHARCOS binds exclusively to GABA-ß receptors in the brain, thus exerting a moderate calming effect without causing undesirable sedative effects such as drowsiness, dizziness, reduced attention, or impaired performance. The drug prolongs the latent period and reduces the duration and intensity of nystagmus, and exhibits antiepileptic activity. It does not affect cholinergic or adrenergic receptors.

NOOTROPHEN-PHARCOS significantly reduces manifestations of asthenia and vasovegetative symptoms, including headache and a sensation of heaviness in the head. In patients with asthenia and emotionally labile individuals, NOOTROPHEN-PHARCOS improves general well-being without causing excitation.

Pharmacokinetics.

Absorption and distribution

The drug is well absorbed after oral administration and readily penetrates all tissues of the body, crossing the blood-brain barrier effectively (approximately 0.1% of the administered dose penetrates into brain tissue, and to a significantly greater extent in both young and elderly individuals). The highest binding of phenibut occurs in the liver (80%), and this binding is nonspecific.

Biotransformation and excretion

80−95% of phenibut is metabolized in the liver; the metabolites are pharmacologically inactive.

Distribution in the liver and kidneys is close to uniform, while in the brain and blood it is lower than uniform. A significant amount of administered phenibut is detectable in urine within 3 hours; simultaneously, the concentration of the drug in brain tissue does not decrease—phenibut remains detectable in the brain for up to 6 hours. The following day, phenibut can only be detected in urine; it remains detectable in urine for up to 2 days after administration, although the amount detected constitutes only 5% of the administered dose. With repeated administration, no accumulation is observed.

Clinical characteristics.

Indications.

Asthenic and anxiety-neurotic states: restlessness, fear, anxiety.

Insomnia, nocturnal restlessness in elderly individuals.

Prevention of stress conditions prior to surgeries or painful diagnostic procedures.

Menière's disease, dizziness associated with vestibular analyzer dysfunction of various origins.

Prevention of kinetosis (a specific condition characterized by nausea, vomiting, prostration, and vestibular dysfunction caused by being in a moving object such as a ship or airplane).

Stuttering, tics in children aged 8 to 14 years.

As an adjunctive agent in the treatment of alcohol withdrawal syndrome.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Acute renal failure.

Pregnancy or breastfeeding period.

Interaction with other medicinal products and other forms of interaction.

NOOTROPHEN-PHARCOS can be combined with psychotropic medicinal products, reducing the doses of NOOTROPHEN-PHARCOS and the concomitantly administered medicinal products.

NOOTROPHEN-PHARCOS enhances and prolongs the effects of hypnotics, narcotics, neuroleptics, and antiparkinsonian medicinal products.

Special precautions for use.

The drug should be used with caution in patients with gastric or intestinal disorders. To protect the mucosa from the irritant effect of phenibut, such patients should be prescribed lower doses.

In case of prolonged treatment, blood and liver parameters should be monitored.

The drug contains lactose; therefore, it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Animal studies have not revealed mutagenic, teratogenic, or embryotoxic effects of phenibut. There are insufficient and well-controlled studies on the safety of phenibut use in pregnant women. Therefore, the use of NOOTROFEN-PHARCOS during pregnancy or breastfeeding is contraindicated.

Ability to influence reaction rate when driving or operating machinery.

Patients who experience drowsiness, dizziness, or other central nervous system disturbances during treatment with this drug should refrain from driving or operating machinery.

Dosage and Administration

NOOTROFEN-FARKOS is taken orally before meals with sufficient amount of water.

For asthenic and anxiety-neurotic conditions in adults: 250–500 mg (1–2 tablets) three times daily. Maximum single doses: for adults – 750 mg, for elderly patients – 500 mg.

The treatment course lasts 2–3 weeks. If necessary, the treatment course may be extended to 4–6 weeks.

Children aged 8 to 14 years: 250 mg (1 tablet) three times daily.

The treatment course lasts 2–6 weeks.

Meniere’s disease, dizziness associated with vestibular dysfunction of various origins.

In cases of infectious vestibular dysfunction and Meniere’s disease during exacerbation, NOOTROFEN-FARKOS should be administered at 750 mg (3 tablets) three times daily for 5–7 days; after reduction of vestibular symptoms – 250–500 mg (1–2 tablets) three times daily for 5–7 days, followed by 250 mg once daily for 5 days. In milder cases, NOOTROFEN-FARKOS should be administered at 250 mg (1 tablet) twice daily for 5–7 days, followed by 250 mg once daily for 7–10 days.

For relief of dizziness due to vestibular dysfunction of vascular and traumatic origin: NOOTROFEN-FARKOS should be administered at 250 mg three times daily for 12 days.

For prevention of motion sickness: the drug should be taken at a dose of 250–500 mg as a single dose one hour before the expected onset of motion or at the first symptoms of motion sickness.

For management of alcohol withdrawal syndrome: during the first days of treatment, NOOTROFEN-FARKOS should be administered at 250–500 mg three times daily and 750 mg at bedtime, with gradual reduction of the daily dose to the usual adult dose.

Patients with hepatic impairment

High doses of the drug may cause hepatotoxicity in patients with hepatic impairment. Lower doses should be prescribed for this patient group.

Patients with renal impairment

There are no data on adverse effects of NOOTROFEN-FARKOS in patients with impaired renal function when therapeutic doses are used.

No drug dependence or withdrawal syndrome has been observed during use of this medication.

Information on isolated cases of tolerance to phenibut is available in the literature.

Children

The drug can be used in children aged 8 years and older.

Overdose

NOOTROFEN-FARKOS is a low-toxicity drug: hepatotoxicity may occur only at daily doses of 7–14 g with prolonged use. Data on overdose are limited. These doses significantly exceed the recommended dose (average therapeutic dose is 500–2000 mg).

Symptoms: drowsiness, nausea, vomiting, dizziness. With prolonged use of high doses, arterial hypotension, acute renal failure, eosinophilia, and fatty liver degeneration may develop.

Treatment: gastric lavage. Symptomatic therapy. There is no specific antidote.

Adverse reactions.

NOOTROPHEN-PHARCOS, like other medicinal products, may cause adverse reactions, although they do not occur in all patients.

Classification of adverse reactions by frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data).

From the nervous system: frequency not known – drowsiness (at the beginning of treatment), headache and dizziness (at doses above 2 g per day; the intensity of this adverse effect decreases when the dose is reduced).

From the gastrointestinal tract: frequency not known – nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

From the liver and biliary system: frequency not known – hepatotoxicity (with prolonged use of high doses).

From the immune system: frequency not known – hypersensitivity reactions, including urticaria, erythema, rash, angioneurotic edema, facial swelling, tongue swelling.

From the skin and subcutaneous tissues: rare – allergic reactions (rash, pruritus).

Psychiatric disorders: frequency not known – emotional lability, sleep disturbances (these adverse reactions may occur in children if instructions for use are not followed).

If any adverse reactions occur during treatment that are not listed in this leaflet, or if any of the listed adverse reactions are particularly severe, it is necessary to consult a physician.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets in a blister pack, 2 blisters per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

LLC "Pharmaceutical Company "PharCoS".

Manufacturer's address and location of business activity.

360 Svyato-Pokrovska Street, Hostomel Settlement, Irpin, Kyiv Region, 08290, Ukraine.